Operational Guidelines for Ethics Committees That Review Biomedical Research
World Health Organization, Geneva (WHO 2000)
The ethical and scientific standards for carrying out biomedical research
on human subjects have been developed and established in international
guidelines, including the Declaration of Helsinki, the CIOMS
International Ethical Guidelines for Biomedical Research Involving
Human Subjects, and the WHO and ICH Guidelines for Good Clinical
Practice. Compliance with these guidelines helps to ensure that the
dignity, rights, safety, and well-being of research participants are promoted
and that the results of the investigations are credible.
All international guidelines require the ethical and scientific review of
biomedical research alongside informed consent and the appropriate
protection of those unable to consent as essential measures to protect
the individual person and the communities who participate in research.
For the purposes of these Guidelines, biomedical research includes research
on pharmaceuticals, medical devices, medical radiation and
imaging, surgical procedures, medical records, and biological samples,
as well as epidemiological, social, and psychological investigations.
These Guidelines are intended to facilitate and support ethical review
in all countries around the world. They are based on a close
examination of the requirements for ethical review as established
in international guidelines, as well as on an evaluation of existing
practices of ethical review in countries around the world. They do
not, however, purport to replace the need for national and local guidelines
for the ethical review of biomedical research, nor do they intend
to supersede national laws and regulations.
The majority of biomedical research has been predominantly motivated
by concern for the benefit of already privileged communities.
This is reflected by the fact that the WHO estimates that 90% of the
resources devoted to research and development on medical problems
are applied to diseases causing less than 10% of the present
global suffering. The establishment of international guidelines that
assist in strengthening the capacity for the ethical review of biomedical
research in all countries contributes to redressing this imbalance.