Compilation Of International Human Subject Protections
International Compilation of Human Research Protections
2010 Edition
Compiled By:
Office for Human Research Protections
U.S. Department of Health and Human Services
FINAL VERSION
PURPOSE
This Compilation lists the approximately 1,100 laws, regulations, and guidelines that govern human subjects research in 96 countries, as well as standards from a number of
international and regional organizations. This Compilation was developed for IRBs/Research Ethics Committees, researchers, sponsors, and others who are involved in
international research. Its purpose is to help these groups familiarize themselves with the laws, regulations, and guidelines where the research will be conducted, to assure these
standards are followed appropriately.
The 2010 Edition includes numerous additions and updates to the 2009 Edition, and features the laws, regulations, and/or guidelines for five new countries: Dominica, Guatemala,
Honduras, Kyrgyzstan, and Qatar. Srpska is one of the two political-territorial divisions of Bosnia and Herzegovina, and is now listed under that country.
ORGANIZATION
The Table of Contents is found on page 3. Under each country, the rows categorize the standards as:
1. General, i.e., applicable to most or all types of human subjects research
2. Drugs
3. Privacy/Data Protection (Note: Further information can be found at the website of Privacy Laws and Business: http://www.privacylaws.com/)
4. Human Biological Materials
5. Genetic (Note: Further information can be found in the HumGen International database at http://www.humgen.umontreal.ca/int/)
6. Embryos, Stem Cells, and Cloning
These six categories often overlap, so it may be necessary to review all standards to obtain a full understanding of the country’s requirements.
The information is then organized into four columns:
1. Key Organizations – include those groups that issue regulations or guidelines, or serve in a national oversight role for human subjects research.
2. Legislation – includes statutes, statutory instruments, and legislative decrees, as well as constitutional provisions that relate to human subject protections.
3. Regulations – refer to instruments that are created and issued under the name of governmental administrative bodies.
1
4. Guidelines – pertain to non-binding instruments.
The year of the document’s initial approval or most recent modification is indicated in parenthesis (when that information is available), unless the date is part of the document’s
actual title. For example, Law 46/2006 indicates the law was enacted in 2006. Note that there may be other applicable laws that are not necessarily labeled as pertaining to
research.
HOW TO ACCESS A DESIRED DOCUMENT
Documents can be accessed in five ways:
1. Link to the web address (URL) when provided.
2. Perform an Internet search on the document title.
3. Go to the website of the agency listed in the Key Organizations column and look for the sub-page labeled “guidance,” “regulations,” or similar terms.
4. Go to the website of the corresponding agency and e-mail a request for the document.
5. Request the local research ethics committee to provide the document.
In most cases the documents are available in English. Sometimes the English translation is a non-official version. When the link is to a non-English language website or document,
the language is indicated in parenthesis, e.g., (Spanish).
TOPICS NOT COVERED
In order to focus its scope, the Compilation does not include standards from the state or local levels. Nor does the Compilation cover:
1. Laws, regulations, or guidelines specific to clinical bioethics, medical devices, adverse event reporting, insurance requirements, product liability, clinical trial inspection
procedures, intellectual property, or informed consent in clinical practice.
2. Enabling legislation, i.e., laws that authorize an agency to promulgate human subjects regulations, but do not direct the content of those regulations.
3. Ethics codes of academic, medical, or other professional organizations.
4. Working papers, drafts, commentaries, or discussion papers.
Updates and Broken Links
Updates and broken links should be reported to the attention of Edward E. Bartlett, PhD, Office for Human Research Protections, International Activities Program, at:
edward.bartlett@hhs.gov.
Disclaimer
Although this Compilation contains information of a legal nature, it has been developed for informational purposes only and does not constitute legal advice or opinions as to the
current operative laws, regulations, or guidelines of any jurisdiction. In addition, because new standards are issued on a continuing basis, this Compilation is not an exhaustive
source of all current applicable laws, regulations, and guidelines relating to human subject protections. While reasonable efforts have been made to assure the accuracy and
completeness of the information provided, researchers and other individuals should check with local authorities and/or research ethics committees before starting research
activities.
2
INTERNATIONAL 4
Portugal 65
Qatar 109
NORTH AMERICA
7
Romania 67
Singapore 109
Canada
7
Russia 68
Taiwan 111
10
United States
San Ma
69
rino
Tajikistan 113
EUROPE 17
Serbia 70
Thailand 114
European-wide 17
Slovak Republi 70
c
Vietnam 114
Confederation of Independent States 20
Slovenia 71
LATIN AMERICA and the CARIBBEAN 115
Armenia 21
Spain 73
Pan American Health Orga
11
nization
5
Austria 21
Sweden 76
Argentina 115
Belgium 23
Switzerland 77
Bolivia 116
Bosnia and Herzegovin 26
a
Turkey 79
Brazil 117
Bulgaria 27
Ukraine 81
Chile 119
Croatia 28
United Kingdom 84
Colombia 120
Cyprus 29
England 84
Co
12
sta Rica
1
30
Czech Republic
Northern Irel
88
and:
Dominica 122
Denmark 31
Scotland: 88
Guatemala 122
Estonia 33
Wales: 88
Honduras 122
Finland 34
ASIA/PACIFIC/MIDDLE EA
89
ST
Jamaica 122
France 36
Australia 89
Mexico 123
Georgia 38
Bangladesh 90
Panama 124
Germany 39
Burma (Myanmar) 91
Peru 124
Greece 44
China, People’s Republic 91
of
Uruguay 125
Hungary 45
Hong K
93
ong
Venezuela 125
Iceland 47
India 93
AFRICA 126
Ireland 49
Indonesia 94
Botswana 126
Italy 51
Iran 95
Egypt 126
Latvia 54
Israel 95
Ethiopia 127
Lithuania 55
Japan 97
Gambia 127
Luxembourg 57
Jordan 99
Kenya 127
Macedonia 58
Kazakhstan 100
Malawi 128
Malta 59
Korea, Sout 10
h
1
Nigeria 128
Moldova 59
Kuwait 102
South Afri 12
ca
9
Montenegro 60
Kyrgyzstan 102
Sudan 130
Netherlands 60
Nepal 103
Tanzania 131
Norway 62
10
New Zealand
4
Uganda 131
Poland 64
Philippines 108
Zimbabwe 132
3
INTERNATIONAL
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. International Committee of the Red ICRC:
WHO:
Cross (ICRC): www.icrc.org
1. Geneva Convention Relative
Operational Guidelines for Ethics
2. Office of the United Nations High
to the Treatment of Prisoners of
Committees that Review Biomedical
Commissioner for Human Rights
War, Articles 13 and 130
Research (2000):
(OHCHR):
(1950):
http://whqlibdoc.who.int/hq/2000/TDR_P
http://www.ohchr.org/english/
http://www.icrc.org/Web/Eng/si
RD_ETHICS_2000.1.pdf
teeng0.nsf/html/genevaconventi
3. World Health Organization
ons#a1
CIOMS:
(WHO): http://www.who.int/en/
2. Additional Protocol I
1. International Ethical Guidelines for
4. Council for International
Relating to the Protection of
Biomedical Research Involving Human
Organizations of Medical Sciences
Victims of International Armed
Subjects (2002)
(CIOMS): http://www.cioms.ch/
Conflicts, Article 11 (1977):
2. International Guidelines for Ethical
5. United Nations Educational,
http://www.icrc.org/ihl.nsf/7c4d
Review of Epidemiological Studies (2009)
Scientific, and Cultural Organization, 08d9b287a42141256739003e63
Bioethics Program (UNESCO):
6b/f6c8b9fee14a77fdc125641e0
UNESCO:
http://portal.unesco.org/shs/en/ev.php
052b079
Universal Declaration on Bioethics and
-
OHCHR:
Human Rights (2005)
URL_ID=1372&URL_DO=DO_TOP
IC&URL_SECTION=201.html
International Covenant on Civil
UNAIDS:
and Political Rights, Articles 4
6. UNAIDS:
Ethical Considerations in Biomedical HIV
and 7 (1976)
http://www.unaids.org/en/default.asp
Prevention Trials (2007):
http://data.unaids.org/pub/Report/2007/JC
7. World Medical Association
1399_ethical_considerations_en.pdf
(WMA): http://www.wma.net/e/
WMA:
Declaration of Helsinki (2008)
4
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
1. International Conference on
ICH:
Harmonization (ICH):
http://www.ich.org/
E6 Good Clinical Practice: Consolidated
Guidance (1996):
2. World Health Organization
http://www.ich.org/cache/compo/475-272-
(WHO): http://www.who.int/en/
1.html#E6
WHO:
1. Handbook for Good Clinical Research
Practice (GCP): Guidance for
Implementation (2002):
http://whqlibdoc.who.int/publications/200
5/924159392X_eng.pdf
2. Operational Guidance: Information
Needed to Support Clinical Trials of
Herbal Products (2005)
Privacy/Data
World Medical Association:
Declaration on Ethical Considerations
Protection
http://www.wma.net/e/index.htm
Regarding Health Databases (2002):
http://www.wma.net/en/30publications/10
policies/d1/index.html
Human Biological
1. World Health Organization:
WHO:
Materials
http://www.who.int/en/
Guideline for Obtaining Informed Consent
2. International Air Transport
for the Procurement and Use of Human
Association (IATA):
Tissues, Cells, and Fluids in Research
http://www.iata.org/
(2003): http://www.who.int/reproductive-
health/hrp/tissue.pdf
3. International Society for Biological
and Environmental Repositories
IATA:
(ISBER): http://www.isber.org
Infectious Substances and Diagnostic
Specimens Shipping Guidelines (2005)
ISBER:
Best Practices for Repositories I:
Collection, Storage and Retrieval of
Human Biological Materials for Research
(2005)
5
Country Key
Organizations
Legislation
Regulations
Guidelines
Genetic Research
1. Human Genome Organization
HUGO:
(HUGO): http://www.hugo-
international.org/
1. Statement on the Principled Conduct of
Genetic Research (1996)
2. UNESCO Bioethics Program:
http://portal.unesco.org/shs/en/ev.php
2. Statement on DNA Sampling: Control
-
and Access (1998)
URL_ID=1372&URL_DO=DO_TOP
3. Statement on Gene Therapy Research
IC&URL_SECTION=201.html
(2001)
4. Statement on Human Genomic
Databases (2002)
UNESCO:
1. Universal Declaration on the Human
Genome and Human Rights (1997)
2. International Declaration on Human
Genetic Data (2003)
Embryos, Stem
International Society for Stem Cell
Guidelines for the Conduct of Human
Cells, and Cloning
Research: http://www.isscr.org/
Embryonic Stem Cell Research (2006):
http://www.isscr.org/guidelines/ISSCRhE
SCguidelines2006.pdf
6
NORTH AMERICA
Canada
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. National Defence
National
Defence:
Note: Several
2. Correctional Service of Canada
Research Involving Human Subjects
Canadian provinces
(1998):
and territories also
3. Interagency Advisory Panel on
have standards on
Research Ethics (PRE):
http://www.admfincs.forces.gc.ca/admfinc
human subjects
http://www.pre.ethics.gc.ca/eng/index
s/subjects/daod/5061/0_e.asp
research.
4. National Council on Ethics in
Correctional Service of Canada:
Human Research: http://www.ncehr-
Commissioner’s Directive - Research:
cnerh.org/english/home.php
DCOO9 (2004):
http://www.csc-
scc.gc.ca/text/plcy/cdshtm/009-
cde_e.shtml
PRE:
Tri-Council Policy Statement: Ethical
Conduct for Research Involving Humans
(2005):
http://www.pre.ethics.gc.ca/eng/policy-
politique/tcps-eptc/
Drugs
Health Canada, Therapeutic Products
1. Good Clinical Practice
Directorate: http://www.hc-
Consolidated Guideline (1997):
sc.gc.ca/ahc-asc/branch-dirgen/hpfb-
http://www.hc-sc.gc.ca/dhp-
dgpsa/tpd-dpt/index-eng.php
mps/prodpharma/applic-
demande/guide-ld/ich/efficac/e6-
eng.php
2. Regulations Amending the
Food and Drug Regulations (1024
– Clinical Trials) (2004):
http://www.hc-sc.gc.ca/dhp-
mps/compli-conform/clini-pract-
prat/reg/1024-eng.php
7
Country Key
Organizations
Legislation
Regulations
Guidelines
Privacy/Data
1. Office of the Privacy
1. Privacy Act, Sections 7-8
OPC:
PRE:
Protection
Commissioner of Canada (OPC):
(1983):
http://www.privcom.gc.ca/index_e.as
http://www.privcom.gc.ca/legisl
SOR/2001-6, SOR/2001-7, and
Tri-Council Policy Statement: Ethical
Note: Each of the
p
ation/02_07_01_e.asp
SOR/2001-8 (December 13,
Conduct for Research Involving Humans,
Canadian provinces
2000)
Section 3: Privacy and Confidentiality
and territories has
2. Interagency Advisory Panel on
2. Personal Information
(2005)
also enacted privacy
Research Ethics (PRE):
Protection and Electronic
legislation.
http://www.pre.ethics.gc.ca/eng/index Documents Act, Articles 5 and 7
CIHR:
(2001):
3. Canadian Institutes of Health
CIHR Best Practices for Protecting
http://www.privcom.gc.ca/legisl
Research (CIHR): http://www.cihr-
Privacy in Health Research (2005):
ation/02_06_01_e.asp
irsc.gc.ca/e/193.html
http://www.cihr-
irsc.gc.ca/e/documents/pbp_sept2005_e.p
df
Human Biological
Interagency Advisory Panel on
PRE:
Materials
Research Ethics (PRE):
http://www.pre.ethics.gc.ca/eng/index
Tri-Council Policy Statement: Ethical
Conduct for Research Involving Humans,
Section 10: Human Tissue (2005)
Genetic Research
1. Canadian Biotechnology Advisory
CBAC:
Committee (CBAC): http://cbac-
cccb.ca/epic/internet/incbac-
Genetic Research and Privacy (2004)
cccb.nsf/en/Home
PRE:
2. Interagency Advisory Panel on
Tri-Council Policy Statement: Ethical
Research Ethics (PRE):
Conduct for Research Involving Humans,
http://www.pre.ethics.gc.ca/eng/index
Section 8: Human Genetic Research
3. Biologics and Genetic Therapies
(2005)
Directorate:
http://www.hc-sc.gc.ca/ahc-
asc/branch-dirgen/hpfb-dgpsa/bgtd-
dpbtg/index-eng.php
8
Country Key
Organizations
Legislation
Regulations
Guidelines
Embryos, Stem
1. Interagency Advisory Panel on
Assisted Human Reproduction
Assisted Human Reproduction
PRE:
Cells, and Cloning
Research Ethics (PRE):
Act (2004): http://www.hc-
(Section 8 Consent) Regulations
http://www.pre.ethics.gc.ca/eng/index sc.gc.ca/hl-vs/reprod/hc-
(2007)
Tri-Council Policy Statement: Ethical
sc/legislation/index_e.html
Conduct for Research Involving Humans,
2. Canadian Institutes of Health
Section 9: Research Involving Human
Research (CIHR): http://www.cihr-
Gametes, Embryos, or Foetuses (2005)
irsc.gc.ca/e/193.html
CIHR:
Updated Guidelines for Human
Pluripotent Stem Cell Research (2007):
http://www.cihr-irsc.gc.ca/e/34460.html
9
United States
Note: All of the following departments and agencies subscribe to the Common Rule, which is subpart A (last updated in 2005) of the relevant section of the Code of Federal
Regulations. As indicated below, some departments and agencies subscribe to additional subparts:
Subpart B: Additional Protections for Pregnant Women, Human Fetuses, and Neonates (2001)
Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects (1978)
Subpart D: Additional Protections for Children Involved as Subjects in Research (1991)
Subpart E: Institutional Review Board Registration Requirements (2009)
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Agency for International
22 CFR 225, Subpart A
Protection of Human Subjects in Research
Development: www.usaid.gov/
Supported by USAID: A Mandatory
Reference for ADS Chapter 200 (2006):
http://www.usaid.gov/policy/ads/200/200
mbe.pdf
Central Intelligence Agency:
Executive Order 12333, Subparts
www.odci.gov/
A, B, C, and D
Consumer Product Safety
16 CFR 1028, Subpart A
Commission: www.cpsc.gov/
Department of Agriculture:
7 CFR 1c, Subpart A
www.usda.gov/wps/portal/usdahome/
Department of Commerce:
15 CFR 27, Subpart A
www.commerce.gov/
10
Country Key
Organizations
Legislation
Regulations
Guidelines
Department of Defense, Regulatory
United States Code Title 10,
1. 32 CFR 219, Subpart A
Affairs:
Section 980: Limitation on Use
www.dtic.mil/biosys/org/regulatory.h
of Humans as Experimental
2. DoD Directive 3216.02 (2002)
tml
Subjects
Army:
1. AR 70-25
2. AR 40-38
Navy:
SECNAVINST 3900.39 series
Air Force:
AFI 40-402 (2005)
Office of the Under Secretary of
Defense for Personnel and
Readiness:
USUHS Instruction 3201
Defense Threat Reduction
Agency:
1. DTRA Directive 3216.1
2. DTRA Instruction 3216.2
Department of Education:
1. Protection of Pupil Rights
1. 34 CFR 97 subparts A (1991)
www.ed.gov/
Amendment (1974)
and D (1997)
2. Family Educational Rights
2. 34 CFR 98 (1984)
and Privacy Act (1974)
3. 34 CFR 99 (2000)
4. 34 CFR 350.4(c) (1991)
5. 34 CFR 356.3(c) (1991)
Department of Energy:
1. 10 CFR 745 (1991), Subpart A
www.energy.gov/engine/content.do/
2. Order 1300.3
3. Order 481.1
Department of Health and Human
Public Health Service Act
45 CFR 46, Subparts A, B, C, D,
Various:
Services, Office for Human Research
(1993):
and E
http://www.hhs.gov/ohrp/policy/index.ht
Protections: www.hhs.gov/ohrp/
http://www.hhs.gov/ohrp/human
ml#topics
subjects/guidance/statute.htm
11
Country Key
Organizations
Legislation
Regulations
Guidelines
Department of Homeland Security:
Public Law 108-458, Section
www.dhs.gov/
8306
Department of Housing and Urban
24 CFR 60, Subpart A
Development: www.hud.gov/
Department of Justice:
1. 28 CFR 22 (1976)
www.usdoj.gov/
2. 28 CFR 46 (1991), Subpart A
3. 28 CFR 512 (1994)
Department of Transportation:
49 CFR 11, Subpart A
www.dot.gov/
Department of Veterans Affairs
1. 38 FR 16 (1991), Subpart A
1. Office of Research Oversight
2. 38 CFR 17.85 (1998)
(ORO): www1.va.gov/oro/
2. Office of Research and
Development: www.research.va.gov
12
Country Key
Organizations
Legislation
Regulations
Guidelines
Environmental Protection Agency,
40
CFR
26
Scientific and Ethical Approaches for
Program in Human Research Ethics:
Observational Exposure Studies (2008):
http://www.epa.gov/osa/phre/
1. Subpart A: Common Rule
http://www.epa.gov/nerl/sots/SEAOES_d
2. Subpart B: Prohibition of
oc20080707.pdf
Intentional Exposure Research
Conducted or Supported by EPA
in Children and Pregnant or
Nursing Women (2006)
3. Subpart C: Additional
Protections for Observational
Research Conducted or Supported
by EPA in Pregnant Women and
Fetuses (2006)
4. Subpart D: Additional
Protections for Observational
Research Conducted or Supported
by EPA in Children (2006)
5. Subpart K: Regulation of
Third-Party Intentional Exposure
Research for Pesticides in Non-
Pregnant, Non-Nursing Adults
(2006)
6. Subpart L: Prohibition of
Third-Party Intentional Exposure
Research for Pesticides in
Children and Pregnant or Nursing
Women (2006)
National Aeronautics and Space
14 CFR 1230, Subpart A
Administration: www.nasa.gov/
National Science Foundation:
45 CFR 690, Subpart A
www.nsf.gov/
13
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
Food and Drug Administration:
1. Food, Drug, and Cosmetic
1. 21 CFR 50 (1980)
1. Good Clinical Practice and Human
www.fda.gov
Act, 21 USC Sections 355 and
Subject Protections in FDA-Regulated
371 (Device coverage – Section
2. 21 CFR 312 (1987)
Clinical Trials:
360) (2004):
3. 21 CFR 56 (2001)
http://www.fda.gov/ScienceResearch/Spec
http://www.fda.gov/RegulatoryI
ialTopics/RunningClinicalTrials/default.ht
nformation/Legislation/FederalF
4. 21 CFR 812 (2007)
m
oodDrugandCosmeticActFDCA
ct/default.htm
2. Other:
http://www.fda.gov/ScienceResearch/Spec
2. Public Health Service Act, 42
ialTopics/RunningClinicalTrials/Guidance
USC Section 262 (1944):
sInformationSheetsandNotices/ucm11370
http://www.fda.gov/RegulatoryI
9.htm
nformation/Legislation/ucm148
717.htm
Privacy/Data
1. Department of Health and Human
1. Privacy Act, 5 U.S.C. § 552a
1. HIPAA Privacy Rule:
NIH:
Protection
Services, National Institutes of Health (1974):
Standards for Privacy of
(NIH):
http://www.usdoj.gov/oip/04_7_
Individually Identifiable Health
1. Protecting Personal Health Information
http://privacyruleandresearch.nih.gov
1.html
Information, Final Rule, 45 CFR
in Research: Understanding the HIPAA
/
parts 160 and 164 (2002):
Privacy Rule (2004)
2. Health Insurance Portability
2. Department of Health and Human
and Accountability Act (1996):
http://www.hhs.gov/ocr/hipaa/pri
http://privacyruleandresearch.nih.gov/pr_0
Services, Office for Civil Rights
http://www.hhs.gov/ocr/hipaa/pr
vrulepd.pdf
2.asp
(OCR):
ivrulepd.pdf
2. Research Repositories, Databases, and
http://www.hhs.gov/ocr/hipaa/
2. HIPAA Security Rule, 45 CFR
3. Confidential Information
parts 160, 162, and 164:
the HIPAA Privacy Rule (2004):
Protection and Statistical
http://www.hhs.gov/ocr/hipaa/
http://privacyruleandresearch.nih.gov/rese
Efficiency Act (2002):
arch_repositories.asp
http://www.whitehouse.gov/om
3. Institutional Review Boards and the
b/inforeg/cipsea/cipsea_statute.p
HIPAA Privacy Rule (2004):
df
http://privacyruleandresearch.nih.gov/irba
ndprivacyrule.asp
14
Country Key
Organizations
Legislation
Regulations
Guidelines
Human Biological
1. Department of Health and Human
OHRP:
Materials
Services, Office for Human Research
Protections (OHRP):
1. Issues to Consider in the Research Use
http://www.hhs.gov/ohrp/
of Stored Data or Tissues (1997)
2. Food and Drug Administration
2. Guidance on Research Involving Coded
Private Information or Biological
Office of In Vitro Diagnostic
Specimens (2008)
Device Evaluation and Safety:
FDA:
http://www.fda.gov/MedicalDevices/
Guidance on Informed Consent for In
ProductsandMedicalProcedures/InVit
Vitro Diagnostic Device Studies Using
roDiagnostics/default.htm
Leftover Human Specimens That are Not
Individually Identifiable (2006):
http://www.fda.gov/MedicalDevices/Devi
ceRegulationandGuidance/GuidanceDocu
ments/ucm078384.htm
Genetic Research
National Institutes of Health, Office
Research on Transplantation of
NIH Guidelines for Research Involving
of Biotechnology Activities:
Fetal Tissue, Public Law 103-43
Recombinant DNA Molecules, Appendix
http://www4.od.nih.gov/oba/
M (2009):
http://www4.od.nih.gov/oba/RAC/guideli
nes_02/NIH_Guidelines_Apr_02.htm
15
Country Key
Organizations
Legislation
Regulations
Guidelines
Embryos, Stem
1. Food and Drug Administration,
Research on Transplantation of
FDA:
Cells, and Cloning
Center for Biologics Evaluation and
Fetal Tissue. Public Law 103-43
Research:
Application of Current Statutory
http://www.fda.gov/BiologicsBloodV
Authorities to Human Somatic Cell
accines/default.htm
Therapy Products and Gene Therapy
Products. October 14, 1993. 58 FR 53248
2. National Academy of Sciences
(NAS):
NAS:
http://www.nationalacademies.org/nr
1. Guidelines for Human Embryonic Stem
c/
Cell Research (2005):
3. National Institutes of Health:
http://www.nap.edu/catalog.php?record_i
http://stemcells.nih.gov/index.asp
d=11278
2. 2007 Amendments to the National
Academies’ Guidelines for Human
Embryonic Stem Cell Research:
http://books.nap.edu/catalog.php?record_i
d=11871
3. 2008 Amendments to the National
Academies’ Guidelines for Human
Embryonic Stem Cell Research:
http://books.nap.edu/catalog.php?record_i
d=12260
NIH: http://stemcells.nih.gov/policy :
1. Removing Barriers to Responsible
Scientific Research Involving Human
Stem Cells, Executive Order 13505 (2009)
2. NIH Guidelines on Human Stem Cell
Research (2009)
3. NIH Human Embryonic Stem Cell
Registry (2009)
16
EUROPE
European-wide
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. Council of Europe, Bioethics
CoE:
EGE:
Division (CoE):
http://www.coe.int/bioethics
1. Convention on Human Rights
Ethical Aspects of Clinical Research in
and Biomedicine (Convention
Developing Countries (2003):
2. European Group on Ethics in
of Oviedo), Articles 15-18, ETS
http://ec.europa.eu/european_group_ethics
Science and New Technologies
No. 164 (1997):
/docs/avis17_en.pdf
(EGE):
http://europa.eu.int/comm/european_
http://conventions.coe.int/Treaty
group_ethics/index_en.htm
/Commun/QueVoulezVous.asp?
NT=164&CM=7&DF=9/15/200
8&CL=ENG
2. Additional Protocol
Concerning Biomedical
Research, CETS No. 195
(2005):
http://conventions.coe.int/Treaty
/Commun/QueVoulezVous.asp?
