SELECTED HUMAN RESEARCH
ETHICS
NORMS, ORGANIZATIONS & RESOURCES
This page collects a sampling of links
to (I) selected human research ethics norms,
(II) selected organizations involved in
the ethics or human research, and (III) other
resources. Each section begins with a sampling from Canada,
and then surveys selected nations and the international community.
The international dimension is intended to assist the Interagency
Advisory Panel on Research Ethics (PRE)
in its mandate to advise on
the evolution of the Tri-Council Policy Statement, Ethical Conduct
of Research Involving Humans, 1998 (TCPS)
in both a national and international context.
I.
SELECTED HUMAN RESEARCH ETHICS NORMS: POLICIES, LAWS & GUIDELINES
This section generally collects governmental
policy statements, laws or guidelines on the ethics of research
involving humans from Canada and the international community. Selected
guidelines from international non-governmental organizations are
also noted. In general, however, reports and guidelines from professional
or non-governmental groups are collected under the works of selected
organizations in section II, below.
CANADA
- Aboriginal
Healing Foundation, Ethics
Guidelines for Aboriginal Communities Doing Healing Work
(pdf files) (2000)
- Alberta, Health
Information Act (1999) (pdf document), arts. 27(1)(d),
48-56
- Canadian Institutes of Health
Research, Human Pluripotent Stem Cell Research:
Guidelines for CIHR-Funded Research
(2002, updated 2005)
- Canadian Institutes of Health
Research (CIHR), Natural Sciences and Engineering Research Council
(NSERC), and the Social Sciences and Humanities Research Council
(SSHRC), Interim
Tri-Agency Measures for Human Pluripotent Stem Cell Research
- Correctional Services Canada, Commissioner's
Research Directives: DCOO9 (1987)
- Health Canada, (clinical trials regulations)
Regulations Amending the Food and Drug Regulations: 1024,
(2001), especially arts. C.05.001 C.05.006, C.05.010(d), C.05.012;
see also, the Health
Canada Therapeutic Products Directorate Guidelines,
which incorporate standards of the International Conference
on Harmonization (see below)
- Health Canada, Medical Device
Regulations (revised, 1998), sections 1,32, 79-88
- Health Canada, Proposed
Assisted Human Reproduction (Section 8) Regulations (September
2005)regarding consent,
inter alia, for use of an in vitro embryo for any purpose (e.g.,
for research purposes)based on sections 8, 65 of the Assisted
Human Reproduction Act, 2004, Laws of Canada, ch. 2
- Health Canada, Therapeutic
Products Directorate Guidelines. Inclusion of Women in Clinical
Trials During Drug Development (Sept. 1996) (pdf document)
- Manitoba, The
Personal Health Information Act, sections 22-24 (1997)
- National Homelessness Initiative,
Ethical
Guidelines for Conducting Research Involving Homeless People
(2004)
- National Defence, Research
Involving Human Subjects: DAOD 5061-0,5061-1 (1998)
- Northwest Territories: Scientist Act, RSNWT, c.S-4
- Personal
Information Protection & Electronic Documents Act (PIPEDA)
(2000), especially arts.5,7
- Privacy Commissioner of Canada, Privacy Act,
sections 7-8
- Quebec, Civil
Code of Quebec, sections 10-11, 20-24 (Book One)
- Fonds de la recherche en santé
du Québec (FRSQ):
- Fonds
de Recherche sur la Société et la Culture,
-
|
Ethique
de la Recherche Sociale, (November 2002) (draft)
(pdf document) |
- Quebec, Minister of Health and Social
Services
- Royal Commission on Aboriginal Peoples,
Ethical Guidelines for Research
(1993) (pdf document)
- Saskatchewan, The
Health Information Protection Act
(HIPA) (overview) (1997)
- Statistics Canada. Statistics Canada Act,
especially arts.12,17-18, and the Companion
Guide to the Statistics Act (1999)
- Tri-Council
Policy Statement: Ethical Conduct for Research Involving Humans
(1998) of the Canadian Institutes of Health Research (CIHR), Social Sciences and Humanities
Research Council of Canada (SSHRC), and Natural Sciences and Engineering
Research Council of Canada (NSERC)
- Yukon, Council of Yukon First Nations,
Traditional Knowledge Research Guidelines: A Guide for Researchers
in the Yukon (2000)
INTERNATIONAL &
OTHER NATIONS
- Convention
for the Protection of Individuals with Regard to Automatic Processing
of Personal Data, (Jan.1981, effective Jan. 1985)
- Recommendation
No (83) 10 on the Protection of Personal Data Used for Scientific
Research and Statistics (23 September 1983)
- Council of Europe, Recommendation
No R(90)3 of the Committee of Ministers on Medical Research Involving
Humans (Feb. 1990)
- Recommendation
No (97) 5 on the Protection of Medical Data (13 February
1997)
- Convention
on Human Rights & Biomedicine (Oviedo, 1997), especially
arts. 1-2, 5-6,10, 13,15-18, 28.
