Potential HIV Vaccine Trial Participants Tell Researchers: Be Open And HonestAnd Do No Harm

July 02, 1998

GENEVA, Switzerland--Members of communities similar to those likely to be targeted for participation in HIV vaccine trials have specific concerns about how this research is carried out.

They want full and honest disclosure about all aspects of the research and the experimental vaccine, including its potential side-effects. They also want researchers to minimize any physical and social harm that might result from their involvement and to be treated with respect by the research teams. The concerns are included in new study findings reported here today (July 2) at the 12th World AIDS Conference.

Participants in the study also said it is important for future HIV vaccine trials to be a real community collaboration, with researchers working closely with the communities in which the testing is conducted, said lead author Susan M. Kegeles, PhD, associate professor of medicine at the University of California San Francisco Center for AIDS Prevention Studies.

In the study, Kegeles and her colleagues did in-depth interviews with 90 people from three different communities that are representative of some of the groups most heavily impacted by the AIDS epidemic in the U.S. Participants included African Americans in Durham, N.C., ethnically diverse gay men in San Francisco, and ethnically diverse injecting drug users in Philadelphia.

Kegeles said these groups tend to be wary of participating in research because of past experiences in which the rights of test subjects were clearly violated or because of researchers' lack of awareness of community sensitivities. She noted that the Tuskegee Study of Untreated Syphilis, in which African-American men participating in the study between 1932-72 did not receive the proper medical treatment they needed to cure their illness, continues to be a potent symbol of institutional mistreatment of trial participants. Kegeles said she was not surprised when volunteers in the latest study, when asked how they believed HIV vaccine trials should be run, responded with clear concerns of distrust.

"The first and very clear thing that came out in all three communities was the issue of full and complete disclosure by the researchers," she said. "They don't want any surprises. They don't want to find out later that a researcher did not inform them of something because of a loophole. Some even used very strong language like, 'Don't lie to us. Don't cover things up. Be honest and put things on the table.' They also want to know the history of this particular vaccine, why it is being tested, and what its problems may have been in the past. And why they, as a group, are being asked to participate in the research."

Study participants cited several issues important to potential vaccine trial participants. Among them:

"There was a real desire that the commitment be mutual--that if the researchers were expecting the participants to give their all, then the researchers should also come forward and do what they could to help them," Kegeles said. "They felt that this should go beyond the length of the trial because the implications of participation could last far into the future."

Kegeles said that those interviewed also spoke about the need for researchers to regard and interact with trial participants with respect and dignity, and not be patronizing or manipulative or take advantage of people who have hardships. "The people we interviewed said 'Don't treat us like guinea pigs and call us Subject A or Subject B, because we are real people,'" Kegeles said. "They want to be treated as equals."

She also noted that some of the respondents offered suggestions on who they thought should participate in the trial. Some proposed that scientists and pharmaceutical company representatives be part of the testing. Others suggested that anyone who could benefit from being given a vaccine should also participate, not just those from disenfranchised groups.

Respondents also felt it was important for communities to be partners in the trial, she said. "The general feeling was that there should be a real community collaboration in running these trials--that the researchers should care about the community, educate the community and the community should be involved in some decision-making about the trial," she said.

"I think communities have to be educated about the fact that vaccine research will be done in incremental steps. We can't expect a single trial will yield a vaccine that will be 100 percent effective. Communities have to understand that from the start; there isn't going to be 'the one'. That's where educating the community comes into play," she added.

"But in addition," she said, "researchers need to be aware that mistrust will continue if clear, honest and complete information isn't presented to prospective study participants."

Kegeles' colleagues in the study are Ronald P. Strauss, DMD, PhD, University of North Carolina at Chapel Hill; David Metzger, PhD, University of Pennsylvania; and Kathleen MacQueen, PhD, MPH, federal Centers for Disease Control and Prevention.

Co-investigators from UCSF CAPS are Tom Slama, research associate; Brady Ralston, research associate; and Robert Hays, PhD, research scientist.

This study was funded jointly by the Centers for Disease Control and Prevention and the National Institute of Allergy and Infectious Disease.

University of California - San Francisco

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