NT=195&CM=1&DF=10/24/20
07&CL=ENG
Drugs
1. European Commission, Enterprise
EC:
EC:
EMEA:
Directorate-General, Pharmaceuticals
Unit (EC):
1. Directive 2001/20/EC:
See EudraLex Volume 10:
Note for Guidance on Good Clinical
http://europa.eu.int/comm/enterprise/
http://europa.eu/eur-
Clinical Trials:
Practice (CPMP/ICH/135/95) (1997)
pharmaceuticals/index_en.htm
lex/pri/en/oj/dat/2001/l_121/l_1
http://ec.europa.eu/enterprise/pha
2120010501en00340044.pdf
rmaceuticals/eudralex/vol10_en.h
EC:
2. European Medicines Agency
tm
See EudraLex Volume 10: Clinical Trials:
(EMEA):
2. Directive 2005/28/EC:
http://eur-
http://ec.europa.eu/enterprise/pharmaceuti
http://www.emea.europa.eu/
lex.europa.eu/LexUriServ/site/e
cals/eudralex/vol10_en.htm
n/oj/2005/l_091/l_09120050409
en00130019.pdf
17
Country Key
Organizations
Legislation
Regulations
Guidelines
Privacy/Data
1. European Commission (EC):
EC:
Protection
http://europa.eu.int/
Data Protection Directive
2. Council of Europe, Bioethics
95/46/EC of the European
Division (CoE):
Parliament and of the Council
http://www.coe.int/T/E/Legal_affairs/
(1995):
Legal_co-operation/Bioethics/
http://europa.eu.int/smartapi/cgi/
sga_doc?smartapi!celexapi!prod
!CELEXnumdoc&lg=EN&num
doc=31995L0046&model=guic
hett
CoE:
1. Convention for the Protection
of Individuals with Regard to
Automatic Processing of
Personal Data (1985)
2. Recommendation No. R (97)
5 on the Protection of Medical
Data (1997)
Human Biological
1. European Commission (EC):
EC:
EGE:
Samples
http://europa.eu.int/
Directive 2004/23/EC on
Ethical Aspects of Human Tissue Banking
2. Council of Europe, Bioethics
Setting Standards of Quality and
(1998)
Division (CoE):
Safety for the Donation,
http://www.coe.int/bioethics
Procurement, Testing,
EMEA:
Processing, Preservation,
3. European Group on Ethics in
Concept Paper on the Development of a
Storage, and Distribution of
Science and New Technologies
Guideline on Biobanks Issues Relevant to
Human Tissues and Cells:
(EGE):
Pharmacogenetics (2005)
http://europa.eu/eur-
http://europa.eu.int/comm/european_
lex/pri/en/oj/dat/2004/l_102/l_1
CoE:
group_ethics/index_en.htm
0220040407en00480058.pdf
Recommendation Rec (2006) 4 of the
4. European Medicines Agency
CoE:
Committee of Ministers to Member States
(EMEA):
on Research on Biological Materials of
1. Convention on Human Rights
http://www.emea.europa.eu/
Human Origin (2006):
and Biomedicine (Convention
http://wcd.coe.int/ViewDoc.jsp?id=97785
of Oviedo), Articles 21-22, ETS
9&Site=CM&BackColorInternet=9999CC
No. 164 (1997):
&BackColorIntranet=FFBB55&BackColo
http://conventions.coe.int/Treaty
rLogged=FFAC75
/Commun/QueVoulezVous.asp?
NT=164&CM=7&DF=9/15/200
8&CL=ENG
18
Country Key
Organizations
Legislation
Regulations
Guidelines
Genetic Research
Council of Europe, Bioethics
1. Convention on Human Rights
1. Recommendation No. R (92) on
Division:
and Biomedicine (Convention
Genetic Testing and Screening for Health
http://www.coe.int/bioethics
of Oviedo), Articles 12-14, ETS
Care Purposes (1992):
No. 164 (1997):
http://wcd.coe.int/ViewDoc.jsp?id=61200
7&Site=CM&BackColorInternet=9999CC
http://conventions.coe.int/Treaty
&BackColorIntranet=FFBB55&BackColo
/Commun/QueVoulezVous.asp?
rLogged=FFAC75
NT=164&CM=7&DF=9/15/200
8&CL=ENG
2. Recommendation Rec(2006)4 of the
Committee of Ministers to Members
2. Additional Protocol
States on Research on Biomedical
Concerning Biomedical
Materials of Human Origin (2006):
Research, CETS No. 195
(2005):
http://wcd.coe.int/ViewDoc.jsp?id=97785
9&Site=CM&BackColorInternet=9999CC
http://conventions.coe.int/Treaty
&BackColorIntranet=FFBB55&BackColo
/Commun/QueVoulezVous.asp?
rLogged=FFAC75
NT=195&CM=1&DF=10/24/20
07&CL=ENG
19
Country Key
Organizations
Legislation
Regulations
Guidelines
Embryos, Stem
1. Council of Europe, Bioethics
CoE:
EGE:
Cells, and Cloning
Division (CoE):
http://www.coe.int/bioethics
1. Convention on Human Rights
Opinion No. 15 - Ethical Aspects of
and Biomedicine (Convention
Human Stem Cell Research and Use
2. European Commission (EC),
of Oviedo), Articles 18, ETS
(2000)
Directorate-General for Research:
No. 164 (1997):
http://ec.europa.eu/research/science-
2. Opinion No. 22 - The Ethics Review of
society/index.cfm?fuseaction=public.
http://conventions.coe.int/Treaty
hESC FP7 Research Projects (2007)
topic&id=22
/Commun/QueVoulezVous.asp?
NT=164&CM=7&DF=9/15/200
3. European Group on Ethics in
8&CL=ENG
Science and New Technologies
(EGE):
2. Additional Protocol on
http://ec.europa.eu/european_group_e
Prohibition of Human Cloning,
thics/index_en.htm
ETS No. 168 (1998):
http://conventions.coe.int/Treaty
/Commun/QueVoulezVous.asp?
NT=168&CM=7&DF=9/15/200
8&CL=ENG
EC:
Decision No. 1982/2006/EC:
http://eur-
lex.europa.eu/LexUriServ/site/e
n/oj/2006/l_412/l_41220061230
en00010041.pdf
Confederation of Independent States
Country Key
Organizations
Legislation
Regulations
Guidelines
General Interparliamentary
Assembly:
Model Law on the Protection of Human
http://www.iacis.ru/html/index-
Rights and Dignity in Biomedical
eng.php
Research in the CIS Member States
(2005): http://www.iacis.ru/html/index-
eng.php?id=54&pag=596&nid=9
20
Armenia
Note: For an overview of human subject protections in Armenia, see “Ethical Review of Biomedical Research in the CIS Countries,” Chapter 3, Section 1:
http://www.unesco.ru/files/docs/shs/2007/publications/ethical_review_cis_book_kubar_english.pdf
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
1. Drug and Medical Technology
1. Law of the Republic of
Agency
Armenia of May 4, 1996: About
Medical Aid, The Maintenance
2. National Ethics Committee
of the Population, Article 21
2. Resolution of the
Government of Armenia of
January 24, 2002: Procedure for
Clinical Trials of New
Medications in Armenia
Austria
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. Forum of Austrian Ethics
1. University Act (2002):
Forum
of
Austrian Ethics Committees:
Committees (German):
http://www.ethikkommissionen.at
http://www.ris.bka.gv.at/Dokum
Various guidelines.
ent.wxe?Abfrage=Erv&Dokume
2. Ministry of Health (German):
ntnummer=ERV_2002_1_120&
http://www.bmg.gv.at
ResultFunctionToken=7323e17
4-9167-4ce6-b47d-
3. Bioethics Commission:
2bbfb8982d55&Titel=&Quelle=
http://www.bundeskanzleramt.at/site/
&ImRisSeit=Undefined&Result
3575/default.aspx
PageSize=50&Suchworte=*
2. Hospitals Act (2002)
(German):
http://www.ris.bka.gv.at/Gelten
deFassung.wxe?Abfrage=Bunde
snormen&Gesetzesnummer=10
010285&ShowPrintPreview=Tr
ue
21
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
1. Ministry of Health (German):
Austrian Drug Law (2005)
Regulation on Leading Ethics
Forum of Austrian Ethics Committees:
http://www.bmg.gv.at
(German):
Committees (German):
http://www.ris.bka.gv.at/Gelten
Various guidelines.
2. Austrian Agency for Health and
deFassung.wxe?Abfrage=Bunde
http://www.ris.bka.gv.at/Geltende
Food Safety:
snormen&Gesetzesnummer=10
Fassung.wxe?Abfrage=Bundesno
rmen&Gesetzesnummer=200033
http://www.ages.at/ages/ueber-
010441&ShowPrintPreview=Tr
52&ShowPrintPreview=True
uns/english-what-is-ages/
ue
Privacy/Data
Austrian Data Protection
1. Federal Act Concerning the
Protection
Commission:
Protection of Personal Data
http://www.dsk.gv.at/DesktopDefault
(2007):
Note: A number of
.aspx?alias=dsken
Austrian states have
http://www.ris.bka.gv.at/Dokum
privacy/data
ent.wxe?Abfrage=Erv&Dokume
protection laws
ntnummer=ERV_1999_1_165&
(German):http://ww
ResultFunctionToken=7323e17
w.dsk.gv.at/site/620
4-9167-4ce6-b47d-
2/default.aspx
2bbfb8982d55&Titel=&Quelle=
&ImRisSeit=Undefined&Result
PageSize=50&Suchworte=*
Human Biological
1. Ministry of Health (German):
1. Law on Safety of Blood
Regulation on Tissue Banks
Bioethics Commission:
Materials
http://www.bmg.gv.at
(2009) (German):
(German):
http://www.ris.bka.gv.at/Gelten
1. Opinion of the Bioethics Commission
2. Bioethics Commission:
deFassung.wxe?Abfrage=Bunde
http://www.ris.bka.gv.at/Geltende
at the Federal Chancellery: Biobanks for
http://www.bundeskanzleramt.at/site/
snormen&Gesetzesnummer=10
Fassung.wxe?Abfrage=Bundesno
Medical Research (2007):
3575/default.aspx
011145&ShowPrintPreview=Tr
rmen&Gesetzesnummer=200058
48&ShowPrintPreview=True
http://www.bundeskanzleramt.at/DocVie
ue
w.axd?CobId=25510
2. Law on Quality and Safety of
2. Ruling of the Bioethics Commission:
Human Tissue and Cells (2009)
Cord Blood Banking (2008):
(German):
http://www.bundeskanzleramt.at/DocVie
http://www.ris.bka.gv.at/Gelten
w.axd?CobId=31001
deFassung.wxe?Abfrage=Bunde
snormen&Gesetzesnummer=20
005698&ShowPrintPreview=Tr
ue
22
Country Key
Organizations
Legislation
Regulations
Guidelines
Genetic Research
1. Ministry of Health (German):
Gene Technology Act
http://www.bmg.gv.at
(German):
http://www.ris.bka.gv.at/Gelten
2. Bioethics Commission:
deFassung.wxe?Abfrage=Bunde
http://www.bundeskanzleramt.at/site/
snormen&Gesetzesnummer=10
3575/default.aspx
010826&ShowPrintPreview=Tr
ue
Embryos, Stem
1. Ministry of Health (German):
1. Reproductive Medicine Act
Bioethics Commission:
Cells, and Cloning
http://www.bmg.gv.at
(2009) (German):
http://www.ris.bka.gv.at/Gelten
Research on Human Embryonic
2. Bioethics Commission:
deFassung.wxe?Abfrage=Bunde
Stem Cells (2009) (German):
http://www.bundeskanzleramt.at/site/
snormen&Gesetzesnummer=10
3575/default.aspx
http://www.bundeskanzleramt.at/
003046&ShowPrintPreview=Tr
DocView.axd?CobId=34240
ue
2. Convention on Human Rights
and Biomedicine (Convention
of Oviedo), Additional Protocol
on Prohibition of Human
Cloning (2002)
Belgium
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Belgium Advisory Committee on
Law Relating to
1. Opinion No. 13: Regarding
Bioethics:
Experimentation on Humans
Experimentation on Man (2001)
https://portal.health.fgov.be/portal/pa
(2004)
ge?_pageid=56,512676&_dad=portal
2. Opinion No. 31: Regarding
&_schema=PORTAL
Experimentation Involving Pregnant and
Breastfeeding Women (2004)
23
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
Medicines Directorate-General
1. Royal Decree of September 27,
(French):
1994.
https://portal.health.fgov.be/portal/pa
ge?_pageid=56,512460&_dad=portal
2. Royal Decree of June 30, 2004
&_schema=PORTAL
Determining the Implementation
Measures of the Law
3. Royal Decree of June 30, 2004
Modifying the Royal Decree of
June 6, 1960
4. Royal Decree of July 15, 2004
Determining Payments for Ethical
Opinions or Authorization for the
Conduct of a Clinical Trial or
Experiment.
5. Application of the Law of May
7, 2004 Relating to Experiments
on Human Volunteers who
Participate in Phase I Trials
(2004)
6. Explanations Concerning the
Submission of a Request for an
Ethical Opinion or Authorization
for the Conduct of a Clinical Trial
(2004)
Privacy/Data
Commission for the Protection of
Law of December 8, 1992 on
Decree of February 13, 2001
Protection
Privacy (French and Flemish):
Privacy Protection in Relation to Implementing the Law of
http://www.privacy.fgov.be/
the Processing of Personal Data
December 8, 1999
as Modified by the Law of
December 11, 1998
Implementing Directive
95/46/EC:
http://www.law.kuleuven.ac.be/i
cri/itl/12privacylaw.php
24
Country Key
Organizations
Legislation
Regulations
Guidelines
Human Biological
1. Conseil Supérieur de la
1. Royal Decree (1987),
CSS:
Materials
Santé/Hoge Gezondheidsraad (CSS)
Regarding the Expression of
(French and Dutch):
Consent for the Removal of
Common Quality Standards for All
http://www.health.fgov.be/CSS_HGR Organs and Tissues on Living
Tissues and Cells of Human Origin
Donors
Intended for Human Application (2007)
2. Federal Public Service:
(French):
www.health.fgov.be
2. Royal Decree (1997)
Regarding the Removal and
https://portal.health.fgov.be/pls/portal/doc
Allocation of Organs of Human
s/PAGE/INTERNET_PG/HOMEPAGE_
Origin
MENU/ABOUTUS1_MENU/INSTITUTI
ONSAPPARENTEES1_MENU/HOGEG
3. Act on the Removal and
EZONDHEIDSRAAD1_MENU/ADVIEZ
Transplantation of Organs
ENENAANBEVELINGEN1_MENU/AD
(2006) (French):
VIEZENENAANBEVELINGEN1_DOCS
/7691_SQ_COMMUNS_2007_FR.PDF
http://www.staatsbladclip.be/loi
s/2006/08/28/loi-
2006022815.html
4. 2007 Amendment (French):
http://www.staatsbladclip.be/loi
s/2007/04/13/loi-
2007022504.html
Embryos, Stem
1. Federal Public Service:
1. Royal Decree Fixing the
Cells, and Cloning
www.health.fgov.be
Criteria for the Program
Applicable to the Care Programs
2. Federal Commission for Medical
‘Reproductive Medicine’
and Scientific Research on Embryos
(15/02/1999)
in Vitro
2. Act on Research on Embryos
in Vitro (2003):
http://www.eshre.com/ESHRE/
English/Legal-Matters-and-
Guidelines/Legal-
documentation/Belgium/page.as
px/164
3. Law on Medically Assisted
Reproduction and the
Destination of Supernumerary
Embryos and Gametes (2007)
(French):
http://www.staatsbladclip.be/loi
s/2007/07/17/loi-
2007023090.html
25
Bosnia and Herzegovina
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
Federation of Bosnia and
1. Law on Drugs No. 51/01
1. Regulation on Good Clinical
Herzegovina:
Practice and Clinical Trials No.
2. Law on Changes and
61/04
Ministry of Health:
Amendments of the Law on
http://www.fmoh.gov.ba/
Drugs No. 29/05
2. Regulation Amending the
Regulation of Good Clinical
Practice and Clinical Trials No.
56/05
Republic of Srpska:
1. Law on Drugs No. 19/01
1. Regulation of Clinical Trials
No. 64/05
Ministry of Health and Social
2. Law on Changes and
Welfare (Bosnian):
Amendments of Law on Drugs
2. Regulation on Changes and
No. 34/08
Amending the Regulation of
http://www.vladars.net/sr-SP-
Clinical Trials No. 23/07
Cyrl/Vlada/Ministarstva/MZSZ/OMi
n/Pages/Splash.aspx
Privacy/Data
Personal Data Protection Agency of
Law on the Protection of
Protection
Bosnia and Herzegovina
Personal Data in Bosnia and
Herzegovina (2001):
http://www.privacyinternational.
org/article.shtml?cmd[347]=x-
347-63545
26
Bulgaria
Note: For an overview of human subject protections in Bulgaria, see “National Regulations on Ethics and Research in Bulgaria:” http://ec.europa.eu/research/science-
society/pdf/bg_eng_lr.pdf
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Ministry of Healthcare (Bulgarian):
1. Constitution of the Republic
http://www.mh.government.bg/
of Bulgaria, Article 29 (1991)
2. Oviedo Convention on
Human Rights and Biomedicine
(2001)
3. Law Ratifying the Additional
Protocol on Biomedical
Research (2005)
4. Law on Medicinal Products in
Human Medicine (2007)
5. Healthcare Act, Articles 199
and 200 (2007)
Drugs
1. Ministry of Healthcare (MOH)
Law for Medicinal Products in
MOH:
(Bulgarian):
Human Medicine (2007),
http://www.mh.government.bg/
Chapter 4
Regulation No. 31 on the Rules
for GCP (2007)
2. Bulgarian Drug Agency (BDA):
http://www.bda.bg/?lang=en
Privacy/Data
1. Bulgarian Commission for
Personal Data Protection Act
Protection
Personal Data Protection:
(2006):
http://www.ceecprivacy.org/pdf/
http://www.ceecprivacy.org/main.php
law_bulgaria.pdf
?s=2&k=bulgaria
2. Ombudsman: www.ombudsman.bg
Human Biological
1. Executive Agency for
Law on Transplantation of
Regulation No. 13 of 04 April
Materials:
Transplantation (Bulgarian):
Organs, Tissues, and Cells
2007 for the Terms and
http://bgtransplant.bg/
(2006)
Conditions of Informing
Bulgarian Citizens on the
2. Council of Ministers, Ethics
Activities regarding the
Committee for Transplantation
Transplantation of Organs,
Tissues and Cells
27
Country Key
Organizations
Legislation
Regulations
Guidelines
Embryos, Stem
Ministry of Healthcare (Bulgarian):
Law Ratifying the Convention
Cells, and Cloning
http://www.mh.government.bg/
for Human Rights (2007)
2. SG No. 13/8,
Article 134 (2008)
Croatia
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Oviedo Convention on Human
Rights and Biomedicine (2003)
Drugs
1. Ministry of Health and Social
Law on Drugs (2007)
MZSS:
Welfare (MZSS):
http://www.mzss.hr/
Ordinance on Clinical Trials and
Good Clinical Practice (2007)
2. Agency for Medicinal Products
(Croatian): http://narodne-
and Medical Devices:
novine.nn.hr/clanci/sluzbeni/3297
74.html
http://www.almp.hr/
Privacy/Data
Croatian Personal Data Protection
Personal Data Protection Act
Protection
Agency (Croatian):
(2008):
http://www.azop.hr/default.asp
http://www.legal500.com/c/croa
tia/developments/4908
Embryos, Stem
1.
Additional Protocol to the
Cells, and Cloning
Convention for the Protection of
Human Rights and Dignity of
the Human Being with regard to
the Application of Biology and
Medicine, on the Prohibition of
Cloning Human Beings (2003)
2. Additional Protocol
Concerning Transplantation of
Organs and Tissues of Human
Origin (2007)
28
Cyprus
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Law No. 31 (III)/2001 (Oviedo
Convention on Human Rights
and Biomedicine)
Drugs
1. National Health Authority
Law for Good Clinical Practice
(Medicines Council):
(2004)
http://www.moh.gov.cy/moh/moh.nsf
/index_en/index_en#
2. Ministry of Health, National
Bioethics Committee:
http://www.moh.gov.cy
Privacy/Data
Commissioner for Personal Data
1. Processing of Personal Data
Protection
Protection:
(Protection of Individuals) Law
138 (1) 2001:
http://www.dataprotection.gov.cy/dat
aprotection/dataprotection.nsf/index_
http://www.dataprotection.gov.c
en/index_en?opendocument
y/dataprotection/dataprotection.
nsf/697e70c0046f7759c2256e8c
004a0a49/f8e24ef90a27f34fc22
56eb4002854e7/$FILE/138(I)-
2001_en.pdf
2. Amended in 2003:
http://www.dataprotection.gov.c
y/dataprotection/dataprotection.
nsf/697e70c0046f7759c2256e8c
004a0a49/f8e24ef90a27f34fc22
56eb4002854e7/$FILE/37(I)-
2003_en.pdf
Embryos, Stem
Additional Protocol to the
Cells, and Cloning
Convention for the Protection of
Human Rights and Dignity of
the Human Being with regard to
the Application of Biology and
Medicine, on the Prohibition of
Cloning Human Beings (2002)
29
Czech Republic
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Ministry of Health, Central Ethics
1. Act No. 20/1996 on the Care
Committee (Czech):
for the Health of People
http://www.mzcr.cz
2. Oviedo Convention on
Human Rights and Biomedicine
(2001)
3. Act No. 130/2002 Collection
on the Research and
Development Support as
Amended
Drugs
1. Ministry of Health (MOH)
Act No. 378/2007 Collection on MOH:
SUKL:
(Czech): http://www.mzcr.cz
Pharmaceuticals
Decree No. 226/2008 on Good
1. KHL-8: Clinical Trial Protocol and
2. State Institute for Drug Control
Clinical Practices and on Detailed Protocol Amendments (1998)
(SUKL):
Conditions for Evaluation of
http://www.sukl.cz/index.php?lchan=
Pharmaceutical Products
2. KLH-10: Terminology and Principles
1&lred=1
of Good Clinical Practice (1998)
3. KLH-11: Ethics Committees (1998)
4. KLH-10: Terminology and Principles
of Good Clinical Practice (1998)
5. KLH-19: Documentation Required for
an Approval of a Clinical Trial on a
Human Pharmaceutical (2001)
6. KLH-20: Application for Approval/
Notification of a Clinical Trial (2004)
Privacy/Data
Office for Personal Data Protection:
Act on the Protection of
Position No. 3/2004 Personal
Protection
http://www.uoou.cz/uoou.aspx
Personal Data and on
Data Processing in the Context of
Amendment to Some Related
Clinical Testing of Drugs and
Acts (No. 101 of April 4, 2000): Other Medical Substances
http://www.uoou.cz/uoou.aspx?
menu=4&submenu=5
30
Country Key
Organizations
Legislation
Regulations
Guidelines
Embryos, Stem
1. Ministry of Education, Youth, and
1. Additional Protocol to the
Cells, and Cloning
Sport:
Convention for the Protection of
http://www.msmt.cz/index.php?lchan
Human Rights and Dignity of
=1&lred=1
the Human Being with regard to
the Application of Biology and
2. Research and Development
Medicine, on the Prohibition of
Council, Bioethical Commission:
Cloning Human Beings (2001)
http://www.vyzkum.cz/FrontClanek.a
spx?idsekce=15908
2. Act of 26 April 2006 on
Research on Human Embryonic
Stem Cells
Access:
http://www.eshre.com/ESHRE/
English/Legal-Matters-and-
Guidelines/Legal-
documentation/Czech-
Rep/page.aspx/165
Denmark
Note: For an overview of human subject protections in Denmark, see http://www.cvk.sum.dk/cvk/site.aspx?p=119 .
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Danish National Committee on
1. Oviedo Convention on
Ministerial Order No. 806 of 12
CVK:
Biomedical Research Ethics (CVK):
Human Rights and Biomedicine July 2004 on Information and
(1999)
Consent at Inclusion of Trial
1. Guidelines about Notification etc. of a
http://www.cvk.sum.dk/CVK/Home/
Subjects in Biomedical Research
Biomedical Research Project to the
English.aspx
2. Act on the Biomedical
Projects (2004):
Committee System on Biomedical
Research Ethics Committee
http://www.cvk.sum.dk/English/
Research Ethics (2008)
System (2003):
ministerialorder806.aspx
http://www.cvk.sum.dk/English/
2. Appendices (2008)
actonabiomedicalresearch.aspx
3. Act Amending the Act on the
Biomedical Research Ethics
Committee System (2006)
http://www.cvk.sum.dk/English/
actamending.aspx
31
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
Danish Medicines Agency:
Medicinal Product Act No. 382
1. Executive Order No. 935 on
Guideline on Informed Consent from
http://www.dkma.dk
(2003)
Informed Consent from Patients
Patients in Biomedical Trials (2000)
in Biomedical Trials (2000)
2. Executive Order on Clinical
Trials on Medicinal Products,
Human Use (2004)
3. Danish Guideline on
Notification of Clinical Trials of
Medicinal Products in Humans
(2004)
Privacy/Data
Danish Data Protection Agency
The Act on Processing of
DCE:
Protection
(DPA):
Personal Data (Act No. 429)
http://www.datatilsynet.dk/english/
(2007):
Protection of Sensitive Personal
http://www.datatilsynet.dk/engli
Information
sh/the-act-on-processing-of-
http://www.etiskraad.dk/sw314.asp
personal-data/
Other guidelines can be accessed at:
http://www.privireal.group.shef.ac.uk/cont
ent/dp/denmark.php
Human Biological
Danish National Committee on
Health Law, Chapter 7 (2005)
Materials
Biomedical Research Ethics (CVK):
http://www.cvk.sum.dk/CVK/Home/
English.aspx
Embryos, Stem
Danish Council of Ethics (DCE):
1. Act on Medically Assisted
DCE:
Cells, and Cloning
http://www.etiskraad.dk/sw293.asp
Procreation (1997)
1. Cloning (2001)
2. Convention on Human Rights
and Biomedicine (Convention
2. Research in Human Gametes, Fertilized
of Oviedo), Additional Protocol
Ova, Embryos and Fetuses (2004)
on Prohibition of Human
Cloning (2002)
3. Law No. 535, Chapter 7,
Sections 25 and 28 (2008):
http://www.eshre.com/ESHRE/
English/Legal-Matters-and-
Guidelines/Legal-
documentation/Denmark/page.a
spx/365
32
Estonia
Note: For an overview of human subject protections in Estonia, see “National Regulations on Ethics and Research in Estonia:” http://ec.europa.eu/research/science-
society/pdf/et_eng_lr.pdf
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Estonian Council of Bioethics:
1. Constitution of the Republic
Code of Ethics of Estonian Scientists:
http://www.eetikakeskus.ut.ee/index.
of Estonia, Paragraph 18 (1992)
http://www.akadeemia.ee/_repository/File
aw/set_lang_id=2
/ALUSDOKUD/Code-ethics.pdf
2. Oviedo Convention on
Human Rights and Biomedicine
(2002)
Drugs
1. State Agency of Medicines:
Medicinal Products Act,
MSA:
http://www.sam.ee/index.aw?set_lang Chapter 5 (2005):
_id=2
http://www.ravimiamet.ee/orb.a
1. RTL 2001, 90, 1258:
w/class=file/action=preview/id=
Requirements for Membership of
2. Minister of Social Affairs (MSA):
5118/EstonianAct-
Medical Ethics Committees for
http://www.sm.ee/eng.html
10May2005.doc
Clinical Trials, Rules of
Procedures for Committee, Rate
of Fee for Evaluation of Clinical
Trials, and List of Information to
be Submitted in Order to Obtain
Approval (2001)
2. Conditions and Procedure for
Conducting Clinical Trials of
Medicinal Products. Regulation
No. 23 (2005):
http://www.sam.ee/627
Privacy/Data
Estonian Data Protection
1. Databases Act (1997)
Protection
Inspectorate: http://www.aki.ee/eng/
2. Personal Data Protection Act
(2003):
http://www.legaltext.ee/en/andm
ebaas/tekst.asp?loc=text&dok=
X70030&keel=en&pg=1&ptyyp
=RT&tyyp=X&query=data%2B
protectionLink
Genetic Research
Human Genes Research Act
(RT I 2000, 104, 685) (2000):
http://www.geenivaramu.ee/inde
x.php?id=98
33
Country Key
Organizations
Legislation
Regulations
Guidelines
Embryos, Stem
1. Additional Protocol to the
Cells, and Cloning
Convention for the Protection of
Human Rights and Dignity of
the Human Being with regard to
the Application of Biology and
Medicine, on the Prohibition of
Cloning Human Beings (2002)
http://conventions.coe.int/Treaty
/en/Treaties/Html/168.htm
2. Artificial Insemination and
Embryo Protection Act (2003)
Finland
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. Ministry of Social Affairs and
Medical Research Act No.
