Biomedical Research in Developing Countries - UNICRI

Guidelines for Good
Clinical Practice in
Clinical Trials
1998
The United
Kingdom, Medical
Research Council
This document provides good clinical
practices for trials funded by the Medical
Research Council, the largest public sector
organization in the United Kingdom that
directly finances human health research.
Guidelines on
Ethical Review of
Medical Research
1998
China, Committee
on Research
Involving Human
Subjects
Chinese Guidelines are not substantially
different from those in Europe and in USA.
They regulate topics such as informed
consent, the responsibilities of
investigators, the rights of research
subjects, and the administrative
management of ethical reviews and legal
responsibilities. The document states also
that research in China be based on
international recognized ethical principles.
Operational
Guidelines for
Ethics
Committees that
Review Biomedical
Research
2000
WHO
This guidance was published by WHO in
order to set the appropriate procedures for
the work of Ethics Committees that review
biomedical research, in compliance with the
ethical and scientific standards established
by international guidelines. The purpose of
the guidelines is to practically support and
facilitate the ethical review function within
countries, in line with existing national laws
and regulations or the strengthen this
functions, where needed. In fact, the
guidelines “should be used by national and
local bodies in developing, evaluating, and
progressively refining standard operating
procedures for the ethical review of
biomedical research.” The guidance includes
a detailed discussion on the role of an
Ethical Committee, on the minimum
requirement for the proper functioning of a
EC (including membership requirements,
terms and conditions of appointments,
training for members and consultants) on
the review and decision making process.
Ethical
Considerations in
HIV Preventive
Vaccine Research
2000
UNAIDS
This document is composed by 18 guidance
points on Ethical Considerations in HIV
Preventive Vaccine Research and it is the
result of a series of meeting held in Geneva,
Switzerland, in 2000. This document
underlines the importance of the analysis of
critical elements in HIV vaccine research
and other references in this field, which
should be consulted during the research: the
Nuremberg Code (1947); the Declaration of
Helsinki; the Belmont Report (1979 - US
National Commission for the Protection of
Human Subjects of Biomedical and
Behavioral Research); the International
Ethical Guidelines for Biomedical Research
Involving Human Subjects (1993 - CIOMS),;
the WHO’s Good Clinical Practice
Guideline (1995); and the International
Conference on Harmonisation Good
Clinical Practice Guideline (1996).
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