That’s 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 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.
Not infrequently, participants misunderstand study terminology, he said.
For example, parents of critically ill babies in a United Kingdom study were confused about the words “random” and “placebo.” Health workers told HIV-positive subjects in a Ugandan tuberculosis study that they would be treated “with a placebo drug,” although placebos are chosen so as not to produce any physiologic effect. A woman in an Ivory Coast study thought participating in a study of the AIDS drug formerly called AZT would help her child and ease her childbirth.
“Individual informed consent has traditionally been understood as a substantive ethical requirement, an agreement between the researcher and the research subject concerning the roles and obligations of each party in a study,” Strauss said. “The researcher seeks to enroll fully informed, consenting individual subjects in a study. When informed consent is not obtained, or when subjects are not fully informed, research abuses can occur.”
Since the Nuremburg Code of 1947, several organizations have worked to provide ethical guidelines and principals for human subject research, he said. These include the Council for International Organizations of Medical Sciences, the World Medical Association and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
The principles, which promote respect for individuals, beneficence and justice, require that enough information about the risk and benefits of studies be given in easily understandable ways and that subjects agree in writing that their participation is voluntary, the scientist said.
Community advisory boards are most useful when they are composed of community members who share a common identity, history, symbols and language and culture, he said.
“For example, gay activists and gay HIV-affected individuals could serve on a CAB for an AIDS clinical trials group interested in recruiting participants from the gay community,” Strauss said. “Representatives from the African-American community could serve on a CAB that is linked to a study testing a comprehensive prenatal program for high-risk minority pregnant women.”
HIV and AIDS-related boards already have proven useful in helping recruit patients, developing educational materials and convincing investigators to modify or stop studies board members felt were not entirely in participants’ best interests, he said. If CABS are to be effective, investigators need to be willing to listen to listen to and understand their concerns.
Note: Strauss can be reached at (919) 966-2788 or via e-mail at ron_strauss@unc.edu School of Dentistry Contact: Alice Lockhart, (919) 966-4563 Contact: David Williamson, (919) 966-8596
By DAVID WILLIAMSON
UNC News Services