MSAH:
TUKIJA:
Health (MSAH):
295/2004:
http://www.stm.fi/en/frontpage
http://www.finlex.fi/en/laki/kaa
1. Decree on the National
1. Checklist for Researchers and Members
nnokset/1999/en19990488
Advisory Board on Health Care
of Ethics Committees (2009) (Finnish):
2. Sub-Committee on Medical
Ethics No. 494/1998
Research Ethics (TUKIJA):
http://www.etene.org/tukija/dokumentit/T
http://www.etene.org/e/tukija/index.s
2. Decree on the National
UKIJAn-muistilista-170409.pdf
html
Research Ethics Council of
Finland No. 1347/2002
2. Operating Procedures (2009) (2005
3. National Advisory Board on
English translation):
Research Ethics (TENK):
3. Decree on Medical Research
http://www.etene.org/tukija/dokumentit/T
http://pro.tsv.fi/tenk/english1.htm
and Subsidiary Regulations
Issued in Pursuance Hereof, No.
UKIJA_eng_1307.pdf
313/2004
4. Decree on Clinical Trials on
Medicinal Products No. 316/2005
Drugs
1. National Agency for Medicines
Medicines Act and Decree No.
NAM:
(NAM):
296/2004
http://www.nam.fi/index.html
Administrative Regulation on
Clinical Trials on Medicinal
2. Ministry of Social Affairs and
Products in Human Subjects No.
Health (MSAH): http://www.stm.fi
2/2004
MSAH:
Decree on Clinical Trials No.
316/2005
34
Country Key
Organizations
Legislation
Regulations
Guidelines
Privacy/Data
Office of the Data Protection
1. Personal Data Act No.
Protection
Ombudsman:
523/1999:
http://www.tietosuoja.fi/1560.htm
http://www.tietosuoja.fi/uploads
/hopxtvf.HTM
2. Act on the Amendment of the
Personal Data Act No.
986/2000:
http://www.tietosuoja.fi/uploads
/p9qzq7zr3xxmm9j.rtf
Human Biological
Act on the Medical Use of
Materials
Human Organs and Tissues No.
101/2001:
http://www.finlex.fi/pdf/saadkaa
n/E0010101.PDF
Genetic Research
Gene Technology Act No.
377/1995
Embryos, Stem
National Advisory Board on
1. Convention on Human Rights
Human Stem Cells, Cloning, and
Cells, and Cloning
Research Ethics:
and Biomedicine (Convention
Research (2005) (Finnish):
http://www.tenk.fi/ENG/function.htm of Oviedo), Additional Protocol
http://videnskabsministeriet.dk/site/forside
on Prohibition of Human
/publikationer/2000/guidelines-on-
Cloning (2002)
biomedical-
experiments/html/guidelines.pdf
2. Medical Research Act No.
295/2004:
http://www.finlex.fi/en/laki/kaa
nnokset/1999/en19990488
35
France
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. Ministry of Health and Sport
1. Decree No. 97-555
MHS:
CCNE - Various:
(MHS) (French): http://www.sante-
Concerning the National
sports.gouv.fr/
Consultative Ethics Committee
1. Protection of Persons who
http://www.ccne-ethique.fr/opinions.php
for Health and Life Sciences
Participate in Biomedical
2. National Consultative Bioethics
(1997):
Research (Public Health Code,
Committee for Health and Life
Regulatory Section, Additional
Sciences (CCNE): http://www.ccne-
http://www.ccne-
Book II, Articles R.2001 to
ethique.fr/?langue=2
ethique.fr/decree_n_97555.php
R.2053)
3. National Conference of CPPRB
2. Biomedical Research (Loi
2. Decision of August 20, 2002
(French): http://cncp.med.univ-
Huriet-Sérusclat), Articles
tours.fr/html/index.php
L1121-1 to L1126-7 (2004)
Access: The laws can be found
at the following web site
(French):
http://www.legifrance.gouv.fr/
From there, go to “Les Codes en
Vigeur.” Go to the “Recherche
d'un article au sein d'un code”
box. In the “Nom de code” box
select “Code de la Santé
Publique” and in the “Numéro
d'article” box enter the number
of the desired article.
Drugs
1. National Consultative Bioethics
Medications for Human Use,
CCNE:
Committee for Health and Life
Articles L5121-11, L5124-1,
Sciences (CCNE): http://www.ccne-
and L5126-1) (2004)
1. Phase I Trials in Cancer (2002)
ethique.fr
http://www.legifrance.gouv.fr/
2. Transposition into French Law of the
2. French Health Products Safety
European Directive Relating to Clinical
Agency (AFSSAPS):
Trials on Medicinal Products: A New
http://agmed.sante.gouv.fr/ang/
Ethical Framework for Human Research
indang.htm
(2003)
36
Country Key
Organizations
Legislation
Regulations
Guidelines
Privacy/Data
1. National Commission of
Law 2004-801 of August 6,
CCNE:
Protection
Information and Liberty (CNIL):
2004 Modifying Law 78-17 of
http://www.cnil.fr/index.php?id=4
January 6, 1978 Relating to the
1. Ethical Questions Arising from the
Protection of Data Subjects as
Transmission of Scientific Information
2. National Consultative Bioethics
Regards the Processing of
Concerning Research in Biology and
Committee for Health and Life
Personal Data:
Medicine (1995)
Sciences (CCNE): http://www.ccne-
ethique.fr
http://www.cnil.fr/fileadmin/doc
2. Biometrics, Identifying Data and
uments/uk/Decree_20_October_
Human Rights (2007)
2005_English_version.pdf
Human Biological
National Consultative Bioethics
Donation and Use of the
CCNE:
Materials
Committee for Health and Life
Components and Products of the
Sciences (CCNE): http://www.ccne-
Human Body, Articles L1211-1
1. Umbilical Cord Blood Banks for
ethique.fr
to L1274-3 (2004) (French):
Autologous Use for Research (2002)
http://www.legifrance.gouv.fr/
2. Ethical Issues Raised by Collections of
Biological Material and Associated
Information Data: “Biobanks,”
“Biolibraries” (2003)
Genetic Research
National Consultative Bioethics
CCNE:
Committee for Health and Life
Sciences (CCNE): http://www.ccne-
1. Opinion on Gene Therapy (1990)
ethique.fr
2. Opinion regarding the Application of
Genetic Testing to Individual Studies,
Family Studies and Population Studies.
(Problems related to DNA "Banks," Cell
"Banks," and Computerization) (1991)
3. Opinion that the Human Genome
should not be Used for Commercial
Purposes. Report. Thoughts Relating to
Ethical Problems of Human Genome
Research (1991)
4. Opinion on the Use of Somatic
Gene Therapy Procedures. Report (1993)
37
Country Key
Organizations
Legislation
Regulations
Guidelines
Embryos, Stem
National Consultative Bioethics
1. Convention on Human Rights CCNE:
Cells, and Cloning
Committee for Health and Life
and Biomedicine (Convention
Sciences (CCNE): http://www.ccne-
of Oviedo), Additional Protocol
Commercialisation of Human Stem Cells
ethique.fr
on Prohibition of Human
and Other Cell Line (2006)
Cloning (2002)
2. Law No. 2004-800 (2004)
3. Biomedical Research,
Articles L2151-1, L2151-2,
L2151-6, and L2151.7:
http://www.eshre.com/ESHRE/
English/Legal-Matters-and-
Guidelines/Legal-
documentation/France/page.asp
x/166
Georgia
Note: For an overview of human subject protections in Georgia, see “Ethical Review of Biomedical Research in the CIS Countries,” Chapter 3, Section 4:
http://www.unesco.ru/files/docs/shs/2007/publications/ethical_review_cis_book_kubar_english.pdf
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Oviedo Convention on Human
Rights and Biomedicine (2000)
Drugs
Drug Agency of the Ministry of
1. Drug and Pharmacy Law No.
Regulation about the Rules and
Labor, Health, and Social Affairs:
659 (1997)
Conditions of Issuing of the
Approval of Clinical Trials
http://www.healthministry.ge/eng/ind
2. Licenses and Approvals Law
ex.php
(2005)
Approved #176 (2005)
Embryos, Stem
Convention on Human Rights
Cells, and Cloning
and Biomedicine (Convention
of Oviedo), Additional Protocol
on Prohibition of Human
Cloning (2000)
38
Germany
Note: For an overview of human subject protections in Germany, see http://www.eurecnet.org/information/germany.html
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. German Medical Association
BÄK:
(BÄK):
(Model) Professional Code of Conduct,
http://www.bundesaerztekammer.de/
Section 15 (2006) (German):
page.asp?his=4.3569
http://www.bundesaerztekammer.de/page.
asp?his=1.100.1143
2. Central Ethics Commission of the
BÄK (German):
www.zentrale-ethikkommission.de/
3. Working Group of the Medical
Ethics Committees in Germany
(German):
http://www.ak-med-ethik-komm.de/
4. German Ethics Council (NER):
http://www.ethikrat.org/en_index.php
5. Federal Ministry of Health (BMG):
http://www.bmg.bund.de/cln_041/nn
_600110/EN/Home/homepage__node
,param=.html__nnn=true
39
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
1. Federal Institute for Drugs and
Medicinal Products Act,
BfArM :
BfArM:
Medical Devices (BfArM):
Sections 40-42 (2008):
http://www.bfarm.de/cln_029/EN/Ho
http://www.bfarm.de/cln_028/n
1. Promulgation on the Principles
Third Announcement on Clinical Trials of
me/homepage__node.html__nnn=true n_424928/EN/BfArM/BfArMSe
of the Conduct of Clinical Trials
Medicinal Products in Humans (2006):
rvice/AMG__en/amg-node-
of Drugs According to the Rules
http://www.bfarm.de/cln_012/nn_119978
2. Federal Ministry of Education and
en.html__nnn=true
(1987)
0/SharedDocs/Bekanntmachungen/EN/dru
Research (BMBF):
gs/clinTrials/bm-KlinPr-20060810-klinPr-
http://www.bmbf.de/en/index.php
2. Second Promulgation on the
pdf-
Clinical Trial of Drugs in Human
en,templateId=raw,property=publicationFi
3. Paul Ehrlich Institute (PEI)
(1997)
le.pdf/bm-KlinPr-20060810-klinPr-pdf-
(German):
3. Regulation for the Application
en.pdf
http://www.pei.de/cln_048/DE/home/
of Good Clinical Practice of
http://www.bfarm.de/cln_012/nn_119971
de-node.html?__nnn=true
Clinical Medications for Human
6/EN/drugs/1__befAuth/clinTrials/clintria
Use (2006)
4. Federal Ministry of Health (BMG):
ls-node-en.html__nnn=true
BMBF:
http://www.bmg.bund.de/cln_041/nn
_600110/EN/Home/homepage__node
Principles and Responsibilities
,param=.html__nnn=true
Related to Clinical Studies
(2003):
http://www.bmbf.de/en/1173.php
http://www.bmbf.de/en/4861.php
Privacy/Data
Federal Commissioner for Data
Federal Data Protection Act, as
Protection
Protection and Freedom of
Amended (2003):
Information:
http://www.bfdi.bund.de/cln_02
Note: The 16
http://www.bfdi.bund.de/cln_030/nn_
9/nn_535764/EN/DataProtectio
German states also
533554/EN/Home/homepage__node.
nActs/DataProtectionActs__nod
have data protection
html__nnn=true
e.html__nnn=true
laws (German):
http://www.datensch
utz-
bayern.de/infoquel/d
s-
inst/deutschland.htm
l
40
Country Key
Organizations
Legislation
Regulations
Guidelines
Human Biological
1. German Society of Surgery
1. Transplantation Law (2007)
DGCH Rule for the Production of BÄK:
Materials
(DGCH) (German):
(German):
Human Tissues (German)
http://www.dgch.de/
http://www.bmg.bund.de/cln_11
http://www.bundesaerztekammer.de/page.
0/nn_1200474/SharedDocs/Dow
asp?his=0.7.45&all=true
2. German Medical Association
nloads/DE/GV/GT/Organspende
(BÄK):
NER:
/TransplantationsG,templateId=r
http://www.bundesaerztekammer.de/
aw,property=publicationFile.pdf
Opinion on Biobanks for Research (2004):
page.asp?his=4.3569
/TransplantationsG.pdf
http://www.ethikrat.org/_english/publicati
3. German Ethics Council (NER):
ons/Opinion_Biobanks-for-research.pdf
2. Transfusion Law (2007)
http://www.ethikrat.org/en_index.php (German):
ZEKO (German):
4. Central Ethics Commission of the
http://www.bmg.bund.de/cln_11
http://www.zentrale-
German Medical Association
0/nn_1200364/SharedDocs/Dow
ethikkommission.de/downloads/Koerperm
(ZEKO) (German):
nloads/DE/GV/GT/Blutprodukte
at.pdf
http://www.zentrale-
/3-Gesetz-zur-Regelung-des-
ethikkommission.de/
Trans-
DIZG:
,templateId=raw,property=publi
5. German Institute for Cell and
1. Ethical Code (2000)
cationFile.pdf/3-Gesetz-zur-
Tissue Replacement (DIZG)
Regelung-des-Trans-.pdf
2. Common Standards: Tissues and Cell
(German): http://www.dizg.de
Banking (2004)
3. Act of Quality and Security
of Human Tissue and Cells
(2007) (German):
http://www.bmg.bund.de/cln_04
1/nn_600110/SharedDocs/Geset
zestexte/Arzneimittel/Gewebege
setz,templateId=raw,property=p
ublicationFile.pdf/Gewebegeset
z.pdf
41
Country Key
Organizations
Legislation
Regulations
Guidelines
Genetic Research
1. German Medical Association
Law of 20 June
BÄK:
1990/16.12.1993 to Regulate
(BÄK):
Matters Related to Gene
Guideline on Gene Transfer (1995)
(German)
http://www.bundesaerztekammer.de/
Technology (2006)
page.asp?his=4.3569
http://www.bundesaerztekammer.de/30/Ri
chtlinien/Richtidx/Gentransferpdf.pdf
2. German Society of Human
Genetics (GFHEV):
GFHEV:
http://www.gfhev.de/en/gfh/
1. Position Paper of the German Society
3. Paul-Ehrlich-Institut (PEI)
of Human Genetics (1996)
(English):
http://www.pei.de/cln_048/nn_15903
2. DNA Banking and Personal Data in
0/EN/institute-en/institut-node-
Biomedical Research: Technical, Social,
en.html?__nnn=true
and Ethical Questions (2004)
PEI – Various:
http://www.pei.de/cln_048/nn_162568/EN
/infos-en/fachkreise-en/genther-fach-
en/genther-fach-node-en.html?__nnn=true
42
Country Key
Organizations
Legislation
Regulations
Guidelines
Embryos, Stem
1. Federal Ministry of Education and
1. Embryo Protection Act
Implementation Regulation for
NER:
Cells, and Cloning
Research (BMBF):
(1990):
the Stem Cell Act (German):
http://www.bmbf.de/en/index.php
http://www.bmj.bund.de/enid/P
1. On the Import of Human Embryonic
ublications/Embryo_Protection_
http://bundesrecht.juris.de/zesv/in
Stem Cells (2001):
2. German Ethics Council (NER):
Act_19u.html
dex.html
http://www.ethikrat.org/_english/publicati
http://www.ethikrat.org/en_index.php
ons/stem_cells/Opinion_Import-
2. Stem Cell Act (2008):
HESC.pdf
3. Central Ethics Commission of the
English translation of 2002
German Medical Association
version:
2. Cloning for Reproductive Purposes and
Cloning for the Purposes of Biomedical
(ZEKO) (German):
http://www.bmj.bund.de/files/-
/1146/Stammzellgesetz%20engl
Research (2004):
http://www.zentrale-
isch.pdf
http://www.ethikrat.org/_english/publicati
ethikkommission.de/
BMBF:
ons/Opinion_Cloning.pdf
4. German Research Foundation
3. Should the Stem Cell Law be
(DFG):
Law Allowing the Import of
Embryonic Stem Cells (2002):
Amended? (2007):
http://www.dfg.de/en/
http://www.ethikrat.org/_english/publicati
http://www.bmbf.de/en/1056.ph
ons/Opinion_Should_the_Stem_Cell_Law
5. Central Ethics Committee for
p
_be_amended.pdf
Stem-Cell Research (ZES):
http://www.rki.de/cln_048/nn_21678
ZEKO:
2/EN/Content/Institute/DepartmentsU
1. Stem Cell Research (2002) (German):
nits/StemCell/StemCel__node.html?_
_nnn=true
http://www.zentrale-
ethikkommission.de/downloads/Stammzel
l.pdf
2. Cloning (2006) (German):
http://www.zentrale-
ethikkommission.de/downloads/TherapKl
onen.pdf
DFG:
Opinion on Stem Cell Research (2006)
(German):
http://www.dfg.de/aktuelles_presse/reden
_stellungnahmen/2006/download/stammz
ellforschung_deutschland_lang_0610.pdf
43
Greece
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
1. National Organization for
1. A6/10983/1 (1984)
NOM:
NBC:
Medicines (NOM):
http://www.eof.gr/web/guest/home ,
2. Act 2619/98: Ratification of
1. Ministerial Decision
1. Report on Biomedical
then click on flag icon in upper left
the Convention for the
A6/10983/1/12-20.12.1984 on
Experimentations Involving Human
hand section for English
Protection of Human Rights and Clinical Trials and Protection of
Subjects and Clinical Trials of Medicinal
Dignity of the Human Being
the Human Being (1984)
Products (2005)
2. National Bioethics Commission
with Regard to the Application
(NBC):
of Biology and Medicine (1998) 2. Ministerial Decision
2. Code of Medical Ethics (2005)
http://www.bioethics.gr/index.php?ca
DYG3/89292/31.12.2003 (2003)
3. Clinical Trials (2005)
tegory_id=3
3. Greek Republic Gazette No.
1973 (2003)
4. A Guide for Research Ethics
4. Act 3418/2005 Code of
Committees for Biological Research
Medical Ethics
(2009)
Access: Enter the name of the guideline in
the Search box in the upper right-hand
corner of the NBC home page.
Privacy/Data
1. Hellenic Data Protection Authority 1. Greek Constitution
Protection
(Greek): http://www.dpa.gr/
1975/1986/2001 Article 9.1
2. Act 2619/98 (Biomedicine
Convention of the Council of
Europe) (1998)
3. Law 2472/1997 on the
Protection of Individuals with
Regard to the Processing of
Personal Data (As Amended by
Laws 2819/2000 and
2915/2000) (Greek):
http://www.dpa.gr/Documents/E
ng/2472engl_all.doc
4. Act 3418/2005 Code of
Medical Ethics
Genetic Research
1. Hellenic Data Protection Authority 1. Greek Constitution
HDPA:
(HDPA) (Greek): http://www.dpa.gr/
1975/1986/2001, Article 5.5
Opinion No. 15/2001
2. National Bioethics Commission
2. Act 2619/98 (Biomedicine
(NBC):
Convention of the Council of
NBC:
Europe) (1998)
http://www.bioethics.gr/index.php?ca
1. On the Collection and Use of Genetic
tegory_id=3
Data (2002)
44
Country Key
Organizations
Legislation
Regulations
Guidelines
Embryos, Stem
1. National Bioethics Commission
1. Additional Protocol to the
NBC:
Cells, and Cloning
(NBC):
Convention for the Protection of
Human Rights and Dignity of
1. On the Use of Stem Cells in Biomedical
http://www.bioethics.gr/index.php?ca
the Human Being with regard to
Research and Clinical Medicine (2002)
tegory_id=3
the Application of Biology and
2. On Prenatal and Pre-implantation
2. National Authority for Medically
Medicine, on the Prohibition of
Diagnostic Tests and the Question of
Assisted Reproduction (Greek):
Cloning Human Beings (1998)
Choice of Embryo (2007)
http://www.iya.gr
2. Act 3089/2002 on Medically
Assisted Human Reproduction
3. Act 3305/2005
Hungary
Note: For an overview of human subject protections in Hungary, see “National Regulations on Ethics and Research in Hungary:” http://ec.europa.eu/research/science-
society/pdf/hu_eng_lr.pdf
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. Ministry of Health (EüM):
1. Act XX of 1949 on the
EüM:
http://www.eum.hu/?akt_menu=2&se
Constitution of the Republic of
t_lang=2
Hungary, Article 54.
Decree 23/2002 (V. 9.) EüM on
Biomedical Research on Human
2. Medical Research Council,
2. Act CLIV of 1997 on Health
Beings
Scientific and Research Ethics
Care, Chapter VIII
Committee
3. Act IV of 1978 on the
Criminal Code Title II of
Chapter XII. Crimes Against the
Order of Medical Interventions
and Medical Research and
Against Self-Determination
Related to Health Issues
4. Act VI. of 2002 on the
promulgation of the Oviedo
Convention on Human Rights
and Biomedicine
5. Act LXXXI of 2006 on the
Promulgation of the Additional
Protocol to the Convention on
Human Rights and Biomedicine,
concerning Biomedical
Research
45
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
1. National Institute of Pharmacy:
Act XCV of 2005 on Medicinal
EüM:
http://www.ogyi.hu/main_page
Products for Human Use:
http://net.jogtar.hu/jr/gen/getdoc
Decree 35/2005 (VIII. 26) of the
2. Medical Research Council, Ethics
.cgi?docid=a0500095.tv&dbnu
Minister of Health on the Clinical
Committee for Clinical
m=62
Trial and Application of Correct
Pharmacology:
Clinical Practices of
http://www.ett.hu/kfeb/kfeb.htm
Investigational Medicinal
Products Intended for Use in
Humans:
http://www.ogyi.hu/dynamic/Dec
ree35_2005.doc
Privacy/Data
Parliamentary Commissioner for Data 1. Act LXIII of 1992 on
Protection
Protection and Freedom of
Protection of Personal Data and
Information:
Disclosure of Data of Public
http://www.obh.hu/indexen.htm
Interest, Amended by the
Parliamentary Act No XLVIII
of 2003:
http://abiweb.obh.hu/dpc/index.
php?menu=gyoker/relevant/nati
onal/1992_LXIII
2. Act XLVII of 1997 on the
Handling of Medical and Other
Related Data:
http://abiweb.obh.hu/dpc/index.
php?menu=gyoker/relevant/nati
onal/1997_XLVII
Human Biological
Ministry of Health (EüM):
Act LXXX of 2006 on the
Decree 18/1998 (XII 27) EüM on
Materials
http://www.eum.hu/english
Promulgation of the Additional
Implementing Act CLIV of 1997
Protocol to the Convention on
on Health Care as regards
Human Rights and Biomedicine, Transplantation and Storage of
Concerning Transplantation of
Organs and Tissues and Certain
Organs and Tissues of Human
Histopathology Examinations
Origin
Genetic Research
Act XXI of 2008 on the Rules
Decree 60/2003 (X. 20.) on the Minimum
of Protection of Human Genetic
Professional Requirements Necessary for
Data, of Human Genetic
Providing Health Services
Examinations and Research and
of the Operation of Biobanks
46
Country Key
Organizations
Legislation
Regulations
Guidelines
Embryos, Stem
1. Ministry of Health (EüM):
1. Act CLIV of 1997 on Health
Decree 30/1998 (VI. 24.) NM on
Decree 18/1998 (XII 27) EüM on
Cells, and Cloning
http://www.eum.hu/english
Care, Articles 180-182:
Regulations on Specific
Implementing Act CLIV of 1997 on
http://www.eshre.com/ESHRE/
Procedures for Human
Health Care as regards Transplantation
2. Medical Research Council
English/Legal-Matters-and-
Reproduction
and Storage of Organs and Tissues and
Guidelines/Legal-
Certain Histopathology Examinations
documentation/Hungary/page.as
px/557
2. Act VI of 2002 on the
Promulgation of the Convention
on Human Rights and Medicine
and the Additional Protocol on
Cloning
Iceland
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. Ministry of Health and Social
1. Act on the Rights of Patients
MOH:
NBC:
Security (MOH):
No. 74 (1997):
Regulation on Scientific Research 1. Research Projects
http://ministryofhealth.is
http://ministryofhealth.is/laws-
in the Biomedical field, No. 286
and-regulations//nr/34
(2008)
2. Withdrawal
2. National Bioethics Committee
(NBC):
2. Oviedo Convention on
http://eng.heilbrigdisraduneyti.is/l
Human Rights and Biomedicine aws-and-
www.visindasidanefnd.is (Select
(2004)
regulations/Regulations//nr/2847
“English” in the upper-right hand
corner.)
Drugs
1. Icelandic Medicines Control
Medicinal Products Act No. 93
MCA:
Agency (MCA):
(1994):
Regulation on Clinical Trials of
http://www.imca.is/
http://ministryofhealth.is/media/
Medicinal Products in Humans
Laws%20in%20english/The_M
No. 443 (2004):
2. National Bioethics Committee
edicinal_Products_Act_No_93-
(NBC):
1994.pdf
http://eng.heilbrigdisraduneyti.is/
media/Reglugerdir-
www.visindasidanefnd.is
enska/Regulation_on_clinical_tri
als_of_medicinal_products_in_hu
mans_No443-2004.pdf
47
Country Key
Organizations
Legislation
Regulations
Guidelines
Privacy/Data
Data Protection Authority:
1. Judgment by the Supreme
Government Regulation on a
Protection
http://www.personuvernd.is/informati
Court of Iceland Concerning the Health Sector Database No. 32
on-in-english/
Health Sector Database (2003):
(2000):
http://www.personuvernd.is/info
rmation-in-english/
http://eng.heilbrigdisraduneyti.is/l
aws-and-regulations/nr/670
2. Act on the Protection of
Privacy as Regards the
Processing of Personal Data,
No. 77/2000, as Amended
(2003):
http://www.personuvernd.is/info
rmation-in-english/
Human Biological
1. Ministry of Health:
Act on Biobanks No. 110
Regulations on the Keeping and
NBC:
Materials
(2000):
Utilization of Biological Samples
http://ministryofhealth.is
http://ministryofhealth.is/laws-
in Biobanks No. 134 (2001):
1. Biological Samples (2001)
2. National Bioethics Committee
and-regulations/nr/31
http://eng.heilbrigdisraduneyti.is/l
2. Research Services (no date)
(NBC):
aws-and-regulations/nr/684
www.visindasidanefnd.is
Embryos, Stem
1.
