Biomedical Research in Developing Countries - UNICRI

Ethical Guidelines
for Biomedical
Research on
Human Subjects
2000
India, Central
Ethics Committee
on Human
Research, Indian
Council of Medical
Research
The CECHR (Central Ethics Committee
on Human Research) Guidelines include a
series of chapters addressing the following
issues: Statement of general principles on
ethical considerations involving human
subjects; Ethical review procedures;
General ethical issues; Statement on
specific principles for clinical evaluation of
drugs/devices/diagnostics/vaccines/herbal
remedies; Statement of specific principles
for epidemiological studies; Statement of
specific principles for human genetic
research; Statement of specific principles
for research in transplantation including
fetal tissue transplantation; Statement of
specific principles for assisted reproductive
technologies.
Guidelines on
Ethics for Medical
Research
2000
(rev.)
1993
South Africa,
Medical Research
Council
These guidelines were recently revised to
bring them closer to the South African
context and needs.Their revision is based on
the SA Constitution’s Bill of Rights and the
ethical and human rights concepts such as the
dignity of the person, the respect for
autonomy and the paramount importance of
informed consent are especially stressed out.
The revised version also stresses the concept
of the best interest of the research participant
and emphasizes that developing communities
must not be exploited and that in some way
participating communities must benefit from
the research done in or with them.
Guidelines for
Good Practice in
the Conduct of
Clinical Trials in
Human
Participants in
South Africa
2000
South Africa
Department of
Health
These guidelines are the output of a
working group organized by the South
African Directorate General of the
Department of Health and it has included
representatives from the Department of
Health, South African Drug Action
Programme / World Health Organization,
Medical Research Council, the Medicines
Control Council, Universities of Natal and
the Witwatersrand and the AIDS Law
Project. The main purpose of these
guidelines is to provide South Africa with
GCP standards and to become a reference
text for people involved in clinical trials
research in South Africa.
United Nations
Millennium
Declaration
2000
The United
Nations 55th
General Assembly
In the context of health research, the
Declaration sets an important goal: to halt
and start reversing by 2015 the spread of
AIDS and the major diseases that affect
developing countries.
The Declaration also directly encourages
the pharmaceutical industry to make
essential drugs available and affordable to
affected countries. A special section is
devoted to meet the special needs of
Africa, sustaining its efforts to development
and to the establishment or consolidation
of democracy and the rule of law. The
respect of human rights and fundamental
freedom and the protection of the
vulnerable subjects are strongly reaffirmed.
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