Community ethics training program wins award
Community ethics training program wins award
Curriculum is available to public online
Formal ethics training and education for community representatives who serve on IRBs or otherwise provide an ethical perspective regarding human subjects research is one area of research training that has been overlooked by many institutions.
To fill that gap, Family Health International of Research Triangle Park, NC, has developed an educational program called Ethics Training Curriculum for Community Representatives.
The curriculum recently won a 2005 Award for Excellence in Human Research Protection from the Human Improvement Institute of Bethesda, MD. FHI won a second award of excellence for a sister program called Research Ethics Training Curriculum.
The curriculum is available as an on-line course or a PDF file to download at the organization’s web site at www.fhi.org. It’s also available as a CD-ROM.
"We wanted to develop something that could be used as a tool for self-training or for group training," says Roberto Rivera, MD, director of the Office of International Research Ethics at FHI.
The training curriculum is or soon will be translated into Spanish, French, and Portuguese for the web version, and a Chinese Mandarin version has been translated for CD-ROM.
"When we did the first curriculum we had investigators in mind, and we started the process in the year 2000," Rivera says. At that time, training community representatives was a new concept, he says. "Many people would say, You’re going to do that? What do people at the community level know about research?’" Rivera recalls.
It was necessary to involve community representatives in research planning for both cultural and ethical reasons, Rivera says. "Once the research is conducted you want results accepted by the community, so you have to involve the community and give ownership from the beginning."
Once FHI was committed to making the most of involving community representatives, the next step was to provide ethical training for these people, Rivera says.
FHI started with community advisory boards. "If you do a study on a new microbicide or vaccine in which communities are going to play a very important role. They are going to help you with how the process should be conducted and how participants should be enrolled. The board tells you what kind of community consultation should be required before you start the research project."
FHI’s ethical training curriculum for community representatives provides background information that is necessary for the local IRBs and community advisory boards to know when they consider research proposals.
FHI’s IRB has instructions to ask specific questions about the involvement of community advisory boards, including asking what type of community consultation was done before the initiation of the project, Rivera says.
"It also addresses the principles of informed consent in a more simple language," Rivera says. For instance, research participants often do not know what is meant by the term benefit, and during the informed consent process this needs to be made clear to them and at times to community representatives, Rivera says.
The training curriculum, which could be presented in six to eight hour sessions on two days, covers the following: community participation in the research process; researchers and sponsors; ethics committees; principles of research ethics; informed consent; and research ethics documents.
The on-line version contains interactive case studies, which reinforce key content messages and stimulate discussion.
Formal ethics training and education for community representatives who serve on IRBs or otherwise provide an ethical perspective regarding human subjects research is one area of research training that has been overlooked by many institutions.Subscribe Now for Access
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