Additional Protocol to the
Cells, and Cloning
Convention for the Protection of
Human Rights and Dignity of
the Human Being with regard to
the Application of Biology and
Medicine, on the Prohibition of
Cloning Human Beings (2004)
2. Artificial Fertilization Act
No. 55/1996 as Amended by
Laws No. 65/2006, 27/2008,
and 54/2008 (Icelandic):
http://althingi.is/lagas/nuna/199
6055.html
English translation of 1996 law:
http://eng.heilbrigdisraduneyti.is
/laws-and-regulations/nr/685
48
Ireland
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. Irish Council for Bioethics (ICB):
ICB:
http://www.bioethics.ie
Operational Procedures for Research
2. Irish Medicines Board (IMB):
Ethics Committees: Guidance 2004
http://www.imb.ie/
IMB:
Guide to Clinical Trials (2004)
49
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
Irish Medicines Board:
1. European Communities
http://www.imb.ie/
(Clinical Trials on Medicinal
Products for Human Use)
Regulations, 2004
http://www.dohc.ie/legislation/st
atutory_instruments/pdf/si20040
190.pdf
2. European Communities
(Clinical Trials on Medicinal
Products for Human Use)
Regulations 2004 (S.I. No. 878
of 2004)
http://www.dohc.ie/issues/clinic
al_trials_2004/Commission_Dir
ective_2003_94_EC.pdf
3. European Communities
(Clinical Trials on Medicinal
Products for Human Use)
(Amendment No. 2) Regulations
2006 (S.I. 374 of 2006)
http://www.dohc.ie/issues/clinic
al_trials_2004/CT_EC_No2_Re
gulations_2006.pdf
4. European Communities
(Clinical Trials on Medicinal
Products for Human Use)
Regulations 2004 to 2006
(Informal Codification Text)
http://www.dohc.ie/issues/clinic
al_trials_2004/Final_Consolidat
ed_Regulations_2007.pdf
Access: These Statutory
Instruments can be viewed at:
http://www.dohc.ie/issues/clinic
al_trials/
Privacy/Data
Data Protection Commissioner:
Data Protection Act (1988), as
Protection
http://www.dataprotection.ie/docs/Ho
amended (2003):
me/4.htm
http://www.irishstatutebook.ie/2
003/en/act/pub/0006/index.html
50
Country Key
Organizations
Legislation
Regulations
Guidelines
Human Biological
Irish Council for Bioethics:
Human Biological Material:
Materials
http://www.bioethics.ie
Recommendations for Collection, Use,
and Storage in Research (2005):
http://www.bioethics.ie/pdfs/BioEthics_fi
n.pdf
Genetic Research
Irish Medicines Board:
Guidelines for Pharmacogenetic Research
http://www.imb.ie/
(2006):
http://www.imb.ie/images/uploaded/docu
ments/AUT-
G0003_Guidelines_for_pharmacogenetic_
research_v1.pdf
Embryos, Stem
Convention on Human Rights
Cells, and Cloning
and Biomedicine (Convention
of Oviedo), Additional Protocol
on Prohibition of Human
Cloning (2002)
Italy
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. National Federation of Ethics
Statute on the National
FNACE:
NBC:
Committees (FNACE) (Italian):
Federation of Ethics
http://www.unich.it/fnace/
Committees (1995) (Italian):
Regulation Implementing the
Opinion of the National Bioethics
http://www.unich.it/fnace/statut
Statute on the National Federal of Committee on the European Protocol on
2. National Monitoring Center for
o.htm
Ethics Committees (1995)
Biomedical Research (1999)
Clinical Trials (OSS):
OSS:
https://oss-sper-
clin.agenziafarmaco.it/index_ingl.htm
Ministerial Decree: Terms of
Reference for the Establishment
3. National Bioethics Committee
and the Functioning of Ethics
(NBC):
Committees (May 12, 2006)
http://www.governo.it/bioetica/eng/in
dex.html
4. Ministry of Health (Italian):
http://www.ministerosalute.it
51
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
1. National Monitoring Center for
1. Decree of the President of the Italy has numerous regulations
Clinical Trials:
Republic: Regulations to
that govern drug research
Simplify the Procedures and to
(Italian):
https://oss-sper-
Verify and Check New Systems
clin.agenziafarmaco.it/index_ingl.htm and Experimental Therapeutic
http://oss-sper-
clin.agenziafarmaco.it/normativa/
2. Italian Medicines Agency (Italian): Protocols (September 21, 2001)
http://www.agenziafarmaco.it/
(Italian): http://oss-sper-
The following are the most
clin.agenziafarmaco.it/normativ
important:
3. Ministry of Health (MOH)
a/ , then select document in the
(Italian):
left column.
1. Ministerial Decree 21
December 2007:
http://www.ministerosalute.it
2. Legislative Decree No. 211:
Modalities of Submission of the
Transposition of Directive
2001/20/EC Relating to the
Application to the Competent
Implementation of Good
Authority, for Communication of
Clinical Practice in the Conduct
Substantial Changes and
of Clinical Trials on Medicinal
Declaration of Conclusion of the
Products for Clinical Use
Clinical Trial, and for Request of
(2003):
an Ethics Committee Opinion
https://oss-sper-
2. Ministerial Decree 31 March
clin.agenziafarmaco.it/normativ
2008:
a/decreto_24062003_inglese.pdf Definition of the Minimum
3. Legislative Decree No. 200:
Requirements that Contract
Transposition of Directive
Research Organisations (CROs)
2005/28 EC Laying down
Shall Satisfy in Order to Work on
Principles and Detailed
Clinical Trials on Medicinal
Guidelines as Regards
Products
Investigational Medical
3. Ministerial Decree 14 of July
Products for Human Use, as
2009:
well as the Requirements for
Authorizing of Manufacturing
Minimal Insurance Requirements
or Importing of such Products
for Subjects Involved in Clinical
(2007) (Italian):
Trials
http://www.aifa.gov.it/allegati/d
lgs_200-6nov2007.pdf
52
Country Key
Organizations
Legislation
Regulations
Guidelines
Privacy/Data
Italian Data Protection Independent
Italian Personal Data Protection
1. Administrative Decree:
Protection
Authority
Code, Legislative Decree No.
Electronic Data Transmission
196 of June 30, 2003:
Pertaining to Clinical Medical
http://www.garanteprivacy.it/gar Experimentation (May 25, 2000)
ante/doc.jsp?ID=1030925
2. Ministerial Decree No. 277
(2007)
Regulation for the
Implementation of Articles No.
20 and 21 of the Legislative
Decree No. 196 of June 30, 2003
Genetic Research
1. Instituto Superiore di Sanita (ISS):
ISS:
http://www.iss.it/chis/?lang=2
Guidelines for Phase I Clinical Trials with
2. Italian Society of Human Genetics
Investigational Medicinal Products
(SIGU):
Employed in Gene Somatic Therapy
http://www.sigu.net/news.php
(2004) (Italian):
http://www.iss.it/binary/publ/publi/0478.1
106653420.pdf
SIGU:
Guidelines for Genetic Biobanks (2004):
http://www.gaslini.org/DPPM/BIOBANK
_GUIDELINES.pdf
Embryos, Stem
Regulation of Medically
Cells, and Cloning
Assisted Reproduction, Law No.
40, Article 13 (2004):
http://www.eshre.com/ESHRE/
English/Legal-Matters-and-
Guidelines/Legal-
documentation/Italy/page.aspx/1
67
53
Latvia
Note: For an overview of human subject protections in Latvia, see the report “National Regulations on Ethics and Research in Latvia:” http://ec.europa.eu/research/science-
society/pdf/lv_eng_lr.pdf
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
1. State Agency of Medicines:
Pharmaceutical Law, Amended
1. Cabinet Regulation No. 172,
http://www.vza.gov.lv/index.php?setl
April 24, 2008 (Latvian):
Regulations Regarding the
ang=en&large=
http://www.vza.gov.lv/index.ph
Conduct of Clinical Trials and
p?id=355&sa=355&top=333
Non-interventional Trials, the
2. Central Medical Ethics Committee
Procedures for the Labeling of
Investigational Medicinal
Products, and the Procedures for
Inspection of Conformity with the
Requirements of Good Clinical
Practice, February 28, 2006:
http://www.vza.gov.lv/doc_upl/M
K-172-28022006-ENGv3.pdf
2. Amended January 15, 2008:
http://www.vza.gov.lv/doc_upl/M
K_172_groz_15012008-Eng.pdf
Privacy/Data
1. Data State Inspectorate:
1. Medical Treatment Law,
Protection
http://www.dvi.gov.lv/eng/
Amended May 8, 2008
2. Central Medical Ethics Committee
2. Personal Data Protection
Law, Amended February 21,
2008:
http://www.dvi.gov.lv/eng/legisl
ation/pdp/
Human Biological
Central Medical Ethics Committee
Law on the Protection of Dead
Cabinet of Ministers Regulation
Materials
Human Beings and Use of
No. 208 (2007): Order of Use of
Human Organs and Tissue,
Human Biological Materials
Amended February 6, 2004
Genetic Research
1. Ministry of Health:
1. Human Genome Research
Regulation of the Cabinet of
http://www.vm.gov.lv/index.php?setl
Law, Amended January 3, 2005
Ministers, “Procedures for
ang=en
Genetic Research” (2004)
2. Law on the Development and
2. Data State Inspectorate:
Use of the National DNA
http://www.dvi.gov.lv/eng/
Database, Amended March 9,
2006
3. Central Medical Ethics Committee
54
Country Key
Organizations
Legislation
Regulations
Guidelines
Embryos, Stem
1. Ministry of Health:
Sexual and Reproductive Health Cabinet Regulation No. 716
Cells, and Cloning
http://www.vm.gov.lv/index.php?setl
Law, amended March 29, 2007:
(2003.16.12): Order of
ang=en
http://www.ttc.lv/New/lv/tulkoj
Medically-Assisted Procreation,
umi/E0750.doc
Donor Registry, and Donor Bank
2. Central Medical Ethics Committee
Lithuania
Note: For an overview of human subject protections in Lithuania, see the report “National Regulations on Ethics and Research in Lithuania:” http://ec.europa.eu/research/science-
society/pdf/lt_eng_lr.pdf http://www.eurecnet.org/information/lithuania.html
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. Ministry of Health (MOH):
1. Oviedo Convention on
MOH:
http://www.sam.lt/en/
Human Rights and Biomedicine
(2002):
1. Decree on the Procedure for
2. Lithuanian Bioethics Committee
http://conventions.coe.int/treaty/
the Estimation and Covering of
(LBEC):
en/treaties/html/164.htm
Expenses Incurred by Research
Subjects, No. 677 (2000)
http://bioetika.sam.lt/index.php?-
2. Law on Ethics of Biomedical
1702632112
Research, No. VIII-1679 (2007): 2. Decree on the List of the
http://www3.lrs.lt/pls/inter3/dok
Documents to be Presented by the
paieska.showdoc_l?p_id=32605
Sponsor of Biomedical Research
7
and (or) by the Principal
Investigator in Order to be
Authorized to Conduct
Biomedical Research, No. 29
(2001)
3. Decree on the Procedure to
Issue Approvals to Conduct
Biomedical Research, No. V-2
(2008)
LBEC:
Decree on the List of Documents
to be Presented by the Sponsor of
Medical Research and (or) by the
Principal Investigator in Order to
be Authorized to Conduct
Biomedical Trial No. V-21
(2004)
55
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
1. State Medicines Control Agency
1. Law on Ethics of Biomedical
SMCA:
LBEC - Various:
(SMCA):
Research, No. VIII-1679 (2000):
http://bioetika.sam.lt/index.php?-
http://www.vvkt.lt/index.php?332772
http://www3.lrs.lt/pls/inter3/dok
1. Decree on Pediatric Clinical
82619484
3903
paieska.showdoc_l?p_id=32605
Trials No. 70 (2002)
7
2. Lithuanian Bioethics Committee
2. Detailed Guidance for the
(LBEC):
2. Law on Pharmacy, No. X-709 Request for Authorisation of a
(2008):
Clinical Trial on a Medicinal
http://bioetika.sam.lt/index.php?-
http://www3.lrs.lt/pls/inter3/dok
Product for Human Use to the
1876243809
paieska.showdoc_l?p_id=33813
Competent Authorities,
Notification of Substantial
3. Ministry of Health (MOH):
9
Amendments, and Declaration of
http://www.sam.lt/en/
the End of the Trial (2006)
http://www.vvkt.lt/index.php?305
3919977
LBEC:
Decree on the Regulation for the
Submission of the Documents to
the Lithuanian Bioethics
Committee to Issue Favourable
Opinion to Conduct a Clinical
Trial on Medicinal Products No.
V-11 (2004)
MOH:
Health Care Ministry Decree on
the Procedure to Issue Approvals
to Conduct Clinical Trial on
Medicinal Product, No. V-435
(2006)
Privacy/Data
State Data Protection Protectorate
Law Amending the Law on
Protection
Legal Protection of Personal
Data, No. X-1444 (2008):
http://www3.lrs.lt/pls/inter3/dok
paieska.showdoc_l?p_id=31563
3
56
Country Key
Organizations
Legislation
Regulations
Guidelines
Human Biological
Law on Donation and
Materials
Transplantation of Human
Tissues, Cells and Organs
(2006):
http://www3.lrs.lt/pls/inter3/dok
paieska.showdoc_l?p_id=31439
6
Embryos, Stem
Ministry of Health (MOH):
1. Law on Ethics of Biomedical
MOH:
Cells, and Cloning
Research, No. VIII-1679,
http://www.sam.lt/en/
Article 3 (2000):
Decree on the Procedure to Issue
Authorization for the Transit of
http://www3.lrs.lt/pls/inter3/dok
paieska.showdoc_l?p_id=32605
Tissues of Human Embryonic
7
Tissue, Embryonic Stem Cells
and their Lines, Fetal Tissue, and
2. Additional Protocol to the
Fetal Stem Cells throughout the
Convention for the Protection of Territory of the Republic of
Human Rights and Dignity of
Lithuania, No. V-660 (2007)
the Human Being with regard to
the Application of Biology and
Medicine, on the Prohibition of
Cloning Human Beings No. IX-
1085 (2002):
http://conventions.coe.int/Treaty
/EN/Treaties/Html/168.htm
Luxembourg
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Hospitals Act of 1998, Article
25 (French):
http://www.legilux.public.lu/leg
/a/archives/1998/0078/a078.pdf
#page=2
57
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
1. Ministry of Health (French):
Grand-Ducal Decree of 30th of
http://www.ms.public.lu and
May, 2005 on Good Clinical
http://www.sante.lu
Practice (French):
http://www.legilux.public.lu/leg/a
2. National Committee on Ethics in
/archives/2005/0084/2005A15161
Research (CNER) (French):
.html
http://www.cne.lu
3. Division of Pharmacy and
Medicines (French)
http://www.ms.public.lu/fr/direction/
divisions-services/pharmacie-
medicaments/index.html
Privacy/Data
National Commission for Data
Law of August 2, 2002 on the
Grand-Ducal Decree of October
Protection
Protection:
Protection of Persons with
2nd, 1992 on the Use of Personal
http://www.cnpd.lu/en/index.html
Regard to the Processing of
Medical Data in IT Processing
Personal Data as amended by a
(French):
law of July 27, 2007:
http://www.legilux.public.lu/leg/a
/archives/1992/0074/a074.pdf#pa
http://www.cnpd.lu/objets/en/do
ge=12
c_loi02082002mod_en.pdf#zoo
m=125,0,0
Macedonia
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
Macedonian Drug Agency
1. Law for Drugs and Medical
Regulations on Clinical Trials of
Devices (2007)
Medicinal Products on Human
http://moh.gov.mk/index.php?categor
Subjects (2009)
y=39
2. Pharmaco-Vigilance Law
(2008)
http://www.reglek.com.mk/
Privacy/Data
Directorate for Personal Data
Law on Personal Data
Protection
Protection (Macedonian):
Protection (2005):
http://www.dpdp.gov.mk/
http://www.ceecprivacy.org/pdf/
Law%20on%20Personal%20Da
ta%20Protection.pdf
58
Malta
Note: For an overview of human subject protections in Malta, see “National Regulations on Ethics and Research in Malta:” http://ec.europa.eu/research/science-
society/pdf/mt_eng_lr.pdf
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Health Ethics Committee:
http://sahha.gov.mt/pages.aspx?page=
134
Drugs
Medicines Authority:
Medicines Act, 2003 (English
Legal Notice 490: Clinical Trials
Guidance Notes on Good Clinical Practice
http://medicinesauthority.gov.mt/
translation begins on page 66):
Regulations, 2004 (English
(2005)
http://www.doi.gov.mt/EN/parli
translation begins half way
amentacts/2003/Act%203.pdf
through document):
As amended by Act No. III of
http://www.doi.gov.mt/EN/legaln
2004:
otices/2004/11/LN490.pdf
http://www.doi.gov.mt/EN/parli
amentacts/2004/ACTIIIe.pdf
Privacy/Data
Office of the Data Protection
Data Protection Act (2006):
Protection
Commissioner:
http://www.dataprotection.gov.
http://www.dataprotection.gov.mt/
mt/dbfile.aspx/DPA.pdf
Moldova
Note: For an overview of human subject protections in Moldova, see “Ethical Review of Biomedical Research in the CIS Countries,” Chapter 3, Section 7:
http://www.unesco.ru/files/docs/shs/2007/publications/ethical_review_cis_book_kubar_english.pdf
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Oviedo Convention on Human
Rights and Biomedicine (2002)
Drugs
Ministry of Public Health, National
Moldova Republic Law on
Ordnance No. 10: On
Ethics Committee
Medicines of December 17,
Performance of Clinical Trials in
1997, Articles 11 and 12
the Republic of Moldova (2002)
Embryos, Stem
Additional Protocol to the
Cells, and Cloning
Convention for the Protection of
Human Rights and Dignity of
the Human Being, on the
Prohibition of Cloning Human
Beings (2002)
59
Montenegro
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
Ministry of Health of Montenegro:
Law for Drugs and Pharmacies
www.mz.cg.yu
of Montenegro, Articles 37-39
Netherlands
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Central Committee for Research
1. Population Screening Act
1. Concerning the Use of a
Manual for the Review of Medical
Involving Human Subjects (CCMO):
(1996):
Special Form (2002)
Research Involving Human Subjects
http://www.ccmo.nl
http://www.gr.nl/wbo.php?phpL
(2002)
ang=en
2. Concerning Requirements of
Expertise of Accredited Review
2. Medical Research Involving
Board Members (2002)
Human Subjects Act (2006):
3. Concerning the Organization
http://www.ccmo-
and Working Method of
online.nl/hipe/uploads/downloa
Accredited Review Board
ds_catw/Medical%20Research
Members (2003)
%20involving%20Human%20S
ubjects%20Act%20March%200
4. External Review Guideline
1%202006.pdf
(2004)
3. Medical Research (Human
5. Research Contract Review
Subjects) Compulsory Insurance Guideline (2009)
Decree (2003):
http://www.ccmo-
online.nl/hipe/uploads/downloa
ds/Verzekeringsbesluit_2003-
ENG(1).pdf
60
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
1. Ministry of Health, Welfare, and
Medicines Act (2007) (Dutch):
MHWS:
CCMO:
Sport (MHWS):
http://www.minvws.nl/en/
http://wetten.overheid.nl/cgi-
1. Medicines Act Decree (2007)
Clinical Research with Medicinal
bin/deeplink/law1/title=Genees
(Dutch):
Products in the Netherlands: Instructional
2. Central Committee for Research
middelenwet
Manual (2005):
Involving Human Subjects (CCMO):
http://wetten.overheid.nl/cgi-
http://www.ccmo.nl
bin/deeplink/law1/title=Besluit%
http://www.ccmo-
20Geneesmiddelenwet
online.nl/hipe/uploads/downloads_cati/Ins
3. Medicines Evaluation Board
truction%20manual%20versie%202.pdf
(MEB): http://www.cbg-
2. Medicines Act Regulation
meb.nl/cbg/en/default.htm
(2007) (Dutch):
http://wetten.overheid.nl/cgi-
bin/deeplink/law1/title=Regeling
%20Geneesmiddelenwet
Privacy/Data
1. Federation of Biomedical
Personal Data Protection Act
FMWV:
Protection
Scientific Societies (FMWV)
(2004) (Dutch):
(Dutch): http://www.federa.org/
http://www.cbpweb.nl/downloa
Code for Adequate Secondary Use of Data
ds_wetten/WBP.PDF
(2004):
2. Dutch Data Protection Authority:
http://www.dutchdpa.nl/index.stm
English translation of 2002
http://www.federa.org/DB_FILES/product
version:
ie/general/1_78_301/Code%20of%20cond
uct%20for%20medical%20research%20.p
http://www.dutchdpa.nl/downlo
df
ads_wetten/wbp.pdf?refer=true
&theme=purple
Human Biological
Federation of Biomedical Scientific
Civil Code, Article 467 (1994)
Code for Proper Secondary Use of Human
Materials
Societies (Dutch):
(Dutch):
Tissue in the Netherlands (2002):
http://www.federa.org/
http://www.healthlaw.nl/wgboe
http://www.federa.org/?s=1&m=78&p=&
ng.html
v=4
Genetic Research
1. Ministry of Housing, Spatial
Medical Research Involving
VROM, IGZ, and CCMO: Guidelines for
Planning, and Environment (VROM): Human Subjects Act (2006):
Researchers and Sponsors with Regard to
www.vrom.nl
the Assessment by Official Bodies of
http://www.ccmo-
Clinical Research Involving Gene
2. Dutch Health Care Inspectorate
online.nl/hipe/uploads/downloa
Therapeutics in the Netherlands (2007):
(IGZ): http://www.igz.nl/
ds_catw/Medical%20Research
%20involving%20Human%20S
http://213.154.234.72/Documenten/Docu
3. Central Committee for Research
ubjects%20Act%20March%200
menten%20IM/Guidelines%20gene%20th
Involving Human Subjects (CCMO):
1%202006.pdf
erapy%20applications.pdf
http://www.ccmo.nl/
61
Country Key
Organizations
Legislation
Regulations
Guidelines
Embryos, Stem
Central Committee for Research
1. Foetal Tissue Act (2001):
Explanatory Notes to the Embryos Bill
Cells, and Cloning
Involving Human Subjects (CCMO):
(no date):
http://www.ccmo.nl
http://www.minvws.nl/includes/
dl/openbestand.asp?File=/image
http://www.minvws.nl/includes/dl/openbe
s/Foetal%20act_tcm20-
stand.asp?File=/images/explanatory-
107821.pdf
notes-to-the-embryos-bill_tcm20-
108037.pdf
2. Embryos Act (2002)
http://www.minvws.nl/includes/
dl/openbestand.asp?File=/image
s/eng-embryowettekst_tcm20-
107819.pdf
Norway
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. Regional Committees for Medical
1. Oviedo Convention on
REK:
NEM:
Research Ethics (REK):
Human Rights and Biomedicine
http://www.etikkom.no/English/NEM
(2006)
Terms of Reference for the
1. Research Ethical Review in Norway
/REK
Regional Committees for Medical (1998)
2. Law regarding Ethics and
Research Ethics, Norway (2003)
2. National Committee for Medical
Integrity in Research (2006):
2. NEM: Standard Operating Procedures
Research Ethics (NEM):
http://www.etikkom.no/English/N
for the Regional Committees for Medical
http://www.etikkom.no/English
http://www.ub.uio.no/ujur/ulovd
EM/REK/reference
Research Ethics (2002)
ata/lov-20060630-056-eng.pdf
3. National Committee for Research
NESH:
Ethics in the Social Sciences and the
3. Act on Health Care Research
Guidelines for Research Ethics in the
Humanities (NESH):
(2008) (Norwegian):
Social Sciences, Law, and the Humanities
http://www.etikkom.no/English/NES
http://www.lovdata.no/cgi-
(2001)
H
wift/wiftldles?doc=/usr/www/lo
NENT:
4. National Committee for Research
vdata/all/nl-20080620-
Ethics in Science and Technology
044.html&emne=helseforskning
Research Ethics Guidelines for Science
(NENT):
slov*&&
and Technology (2007) (Norwegian):
http://www.etikkom.no/English/NEN
www.etikkom.no/retningslinjer/nent
T
Drugs
Norwegian Medicines Agency:
Regulation Relating to Clinical
1. Guidelines for the Regulations
Trials on Medicinal Products for
Concerning Clinical Trials of Human
http://www.regjeringen.no/en/dep/ho
Human Use (2003)
Drugs (1999)
d/About-the-Ministry/Subordinate-
institutions/The-Norwegian-
2. Guidance to the Regulation (2004)
Medicines-Agency.html?id=279753
(Norwegian):
www.legemiddelverket.no/upload/78182/
Endelig%20veiledning%202004.doc
62
Country Key
Organizations
Legislation
Regulations
Guidelines
Privacy/Data
Data Inspectorate:
Personal Data Act No. 31
Regulations on the Processing of
Protection
http://www.datatilsynet.no/templates/
(2000):
Personal Data (2003):
Page____194.aspx
http://www.datatilsynet.no.htest.
http://www.datatilsynet.no.htest.o
osl.basefarm.net/upload/Dokum
sl.basefarm.net/upload/Dokument
enter/regelverk/lov_forskrift/lov
er/regelverk/lov_forskrift/lov-
-20000414-031-eng.pdf
20000414-031-eng.pdf
Human Biological
1. Ministry of Health and Care
1. Act on Biobanks (February
MHCS:
Materials
Services (MHCS):
21, 2003, No. 12):
Guidelines for the Norwegian Act
http://www.odin.no/hod/english/bn.ht
http://www.regjeringen.no/uploa on Biobanks (2003) (Norwegian):
ml
d/kilde/hod/red/2005/0078/ddd/
pdfv/242629-
http://odin.dep.no/hod/norsk/publ
2. Ministry of Education and
act_relating_to_biobanks_bioba
/rundskriv/042051-990014/
Research (MER):
nkloven_.pdf
http://www.odin.no/kd/english/bn.ht
ml
2. Act Relating to the
Application of Biotechnology in
Human Medicine, etc.
(December 5, 2003, No. 100)
3. Act on Health Care Research
(2008) (Norwegian):
http://www.lovdata.no/cgi-
wift/wiftldles?doc=/usr/www/lo
vdata/all/nl-20080620-
044.html&emne=helseforskning
slov*&&
Genetic Research
1. Ministry of Health and Care
Act Relating to the Application
Services (MHCS):
of Biotechnology in Human
Medicine, etc. (December 5,
http://www.odin.no/hod/english/bn.ht
2003, No. 100):
ml
http://www.odin.no/hod/english/
2. Norwegian Biotechnology
doc/legislation/acts/048051-
Advisory Board:
990012/dok-bn.html
http://www.bion.no/index_eng.shtml
3. Regional Committees for Medical
Research Ethics (REK):
http://www.etikkom.no/English/NEM
/REK
63
Country Key
Organizations
Legislation
Regulations
Guidelines
Embryos, Stem
Directorate for Health and Social
1. Revised Act Relating to the
Cells, and Cloning
Affairs:
Application of Biotechnology in
http://www.helsedirektoratet.no/porta
Human Medicine (June 15,
l/page?_pageid=134,112387&_dad=p
2007) Regarding Changes in the
ortal&_schema=PORTAL&language
Act Related to Stem Cell
=english
Research and Pre-implantation
Diagnostics (2007)
2. Norwegian Law on the
Human-Medical Use of
Biotechnology, Chapter 3:
http://www.eshre.com/ESHRE/
English/Legal-Matters-and-
Guidelines/Legal-
documentation/Norway/page.as
px/168
Poland
Note: For an overview of human subject protections in Poland, see “National Regulations on Ethics and Research in Poland:” http://ec.europa.eu/research/science-
society/pdf/pl_eng_lr.pdf
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. Ministry of Health, Bioethics
1. Constitution of the Republic
MOH:
NIL:
Appeals Commission (MOH):
of Poland, Article 39 (1997)
http://www.kb.mz.gov.pl/index_en.ht
Order of the Minister of Health
Code of Medical Ethics, Chapter II (2003)
ml
2. Medical Profession Act,
and Social Welfare on How to
Articles 21-29 (1997)
Establish, Finance, and the Mode
2. Polish Chamber of Physicians and
of Action of Bioethics
Dentists (NIL):
Committees (1999)
http://www.nil.org.pl/xml/nil/wladze/
nil_eng
64
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
Ministry of Health, Office for
1. Pharmaceutical Law, Act of
1. Order of the Minister of Health
Registration of Therapeutic, Medical, Sept. 6, 2001, Article 6
in the Matter of Central Register
and Biocidal Products:
of Clinical Trials (2004)
2. Law of 20/04/2004 on
http://www.urpl.gov.pl/english/index.