- Additional
Protocol on the Prohibition of Cloning Human Beings to the Convention
on Human Rights & Medicine (Paris, 1998)
- Additional
Protocol on Biomedical Research to the Convention on Human Rights
& Medicine, (2005)
-
Law No. 503 of 24 June 1992 on the Scientific Ethical Committee
System and the Examination of Biomedical Research Projects
- Danish Central Scientific Ethical Committee,
Guidelines on Biomedical Experiments
(Nov. 2000)
-
See World Medical Association
- Department
of Health, Governance
Arrangements for NHS Research Ethics Committees (2001)
- Data Protection Authority, Data Protection
Act of 1998, arts.1-4, 33 (data for research purposes),
and Schedule 3, art.8 (medical research). See also, The Data Protection (Processing
of Sensitive Personal Data) Order 2000: Statutory Instrument 2000
No. 417. London, Feb. 2000, para. 9.
- Economic and Social Research Council,
Research
Ethics Framework (2005)
(pdf document)
- Human Fertilisation and Embryology Authority,
Human
Fertilisation and Embryology Act 1990, especially arts.3,
11, 15
- Welcome Trust, Research
Involving People Living in Developing Countries
(2005)
- Medical Research Council, Ethics
Series
- Medical
research involving children (2004) (pdf document)
- Medical
Research Council position statement on research regulation and
ethics (2005) (pdf document)
- Belmont
Report: Ethical
Principles and Guidelines for Protection of Human Subjects Research
(1979)
- Federal
(Common Rule) Policy for the Protection of Human Subjects:
(June 1991) (adopted by 15+ US federal departments: e.g., health,
education, defense, veteran affairs, justice, etc.) (pdf document).
- Department of Education, Protection of Human
Subjects in Research, 34
Code of Federal Regulations (CFR) 97 (common rule)
- Food & Drug Administration (FDA),
21 CFR 50,56: Protection
of Human Subjects (under the Federal Food & Drug Act)
- FDA, Guidance
for Institutional Review Boards and Clinical Investigators: Medical
Devices (1998 Update)
- FDA, Regulations
Requiring Manufacturers to Assess the Safety and Effectiveness
of New Drugs and Biological Products in Pediatric Patients
(1998), 21 CFR 201.23,based on the Food, Drug Administration
Modernization Act of 1997/, Section 505(A) of the Federal
Food, Drug, and Cosmetic Act: (The so-called paediatric rule
was suspended by court
judgement (pdf document) in autumn 2002) and complemented
by the Best
Pharmaceuticals for Children Act (2002)
- Department
of Health & Human Services: 45 CFR
46.101 et seq. (common rule)
- Department of Health & Human Services,
Standards for Privacy of Individually
Identifiable Health Information (HIPPA, 2002), especially
arts.,164.501-502,164.512(i), 164.514
- Department of Justice, Regulations
on Protection of Human Subjects (common rule),
28 CFR 46; Regulations
on Confidentiality of Identifiable Research and Statistical Information,
28 CFR 22.
- Indian Health Service (federal), Guidelines for the Collection & Use of Research
Specimens (Sept. 1998) (pdf document)
- Office
of Human Research Protection (OHRP) -Guidance Documents e.g.,:
continuing review, IRB written procedures, etc.
