Biology Reference
In-Depth Information
Table 3.2
Main Guidelines on Benefit Sharing with Human Research Participants
Guidelines
Issuing Body
Issued
Benefit Sharing
International Covenant on Economic,
Social and Cultural Rights
UN General
Assembly
1966
Article 15(b)
Declaration of Helsinki
WMA
1964/
2008
Articles 14, 17 and 33
International Ethical Guidelines
for Biomedical Research
Involving Human Subjects
CIOMS
1982/
2002
Guidelines 5(12), 10, 21
Convention on Human Rights
and Biomedicine
Council
of Europe
1997
Preamble
Statement on Benefit Sharing
HUGO Ethics
Committee
2000
Entire document
Universal Declaration on
Bioethics and Human Rights
UNESCO
2005
Article 15
International Declaration
on Human Genetic Data
UNESCO
2003
Article 19
Operational Guidelines for
Ethics Committees that
Review Biomedical Research
WHO
2000
Guideline 6.2.3.10
what became of the whole study
[emphasis added].'
14
This benefit-sharing provi-
sion of the Declaration of Helsinki could therefore address some of the concerns
and dissatisfaction raised in the context of collaborative research in developing
countries (Table
3.2
).
3.4 CIOMS International Ethical Guidelines for Biomedical
Research Involving Human Subjects
The Council for International Organizations of Medical Sciences (CIOMS) was
established jointly by the WHO and UNESCO in 1949. It is an international, non-
governmental organization which works on a non-profit basis. Its International
Ethical Guidelines for Biomedical Research Involving Human Subjects is one of
the most frequently quoted guideline documents on research ethics in the aca-
demic literature.
The current document (CIOMS
2002
) consists of general ethics principles and
21 guidelines. The text was designed to assist in the definition of national research
ethics policies, with particular emphasis on developing countries. In contrast to
the Declaration of Helsinki, the CIOMS guidelines include a helpful and extensive
commentary.
14
Interview with a member of the Kenya Medical Research Institute (KEMRI) Ethical Review
Committee quoted in Andanda and Cook Lucas (
2007
).