Amendment of the
2. Decree of the Minister of
htm
Pharmaceutical Law, Law on
Health on Clinical Trials on
the Profession of Medical
Minors (2004)
Doctor, and Regulations
Introducing the Pharmaceutical
3. Order of the Minister of
Law, Law on Medical Devices,
Finance Concerning the
and Law on the Office for
Mandatory Civil Liability
Registration of Medicinal
Insurance of Researchers and
Products, Medical Devices and
Sponsors (2004)
Biocidal Products (Journal of
4. March 11, 2005 Order of the
Laws No. 92, Item 882)
Minister of Health Concerning
Detailed Requirements of Good
Clinical Practice (2005)
Privacy/Data
Inspector General for the Protection
Act on the Protection of
Protection
of Personal Data:
Personal Data (2006):
http://www.giodo.gov.pl/168/j/en/
http://www.giodo.gov.pl/data/fil
emanager_en/61.doc
Human Biological
1. Act of 26 October 1995 on
Materials
the Collection and
Transplantation of Cells
2. Act of 22 August 1997 on the
Public Blood Service
Portugal
Country Key
Organizations
Legislation
Regulations
Guidelines
General
National Council of Ethics for the
Oviedo Convention on Human
1. Opinion 4/CNE/93 on Clinical Trials
Life Sciences:
Rights and Biomedicine (2001)
(1993)
http://www.cnecv.gov.pt/cnecv/en/
2. Opinion 9/CNE/94 on Ethics
Commissions (1994)
3. Doc. 13/CNECV/95 on Legislation on
Clinical Trials and Ethics Committees
(1995)
4. Doc. 34/CNECV/2001 on the Helsinki
Declaration (2001)
65
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
1. National Institute of Pharmacy and 1. Approval of the Applicable
Decree-Law No. 102/2007 of
Medicines:
Legal Standards for the Conduct April 2
http://www.infarmed.pt/portal/page/p
of Clinical Trials of Medicines
ortal/INFARMED/ENGLISH
for Human Use, Law No.
46/2004
2. Ethics Commission for Clinical
Research (CEIC):
2. Approval of the Composition,
Operations, and Financing of
http://www.infarmed.pt/portal/page/p
the Ethics Commission for
ortal/INFARMED/MEDICAMENTO
Clinical Research, Decree No.
S_USO_HUMANO/CEIC
57/2005 (Portuguese):
http://www.infarmed.pt/portal/p
age/portal/INFARMED/LEGIS
LACAO/LEGISLACAO_FAR
MACEUTICA_COMPILADA/
TITULO_III/TITULO_III_CAP
ITULO_I/portaria_57-2005.pdf
Privacy/Data
National Data Protection
1. Constitution, Article 35
Protection
Commission:
(1997)
http://www.cnpd.pt/english/index_en.
htm
2. Act on the Protection of
Personal Data, No. 67/98
(1998):
http://www.cnpd.pt/english/bin/l
egislation/Law6798EN.HTM
Genetic Research
Ministry of Health
Law 12/2005
Embryos, Stem
National Council of Ethics for the
Oviedo Convention on Human
1. Opinion 15/CNECV/95 on Embryo
Cells, and Cloning
Life Sciences
Rights and Biomedicine,
Research (1995)
http://www.cnecv.gov.pt/cnecv/en/
Additional Protocol on
Prohibition of Human Cloning
2. Opinion 47/CNECV/2005 on Stem Cell
(2001)
Research (2005):
http://www.cnecv.gov.pt/NR/rdonlyres/F1
2. Portuguese Law on Assisted
3B34FD-F9F7-4C9D-96DC-
Reproductive Technologies,
419999D9B693/0/47CNECV2005.pdf
Articles 7 and 9 (2006)
http://www.eshre.com/ESHRE/
3. Opinion 48/CNECV/2006 on Human
English/Legal-Matters-and-
Cloning (2006):
Guidelines/Legal-
http://www.cnecv.gov.pt/NR/rdonlyres/77
documentation/Portugal/page.as
0EA390-9326-4FF9-B28D-
px/473
D70A7E9AD961/0/p048_en.pdf
66
Romania
Note: For an overview of human subject protections in Romania, see “National Regulations on Ethics and Research in Romania:” http://ec.europa.eu/research/science-
society/pdf/ro_eng_lr.pdf
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Ministry of Health (MOH)
1. Law 336/2002
Ordinance No. 57/16.08.2002
(Romanian): http://www.ms.ro/
(2002)
2. Oviedo Convention on
Human Rights and Biomedicine
(2001)
Drugs
1. Ministry of Health (MOH)
MOH:
MOH:
(Romanian): http://www.ms.ro/
1. Emergency Ordinance
Guideline for Clinical Trials in Pediatric
2. National Medicines Agency:
152/1999 on Medicinal Products
Populations (CPMP/ICH/2711/99) (1999)
http://www.anm.ro/en/home.html
for Human Use
2. Order of MOH No. 1300/2004:
Detailed Guidance on the
Application Format and
Documentation to be Submitted
in an Application for an Ethics
Committee Opinion on the
Clinical Trial on Medicinal
Products for Human Use (2004)
3. Order of MOH No. 1117/2004:
Detailed Guidance for the
Request for Authorization of a
Clinical Trial on a Medicinal
Product for Human Use to the
Competent Authorities, Approval
of Substantial Amendments and
Declaration of the End of the
Trial (2004)
4. Order of MOH No.
904/25.07.2006 Transposing
Directive 2001/20/EC of the
European Parliament and of the
Council (2006)
67
Country Key
Organizations
Legislation
Regulations
Guidelines
Privacy/Data
National Supervisory Authority for
Law No. 667/2001 On the
Protection
Personal Data Processing:
Protection of Individuals with
http://www.dataprotection.ro/index.js
Regard to the Processing of
p?page=documents&lang=en
Personal Data and on the Free
Movement of Such Data:
http://www.dataprotection.ro/ser
vlet/ViewDocument?id=174
Embryos, Stem
Additional Protocol to the
Cells, and Cloning
Convention for the Protection of
Human Rights and Dignity of
the Human Being with regard to
the Application of Biology and
Medicine, on the Prohibition of
Cloning Human Beings (2001)
Russia
Note: For an overview of human subject protections in Russia, see “Ethical Review of Biomedical Research in the CIS Countries,” Chapter 3, Section 8:
http://www.unesco.ru/files/docs/shs/2007/publications/ethical_review_cis_book_kubar_english.pdf
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. Federal Service on Surveillance in
Constitution of the Russian
FSSHSD:
Healthcare and Social Development
Federation, Article 21 (1993):
(FSSHSD) (Russian):
Order No. 2314-Pr/07 17 on
http://www.roszdravnadzor.ru/
http://www.constitution.ru/en/10 August 2007 About the Ethics
003000-03.htm
Committee (Russian):
2. Ethics Committee of the Federal
Service on Surveillance in Healthcare
http://www.roszdravnadzor.ru/ab
and Social Development (Russian):
out/news/11698
http://www.roszdravnadzor.ru/etika/e
t/norm
68
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
1. Ministry of Health (MOH)
On Medicinal Products, Federal
MOH:
(Russian): http://www.minzdrav-
Law No. 86-FZ, Articles 35-41
rf.ru/
(2006) (1998 version in
1. Ministry of Health Order No.
Russian):
103 (March 24, 2000)
2. Federal Agency for Technical
Regulation and Metrology (GOST):
2. Clinical Practice Rules in the
http://www.medtran.ru/rus/trials
http://www.gost.ru/wps/portal/pages.
/gov/zakon_86.htm
Russian Federation, Minister’s
en.Main
Decree #266 (2003)
3. Ethics Committee of the Federal
GOST:
Service on Surveillance in Healthcare
Good Clinical Practice. GOST-R
and Social Development (Russian):
52379-2005 (September 27,
http://www.roszdravnadzor.ru/etika/e
2005)
t/norm
4. Scientific Center for Expertise of
the Remedies for Medicinal Use
(Russian): http://www.regmed.ru/
Privacy/Data
1. Federal Law of the Russian
Protection
Federation on Information,
Information Technologies, and
Protection of Information
(2006) 2. Federal Law of the
Russian Federation No. 152-FZ
on Personal Data (2006):
http://www.hunton.com/files/tbl
_s47Details/FileUpload265/162
5/Privacy_Russia_White_Paper.
pdf
Genetic
Federal Law of July 5, 1996, N
OF 8'-FZ “About the
Government Control in the Area
of Genetic-Engineering
Activity” (With changes of July
12, 2000)
San Marino
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Oviedo Convention on Human
Rights and Biomedicine (1998)
69
Serbia
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
1. Ministry of Health (MOH):
Law on Medicines and Medical
MOH:
Devices No. 84/2004 and
http://www.zdravlje.gov.rs/
85/2005:
1. Regulation on the Conditions
and Manner of Clinical Testing of
2. Serbian Drug Agency
http://www.alims.sr.gov.yu/eng/
regulativa/zakon.php
Medicinal Products, Procedure
http://www.alims.sr.gov.yu/
and Contents of Documentation
for Authorizing Clinical Trials of
Medicinal Products No. 19/2007:
http://www.alims.sr.gov.yu/eng/r
egulativa/pravilnici_l.php
2. Regulation on Changes of the
Regulation on Conditions and
Manner of Clinical Testing of
Medicinal Products, Procedure
and Contents of Documentation
for Authorizing Clinical Trials of
Medicinal Products No. 44/2009
Slovak Republic
Note: For an overview of human subject protections in the Slovak Republic, see “National Regulations on Ethics and Research in Slovak Republic:”
http://ec.europa.eu/research/science-society/pdf/sk_eng_lr.pdf http://www.eurecnet.org/information/slovakia.html
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. Ministry of Health (Slovak):
1. Act No. 576/2004 Coll., as
amended by Act No. 282/2006
http://www.health.gov.sk/
Coll.
2. Institute of Medical Ethics and
2004 law:
Bioethics:
http://www.privireal.org/content
http://www.bioethics.sk/
/rec/documents/Slovakia_ActNo
576_Healthcare_2004.pdf
2. Oviedo Convention on
Human Rights and Biomedicine
(1998)
3. Additional Protocol on
Biomedical Research (2005)
70
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
State Institute for Drug Control
Act on Drugs and Medical
Ministerial Regulation No.
(Slovak): http://www.sukl.sk/
Devices No. 140/1998, Coll., as
239/2004 Coll. on Requirements
amended by Act No. 545/2006
for Clinical Trials and Good
Clinical Practice (2004)
Privacy/Data
Office for Personal Data Protection:
Act No. 428/2002 Coll. on
Protection
http://www.dataprotection.gov.sk/bux
Protection of Personal Data, as
us/generate_page.php3?page_id=413
Amended (2005):
http://www.privireal.org/content
/dp/documents/SlovakiaAct428_
2002%20_2005_PersonalData.p
df
Human Biological
Act No. 576/2004 Coll.,
Materials
Sections 35-39.
Embryos, Stem
Additional Protocol to the
Cells, and Cloning
Convention for the Protection of
Human Rights and Dignity of
the Human Being with regard to
the Application of Biology and
Medicine, on the Prohibition of
Cloning Human Beings (1998)
Slovenia
Note: For an overview of human subject protections in Slovenia, see “National Regulations on Ethics and Research in Slovenia:” http://ec.europa.eu/research/science-
society/pdf/sl_eng_lr.pdf
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. Oviedo Convention on
Slovenian Code of Medical Deontology,
Human Rights and Biomedicine
Articles 47-50 (1992)
(1998)
2. Additional Protocol on
Biomedical Research (2006)
71
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
1. National Medical Ethics
NMEC:
Committee (NMEC)
1. Ministerial Decree No. 30
2. Agency for Medicinal Products
(1995)
and Medical Devices (Slovenian):
http://www.jazmp.si/index.php?id=56
2. Statutory Notes (1998)
3. Slovenian Directive on Clinical
Drug Testing No. 67.8372-8385
(2000)
4. On the Ethical Review of
Phase IV Clinical Studies (2003)
(Slovenian): http://www.mf.uni-
lj.si/kme-
nmec/Docu/Ocenjevanje_klin_stu
dij_IV_faze.pdf
Privacy/Data
Inspectorate for Personal Data
1. Personal Data Protection Act
Protection
Protection (Slovenian):
No. 59 (1999)
http://www.ip-rs.si/
2. Act Amending the Personal
Data Protection Act No.
57/2001
Human Biological
National Medical Ethics Committee
On Interventions into the Human
Convention on Human Rights and
Materials
(NMEC)
Corpse Which are not Part of the
Biomedicine (Convention of Oviedo),
Routine Autopsy and on
Articles 21-22 (1999)
Handling with Biologic Material
of Human Origin (2004)
Embryos, Stem
1. Additional Protocol to the
Cells, and Cloning
Convention for the Protection of
Human Rights and Dignity of
the Human Being with regard to
the Application of Biology and
Medicine, on the Prohibition of
Cloning Human Beings (2002)
http://conventions.coe.int/Treaty
/en/Treaties/Html/168.htm
2. Law on Biomedically
Assisted Fertilization No. 70
(2000)
72
Spain
Note: For an overview of human subject protections in Spain, see “National Information – Spain”: http://www.eurecnet.org/information/spain.html
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. Spanish Bioethics Committee:
1. Oviedo Convention on
http://www.comitedebioetica.es/?lang
Human Rights and Biomedicine
=en_US
(1999)
2. Coordinating Center for Ethical
2. Law 14/2007 on Biomedical
Committees on Clinical Research
Research:
(Spanish):
http://www.catedraderechoygen
http://www.msc.es/profesionales/far
omahumano.es/images/novedad
macia/ceic/home.htm
es/SpanishLawonBiomedicalRe
searchEnglish.pdf
Drugs
Spanish Agency for Medications and
Royal Decree 223/2004:
1. Order SCO/256/2007 That
Health Products, Clinical Trials
Regulation of Medication
Establishes the Principles and
Note: Many of the
(Spanish):
Clinical Trials (Spanish):
Detailed Directives on Good
Spanish autonomous http://www.agemed.es/profHumana/e http://www.agemed.es/actividad Clinical Practice, and the
communities have
nsayosClinicos/home.htm
/legislacion/espana/ensayos.htm
Requirements to Approve the
their own laws and
Manufacture and Import of
regulations
Research Medications for Human
pertaining to drug
Use (Spanish):
research.
http://www.agemed.es/actividad/l
egislacion/espana/ensayos.htm
2. Order SCO/362/2008 that
Modifies Order SCO/256/2007
(Spanish):
http://www.agemed.es/actividad/l
egislacion/espana/ensayos.htm
Privacy/Data
Spanish Data Protection Authority
1. Organic Law 15/1999 of
Protection
(Spanish):
December 13 on the Protection
https://www.agpd.es/portalweb/index
of Personal Data:
Note: Many of the
-ides-idphp.php
https://www.agpd.es/upload/Ley
Spanish autonomous
%20Org%E1nica%2015-
communities have
99_ingles.pdf
their own laws and
regulations on
2. Law 14/2007 on Biomedical
privacy/data
Research, Title I, Article 5:
protection.
http://www.catedraderechoygen
omahumano.es/images/novedad
es/SpanishLawonBiomedicalRe
searchEnglish.pdf
73
Country Key
Organizations
Legislation
Regulations
Guidelines
Human Biological
Ministry of Health and Consumption: 1. Royal Decree 1301/2006 of
Royal Decree 65/2006 of
Materials
November 10 Regarding the
Requirements for the Import and
http://www.msc.es/en/home.htm
Use of Cells and Human Tissue: Export of Biological Samples
(2006)
http://www.ont.es/legislacion/fic
herosPDF/RD1301.pdf
2. Royal Decree 2070/1999 of
December 30, Regarding
Activities of Collection and
Clinical Use of Human Organs
for Organ Transplants and
Tissues
3. Law 14/2007 of July 3 on
Biomedical Research, Title I,
Article 11; Title III, Article 37;
Title V:
http://www.catedraderechoygen
omahumano.es/images/novedad
es/SpanishLawonBiomedicalRe
searchEnglish.pdf
Genetic
Spanish Bioethics Committee:
Law 14/2007 of July 3 on
Biomedical Research, Title I,
http://www.comitedebioetica.es/?lang
Articles 6-9; Title V:
=en_US
http://www.catedraderechoygen
omahumano.es/images/novedad
es/SpanishLawonBiomedicalRe
searchEnglish.pdf
74
Country Key
Organizations
Legislation
Regulations
Guidelines
Embryos, Stem
Spanish Bioethics Committee:
1. Additional Protocol to the
Cells, and Cloning
Convention for the Protection of
http://www.comitedebioetica.es/?lang
Human Rights and Dignity of
=en_US
the Human Being with regard to
the Application of Biology and
Medicine, on the Prohibition of
Cloning Human Beings (2000)
2. Law 14/2006 on Methods of
Assisted Human Reproduction,
Chapters IV and V:
http://www.eshre.com/ESHRE/
English/Legal-Matters-and-
Guidelines/Legal-
documentation/Spain/page.aspx/
170
3. Law 14/2007 of July 3 on
Biomedical Research, Title III:
http://www.catedraderechoygen
omahumano.es/images/novedad
es/SpanishLawonBiomedicalRe
searchEnglish.pdf
75
Sweden
Note: For an overview of human subject protections in Sweden, see “CODEX: Rules and Guidelines for Research:” http://www.codex.uu.se/en/index.shtml
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. Central Ethical Review Board
Law No. 460 on the Ethical
CEPN:
CEPN:
(CEPN):
Review of Research Involving
Humans (2003)
1. Ordinance No. 615 Concerning Information for Research Participants
http://www.epn.se/start/startpage.asp
the Ethical Vetting of Research
x 2. Swedish Research Council
Involving Humans (2003)
SRC:
(SRC): http://www.vr.se/english
2. Statute No. 2007:1069
1. Ethical Guidelines of Epidemiological
Containing Instructions for
Research (1994)
Regional Ethical Review Boards
2. Guidelines for Good Medical Research
(2007)
(1996)
3. Statute No. 2007:1068
3. Guidelines for the Ethical Evaluation of
Containing Instructions for the
Medical Research on Humans (2003)
Central Ethical Review Boards
(2007)
4. Policy Statement Regarding the
Assessment of Scientific Studies in which
Patients or Healthy Subjects are to
Undergo Invasive Operations (2003)
Drugs
Medical Products Agency:
Pharmaceuticals Act No. 1992:
1. Medical Products Agency’s
859 (Swedish):
Provisions and Guidelines on the
http://www.lakemedelsverket.se/Tpl/
Clinical Trials of Medicinal
StartPage____395.aspx
http://www.notisum.se/rnp/SLS/
Products (1996):
LAG/19920859.HTM
http://www.lakemedelsverket.se/u
pload/foretag/humanlakemedel/K
linisk%20pr%c3%b6vning/Provis
ions%20and%20guidelines%20o
n%20clinical%20trials%201996-
17.pdf
2. Medical Product Agency’s
Provisions and Guidelines on
Clinical Trials of Medicinal
Products for Human Use (2003):
http://www.lakemedelsverket.se/u
pload/foretag/humanlakemedel/K
linisk%20pr%c3%b6vning/Provis
ions%20and%20guidelines%20o
n%20clinical%20trials%202003-
11.pdf
76
Country Key
Organizations
Legislation
Regulations
Guidelines
Privacy/Data
Swedish Data Inspection Board:
1. Personal Data Act No. 204
Swedish Data Inspection Board Report
Protection
http://www.datainspektionen.se/in-
(1998):
2004:2
english/
http://www.datainspektionen.se/
pdf/ovrigt/pul-eng.pdf
Human Biological
1. National Board of Health and
2. Biobanks in Medical Care
SOS:
SRC:
Materials
Welfare (SOS):
Act No. 297 (2002):
http://www.socialstyrelsen.se/english
http://www.sweden.gov.se/conte
1. Regulation No. 746 (2002)
Research Ethics Guidelines for Using
nt/1/c6/02/31/26/f69e36fd.pdf
Biobanks (2003)
2. Swedish Research Council (SRC):
2. SOSFS No. 11 (2002)
http://www.vr.se/english
3. SOSFS No. 2 (2004)
3. Swedish National Biobank
Program: http://www.biobanks.se/
Genetic Research
1. Ministry of Health and Social
Act on Genetic Integrity
Genetics and Gene Technology in the
Affairs:
(2006:351) (Swedish):
Health Care: State of the Art and
http://www.sweden.gov.se/sb/d/2061
http://www.notisum.se/rnp/sls/la
Guidelines for Ethical Considerations
g/20060351.htm
(1999)
2. National Board of Health and
Welfare:
http://www.socialstyrelsen.se/english
Embryos, Stem
Act on Genetic Integrity
Legal Regulation of Stem Cell
Cells, and Cloning
(2006:351) (Swedish):
Research 2002:119:
http://www.notisum.se/rnp/sls/la
http://www.regeringen.se/sb/d/10
g/20060351.htm
8/a/2717
Switzerland
Note: For an overview of human subject protections in Switzerland, see “National Information – Switzerland:” http://www.eurecnet.org/information/switzerland.html
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. Swiss Academy of Medical
SAMS:
Sciences (SAMS):
Note: Many Swiss
http://www.samw.ch/
1. Guidelines on Human Research (1997)
cantons have
implemented
2. Swiss National Advisory
2. Memorandum Concerning Research on
pertinent regulations Commission on Biomedical Ethics
Human Beings (2009)
(French):
(NEK-CNE): http://www.nek-
http://www.swisseth
cne.ch/?langId=2
ics.ch/fileadmin/user
_upload/Dokumente/ 3. Swiss Ethics Committees for
f_RegelungenKant.d
Research:
oc
http://www.swissethics.ch/fileadmin/
se/swissethics_en.htm
77
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
Swiss Agency for Therapeutic
Federal Law on Medicinal
Ordinance on Clinical Trials of
Products (Swissmedic):
Products and Medical Devices
Therapeutic Products, RS
http://www.swissmedic.ch/index.html
(2002)
812.214.2 (2004):
?lang=en
http://www.swissmedic.ch/files/p
df/VKlin%20_e_%202005-03-
14.pdf
Privacy/Data
Federal Data Protection
1. Federal Law on Data
Protection
Commissioner:
Protection (1992) (French):
http://www.edoeb.admin.ch/index.ht
http://www.admin.ch/ch/f/rs/c23
Note: Many Swiss
ml?lang=en
5_1.html
cantons have
enacted laws
2. Regulation of June 14, 1993
regarding data
Regarding the Release of
collection in the
Professional Secrets in the Area
public sector.
of Medical Research, RS
235.154 (French):
http://www.admin.ch/ch/f/rs/235
_154/index.html
3. Confidentiality in Medical
Research (2006) (French):
http://www.admin.ch/ch/f/rs/311
_0/a321bis.html
Human Biological
Swiss Academy of Medical Sciences
Biobanks: Obtainment, Preservation and
Materials
(SAMS): http://www.samw.ch/
Utilization of Human Biological Material
(2006)
Genetic Research
1. Swiss Academy of Medical
Swiss Federal Constitution,
Ordinance on Clinical Trials of
Sciences: http://www.samw.ch/
Article 119 (2006):
Therapeutic Products RS
812.214.2, Section 2 (2004):
2. Swiss Society of Medical Genetics: http://www.oefre.unibe.ch/law/i
http://www.swissmedic.ch/files/p
cl/sz00000_.html
http://www.ssgm.ch/
df/VKlin%20_e_%202005-03-
14.pdf
78
Country Key
Organizations
Legislation
Regulations
Guidelines
Embryos, Stem
Swiss National Advisory
NEK-CNE:
Cells, and Cloning
Commission on Biomedical Ethics
(NEK-CNE):
1. Pre-Implantation Genetic Diagnosis,
http://www.bag.admin.ch/nek-
Opinion No. 10/2005
cne/04236/index.html?lang=en
2. Research Involving Human Embryos
and Fetuses. Opinion No. 11/2006
3. Pre-Implantation Genetic Diagnosis II,
Opinion No. 14/2007:
http://www.bag.admin.ch/nek-
cne/04229/04232/index.html?lang=en
Turkey
Note: For an overview of human subject protections in Turkey, see “National Regulations on Ethics and Research in Turkey:” http://ec.europa.eu/research/science-
society/pdf/tr_eng_lr.pdf
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Ministry of Health (Turkish):
1. Turkish Constitution, Article
1. Regulation on Medical
http://www.saglik.gov.tr/
17
Deontology, Article 11 (1960)
2. Health Services Basic Law
2. Bylaw on Patient Rights No.
No. 3359 (1987)
23420 (1998)
3. Oviedo Convention on
Human Rights and Biomedicine
(2004)
Drugs
Ministry of Health (Turkish):
Turkish Penal Law, Article 90
1. Bylaw on the Evaluation and
GCP Guideline (2009)
http://www.saglik.gov.tr/
(2005)
Monitoring of the Safety of
Medical Products (2005)
Access: http://www.clinicstr.org/
2. Regulation Regarding the
Implementation and Inspection of
the Support for Research and
Development Activities (2008)
3. Regulation Regarding Clinical
Trials (2008)
Access: Many of these documents
are available on the website of the
Turkish Clinical Research
Association:
http://www.clinicstr.org/
79
Country Key
Organizations
Legislation
Regulations
Guidelines
Human Biological
1. Law on Procurement,
Regulation on Blood and Blood
Convention on Human Rights and
Materials
Preservation, Grafting, and
Products, No. 7314 (1983)
Biomedicine (Convention of Oviedo),
Transplantation of Organs and
Articles 21-22 (1999)
Tissues, No. 2238 (1979)
2. Law on Blood and Blood
Products, No. 2857 (1983)
Genetic Research
Regulation on Centers for
Convention on Human Rights and
Diagnosis and Genetic Diseases,
Biomedicine (Convention of Oviedo),
No. 23368 (1998)
Articles 12-14 (1999)
Embryos, Stem
1. Regulation on Centers for
1. Circular on Research of Embryonic
Cells, and Cloning
Medically Assisted Procreation,
Stem Cells (2005)
No. 19551 (1987)
2. Guideline on Clinical Research of Non-
2. Regulation on Organ and
Embryonic Stem Cells (2006)
Tissue Transplantation Services
(2005)
3. Regulation on Cordon Blood
Banks (2005)
80
Ukraine
Note: For an overview of human subject protections in the Ukraine, see “Ethical Review of Biomedical Research in the CIS Countries,” Chapter 3, Section 10:
http://www.unesco.ru/files/docs/shs/2007/publications/ethical_review_cis_book_kubar_english.pdf
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. Ethical Commission with the
EC-HEC:
Higher Education Committee (EC-
HEC)
Order of this Committee for
Requirements of Ethical Review
2. Ukrainian Ministry of Health:
of All Dissertation Theses on
Science, Degree in Biology,
http://www.moz.gov.ua/en/
Medicine, and Veterinary
Medicine (2005)
MOH:
1. Order No. 485 About Creation
and Composition of Central
Ethics Committee of Ministry of
Health of the Ukraine (2006)
(Ukrainian):
http://www.moz.gov.ua/ua/main/
docs/?docID=6893
2. Order No. 142 About
Optimization of Work of Central
Ethics Committee of Ministry of
Health of the Ukraine (2007)
(Ukrainian):
http://www.moz.gov.ua/ua/main/
docs/?docID=7989
81
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
1. State Pharmacological Center:
On Medicines, Articles 7 and 8
1. Ukrainian Ministry of Health
MOH Central Ethics Committee:
http://www.pharma-
No. 123/96ВР (1996):
Order No. 95 About Approval of
center.kiev.ua/view/all_information
Documents Related to the Quality 1. Information Letters on Ethics Questions
http://www.pharma-
Assurance of Medicines (2009)
of Clinical Trials and Implementation of
2. Ukrainian Ministry of Health,
center.kiev.ua/site/file_uploads//
(Ukrainian):
Medicines (2006)
Central Ethics Committee:
en/new_doc/law_en.doc
http://www.moz.gov.ua/ua/main/
2. Ethics Expertise of Clinical Trials
http://www.moz.gov.ua/en/main/siter
docs/?docID=12796
Medicines (2007)
ubr/
2. Ukrainian Ministry of Health
3. Methodological Aspects of Central EC
Order No. 66 About Approval of
Activity of Ukrainian Ministry of Health
Procedure for Conducting
(2007)
Clinical Trials of Medicinal
Products and Expert Evaluation
4. Ethical Aspects of Placebo Controlled
of Materials Pertinent to Clinical
Clinical Trials in Patients with MS (2008)
Trials and Model Regulations of
5. Optimization of Local Ethics
the Ethics Committee (2006):
Committee Activities (2009)
http://www.pharma-
center.kiev.ua/site/file_uploads//e
n/new_doc/66_p.doc
Privacy/Data
Information Act from the
Protection
Cabinet of Ministers of the
Ukraine (2002)
Human Biological
Ukrainian Ministry of Health:
Ukrainian Ministry of Health
Materials
Order No. 630 About Approval of
http://www.moz.gov.ua/en/main/siter
Procedure for Conduction
ubr/
Clinical Trials of Tissue and Cell
Transplants and Expert
Evaluation of Materials of
Clinical Trials (2007)
(Ukrainian):
http://www.moz.gov.ua/ua/main/
docs/?docID=8767
Genetic Research
Academy of Medical Sciences of the
Medical and Ethical Guidelines for
Ukraine
Genetic Investigations in Humans
82
Country Key
Organizations
Legislation
Regulations
Guidelines
Embryos, Stem
1. National Bioethics Committee of
1. About the Ban of
1. Recommendation No. 1046,
NBC:
Cells, and Cloning
the National Academy of Sciences of
Human Reproductive Cloning
Use of the Human Fetus for the
the Ukraine (NBC)
(2004)
Purpose of Diagnosis, Therapy,
Ethical Regulations and Problems of
Research, Industrial Purchase,
Embryo-Tissue Storage
2. Ukrainian Ministry of Health:
2. About Organs and Other
and Trading (1986)
(Recommendations)
Human Materials
http://www.moz.gov.ua/en/main/siter
Transplantology No. 1007-XIV
2. Ukrainian Ministry of Health
ubr/
(2007)
Order No. 630 Regarding
Approval of the Procedure for the
Conduct of Clinical Trials of
Tissue and Cell Transplants and
Expert Evaluation of Materials of
Clinical Trials (2007)
(Ukrainian):
http://www.moz.gov.ua/ua/main/
docs/?docID=8767
83
United Kingdom
Note: Unless otherwise noted, all laws, regulations, and guidelines listed for England apply to the entire United Kingdom.
