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Researchers recommend community advisory boards to prevent lapses in informed consent

CHAPEL HILL Expanding the use of community advisory boards could go a long way toward preventing lapses in the informed consent process and safeguarding the interests of people who agree to participate in clinical research.

Thats the view a group of scientists studying AIDS and other infectious diseases express in the December issue of the American Journal of Public Health.

In a climate where formal research safeguards do not always succeed in protecting the rights of human subjects, the need for community-based methods to augment the process of protection is apparent, said Dr. Ronald P. Strauss of the University of North Carolina at Chapel Hill. Community advisory boards reinforce the importance of community involvement in the decision-making process from the inception of a research study to ensure that consenting human subjects are fully informed about the study in question.

The boards also provide a context in which researchers and community members can discuss the intent, risks, benefits and implications of research projects in culturally sensitive terms, said Strauss, lead author and chair of dental ecology at the UNC School of Dentistry.

Co-authors include Drs. Sohini Sengupta and Susan M. Kegeles of the University of California at San Francisco, Dr. Sandra Crouse Quinn of the University of Pittsburghs department of health services administration, Jean Goeppinger of the UNC schools of nursing and medicine and Dr. Cora Spaulding of UNCs department of family medicine.

While the worst examples of medical research abuses occurred long ago in the United States and abroad, more recent studies in which human subjects werent adequately informed can be found in both industrial and developing countries, the scientists said.

For example, the required voluntary nature of participation was marred a study in which an investigator was the subjects own physician, another in which subjects were asked to participate while u
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Contact: David Williamson
david_williamson@unc.edu
919-962-8596
University of North Carolina at Chapel Hill
10-Dec-2001


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