Award for Excellence in Human Research Protection
Best Practice 2005
Family Health International, Research Triangle Park, NC
Submitted by: Dr. Roberto Rivera, Director, Office of
International Research Ethics
The following information was submitted by the applicant for the award.
The Institute may have edited the text for presentation purposes. Health
Improvement Institute has not verified, and does not guarantee, the
completeness or accuracy of the information for any purpose. Institutions
interested in adopting or adapting the practice would be well advised to
contact the person who submitted the application and to evaluate this and any
additional information for their purposes.
Description: In 2004 Family Health International (FHI) published the Research Ethics Training Curriculum for
Community Representatives (RETC-CR), an educational tool for preparing and
informing community representatives about research ethics, so that they can
fulfill their roles and responsibilities and have a stronger voice in the
planning, implementation and dissemination stages of the research process. The curriculum was developed for training
representatives of the communities in which research
is being conducted, serving as members of the research team, a Community
Advisory Board (CAB) or a Research Ethics Committee. The curriculum was
specifically designed to empower community representatives in developing
countries to have an active participation throughout the research process. An
earlier curriculum, the Research Ethics
Training Curriculum (RETC), was
developed by FHI in 2001. The RETC,
an educational tool for instructing research staff in the principles of basic
human subjects research ethics, was designed for
training international researchers based in developing countries. Both are
online at http://www.fhi.org/en/RH/Training/trainmat/ethicscurr/index.htm.
Genesis: Current regulations do not address
the role of community in the research process.
The attempt to involve host communities in research is an idea that is
still in its infancy, but FHI believes that this will become a global
expectation. Having materials like the curriculum
for community representatives will facilitate the growth and development of
this trend.
Experience: The Research Ethics Training Curriculum for
Community Representatives has been used by research staff to train Community
Advisory Board (CAB) members associated with specific research projects in
Africa, Asia and
Compliance: In 1999 the U.S. National Institutes of Health (NIH)
announced a requirement that key research personnel would be required to obtain
education in basic research ethics.
Also, several internationally prominent organizations — including
the Council for International Organizations of Medical Science (CIOMS) and the
Nuffield Council on Bioethics —made explicit recommendations encouraging
all researchers to complete a basic training program on the ethics of research
involving human subjects. At the time of
the NIH announcement, FHI’s Office of
International Research Ethics (OIRE) initiated an evaluation of selected
research ethics training curricula that were available at that time and found
that these curricula were mostly designed to meet specific institutional and
Protection of human subjects: The RETC
contributes toward the achievement of protection of human subjects through the
professional development of individuals responsible for the design, conduct,
review and analysis of research involving human subjects. For many of the individuals completing the
curriculum, the exposure to the RETC is
the first exposure to the principles of research ethics. The RETC
contributes to a culture in which research is designed and conducted according
to the highest ethical standards.
Monitoring and evaluation/outcomes: The
development of the RETC-CR included
an initial internal review, followed by an international external review and a
series of field-tests, to ensure wide applicability of ethical practices and
curriculum content. The field tests were
conducted in eight countries by HIV prevention research community educators
working with Community Advisory Boards in
Innovation: The
RETC-CR is innovative in its focus on
the communities from which participants are recruited. To our knowledge there
is no other comparable training tool.
Replicability: The RETC-CR and RETC can be
used by a broad spectrum of individuals and institutions from individual
principal investigators to research networks to entire institutions.
Applicant’s
justification for award: The need to include community representatives throughout the research
process has been increasingly recognized. However, community participation
approaches in research are fragmented and have suffered from inadequate
attention to consistent guidance.
Geographic, cultural, political and social differences impact on the operationalization and integration of community
participation into the science at the local level. Research and ethics literacy
in resource constrained communities involves multiple challenges, including a
concerted investment in training and capacity building, as these communities
are often characterized by major disparities; and community representatives may
have little formal education. Of equal
importance is community literacy of researchers, as evidenced by the degree of
investment in the partnership process, including efforts to overcome perceived
power / educational imbalances. To our knowledge the RECT-CR is currently the only available tool designed to meet this
kind of training. In addition, the RETC-CR
is available on FHI’s Web site and on CD-ROMs
in English, French and Spanish. Chinese and Portuguese versions will be
available early in 2006.
For additional information: Dr.
Roberto Rivera
Tel: 919-544-7040, ext 233
Fax: 919-544-7261
Email: ethics@fhi.org