England
Country
Legislation Regulations Guidelines
General
1. Department of Health (DH):
Mental Capacity Act 2005,
DH:
http://www.dh.gov.uk/Home/fs/en
Sections 30-34 (England and
Wales):
1. Governance Arrangements for NHS
2. National Research Ethics Service
Research Ethics Committees (2001)
(NRES):
http://www.opsi.gov.uk/acts/act
s2005/20050009.htm
http://www.dh.gov.uk/en/Publicationsands
http://www.nres.npsa.nhs.uk/home
tatistics/Publications/PublicationsPolicyA
ndGuidance/DH_4005727
3. Medical Research Council (MRC):
http://www.mrc.ac.uk/PolicyGuidanc
2. Research Governance Framework for
e/EthicsAndGovernance/index.htm
Health and Social Care (2005)
4. Royal College of Physicians:
http://www.dh.gov.uk/en/Publicationsands
http://www.rcplondon.ac.uk/
tatistics/Publications/PublicationsPolicyA
ndGuidance/DH_4108962
5. Association of Research Ethics
Committees: http://www.arec.org.uk/
6. Appointing Authority for Phase 1
Ethics Committees (AAPEC)
http://www.aapec.org.uk/
7. Economic and Social Research
Council (ESRC):
http://www.esrc.ac.uk/
84
Country
Legislation Regulations Guidelines
General
NRES:
1. NRES Guidance on Information Sheets
and Consent Forms (2007)
2. NRES Guidance on Research Involving
Adults Unable to Consent for Themselves
(Including Guidance on the Mental
Capacity Act 2005) (2007)
3. Guidance for Applicants to NRES
(2007)
4. Standard Operating Procedures for
Research Ethics Committees in the United
Kingdom (2008)
5. NRES Leaflets (2008):
Building on Improvement
Research Ethics Timeline
Defining Research
Explaining Research
Integrated Research Application System
(2008):
https://www.myresearchproject.org.uk/
MRC:
1. MRC Guidelines for Good Clinical
Practice in Clinical Trials (1998)
2. Good Research Practice (2000)
3. Personal Information in Medical
Research (2000)
4. Research Involving Human Participants
in Developing Societies (2004)
5. Medical Research Involving Children
(2004)
RCP:
Guidelines on the Practice of Ethics
85
Committees in Medical Research with
Human Participants (2007)
ESRC:
Research Ethics Framework
Country
Legislation Regulations Guidelines
Drugs
1. Medicines and Healthcare Products Medicines Act (1968):
MHRA:
MHRA:
Regulatory Agency (MHRA):
http://www.legislation.gov.uk/R
http://www.mhra.gov.uk
evisedStatutes/Acts/ukpga/1968/ 1. The Medicines for Human Use
Consultation Letter on the Medicines for
cukpga_19680067_en_1
(Clinical Trials) Regulations,
Human Use (Clinical Trials) Regulations
2. Medical Research Council (MRC):
Statutory Instrument No. 1031
(2003)
http://www.mrc.ac.uk/index.htm
(2004): http://www.uk-
legislation.hmso.gov.uk/si/si2004
MRC:
3. National Research Ethics Service
/20041031.htm
(NRES):
1. MRC Guidelines for Good Clinical
http://www.nres.npsa.nhs.uk/home
2. Amendment Regulations (SI
Practice in Clinical Trials (1998)
2006/1928)
2. MRC Policy on Antiretroviral Therapy
http://www.opsi.gov.uk/si/si2006/
for People Infected with HIV and
20061928.htm
Involved in AIDS Research in Developing
3. Amendment to the Medicines
Countries (2003)
for Human Use (Clinical Trials)
NRES:
Regulations 2004 and Adults with
Incapacity (Scotland) Act 2000 to Memorandum of Understanding between
Facilitate Clinical Research in
MHRA, COREC, and GTAC (2006)
Emergency Settings (SI
http://www.nres.npsa.nhs.uk/rec-
2006/2984):
community/guidance/
http://www.opsi.gov.uk/si/si2006/
20062984.htm
Privacy/Data
1. Medical Research Council (MRC): Data Protection Act (1998):
MRC:
Collection
http://www.mrc.ac.uk/index.htm
http://www.opsi.gov.uk/acts/act
s1998/19980029.htm
Personal Information in Medical Research
2. Information Commissioner Office:
(2000)
http://www.informationcommissioner
A number of Statutory
.gov.uk/
Instruments have been
NRES:
developed to implement the
3. National Research Ethics Service
Ethical Review of Research Databases
Data Protection Act:
(NRES):
(2008):
http://www.dca.gov.uk/ccpd/dps
http://www.nres.npsa.nhs.uk/home
ubleg.htm
http://www.nres.npsa.nhs.uk/rec-
community/guidance/#useofpersonaldata
NHS Information Governance: Security of
NHS Patient Data Shared for Research
Purposes (2008):
http://www.connectingforhealth.nhs.uk/sy
stemsandservices/infogov/whatsnew
86
Country
Legislation Regulations Guidelines
Human Biological
1. Royal College of Physicians
1. Human Tissue Act (2004):
RCP:
Materials
(RCP):
http://www.opsi.gov.uk/acts/act
http://www.rcplondon.ac.uk/index.as
s2004/20040030.htm
Research Based on Archived Information
p
and Samples (1999)
2. Statutory Instrument 2006
2. Medical Research Council (MRC): No. 1260: The Human Tissue
MRC:
http://www.mrc.ac.uk/index.htm
Act 2004 (Ethical Approval,
Human Tissue and Biological Samples for
Exceptions from Licensing and
3. Department of Health (DH):
Use in Research (2001) + Annex (2004)
Supply of Information about
http://www.dh.gov.uk/Home/fs/en
Transplants) Regulations 2006:
DH:
4. Human Tissue Authority (HTA):
http://www.opsi.gov.uk/si/si200
The Use of Human Organs and Tissue: An
http://www.hta.gov.uk/
6/20061260.htm
Interim Statement (2003):
3. Statutory Instrument 2006
http://www.nres.npsa.nhs.uk/docs/guidanc
No. 1659: The Human Tissue
e/MoU.pdf
Act 2004 (Persons who Lack
Capacity to Consent and
HTA:
Transplants) Regulations 2006:
Codes of Practice 2006
http://www.opsi.gov.uk/si/si200
6/20061659.htm
Genetics Research
1. Advisory Committee on Genetic
ACGT:
Testing (ACGT):
http://www.advisorybodies.doh.gov.u
Advice to Research Ethics Committees
k/genetics/acgt/
(1998)
2. Public Health Genetics Unit:
http://www.phgu.org.uk/index.php
Embryos, Stem
Human Fertilisation and Embryology
Human Fertilisation and
Human Fertilisation and
Cells, and Cloning
Authority: http://www.hfea.gov.uk/
Embryology Act (1990):
Embryology (Research Purposes)
http://www.opsi.gov.uk/acts/act
Regulation (2001)
s1990/Ukpga_19900037_en_1.h
tm
87
Northern Ireland:
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Northern Ireland
Research Governance Framework for
Health and Social Care (2002)
Health and Personal Social Services:
http://www.dhsspsni.gov.uk/
Scotland:
Country Key
Organizations
Legislation
Regulations
Guidelines
General
NHSScotland, Chief Scientist Office: Adults with Incapacity
Adults with Incapacity (Ethics
Research Governance Framework for
http://www.show.scot.nhs.uk/cso/
(Scotland) Act 2000, Section
Committee) (Scotland)
Health and Community Care (2006)
51:
Regulations (2002):
http://www.opsi.gov.uk/legislati
http://www.scotland-
on/scotland/acts2000/20000004.
legislation.hmso.gov.uk/legislatio
htm
n/scotland/ssi2002/20020190.htm
Privacy/Data
NHSScotland:
Protecting Patient Confidentiality (2002)
Collection
http://www.show.scot.nhs.uk/
Wales:
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Wales Office of Research and
Research Governance Framework for
Development for Health and Social
Health and Social Care in Wales (2001)
Care:
http://wales.gov.uk/topics/health/rese
arch/word/?lang=en
88
ASIA/PACIFIC/MIDDLE EAST
Australia
Country Key
Organizations
Legislation
Regulations
Guidelines
General
National Health and Medical
National Health and Medical
National Health and Medical
1. Values and Ethics: Guidelines for
Research Council, Australian Health
Research Council Act (1992):
Research Regulations (2006):
Ethical Conduct in Aboriginal and Torres
Ethics Committee:
http://www.comlaw.gov.au/Co
Strait Islander Health Research (2003)
http://www.nhmrc.gov.au/about/com
mLaw/Legislation/ActCompilati
http://www.comlaw.gov.au/Com
mittees/ahec/index.htm
on1.nsf/all/search/4AFACF8FA
Law/Legislation/LegislativeInstru
2. Keeping Research on Track: A Guide
AF9ED97CA25719C0081EF9F ment1.nsf/all/search/CD6C81A81
for Aboriginal and Torres Strait Islander
Australian Research Council
3A14BCCCA257211000E4F9D
Peoples about Health Research Ethics
(2006)
http://www.arc.gov.au/
3. National Statement on Ethical Conduct
in Human Research (2007)
4. Australian Code for the Responsible
Conduct of Research (2007)
Drugs
Therapeutic Goods Administration:
Therapeutic Goods Act (2009):
Therapeutic Goods Regulations
1. Human Research Ethics Committees
http://www.tga.gov.au/ct/index.htm
(1991)
and the Therapeutic Goods Administration
http://www.comlaw.gov.au/Co
http://www.comlaw.gov.au/Com
(2001)
mLaw/Legislation/ActCompilati
Law/Legislation/LegislativeInstru
on1.nsf/all/search/89DC85FBD
mentCompilation1.nsf/all/search/
2. Australian Clinical Trial Handbook
2CF7799CA25762C000A762F
AC1C41C98B71506ACA257631
(2006)
002F4B15
http://www.tga.gov.au/ct/cthandbook.htm
Privacy/Data
Office of the Privacy Commissioner:
Privacy Act No. 119 (2009):
Privacy (Private Sector)
Protection
http://www.privacy.gov.au/
http://www.comlaw.gov.au/com
Regulations (2001):
law/Legislation/ActCompilation
http://www.comlaw.gov.au/Com
Note: All the
1.nsf/all/search/8039E7AB4B89
Law/Legislation/LegislativeInstru
Australian states and
A16ACA25760700060E24
mentCompilation1.nsf/all/search/
territories have
C46A983B1C8AA3DFCA25760
privacy/data
A00097BFE
protection laws:
http://www.austlii.ed
u.au/au/other/alrc/pu
blications/reports/10
8/vol_3_full.pdf
89
Country Key
Organizations
Legislation
Regulations
Guidelines
Human Biological
National Health and Medical
National Statement on Ethical Conduct in
Materials
Research Council, Australian Health
Human Research (2007): Chapters 3.2 and
Ethics Committee:
3.4
Note: All the
http://www.nhmrc.gov.au/about/com
Australian states and mittees/ahec/index.htm
territories have laws
on the use of human
biological materials.
Genetic Research
1. National Health and Medical
Gene Technology Act (2000):
AHEC:
Research Council, Australian Health
http://www.comlaw.gov.au/Co
Ethics Committee (AHEC):
mLaw/Legislation/ActCompilati
National Statement on Ethical Conduct in
http://www.nhmrc.gov.au/about/com
on1.nsf/all/search/51A2449A3E
Human Research, Chapter 3.5 (2007)
mittees/ahec/index.htm
BB9A1CCA257475001ECD9C
2. Office of the Gene Technology
Regulator: http://www.ogtr.gov.au/
Embryos, Stem
1. National Health and Medical
1. Prohibition of Human
Research Involving Human
AHEC:
Cells, and Cloning
Research Council, Australian Health
Cloning Act (2008):
Embryos Regulations (2003):
Ethics Committee (AHEC):
http://www.comlaw.gov.au/Co
1. National Statement on Ethical Conduct
http://www.nhmrc.gov.au/about/com
mLaw/Legislation/ActCompilati
http://www.comlaw.gov.au/Com
in Human Research, Chapter 3.6 (2007)
mittees/ahec/index.htm
on1.nsf/all/search/ED63FF59CF
Law/Legislation/LegislativeInstru
2. Ethical Guidelines on the Use of
EBB728CA2575280008CFC5
mentCompilation1.nsf/all/search/
2. National Health and Medical
53B9DAE14F396A2CCA25744E Assisted Reproductive Technology in
Research Council: Embryo Research
2. Research Involving Human
0005E313
Clinical Practice and Research (2007)
Licensing Committee
Embryos Act (2008):
http://www.comlaw.gov.au/Co
http://www.nhmrc.gov.au/about/com
mLaw/Legislation/ActCompilati
mittees/lc/index.htm
on1.nsf/all/search/535F95A0A6
D118AACA25752700811D2E
Bangladesh
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Bangladesh Medical Research
Council, Ethics Review Committee:
http://www.bmrcbd.org
Drugs
Bangladesh Directorate of Drug
1. The Drugs Act (1964)
Administration:
http://www.ddabd.org
2. Drugs (Control) Ordinance
1982, Ordinance No. VIII:
http://www.ddabd.org/ordinance
_1982.htm
90
Country Key
Organizations
Legislation
Regulations
Guidelines
Human Biological
Bangladesh Medical Research
Guidelines for Transfer of Human
Materials
Council, Ethics Review Committee:
Biological Materials Abroad for Research
http://www.bmrcbd.org
Purposes (2004)
Burma (Myanmar)
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. Ministry of Health National Ethics
DMR:
Committee on Clinical Research:
Operational Guidelines for
www.moh.gov.mm
Institutional Ethical Review
Committee (2005)
2. Department of Medical Research
(DMR)
China, People’s Republic of
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. Ministry of Health (MOH)
Law on Practicing Doctors
MOH:
(Mandarin): http://www.moh.gov.cn/
(June 26, 1998), Articles 26 and
37
Guidelines on Ethical Review of
2. Chinese Association for Science
Biomedical Research Involving Human
and Technology (CAST)
Subjects (2007) (Mandarin):
http://www.moh.gov.cn/publicfiles/busine
3. Ministry of Science and
ss/htmlfiles/mohkjjys/s3581/200804/1881
Technology
6.htm
CAST:
Moral Standards for Scientists (2007)
91
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
State Food and Drug Administration:
Drug Administration Law
1. Implementation Bylaws for the 1. Guideline for HIV Vaccine Research
http://www.sfda.gov.cn/
(2001)
Drug Administration Law (2002)
Technology (2003) (Mandarin):
(Mandarin)
http://www.sfda.gov.cn/WS01/CL0237/15
705.html
http://www.moh.gov.cn/publicfile
s/business/htmlfiles/mohyzs/s357
2. Guideline for Vaccine Research
2/200804/18293.htm
Technology (2004) (Mandarin):
http://www.sfda.gov.cn/WS01/CL0055/10
2. Chinese Good Clinical Practice 307.html
(2003) (Mandarin):
http://www.sfda.gov.cn/WS01/C
L0053/24473.html
3. Regulation on Drug
Registration (2007) (Chinese):
http://www.sda.gov.cn/WS01/CL
0053/24529.html
4. Qualification and Evaluation of
Clinical Trial Sites (2008)
(Chinese):
http://www.sfda.gov.cn/WS01/C
L0121/29571.html
Human Biological
Ministry of Health (Mandarin):
Materials
http://www.moh.gov.cn/
Genetic Research
1. Ministry of Health (MOH)
MOH and MOST:
(Mandarin): http://www.moh.gov.cn/
Interim Measures for the
2. Ministry of Science and
Administration of Human Genetic
Technology (MOST)
Resources (1998)
92
Country Key
Organizations
Legislation
Regulations
Guidelines
Embryos, Stem
1. Ministry of Health (MOH)
MOH:
Cells, and Cloning
(Mandarin): http://www.moh.gov.cn/
1. Ethical Principles and Conduct
2. Ministry of Science and
Norms for Human Assisted
Technology (MOST)
Reproductive Technologies.
(2003)
2. Regulation on Medical
Technique (2009)
http://www.moh.gov.cn/publicfile
s/business/htmlfiles/zwgkzt/pyzgl
/200903/39511.htm
MOH and MOST:
Ethical Guideline for Research on
Human Embryo Stem Cells
(2004)
Hong Kong
Country Key
Organizations
Legislation
Regulations
Guidelines
Privacy/Data
Privacy Commissioner for Personal
Personal Data (Privacy)
Protection
Data: www.pco.org.hk
Ordinance (1996):
http://www.pco.org.hk/english/o
rdinance/ordfull.html
Embryos, Stem
Government of the Hong Kong
Human Reproductive Technology
Cells, and Cloning
Special Administrative Region
Ordinance, Chapter 561 (2002):
http://www.hklii.org.hk/hk/legis/o
rd/561/
India
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. National Committee for Ethics in
NCESSRH:
Social Science Research in Health
(NCESSRH)
Ethical Guidelines for Social Science
Research (2000)
2. Indian Council of Medical
Research (ICMR):
ICMR:
http://www.icmr.nic.in/human_ethics.
Ethical Guidelines for Biomedical
htm
Research on Human Participants (2006)
93
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
1. Central Drugs Standard Control
Drugs and Cosmetics Act,
DCGI:
ICMR:
Organization, Office of Drugs
Schedule Y (2005)
Controller General of India (DCGI):
Good Clinical Practices for
Ethical Guidelines for Biomedical
http://cdsco.nic.in
Clinical Research in India (2001): Research on Human Subjects: Statement
http://cdsco.nic.in/html/GCP.htm of Specific Principles for Clinical
2. Indian Council of Medical
Evaluation of Drugs/Devices/Diagnostics/
Research (ICMR):
Vaccines/Herbal Remedies (2006)
http://www.icmr.nic.in/human_ethics.
htm
Genetic Research
1. Department of Biotechnology
Environmental Protection Act
DBT:
(DBT): http://dbtindia.nic.in/
1. Recombinant DNA Safety Guidelines
2. Indian Council of Medical
(1990)
Research (ICMR):
http://www.icmr.nic.in/human_ethics.
2. Ethical Policies on the Human Genome,
htm
Genetic Research, and Services (2002)
ICMR:
Ethical Guidelines for Biomedical
Research on Human Subjects: Statement
of Specific Principles for Human Genetics
and Genomics Research (2006)
Embryos, Stem
1. Department of Biotechnology
DBT and ICMR:
Cells, and Cloning
(DBT): http://dbtindia.nic.in/
Guidelines for Stem Cell Research and
2. Indian Council of Medical
Therapy (2007):
Research (ICMR):
http://icmr.nic.in/stem_cell/Stem_cell_gui
http://www.icmr.nic.in/human_ethics.
delines.pdf
htm
Indonesia
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Ministry of Health, National Institute
Indonesian Health Act No.
Regulation No. 39/1995 on
National Guidelines on Ethics in Health
of Health Research and Development 23/1992 Section on Health
Health Research & Development
Research (2003)
Research, Article 69
Drugs
Indonesian FDA
Guidelines on Good Clinical
Practice (2001)
94
Country Key
Organizations
Legislation
Regulations
Guidelines
Human Biological
National Guidelines on Use of
Materials
Stored Biological Materials
(2005)
Iran
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Ministry of Health and Medical
Protection Code for Human
Education, Office for the Study of
Subjects in Medical Research
Humanistic and Islamic Science in
(1999)
Medicine and Medical Ethics:
http://www.mohme.gov.ir/
Israel
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Ministry of Health:
Public
Health
Regulations
http://www.health.gov.il/english/
(Medical Experiments Involving
Human Subjects) (1999)
(Hebrew):
http://www.health.gov.il/pages/de
fault.asp?maincat=11&catid=301
&pageid=2203
95
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
Ministry of Health, Pharmaceutical
Public Health Order (1940)
1. Public Health Regulations
Guidelines for Clinical Trials in Human
Administration:
(Clinical Studies in Human
Subjects (2006) (English):
http://www.health.gov.il/english/Page
Subjects) – 1980 (Hebrew):
http://www.health.gov.il/Download/pages/
s_E/default.asp?maincat=10
GuidelinesforClinicalTrials.doc
http://www.health.gov.il/downloa
d/forms/a365_si12r_81.pdf
2. 1990 Amendment (Hebrew):
http://www.health.gov.il/downloa
d/forms/a1962_mr98_90.pdf
3. 1992 Amendment (Hebrew):
http://www.health.gov.il/downloa
d/forms/a2117_mr23_92.pdf
4. 2005 Amendment (Hebrew):
http://www.health.gov.il/downloa
d/forms/a2672_mk07_05.pdf
Privacy/Data
Israeli Law and Information
1. Privacy Protection Act No.
Protection
Technologies Authority
5741 (1981) (Hebrew):
http://www.itpolicy.gov.il/topics
_security/privacy.htm
2. Protection of Privacy Law
No. 5741, as Amended by Law
No. 5745 (1985)
Genetic Research
Ministry of Health:
Genetic Information Law (2000) 1.
The
Instruction of the Supreme
http://www.health.gov.il/english/
(Hebrew):
Committee for Clinical Studies on
http://www.moital.gov.il/NR/ex
Humans Regarding Establishment and
eres/66F4DD4E-FA4A-4B76-
Usage of Genetic Samples Reservoir
94BC-DC29543471DE.htm
(2005) (Hebrew):
http://www.health.gov.il/download/forms/
a2658_mk01_05.pdf
2. Amendment (2007) (Hebrew):
http://www.health.gov.il/download/forms/
a3037_mk17_07.pdf
Embryos, Stem
Genetic
Intervention
Prohibition
Cells, and Cloning
Law (Human Cloning and
Genetic Changes in
Reproduction Cells) (1999)
96
Japan
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. Ministry of Education, Culture,
MEXT and MHLW:
Sports, Science, and Technology
(MEXT):
Ethics Guidelines for Epidemiological
http://www.mext.go.jp/english/
Research (2007)
2. Ministry of Health, Labor, and
MHLW:
Welfare (MHLW):
Ethical Guidelines for Clinical Research
http://www.mhlw.go.jp/english/index
(2008) (Japanese):
.html
http://www.mhlw.go.jp/general/seido/kou
sei/i-kenkyu/index.html
Drugs
1. Ministry of Health, Labor, and
Pharmaceutical Affairs Law,
MHLW:
Welfare (MHLW)
Article 80-2 (2006)
Good Clinical Practice Guidelines
2. Pharmaceuticals and Medical
(2008)
Devices Agency:
http://www.pmda.go.jp/english/index.
html
Privacy/Data
Consumer Affairs Agency
Personal Information Protection
Protection
(Japanese):
Act (2003)
http://www.caa.go.jp/index.html
Human Biological
Ministry of Health, Labor, and
1. On Research and Development
Materials
Welfare (MHLW):
Utilizing Human Tissues Removed by
http://www.mhlw.go.jp/english/index
Surgery and Other Procedures (1998)
.html
(Japanese)
http://www1.mhlw.go.jp/shingi/s9812/s12
16-2_10.html
2. Guidelines for Quality Assurance and
Safety of Medicines Manufactured from
Human Cells and Tissues (2008)
(Japanese):
http://www.kuhp.kyoto-
u.ac.jp/~ccmt/files/20080208.pdf
97
Country Key
Organizations
Legislation
Regulations
Guidelines
Genetic Research
1. Council for Science and
CST:
Technology (CST)
Fundamental Principles of Research on
2. Ministry of Education, Culture,
the Human Genome (2000):
Sports, Science, and Technology
http://www.mext.go.jp/b_menu/shingi/kag
(MEXT)
aku/rinri/pri00614.htm
3. Ministry of Health, Labor, and
MEXT, MHLW, and METI:
Welfare (MHLW)
Ethical Guidelines for Human
4. Ministry of Economy, Trade, and
Genome/Gene Analysis Research (2008)
Industry (METI)
(Japanese):
http://www.lifescience.mext.go.jp/files/pd
f/40_126.pdf
MEXT and MHLW:
Guidelines for Clinical Research in Gene
Therapy (2008) (Japanese):
http://www.lifescience.mext.go.jp/files/pd
f/6_7.pdf
98
Country Key
Organizations
Legislation
Regulations
Guidelines
Embryos, Stem
1. Council for Science and
Act on Regulation of Human
Rules for Enforcement of Act on
CSTP:
Cells, and Cloning
Technology Policy (CSTP):
Cloning Techniques (2000):
Regulation of Human Cloning
http://www8.cao.go.jp/cstp/english/in
Techniques (2009) (Japanese):
Fundamental Philosophy on Handling of
dex.html
http://www.cas.go.jp/jp/seisaku/
Human Embryo (2004) (Japanese):
hourei/data/htc.pdf
http://www.lifescience.mext.go.jp
2. Ministry of Education, Culture,
/files/pdf/29_224.pdf
http://www.lifescience.mext.go.jp/files/pd
Sports, Science, and Technology
f/6_28.pdf
(MEXT):
MEXT:
http://www.mext.go.jp/english/
1. Guidelines for Handling of a
3. Ministry of Health, Labor, and
Welfare (MHLW):
Specified Embryo (2009) (Japanese):
http://www.mhlw.go.jp/english/index
http://www.lifescience.mext.go.jp/files/pd
.html
f/30_226.pdf
2. Guidelines for Derivation and
Distribution of Human Embryonic Stem
Cells (2009) (Japanese):
http://www.lifescience.mext.go.jp/files/pd
f/56_229.pdf
3. Guidelines for Utilization of Human
Embryonic Stem Cells (2009) (Japanese):
http://www.lifescience.mext.go.jp/files/pd
f/57_232.pdf
Jordan
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
Jordan Food and Drug
1. Narcotic and Psychotropic
Administration:
Law No. 11 (1988)
http://www.jfda.jo/en/default/
2. Clinical Trial Law No. 67
(2001)
3. Pharmacy and Drug Law No.
80 (2001)
99
Kazakhstan
Note: For an overview of human subject protections in Kazakhstan, see “Ethical Review of Biomedical Research in the CIS Countries,” Chapter 3, Section 5:
http://www.unesco.ru/files/docs/shs/2007/publications/ethical_review_cis_book_kubar_english.pdf
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Ministry of Health, Central Bioethics
Guidelines on Ethics in Health Research.
