Biomedical Research in Developing Countries - UNICRI

Resolution on
Research Involving
Human Subjects
1996
Brazil, National
Health Council
This Resolution is based on the most
important international documents on
research involving human subjects and it
includes the following articles: Preamble;
Terms and definitions; Ethical aspects of
research involving human subjects; Freely
given and informed consent; Risks and
benefits; Research protocol; Committee
for Ethics in Research (CER); National
Committee for Ethics in Research
(CONEP/MS); Operationalization;
Transitional provisions.
Guidelines and
Recommendations
for European
Ethics
Committees
1997
European Forum
for Good Clinical
Practice
The document was the output of research
and discussions by the Ethics Working
Party of the European Forum for Good
Clinical Practice. It provides a series of
guidelines proposals and
recommendations for European ethics
review committees involved in clinical
trials ethical review. These guidelines and
recommendations aim to assist and
support the ethical review capacity of
pharmaceuticals products and related
substances trials, but they are also
applicable to other areas of biomedical
research.
Guidelines on
Ethics in Health
Research
1997
New Zealand,
Health Research
Council
This document requires that the ethical
approval from a recognized ethics
committee is obtained before the Health
Research Council of New Zealand funds
for any proposed research may be
granted. The following topics are
contained in the Guidelines: Introduction
to Ethics Committees in New Zealand;
Procedural requirements for ethical
approval; Ethical issues of research
involving humans or human materials;
Specific ethical issues of concern; General
issues that may have legal relevance;
Health research and privacy guidance
notes.
Guidelines for the
Conduct of Health
Research Involving
Human Subjects in
Uganda
1997
Uganda, National
Consensus
Conference on
Bioethics and
Health Research,
National Health
Research
Organization
(UNHRO)
These guidelines have been the result of
several workshops focused on the
conduct of biomedical research with
human subjects. It offered an overview of
the generally accepted ethical principles
and a commentary on the guideline and
on the relevant workshops discussions.
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