Biomedical Research in Developing Countries - UNICRI

Rome Declaration
on Harmonization
2003
Rome High Level
Forum
The Rome Declaration on Harmonization
has been the output of the High Level
Forum, which was held in Rome in
February 2003 with the participation of the
major multilateral development banks,
international and bilateral organizations,
donors and recipient countries. The major
aim of this meeting was to improve the
management and effectiveness of aid, to
achieve and identify concrete progress
before the following Forum (2005).
The Rome Declaration is a very ambitious
programme and it aims to reach its goals
through: guaranteeing that harmonization
efforts are adapted to the country and that
the assistance of the donor is in line with
the priorities of the recipient; Streamlining
donor procedures and practices;
Facilitating harmonization, adapting
institutions and country policies,
procedures and practices; Respecting the
development of community standards and
good practices principles.
A Practical Guide
for Health
Researchers
2004
WHO Regional
Office for the
Eastern
Mediterranean
This is a comprehensive guide for all those
involved in health research: students,
researchers, people engaged in teaching
and training. It provides a series of
principles, methodologies, references and
represents a very useful instrument to
highlight the key points of health research
issues.
The Mexico
Statement on
Health Research
2004
Ministerial Summit
on Health
Research
The Mexico Statement on Health Research
was the result of the Ministerial Summit on
Health Research organized by WHO, held
in Mexico City, Mexico in 2004. The
Summit underlined the importance of
research in the improvement and
sustainable development of population
health and the need to translate knowledge
into action (the know/do gap).
This important event was organized with
the collaboration of the Mexico Ministry of
Health and in conjunction with Forum 8 of
the Global Forum for Health Research.
Code of Federal
Regulations,Title
45 Part 46
Subparts A, B, C
and D.
The “Common
Rule”
2005
(rev.)
1991
USA, Department
of Health and
Human Services
The Common Rule, developed by the
DHHS, was adopted from 1991, as a set of
guidelines to be followed by all 16 federal
agencies for research conducted at the
federal level, by or for the agencies or
oversight by them. It is constituted by four
parts each devoted to an aspect of the
protection of human subjects: Subpart A is
the basic policy for protection of human
research subjects, Subpart B is the
protection for pregnant women, human
fetuses and neonates, Subpart C is the
protection for prisoners, Subpart D is the
protection for children.
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