Commission
(2007)
Drugs
Ministry of Health, Committee of
Drug Law (13.01.2004 No. 522-
1. Order 14.02.2005 No. 53
Guidelines on Clinical Trials in
Pharmacy (Kazakh):
2), Articles 19 and 20 (2004)
Kazakhstan (2003)
(Kazakh):
Instruction on the Conduct of
http://www.mz.gov.kz/
Clinical Trials in Kazakhstan
http://www.zakon.kz/
(2005)
2. Order 25.06.2007 # 442
Rules on Preclinical, Medico-
Biological Experiments, and
Clinical Trials in Kazakhstan
(2007)
Privacy/Data
Ministry of Health (Kazakh):
Law on the Health Care System
protection
http://www.mz.gov.kz/
(4.06.2003 # 430-II) (2003)
(Kazakh):
http://www.zakon.kz/
100
Korea, South
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
1. Ministry of Public Administration
Pharmaceutical Affairs Act (No. MPAS:
and Security (MPAS):
91235) Articles 10 and 31-34
http://www.mopas.go.kr
(2008)
Enforcement Rule of
Pharmaceutical Affairs Act No.
2. Korea Food and Drug
122, Articles 12, 22, 24, 29, 31-
Administration (KFDA) (Korean):
34, 49, 62, 75, 76, and 94 (2009)
www.kfda.go.kr/
KFDA:
1. Korean Good Clinical Practice.
Public Notification of Food and
Drug Administration, No. 2008-
39 (2008): Translation of 1999
version:
http://www.lskglobal.com/english
_htm/regulation/kgcp_00.htm
2. Guideline for Investigational
New Drug Application: Public
Notification No. 2008-32 (2008)
Privacy/Data
Ministry of Public Administration
Act on the Protection of
Enforcement Rule of the
Protection
and Security:
Personal Information
Protection of Personal
http://www.mopas.go.kr
Maintained by Public Agencies
Information Maintained by Public
No. 8871 (2008)
Agencies No. 1 (2008)
Genetic Research
Ministry of Health, Welfare, and
Bioethics and Safety Act,
1. Regulation for Human Risk
Guidelines for Research Involving
Family Affairs:
Articles 2, 6, 9, 24-43, 47, 48,
Assessment of Genetically
Recombinant DNA Molecules (1997)
51-55 (2008)
Modified Organisms. No. 2006-
http://english.mw.go.kr/
81 (2006)
2. Enforcement Decree of
Bioethics and Safety Act, Articles
2, 3, 13, 14-21, 27, and 28 (2008)
3. Guidance for Genetic
Recombination Research No.
2009-150 (2009)
101
Country Key
Organizations
Legislation
Regulations
Guidelines
Embryos, Stem
Ministry of Health, Welfare, and
Bioethics and Safety Act,
1. Enforcement Decree of
Cells, and Cloning
Family Affairs:
Articles 2, 18-21, 38, 41, and 45 Bioethics and Safety Act, Articles
http://english.mw.go.kr/
(2008)
3, 12, and 19-2 (2008)
2. Enforcement Regulation of
Bioethics and Safety Act, Articles
2, 7, and 13 (2008)
Kuwait
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Ministry of Health, Kuwait Institute
Ethical Guidelines for Biomedical
for Medical Specialization:
Research (no date):
http://www.kims.org.kw/
http://www.kims.org.kw/Ethical%202.doc
Kyrgyzstan
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. Ministry of Health (Russian):
1. Constitution of Kyrgyz
Republic Chapter II, Article 19
http://www.med.kg
(2007)
2. National Bioethics Committee
2. Law on Protection of Citizens
Health (09.01.2005 No. 6):
Articles 34 and 73 (Russian):
http://www.med.kg/MyFiles/Зак
оны/Закон%20КР%20%20Об
%20охране%20здоровья%20гр
аждан%20в%20Кыргызской%
20Республике%20_1.rtf
Drugs
1. Ministry of Health (Russian):
Drug Law of Kyrgyz Republic
Order of the Ministry of Health
(30.04.2003 No. 91) Chapter
16.03.2004 No. 120 on the
http://www.med.kg/
VII, Articles 25-29 (2003)
Conduct of Medical Trials (2004)
2. Department of Drug and Medical
(Russian):
(Russian):
Devices Provision (Russian):
http://www.med.kg/MyFiles/Зак
http://pharm.med.kg/Docs/spisok.
http://pharm.med.kg/
оны/Закон%20КР%20%20О%
shtml?m=134&sm=134126
20лекарственных%20средства
3. National Bioethics Committee
х%20.rtf
102
Country Key
Organizations
Legislation
Regulations
Guidelines
Human Biological
1. Ministry of Health (Russian):
Law on Protection of Citizens
Materials
Health in the Kyrgyz Republic
http://www.med.kg/
(09.01.2005 No. 6): Article 39
2. National Bioethics Committee
Privacy/Data
1. Ministry of Health (Russian):
Law on Protection of Citizens
Protection
Health in the Kyrgyz Republic
http://www.med.kg/
(09.01.2005 No. 6): Article 91
2. National Bioethics Committee
Nepal
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Nepal Health Research Council:
National Ethical Guidelines for Health
http://www.nhrc.org.np/
Research in Nepal (2001):
http://www.nhrc.org.np/guidelines/nhrc_et
hicalguidelines_2001.pdf
Drugs
Nepal Health Research Council:
National Guidelines on Clinical Trials
http://www.nhrc.org.np/
with the Use of Pharmaceutical Products
(2005):
https://webapps.sph.harvard.edu/live/grem
ap/files/np_pharmaceutical_trial_guidelin
es.pdf
103
New Zealand
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. Health Research Council (HRC)
1. Health Research Council Act
HDC:
HRC:
Ethics Committee:
1990, Sections 24 and 25
http://www.hrc.govt.nz/root/Publications/
The Code of Health and
Ethics_Reports_and_Guidelines.html :
http://www.hrc.govt.nz/
2. New Zealand Bill of Rights
Disability Services Consumers’
Act, Article 10 (1990)
Rights (the Code of Rights)
1. Guidelines for Researchers on Health
2. National Ethics Advisory
(2004):
Research Involving Māori (1998)
Committee (NEAC):
3. Health and Disability
Commissioner Act 1994
http://www.hdc.org.nz/files/hdc/c
2. Guidelines on Ethics in Health
http://www.neac.health.govt.nz/
ode-leaflet.pdf
Research (2005)
4. New Zealand Public Health
3. Ministry of Health (MOH):
and Disability Act 2000, Section
3. Guidelines on Pacific Health Research
http://www.moh.govt.nz/
16
(2005)
4. Health and Disability
5. Injury Prevention,
NEAC:
Commissioner (HDC):
Rehabilitation, and
Compensation Act 2001
1. Goals, Objectives, and Desired
http://www.hdc.org.nz/
Outcomes of an Ethical Review System
Access: All New Zealand laws
(2003)
5. Health and Disability Ethics
can be found at:
Committees:
2. Ethical Guidelines for Observational
http://www.legislation.govt.nz/a
Studies: Observational Research, Audits
http://www.ethicscommittees.health.g
ct/searchquick.aspx
and Related Activities (2006)
ovt.nz/
Then search for the name of the
MOH:
6. Ministry of Science, Research, and law under “Statutes of New
Technology (MoRST):
Zealand.”
Operational Standard for Ethics
Committees (2006):
http://www.morst.govt.nz/
http://www.moh.govt.nz/moh.nsf/pagesm
h/4703/$File/operational-standard-for-
ethics-committees-updated-edition.pdf
104
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
1. New Zealand Medicines and
1. Medicines Act 1981(2005)
Medsafe:
Medical Devices Safety Authority
(Medsafe):
2. Injury Prevention,
New Zealand Regulatory Guidelines for
http://www.medsafe.govt.nz
Rehabilitation, and
Medicines, Vol. 3: Interim Good Clinical
Compensation Act 2001,
Research Practice Guidelines (1998):
2. Researched Medicines Industry
Section 32 (2008):
(RMI): http://www.rmianz.co.nz
http://www.medsafe.govt.nz/regulatory/G
uideline/NZRGM%20Volume%203.asp
3. Health Research Council (HRC),
Standing Committee on Therapeutic
RMI:
Trials:
Guidelines on Clinical Trials
http://www.hrc.govt.nz/root/pages_re
Compensation for Injury Resulting from
gulatory/Standing_Committee_on_Th
Participation in an Industry-Sponsored
erapeutic_Trials.html
Clinical Trial (2008):
http://www.rmianz.co.nz/compensation%
20guidelines%200808%20final.pdf
Privacy/Data
Privacy Commissioner:
1. Official Information Act 1982 Health Information Privacy Code
Protection
http://www.privacy.org.nz/
(2009)
1994:
http://www.privacy.org.nz/assets/
2. Public Records Act (2005)
Files/Codes-of-Practice-
3. Privacy Act 1993 (2006):
materials/Health-Information-
http://www.legislation.govt.nz/a
Privacy-Code-1994-including-
ct/public/1993/0028/latest/view
Amendment.pdf
pdf.aspx
105
Country Key
Organizations
Legislation
Regulations
Guidelines
Human Biological
1. Health Research Council (HRC)
1. Health Act 1956 (2005)
Standards New Zealand:
HPEGC:
Materials
Ethics Committee:
http://www.hrc.govt.nz/root/Ethics/Et
2. Human Tissue Act 2008
New Zealand Standard 8135:
Ethical Guidelines for Human Specimen
hics%20Overview/HRC_Ethics_Com
2009: Non-Therapeutic Use of
Collection, Storage, Use and Disposal: A
mittee.html
Human Tissue:
Report to the New Zealand Department of
Health (1992)
2. Human Specimen Ethical
http://www.standards.co.nz/web-
Guidelines Committee (HPEGC)
shop/?action=basicShopSearch&
TPK:
mod=search&SearchBox1_txtSho
3. Te Puni Kokiri (TPK):
pName=non+therapeutic+use+of
Guidelines for the Removal, Retention,
http://www.tpk.govt.nz/
+human+tissue&selStatus=CUR
Return, and Disposal of Maori Body Parts.
RENTANDDRAFT&catalog=NZ (1999)
4. Office of the Health and Disability
Commissioner (HDC):
MOH:
http://www.hdc.org.nz
Guidelines for the Use of Human Tissue
5. Ministry of Research Science and
for Future Unspecified Research Purposes
Technology:
(2007):
http://www.morst.govt.nz/wayfinder/i
http://www.moh.govt.nz/moh.nsf/pagesm
ndex.asp
h/6135/$File/guidelines-use-of-human-
tissue-may07.pdf
Genetic Research
1. Environmental Risk Management
Hazardous Substances and New
HRC:
Authority:
Organisms Act 1996 (2008)
http://www.ermanz.govt.nz/
Ethical Considerations Relating to
Research in Human Genetics (2000):
2. Health Research Council (HRC),
Gene Technology Advisory
http://www.hrc.govt.nz/assets/pdfs/public
Committee:
ations/ethumangen.pdf
http://www.hrc.govt.nz/root/pages_re
gulatory/Gene_Technology_Advisory
_Committee.html
106
Country Key
Organizations
Legislation
Regulations
Guidelines
Embryos, Stem
1. Advisory Committee on Assisted
Human Assisted Reproductive
ACART:
Cells, and Cloning
Reproductive Technology (ACART)
Technology Act 2004 (2009)
http://www.acart.health.govt.nz/moh.nsf/i
ndexcm/acart-resources-guidelines :
http://www.acart.health.govt.nz/
1. Guidelines on the Use, Storage, and
2. Ministry of Health
Disposal of Sperm from a Deceased Man
http://www.moh.govt.nz/
(2000)
3. Ethics Committee on Assisted
2. Guidelines on Preimplantation Genetic
Reproductive Technology (ECART)
Diagnosis (2005)
http://www.ecart.health.govt.nz/
3. Guidelines on IVF Surrogacy (2005)
4. Health and Disability Ethics
4. Guidelines on Within-Family Gamete
Committees
Donation (2005)
http://www.newhealth.govt.nz/ethicsc
5. Embryo Donation for Reproductive
ommittees/
Purposes (2005)
6. Guidelines for Research on Gametes
and Non-viable Embryos (Interim)
MOH:
Guidelines on Using Cells from
Established Human Embryonic Stem Cell
Lines for Research (2005):
http://www.moh.govt.nz/moh.nsf/0/DF32
587ABFCA33C5CC2570C800708A24/$F
ile/GuidelinesUsingCells.pdf
107
Philippines
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. Philippine Health Research Ethics
NEC:
Board (PHREB):
http://www.pchrd.dost.gov.ph/index.p
National Ethical Guidelines for Health
hp?option=com_frontpage&Itemid=1
Research (2006):
https://webapps.sph.harvard.edu/live/grem
2. National Ethics Committee (NEC)
ap/files/ph_natl_ethical_gdlns.pdf
3. Department of Science and
This document includes the following:
Technology: http://www.dost.gov.ph/
Ethical Guidelines for International
Collaborative Research
Ethical Guidelines for Herbal Research
Ethical Guidelines for Complementary
and Alternative Medicine Research
Ethical Guidelines for Epidemiological
Research
Ethical Guidelines for Social and
Behavioral Research
Ethical Guidelines for the Conduct of
Research on Populations Traumatized in
Emergencies and Disasters
Ethical Guidelines for HIV/AIDS
Research
Ethical Guidelines for Research on
Assisted Reproductive Technology
Drugs
Bureau of Food and Drugs:
Rules and Regulations on the
Ethical Guidelines for Clinical Trials on
http://www.bfad.gov.ph/
Registration, Including Approval
Drugs, Devices, and Diagnostics (2006):
and Conduct of Clinical Trials,
https://webapps.sph.harvard.edu/live/grem
and Lot or Batch Release
ap/files/ph_natl_ethical_gdlns.pdf
Certification of Vaccines and
Biologic Products
(Administrative Order No. 47-a)
(2001)
108
Country Key
Organizations
Legislation
Regulations
Guidelines
Genetic Research
National Ethics Committee (NEC)
Ethical Guidelines for Genetic Research,
with a Section on Stem Cell Research
(2006):
https://webapps.sph.harvard.edu/live/grem
ap/files/ph_natl_ethical_gdlns.pdf
Embryos, Stem
National Ethics Committee (NEC)
Ethical Guidelines for Genetic Research,
Cells, and Cloning
with a Section on Stem Cell Research
(2006):
https://webapps.sph.harvard.edu/live/grem
ap/files/ph_natl_ethical_gdlns.pdf
Qatar
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Health Research Ethics Committee
Guidelines, Regulations, and Policies for
Research Involving Human Subjects
(2009): http://qatar-
weill.cornell.edu/research/pdf/Ministry%2
0Guidelines.doc
Singapore
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. Ministry of Health (MOH):
Medical Registration Act (Cap.
MOH:
NMEC:
http://www.moh.gov.sg/
174) (1985):
Directive of June 25, 1998:
Ethical Guidelines on Research Involving
2. Ministry of Health National
http://statutes.agc.gov.sg/
Hospital Ethics Committees
Human Subjects (1997)
Medical Ethics Committee (NMEC)
BAC:
3. Bioethics Advisory Committee
(BAC): http://www.bioethics-
Research Involving Human Subjects:
singapore.org
Guidelines for IRBs (2004)
4. Singapore Medical Council
MOH:
(SMC): http://www.smc.gov.sg
1. Governance Framework for Human
Biomedical Research (2007)
2. Operational Guidelines for IRBs (2007)
3. Code of Ethical Practice in Human
Biomedical Research (2009)
109
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
1. Ministry of Health National
1. Medicines Act Section 74
Singapore Guideline for Good
NMEC:
Medical Ethics Committee (NMEC)
(Cap. 176) (1975):
Clinical Practice (1998)
Recommendations On Clinical Trials:
2. Health Sciences Authority of
2. Medicines (Clinical Trials)
Update Focusing On Phase I Trials (2007)
Singapore (HSA):
Regulations (2000)
http://www.hsa.gov.sg
3. Health Products Act (2007)
Access:
http://statutes.agc.gov.sg/
Privacy/Data
1. Ministry of Health (MOH):
Computer Misuse Act (Cap.
MOH:
Protection
http://www.moh.gov.sg/
50A) (1993):
Advisory on Data Protection Standards for
2. Bioethics Advisory Committee
http://statutes.agc.gov.sg/
Electronic Medical Records (EMR)
(BAC): http://www.bioethics-
Systems (2002)
singapore.org
BAC:
Personal Information in Biomedical
Research (2007)
Human Biological
1. Ministry of Health (MOH):
Medical (Therapy, Education,
BAC:
Materials
http://www.moh.gov.sg/
and Research) Act (1973):
Human Tissue Research (2002)
2. Bioethics Advisory Committee
http://statutes.agc.gov.sg/
(BAC): http://www.bioethics-
singapore.org
Genetic Research
1. Ministry of Health National
NMEC:
Medical Ethics Committee (NMEC)
Ethical Guidelines for Gene Technology
2. Bioethics Advisory Committee
(2001)
(BAC): http://www.bioethics-
singapore.org
BAC:
Genetic Testing and Genetic Research
(2005): http://www.bioethics-
singapore.org/uploadfile/55211%20PMG
T%20Research.pdf
Embryos, Stem
1. Bioethics Advisory Committee
Human Cloning and Other
Directives for Private Healthcare
BAC:
Cells, and Cloning
(BAC): http://www.bioethics-
Prohibited Practices Act (2004): Institutions Providing Assisted
singapore.org/
Reproduction Services:
1. Ethical, Legal and Social Issues in
http://statutes.agc.gov.sg/
Regulation 4 of the Private
Human Stem Cell Research, Reproductive
2. Ministry of Health (MOH):
Hospitals and Medical Clinics
and Therapeutic Cloning (2002)
http://www.moh.gov.sg/
Act (2006)
2. Donation of Eggs for Research (2008)
110
Taiwan
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Department of Health:
Medical Care Act, Articles 8,
Enforcement Rules of the
1. Ethical Guidelines for the
http://www.doh.gov.tw/EN2006/inde
78, 79, 80, and 98 (2009):
Medical Care Act (2006)
Announcement of New Medical
x_EN.aspx
(Chinese):
Knowledge or Research Report by
http://www.doh.gov.tw/ufile/do
http://dohlaw.doh.gov.tw/Chi/FL
Medical Institutes or Members (2001)
c/Medical_Care_Act98.pdf
AW/FLAWDAT0202.asp
http://www.doh.gov.tw/ufile/doc/
2. Healthcare Institution Institutional
Review Board Organization and
Operations (2003):
http://www.doh.gov.tw/EN2006/DM/DM
2_p01.aspx?class_no=386&now_fod_list_
no=9064&level_no=1&doc_no=43274
3. Categories of Research that may be
Reviewed by the Institutional Review
Board (IRB) through Expedited Review
(2006) (Chinese):
http://www.doh.gov.tw/CHT2006/DM/D
M2_p01.aspx?class_no=1&now_fod_list_
no=4356&level_no=3&doc_no=43680
4. Human Research Ethics Policy
Guidelines (2007):
http://www.doh.gov.tw/ufile/doc/Human
%20Research%20Ethics%20Policy%20G
uidelines.pdf
111
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
1. Department of Health:
DOH:
DOH:
DOH:
http://www.doh.gov.tw/EN2006/inde
x_EN.aspx
Pharmaceutical Affairs Act
1. Guideline for Good Clinical
1. Operational Guidelines for Drug
(2005):
Practice (2005) (Chinese):
Clinical Trials (2002)
2. Taiwan Food and Drug
http://www.doh.gov.tw/EN2006
http://www.doh.gov.tw/CHT2006
Administration
2. Guidelines for Informed Consent in
/DM/DM1_p01.aspx?class_no=
/DM/DM2_p01.aspx?class_no=2
247&now_fod_list_no=247&lev &now_fod_list_no=6726&level_
Clinical Trials (2007) (Chinese):
el_no=1&doc_no=39739
no=3&doc_no=39852
http://www.doh.gov.tw/ufile/doc/%e5%8f
%97%e8%a9%a6%e8%80%85%e5%90%
2. Enforcement Rules of the
Pharmaceutical Affairs Act
8c%e6%84%8f%e6%9b%b8%e5%85%a7
(2006) (Chinese):
%e5%ae%b9%e5%8f%83%e8%80%83%
http://www.doh.gov.tw/CHT2006
e7%af%84%e6%9c%ac.pdf
/DM/DM2_p01.aspx?class_no=2
3. Principles for Clinical Trial Subject
&now_fod_list_no=8108&level_
Recruitment (2007) (Chinese):
no=3&doc_no=454
http://www.doh.gov.tw/CHT2006/DM/D
M2_p01.aspx?class_no=2&now_fod_list_
no=6726&level_no=3&doc_no=501727
Privacy/Data
Ministry of Justice:
Computer-Processed Personal
Protection
http://www.moj.gov.tw/mp095.html
Data Protection Law (1995):
http://www.privacyexchange.or
g/legal/nat/omni/taiwan.html
Human Biological
Department of Health:
Medical Care Act (2009):
1.Good Tissue Practice (2002) (Chinese):
Materials
http://www.doh.gov.tw/EN2006/inde
http://www.doh.gov.tw/ufile/do
x_EN.aspx
c/Medical_Care_Act98.pdf
http://www.doh.gov.tw/CHT2006/DM/D
M2_p01.aspx?class_no=1&now_fod_list_
no=4356&level_no=3&doc_no=40875
2. Guidelines for Collection and Use of
Human Specimens for Research (2006):
http://www.doh.gov.tw/ufile/doc/Human
%20Research%20Ethics%20Policy%20G
uidelines.pdf
112
Country Key
Organizations
Legislation
Regulations
Guidelines
Genetic Research
1. Department of Health:
DOH:
http://www.doh.gov.tw/EN2006/inde
x_EN.aspx
1. Guidance for Informed Consent Forms
for Pharmacogenetic Research (2005)
2. National Science Council:
(Chinese):
http://web.nsc.gov.tw/default.asp?mp
http://www.doh.gov.tw/ufile/doc/200511_
=7
%e8%97%a5%e7%89%a9%e5%9f%ba%
e5%9b%a0%e5%ad%b8%e7%a0%94%e7
%a9%b6%e4%b9%8b%e5%8f%97%e6%
aa%a2%e8%80%85%e5%90%8c%e6%84
%8f%e6%9b%b8%e5%85%a7%e5%ae%
b9%e5%8f%83%e8%80%83%e6%8c%87
%e5%bc%95.pdf
Embryos, Stem
Department of Health:
Policy Instructions on the Ethics of
Cells, and Cloning
http://www.doh.gov.tw/EN2006/inde
Human Embryo and Embryonic Stem Cell
x_EN.aspx
Research (2007):
http://www.doh.gov.tw/ufile/doc/Policy%
20Instructions%20on%20the%20Ethics%
20of%20Human%20Embryos.pdf
Tajikistan
Note: For an overview of human subject protections in Tajikistan, see “Ethical Review of Biomedical Research in the CIS Countries,” Chapter 3, Section 9:
http://www.unesco.ru/files/docs/shs/2007/publications/ethical_review_cis_book_kubar_english.pdf
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. Ministry of Public Health
1. Order of the Ministry of Public
Health of the Republic Tajikistan
2. Republic Committee on Medical
of 10 March, 2005 No. 118:
Ethics
About the Assertion of the
Normative Documents of
Republic Committee on Medical
Ethics (Russian)
2. Position of the Republic
Committee on Medical Ethics,
Affirmed by the Order of the
Ministry of Public Health of
Republic Tajikistan of March 10,
2005, No. 118 (Russian)
113
Thailand
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. National Research Council of
NCRT:
MCT:
Thailand (NCRT) (Thai):
http://nrct.go.th/
Regulation on the Permission of
1. National Guideline for Ethical Research
Foreign Researchers (1982)
on Human Subjects (2002)
2. Medical Council of Thailand
(MCT) (Thai): http://www.tmc.or.th
MCT:
2. The Ethical Guidelines for Research on
Human Subject in Thailand (2007)
Rule of the Medical Council on
the Observance of Medical Ethics
(2006)
Drugs
Food and Drug Administration, Drug
Consumer Protection Act (2007)
Thailand Good Clinical Practice
Control Division:
Guidelines (2002)
http://www.fda.moph.go.th/eng/index
.stm/
Privacy/Data
Office of the Information
1. Official Information Act, B.E.
Protection
Commission
2540 (1997)
2. National Health Act, B.E.
2549 (2006)
Vietnam
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Ministry of Health:
Decision No. 2626/QD-BYT on
http://www.moh.gov.vn/homebyt/en/
Promulgation of the “Procedure
portal/index.jsp
of Organizing and Functioning
Ethical Committee for Bio-
Medical research, Mission 2008 –
2012” (2008) (Vietnamese)
114
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
Ministry of Health:
1. Regulation on Clinical Trials
Guidelines on Good Clinical Practice of
http://www.moh.gov.vn/homebyt/en/
(2007)
Clinical Trials (2008)
portal/index.jsp
2. Decision No. 799/QD-BYT of
the Minister of Health on the
Promulgation of the “Guidelines
on Good Clinical Practice of
Clinical Trials” (2008)
3. Decision No. 23 /2008/QD-
BYT of the Minister of Health on
the Promulgation of the
“Regulations on Utilization of
Vaccine and Medical Immuno-
Biological Products in Prevention
and Treatment” (2008)
LATIN AMERICA and the CARIBBEAN
Pan American Health Organization
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
Pan American Health Organization:
Good Clinical Practices: Document for the
http://www.paho.org/
Americas (2004):
http://www.paho.org/english/ad/ths/ev/GC
P-Eng-doct.pdf
Argentina
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Ministry of Health:
MOH:
http://www.msal.gov.ar
Note: Several
Ministerial Resolution 1490/2007
provinces have their
Approving the Good Clinical
own regulations
Practice Guideline for Clinical
pertaining to human
Research with Human Beings
subjects research.