- National Aeronautics and Space Administration
(NASA), Protection
of Human Subjects under the Federal Common Rule, 14 CFR
1230 et seq.;
- NASA,
Policy Directive 7100.8D: Protection of Human Research Subjects
(30 May 2002)
- National Science Foundation, 45 CFR 690
(common rule) and FAQs:
Interpreting the Common Rule for the Protection of Human Subjects
for Behavioral and Social Science Research
- National Institutes of Health (NIH),
Office of Human Subjects Research, Guidelines
for Conduct of Research Involving Human Subjects at NIH
- National Institutes of Health, (Amendments)
Under the NIH Guidelines for Research Involving Recombinant DNA
Molecules (Oct. 2000)
- Presidential Memorandum, Strengthened
Protections for Human, Subjects of Classified Research
(27 Mar.1997) Federal Register: 13 May 1997; 62 (92): 26367-26372
II. SELECTED ORGANIZATIONS, SELECTED PUBLICATIONS
This section of the links page collects
national and international organizations involved in the ethics
of research involving humans. The selection thus generally profiles
the activities, advisory opinions, repor ts or publications of selected
professional, non-governmental, governmental organizations.
CANADIAN ORGANIZATIONS
- Alberta College of Physicians and Surgeons,
Research
Ethics Review Program
- Association
of Canadian Universities of Northern Studies
- Association
of Universities and Colleges of Canada (AUCC)
- Canadian
Association of University Teachers (CAUT)
- Canadian
Association of Research Ethics Boards (CAREB)
- Canadian
Association of University Research Administrators (CAURA)
- Canadian
Biotechnology Advisory Committee (CBAC)
- Canadian
Bioethics Society
- Canadian
Institutes of Health Research (CIHR)
- Canadian
Psychological Association, Canadian
Code of Ethics for Psychologists (2000)
- Canadian
Sociology & Anthropology Association (CSAA)
- Genome
Canada
- Health
Canada - Therapeutic Products Directorate
-
Health Canada - A Canadian System of Oversight
- Health
Canada - Research Ethics Board
- National Aboriginal
Health Organization (NAHO) - Aboriginal Research
- National
Council on Ethics in Human Research (NCEHR)
- National
Research Council (NRC), Institute of Biodiagnostics
- Natural
Sciences and Engineering Research Council of Canada (NSERC)
- Social
Sciences and Humanities Research Council of Canada (SHHRC)
- Quebec, College
of Physicians of Quebec
-
|
Code of Ethics of Physicans (2002) (pdf document),
arts. 28-31,45,48,61,78, 87. |
- Quebec, Fonds de la Recherche
en Santé du Québec (FRSQ)
- Quebec, Fonds
de Recherche sur la Société et la Culture
- Quebec, Ministry
of Research, Science & Technology, Committee on the Ethics
of Science and Technology,
INTERNATIONAL
& NATIONAL ORGANIZATIONS
- Accreditation
of Human Research Protection Programs (AAHRPP)
- Advisory
Committee on Human Radiation Experiments - Final Report
(1995)
- American
Anthropological Association (AAA), Statement
on Ethnography and Institutional Review Boards (2004)
- American
Association for the Advancement of Science (AAAS)
- American
Association for Public Opinion Research (AAPOR)
- American College
of Epidemiology, Ethics
Guidelines (2000)
- American Educational Research Association, Ethical
Standards of the American Educational Research Association 1992,
revised 2000.
- American Indian
Law Center, Model
Tribal Research Code (Sept. 1999) (pdf document)
- American
Psychological Association (APA)
- Ethical Principles
of Psychologists and Code of Conduct 2002 (pdf document)
- American
Sociological Association (ASA)
- Department
of Health and Human Services (HHS)
-
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HHS,
FDA - Center for Drug Evaluation and Research (CDER) |
-
|
HHS,
FDA - Bioresearch Monitoring Program Coordination |
-
|
HHS,
Food and Drug Administration (FDA) |
- |
HHS, Indian Health
Service Research Program, Area/Tribal IRB Chairs |
- |
HHS,
National Institutes of Health (NIH) |
- |
HHS,
NIH - Behavioral and Social Sciences Research Coordinating
Committee |
- |
HHS,
Office for Human Research Protections (OHRP) |
-
|
HHS, Office of Inspector General, Office
of Evaluation and Inspections (See clinical Research):
|
|
-
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HHS,
Secretary's Advisory Committee on Human Research Protections |
-
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IRB Handbook (OHRP) |
- National
Academies of Science, Institute of Medicine
- National Academies of Science,
National Research Council
- National
Bioethics Advisory Commission (NBAC, 1995-2001)
- National
Human Research Protections Advisory Committee (NHRPAC) (2000-2002)
Reports:
- President's Council on Bioethics, Human Cloning
and Human Dignity: An Ethical Inquiry (July 2002)
- Public
Responsibility in Medicine and Research (PRIM&R)
III.
OTHER SELECTED RESOURCES
Under construction.
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