Researchers Recommend Community Advisory Boards To Ensure Informed Consent.(Brief Article)

2001 DEC 26 - (NewsRx.com & NewsRx.net) -- 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.

That's the view a group of scientists studying AIDS and other infectious diseases express in the December 2001 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.

Coauthors include Drs. Sohini Sengupta and Susan M. Kegeles of the University of California at San Francisco, Dr. Sandra Crouse Quinn of the University of Pittsburgh's department of health services administration, Jean Goeppinger of the UNC schools of nursing and medicine and Dr. Cora Spaulding of UNC's 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 weren't 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 subject's own physician, another in which subjects were asked to participate while under duress and another in which they were asked to participate when they had few or no options.

Incomplete disclosure also can be a problem, Strauss said. In several studies, investigators did not tell patients and parents of child patients enough about potential side effects. In a New York study, doctors did not inform parents that their children with attention deficit-hyperactivity disorders were taken off medications and subjected to brain chemistry tests. Researchers in Uganda did not tell HIV positive patients that a tuberculosis drug they were given as part of a study was not routinely used in the United States for TB.