115
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
National Administration of
ANMAT:
Medications, Foods, and Medical
Note: Several
Technology (ANMAT) (Spanish):
Provision 5330/97 on Good
provinces have their
http://www.anmat.gov.ar/index.asp
Research Practices in Clinical
own regulations
Pharmaceutical Studies (1997)
pertaining to drug
(Spanish):
research.
http://infoleg.mecon.gov.ar/infole
gInternet/anexos/45000-
49999/46745/norma.htm
Privacy/Data
National Personal Data Protection
Personal Data Protection Act
Protection
Authority (Spanish):
No. 25.326 (2000):
http://www.jus.gov.ar/datospersonale
s/index.html
http://www.protecciondedatos.c
om.ar/law25326.htm
Bolivia
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. Ministry of Health and Sport:
1. Legal Decree No. 15629 of
Regulations on Public Health
Guidelines for the Development of Health
http://www.sns.gov.bo/
July 18, 1978
Research, Chapter V (1978)
Research and Ethical Norms (2002)
2. National Bioethics Committee
2. New Political Constitution of
the State, Article 44 (2009):
http://www.repac.org.bo/docum
entos/NUEVA%20CPE.pdf
Drugs
Ministry of Health and Sport:
Rule on Clinical Studies with Medicines
http://www.sns.gov.bo/
or Products in the Clinical Investigation
Stage (2005)
116
Brazil
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. National Health Council (CNS)
CNS:
CONEP:
(Portuguese):
http://www.conselho.saude.gov.br/
Decree 98 830: Collection by
1. Resolution 196/96: Rules on
Foreigners of Data and
Research Involving Human
2. National Commission on Research
Scientific Materials in Brazil
Subjects (1996):
Ethics (CONEP) (Portuguese):
(1990) (Portuguese):
http://www.conselho.saude.gov.br/co
http://www.conselho.saude.gov.b
missao/eticapesq.htm
http://ibama2.ibama.gov.br/cnia
r/resolucoes/1996/Reso196.doc
2/renima/cnia/lema/lema_texto/
HTM-ANTIGOS/98830-
http://www.conselho.saude.gov.b
90.HTM
r/docs/Resolucoes/reso_196_engl
ish.doc
2. Resolution 304/2000: On
Complimentary Rules for
Research Involving Indigenous
People (2000):
http://www.conselho.saude.gov.b
r/resolucoes/2000/Reso304.doc
3. Internal CONEP Regulation
(2001) (Portuguese):
http://www.conselho.saude.gov.b
r/Web_comissoes/conep/aquivos/
conep/regimento.doc
4. Regulation of Resolution CNS
292/99 on Research with Foreign
Cooperation (2002) (Portuguese):
http://www.conselho.saude.gov.b
r/resolucoes/1999/Reso292.doc
http://www.ensp.fiocruz.br/etica/
docs/cns/Res292i.pdf
5. Resolution 346/2005: On
Multicenter Research (2005)
(Portuguese):
http://www.conselho.saude.gov.b
r/docs/Resolucoes/Reso346.doc
117
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
1. National Health Council (CNS)
CNS:
(Portuguese):
http://www.conselho.saude.gov.br/
Resolution 251/1997: On
Complimentary Rules for
2. National Healthcare Surveillance
Research with New
Agency (Portuguese):
Pharmaceutical Products,
http://www.anvisa.gov.br
Medicines, Vaccines, and
Diagnostic Tests (1997):
http://www.ensp.fiocruz.br/etica/
docs/cns/Res251i.pdf
Human Biological
National Commission on Research
CONEP:
CONEP:
Materials
Ethics (CONEP) (Portuguese):
http://www.conselho.saude.gov.br/co
CNS Resolution 347/05
Approval Guidelines for Ethical Analysis
missao/eticapesq.htm
of Research Projects Involving Storage of
Approval Guidelines for Ethical
Materials or Use of Materials Stored by
Analysis of Research Projects
Previous Research: Resolution 347/05
Involving Storage of Materials or
(2005)
Use of Materials Stored by
Previous Research (Portugese):
http://conselho.saude.gov.br/docs/
Reso347.doc
Genetic Research
1. National Commission on Research
Biosafety Law 11.105/05
CONEP:
CONEP:
Ethics (CONEP) (Portuguese):
(2005):
http://www.conselho.saude.gov.br/W
http://www.ctnbio.gov.br/index.
Resolution 340/2004 : On
Approval Guidelines for Ethical Analysis
eb_comissoes/conep/index.html
php/content/view/12847.html
Research on Human Genetics
and Conduct of Research Projects in the
(2004) (Portuguese):
Special Thematic Area of Human
2. National Biosafety Technical
http://conselho.saude.gov.br/resol
Genetics: Resolution 340/04 (2004)
Commission (CTNBio) (Portuguese):
ucoes/2004/Reso340.doc
http://www.ctnbio.gov.br
CTNBio:
Decree No. 5,591, of November
22, 2005:
http://www.ctnbio.gov.br/index.p
hp/content/view/3670.html
Embryos, Stem
National Biosafety Technical
Biosafety Law 11.105/05
CTNBio:
Cells, and Cloning
Commission (Portuguese):
(2005):
http://www.ctnbio.gov.br
http://www.ctnbio.gov.br/index.
Decree No. 5,591, of November
php/content/view/12847.html
22, 2005:
http://www.ctnbio.gov.br/index.p
hp/content/view/12848.html
118
Chile
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Ministry of Health (Spanish):
1. Supreme Decree No. 42 (1986)
http://www.minsal.cl
2. Supreme Decree No. 1.935
(1993)
3. General Technical Rule No. 2
of the Ministry of Health (1993)
4. Exemption Resolution No. 134
(1994)
5. Supreme Decree No. 494
(1999)
6. Exemption Resolution No.
1.856 (1999)
7. Resolution No. 2.085 of the
Ministry of Health (2001)
Drugs
Ministry of Health (Spanish):
Technical Rule No. 57:
Ethical Guidelines for Clinical Trials with
http://www.minsal.cl
Regulation of the Conduct of
Pharmaceutical and Biological Products
Clinical Trials that Use
(2001)
Pharmaceutical Products in
Human Beings (2001):
http://www.ispch.cl/formularios/n
orma_tec/norm_tec_n_57.pdf
Privacy/Data
Law for the Protection of
Protection
Private Life No. 19.628 (1999)
(Spanish):
http://www.bcn.cl/leyes/141599
Genetic Research
1. Law No. 26.027 (2005):
http://www.lyd.com/programas/l
egislativo/proyecto_ley_genoma
_humano.pdf
2. Law No. 20.120: Scientific
Research Involving Human
Beings, Their Genome, and
Prohibition of Human Cloning
(2007)
119
Country Key
Organizations
Legislation
Regulations
Guidelines
Embryos, Stem
Law No. 20.120: Scientific
Cells, and Cloning
Research Involving Human
Beings, Their Genome, and
Prohibition of Human Cloning
(2007)
Colombia
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Ministry of Social Protection
Scientific, Technical, and
(Spanish):
Administrative Regulations for
Health Research, Resolution No.
www.minproteccionsocial.gov.co/
008430 (1993):
http://www.unal.edu.co/dib/norm
as/etica_res_8430_1993.pdf
Drugs
National Institute of Drug and Food
Resolution No. 2378 of 2008,
Surveillance (Spanish):
Adapting Good Clinical Practices
http://www.invima.gov.co/
for Institutions that Conduct
Research with Medicines in
Human Beings:
http://www.minproteccionsocial.g
ov.co/VBeContent/library/docum
ents/DocNewsNo17655Documen
tNo7224.PDF
Privacy/Data
Constitution
of
Colombia,
Protection
Article 15 (2003)
Human Biological
Ministry of Health, National Institute
Scientific, Technical, and
Materials
of Health (Spanish):
Administrative Regulations for
http://www.ins.gov.co/
Health Research, Resolution No.
008430, Title II, Chapter VI
(1993)
Genetic Research
Ministry of Health, National Institute
Scientific, Technical, and
of Health (Spanish):
Administrative Regulations for
http://www.ins.gov.co/
Health Research, Resolution No.
008430, Title III, Chapter II
(1993)
120
Costa Rica
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. National Council on Health
Law 5395, General Health Law, CONIS:
CONIS:
Research (CONIS) Network of
Articles 64-68 (1973) (Spanish):
Scientific Ethics Committees
http://www.ministeriodesalud.g
Executive Decree No. 31078-S
1. Ethical and Legal Principles
o.cr/leyes/leygeneraldesalud.pdf (2003) (Spanish):
2. Social Security Fund (CCSS),
http://www.ministeriodesalud.go.
2. Duties and Responsibilities of the
Research and Bioethics Subarea:
cr/reglamentos/31078-s.pdf
National Council on Health Research, of
http://www.cendeisss.sa.cr/etica/01-
Investigators, and of the Sponsor
PRESENaa.html
CCSS:
3. Structure and Functioning of the
3. Ministry of Health:
Regulation of Clinical
Committee Network
http://www.ministeriodesalud.go.cr/
Investigation in the Assistance
Services of the Social Security
4. Design of the Research Protocol
Fund (2005)
5. Requirements for the Submission of a
http://www.cendeisss.sa.cr/etica/r
Research Protocol
eglamentobiomedica.pdf
6. Informed Consent
7. Approval and Follow-up of a Research
Project
8. Sanctions
Drugs
1. National Council on Health
Executive
Decree
21085-S: Good CONIS:
Research (CONIS) Network of
Clinical Practice for
Scientific Ethics Committees
Pharmaceutical Products
1. Guidelines for Good Clinical Practice
(Spanish):
(1996)
http://www.ministeriodesalud.go.cr/c
2. Protocol for Clinical Trials
omconis.htm
2. Ministry of Health (Spanish):
www.ministeriodesalud.go.cr
Human Biological
National Council on Health Research
Informed Consent, Research that Requires
Materials
Network (CONIS) of Scientific
Biobanks
Ethics Committees (Spanish):
http://www.ministeriodesalud.go.cr/c
omconis.htm
121
Dominica
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Ministry of Health and Environment:
Guidelines for the Conduct of Research on
http://www.dominica.gov.dm/cms/ind
Human Subjects (2005)
ex.php?q=node/21
Guatemala
Country Key
Organizations
Legislation
Regulations
Guidelines
Drugs
Ministry of Public Health and Social
Ministerial
Accord
SP-M-466-
Assistance
2007, For the Regulation of
Clinical Trials in Humans (2007)
Honduras
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Health Code, Decree No. 65-91,
Articles 175 and 176
Jamaica
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Ministry of Health:
Ministry of Health Guidelines for the
http://www.moh.gov.jm
Conduct of Research on Human Subjects
(2002)
122
Mexico
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Secretariat of Health:
General Health Law, Title V,
Regulation on the General Health
http://www.salud.gob.mx/
Chapter 1, Articles 96-103:
Law in the Matter of Health
Health Research (2007):
Research (1984) (Spanish):
General Health Council:
www.consejomexicano.org.mx/
www.salud.gob.mx/unidades/cdi/
www.csg.salud.gob.mx/
documents/lgs.pdf
nom/compi/rlgsmis.html
As amended (2008):
http://www.diputados.gob.mx/L
eyesBiblio/ref/lgs/LGS_ref36_1
4jul08.pdf
Drugs
Federal Commission for Protection
General Health Law, Title V,
Regulation on the General Health
Against Health Risks:
Chapter 1, Articles 96-103:
Law in the Matter of Health
Health Research (2005):
Research, Title Three (1984)
www.cofepris.gob.mx/
www.consejomexicano.org.mx/
(Spanish):
documents/lgs.pdf
www.salud.gob.mx/unidades/cdi/
nom/compi/rlgsmis.html
Privacy/Data
Federal Institute on Access to Public
Protection
Information (Spanish):
www.ifai.org.mx/
Human Biological
Secretariat of Health:
General Health Law, Title XIV,
Materials
Articles 313-342 (2005):
http://www.salud.gob.mx/
www.consejomexicano.org.mx/
documents/lgs.pdf
Genetic Research
National Institute of Genomic
1. Biosafety Law on Genetically Regulation on the General Health
Medicine:
Modified Organisms (2008
Law in the Matter of Health
http://www.inmegen.gob.mx/
(Spanish):
Research, Title Four, Chapter
Two (1984) (Spanish):
http://www.inmegen.gob.mx/im
www.salud.gob.mx/unidades/cdi/
ages/stories/noticias/2008/pdf/so nom/compi/rlgsmis.html
berania_genomica.pdf
2. Modifications to the General
Health Law to Protect Genomic
Sovereignty (2008):
http://www.inmegen.gob.mx/ind
ex.php?option=com_content&ta
sk=view&id=816&Itemid=155
123
Panama
Country Key
Organizations
Legislation
Regulations
Guidelines
General
National Research Bioethics
Ministry of Health Resolution
Informed Consent (2006) (Spanish):
Committee (Spanish):
No. 390 Adopting the Operational http://www.gorgas.gob.pa/images/bioetica
http://www.gorgas.gob.pa/index.php?
Guide for Research Bioethics,
/Elementos%20del%20Consentimiento%2
option=com_content&task=view&id
Official Gazette 24,938 (2003)
0Informado.pdf
=15&Itemid=43
(Spanish):
http://www.gorgas.gob.pa/images
/Gaceta%20Nº%2024%20938%2
0%20Resolucion390.doc
Human Biological
Law 52 of 1995, Official
Materials
Gazette 22,929
Embryos, Stem
Law 3 of 2004, Official Gazette
Cells, and Cloning
24,969
Peru
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. National Institute of Health
General Health Law No. 26842,
(Spanish): http://www.ins.gob.pe/
Article 28 (1997) (Spanish)
2. National Network of Research
Ethics Committees:
http://www.ins.gob.pe/gxpsites/hgxpp
001.aspx?2,13,59,O,S,0,MNU;C;1;14
;20;5;MNU
Drugs
1. National Institute of Health
1. Supreme Decree No. 017-
(Spanish):
2006-SA: Regulation on Clinical
http://www.ins.gob.pe/gxpsites/hgxpp
Trials in Peru (2006):
001.aspx?2,13,326,O,S,0,MNU;E;1;1
http://www.digemid.minsa.gob.pe
4;20;10;MNU
/normatividad/DS017-
2006SA.pdf
2. National Directorate of Drugs and
Medical Devices:
2. Supreme Decree No. 006-
www.digemid.minsa.gob.pe
2007-SA: Modification of the
Regulation on Clinical Trials in
Peru (2007):
http://www.digemid.minsa.gob.pe
/normatividad/DS006-
2007EP.pdf
124
Country Key
Organizations
Legislation
Regulations
Guidelines
Privacy/Data
National Directorate of Drugs and
Supreme Decree No. 002-2009-
Protection
Medical Devices:
SA: Regulation on Legislative
www.digemid.minsa.gob.pe
Decree No. 1072, Data Protection
http://www.digemid.minsa.gob.pe
/normatividad/DS%20002-2009-
SA09.pdf
Uruguay
Country Key
Organizations
Legislation
Regulations
Guidelines
Human Biological
Ministry of Public Health (Spanish):
Circular No. 40/95 Establishing
Materials
http://www.msp.gub.uy/index_1.html
Rules Regarding the Donation of
Organs and Tissues for Scientific
and Therapeutic Purposes (1995)
Venezuela
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. National Fund on Science and
Constitution, Article 46
Resolution No. 48 (1998)
FONACIT:
Technology, Commission on
(Spanish)
Bioethics and Biosecurity
Code on Bioethics and Biosecurity (2002)
(FONACIT) (Spanish):
IVIC:
http://www.fonacit.gov.ve/bioetica.as
p
1. Annex 1: General Ethical Issues in
Research Involving Living Persons
2. Venezuelan Institute of Scientific
Research, Bioethics Commission
2. Annex 2: Necessity of Establishing a
(IVIC)
Clear and Precise Study Protocol Before
Starting Research
3. Informed Consent
Drugs
National Institute of Hygiene “Rafael
Medicines Act, Articles 72 and
Rangel” (Spanish):
73
http://www.inhrr.gov.ve
Genetic Research
Venezuelan Institute of Scientific
1. Contract for Accessing Genetic
Research, Bioethics Commission
Resources (2003) (Spanish)
(Spanish)
2. Revised Outline of the International
Declaration of Human Genetic Data
(2003)
125
AFRICA
Botswana
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Ministry of Health, Research and
Anthropological Research Act
1. Guide for a Consent Form (2005)
Development Committee:
45 (1967)
http://www.moh.gov.bw/
2. Guidelines for the Review of Research
Proposals (2005)
Drugs
Ministry of Health, Drug Regulatory
Drugs and Related Substances
SADC Guidelines for Regulating Clinical
Unit: http://www.moh.gov.bw/
Regulations (1993)
Trials in Human Subjects (2006)
Privacy/Data
Botswana Telecommunications
Protection
Authority:
http://www.bta.org.bw/background.ht
ml
Egypt
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Medical Profession Union
Constitution of the Arab
Professional Ethics Regulations:
Republic of Egypt, Article 43:
http://www.sis.gov.eg/En/Politic
Conducting Medical Research on
s/Constitution/Text/0407030000
Human Beings
00000001.htm
Articles 52-61 (2003)
Access: Scroll to bottom of page,
click Download Code of Ethics:
http://www.ems.org.eg/2_4/2_4_
4/2_4_4.htm
Drugs
Egyptian Drug Authority:
http://www.eda.mohp.gov.eg/
Human Biological
Professional
Ethics
Regulations:
Materials
Conducting Medical Research on
Human Beings
Articles 49-51 (2003):
http://www.ems.org.eg/2_4/2_4_
4/2_4_4.htm
126
Ethiopia
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Ethiopian Science and Technology
Proclamation 60/1999, Section
National Health Research Ethics Review
Commission, Health Department:
21
Guideline, Fourth Edition (2005):
http://www.estc.gov.et/
http://www.estc.gov.et/Ethics%20Guideli
ne.pdf
Human Biological
Ethiopian Science and Technology
National Health Research Ethics Review
Materials
Commission, Health Department:
Guideline, Fourth Edition, Section 8
http://www.estc.gov.et/
(2005)
Gambia
Country Key
Organizations
Legislation
Regulations
Guidelines
Genetic Research
Medical Research Council (UK) The
Guidelines of the National DNA Bank
Gambia: http://www.mrc.gm/
(2001)
Kenya
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. National Council for Science and
1. Science and Technology Act
NCST:
Technology (NCST)
(2001)
Guidelines for Ethical Conduct of
2. Ministry of Health (MOH):
2. HIV and AIDS Prevention
Biomedical Research Involving
http://www.health.go.ke/index.html
and Control Act, Chapter 14
Human Subjects in Kenya (2004):
(2006)
https://webapps.sph.harvard.edu/l
ive/gremap/files/ke_NCST_guide
lines.pdf
MOH:
Kenya National Guidelines for
Research and Development of
HIV/AIDS Vaccines (2005)
Drugs
Pharmacy and Poisons Board:
Pharmacy and Poisons Act,
http://www.pharmacyboardkenya.org
Chapter 244 (2001)
/
Human Biological
Ministry of Health (MOH):
Kenya National Guidelines for
Materials
http://www.health.go.ke/index.html
Research and Development of
HIV/AIDS Vaccines, page 44
(2005)
127
Malawi
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. National Research Council of
1. Presidential Decree on 30th
NRCM:
NHSRC:
Malawi (NRCM)
March 1974
Procedures and Guidelines for the 1. Operational Guidelines (2001)
2. National Health Sciences Research 2. Malawi Government Gazette, Conduct of Research in Malawi
Committee (NHSRC)
June 11, 1976, General Notice
(2002)
2. Summary Guidelines for Writing
No. 398
Research Proposals (2001)
3. College of Medicine Research and
Ethics Committee (COMREC)
3. Constitution of Malawi,
COMREC:
Article 19(5) (1994)
4. Ministry of Health
Research Guidelines (2004):
http://www.medcol.mw/comrec/res.guidel
ines.php
Drugs
Pharmacy, Medicines, and Poisons
Pharmacy, Medicines, and
Board of Malawi
Poisons Act, Act 15 of 1988)
Genetic Research
National Research Council of Malawi
Procedures and Guidelines for
(NRCM)
Access and Collection of Genetic
Resources in Malawi (2002)
Nigeria
Country Key
Organizations
Legislation
Regulations
Guidelines
General
National Health Research Ethics
National Health Bill 2009
National Code of Health Research Ethics
Committee: http://nhrec.net/
(2006)
Drugs
National Agency for Food, Drug
Decree No. 15 of 1993
Good Clinical Practice
Administration and Control
Regulations (2009):
(NAFDAC):
http://www.nafdac.gov.ng/index.
http://www.nafdac.gov.ng/
php?option=com_docman&task=
doc_download&gid=18&Itemid=
80
128
South Africa
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. Department of Health (DH):
1. Constitution of South Africa,
DH:
http://www.doh.gov.za
Article 12(2) (1996)
Ethics in Health Research: Principles,
2. Medical Research Council of
2. National Health Act No. 61,
Structures, and Processes (2004):
South Africa (MRC):
Chapter 9 (2003):
http://www.mrc.ac.za
http://www.doh.gov.za/docs/legi
http://www.doh.gov.za/nhrec/norms/ethics
slation-f.html
.pdf
3. National Health Research Ethics
Council:
MRC:
http://www.doh.gov.za/nhrec/
http://www.sahealthinfo.org/ethics/index.
htm
1. Guidelines on Ethics in Medical
Research: General Principles (2002)
2. Guidelines on Ethics in the Use of
Biohazards and Radiation (2003)
3. Guidelines on Ethics in HIV Vaccine
Trials (2003)
Drugs
1. Department of Health (DH):
DH:
http://www.doh.gov.za
1. Medicines and Related
2. Medicines Control Council:
Substances Control Act, 101 of
http://www.mccza.com
1965
http://www.info.gov.za/view/Do
wnloadFileAction?id=68096
2. Guidelines for Good Practice
in the Conduct of Clinical Trials
in Human Participants in South
Africa (2006):
http://www.doh.gov.za/nhrec/nor
ms/gcp.pdf
Human Biological
Department of Health (DH):
National Health Act No. 61,
Materials
http://www.doh.gov.za
Chapter 8, Sections 53-68
(2003):
http://www.doh.gov.za/docs/legi
slation-f.html
129
Country Key
Organizations
Legislation
Regulations
Guidelines
Genetic Research
Medical Research Council of South
MRC:
Africa (MRC): http://www.mrc.ac.za
Guidelines on Ethics in Reproductive
Biology and Genetic Research (2002):
http://www.sahealthinfo.org/ethics/book2.
htm
Embryos, Stem
Medical Research Council of South
National Health Act No. 61,
MRC:
Cells, and Cloning
Africa (MRC): http://www.mrc.ac.za
Chapter 8, Section 57 (2003):
http://www.doh.gov.za/docs/legi
Guidelines on Ethics in Reproductive
slation-f.html
Biology and Genetic Research (2002):
http://www.sahealthinfo.org/ethics/book2.
htm
Sudan
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Federal Ministry of Health:
National Guidelines for Health Research
http://www.fmoh.gov.sd/
Ethics (2002)
Drugs
Federal Ministry of Health:
Act on Pharmaceuticals and
http://www.fmoh.gov.sd/
Poisons (2001)
Human Biological
Federal Ministry of Health:
Human Organs and Tissues
Materials
http://www.fmoh.gov.sd/
Transplant Legislation, Chapter
2, Articles 3 and 4 (1978)
Genetic Research
University of Khartoum, Institute of
Guidelines for Genetics Research on
Endemic Diseases
Sudanese Subjects (2005)
130
Tanzania
Country Key
Organizations
Legislation
Regulations
Guidelines
General
1. Ministry of Health (MOH)
1. National Institute for Medical NIMR:
NHREC:
Research, Act of Parliament No.
2. National Institute for Medical
23, of 1979:
1. Coordination of Health
1. Guidelines on Ethics for Health
Research (NIMR), National Health
http://www.parliament.go.tz/Pol
Research in Tanzania
Research in Tanzania (2001)
Research Ethics Committee
is/PAMS/Docs/23-1979.pdf
(NHREC):
2. Coordination of Formation of
2. Brochure for Health Researchers in
http://www.nimr.or.tz/index.php?opti
2. Tanzania Commission for
Institutional Health Research
Tanzania (2006)
on=com_content&task=view&id=26
Science and Technology, Act
Committees to Formally Approve COSTECH:
&Itemid=34
No. 7 of 1986
for Local Health Research
COSTECH Guidelines on Research
3. Tanzania Commission for Science
3. Amendment of NIMR Act
3. Coordination of Research in
Permits and Clearance (2006)
and Technology (COSTECH):
1997, Tanzania Government
Tanzania
www.costech.or.tz
Gazette, No. 675
Drugs
Tanzania Food and Drugs Authority:
Tanzania Food, Drugs, and
http://www.tfda.or.tz/
Cosmetics Act, Sections 61, 66,
67, and 69 (2003):
http://www.tfda.or.tz/tfdaact.pdf
Uganda
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Uganda National Council on Science
National Guidelines for Research
and Technology (UNCST):
Involving Humans as Research
http://www.uncst.go.ug/
Participants (2007)
Drugs
National Drug Authority:
National Drug Authority Statute
http://www.nda.or.ug/
(1993)
131
Zimbabwe
Country Key
Organizations
Legislation
Regulations
Guidelines
General
Medical Research Council of
1. Government Notice Act
1. Guidelines for Researchers and Ethics
Zimbabwe: http://www.mrcz.org.zw
(1974)
Review Committees in Zimbabwe (2004):
2. Research Act (1986)
http://www.mrcz.org.zw/docs/MRCZ%20
guidelines%20for%20researchers%20200
4.pdf
2. Conducting Health Research in
Zimbabwe: What Researchers Need to
Know (2004):
http://www.mrcz.org.zw/docs/conducting
_health_research_in_zim.pdf
Drugs
Medicines Control Authority of
Medicines and Allied
1. Medicines and Allied
Guidelines for Good Clinical Practice
Zimbabwe: http://www.mcaz.co.zw/
Substances Control Act, Chapter Substances Control Act, General
(2002):
15:03 (1997)
Regulations (1991)
http://www.mcaz.co.zw/trials/Guidelines
%20for%20Good%20Clinical%20Trial%
2. Statutory Instrument 150 of
20Practice%20in%20Zimbabwe.pdf
1991
Human Biological
Medical Research Council of
Ethical Guidelines on the Collection of
Materials
Zimbabwe: http://www.mrcz.org.zw
Blood Samples for Research (1999):
http://www.mrcz.org.zw/docs/blood%20c
ollection%20guidelines%201999.pdf
132
