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Views differ on HIV research in the developing world
Americans ask for fewer changes to protocols
IRBs in the United States and research ethics committees (RECs) in the developing world who review HIV vaccine trials must struggle with a number of tough ethical issues – ensuring adequate, culturally sensitive informed consent, protecting privacy, determining the standard of treatment for participants who become infected with HIV during a trial.
A recent survey of U.S. IRB and South African REC members shows the two groups come to that struggle with strikingly different views about some of these issues.1 In general, IRB members tended to ask for major changes to protocols less often than their REC counterparts did and were more likely than the South African boards to think vaccine trial participants understood the informed consent documents given to them.
Robert Klitzman, MD, an associate professor of clinical psychiatry at Columbia University in New York City, says it is the first survey he knows of to quantitatively compare the views of U.S. IRB members and REC members in the developing world.
Klitzman, who has written about HIV and medical ethics, says that at HIV conferences, it's been clear to him that IRBs are having trouble deciding how to handle western-sponsored research in the developing world.
"It seemed that there was a need to understand what kinds of problems were out there and how people were dealing with them," Klitzman says. "So I thought it would be interesting to see how IRBs and research ethics committees deal with these issues."
Surveys sent to IRBs
He mailed out questionnaires to chairs and administrators of U.S. IRBs and South African RECs whose boards had dealt with HIV vaccine trials (HVTs) in the developing world. They were asked to distribute the questionnaires to their members. Klitzman received back a total of 113 surveys – 76 from the U.S. and 37 from South Africa.
Among the questions:
-Has your board asked for major changes to HVT protocols?
-Do you think participants in HVT trials in the developing world understand the risks and benefits of their participation?
-Do you believe they understand that they may receive a placebo?
-Do they adequately understand informed consent documents?
-What standard of medical care should be given to participants who become HIV-infected during a vaccine trial – the best care available anywhere in the world, the best care available in the host country, or the standard care in the host country?
More than 90% of REC members reported that their board had asked for major changes in HVT protocols either "very often" or "sometimes," compared with 57% of IRB members.
Another area where the IRBs and RECs differed was in their view of participant understanding of the informed consent documents.
More than 70% of IRB members surveyed thought participants understood the informed consent "very well" or "somewhat well" – a little more than a third of REC members had a similar confidence in participants' understanding of the document.
"I think that highlights an important lesson for IRB members, which is consistent with other research that shows people don't understand a lot of aspects of informed consent in the developing world," Klitzman says. "There are high rates of illiteracy, they are very different cultures. In another study, we asked, 'Do you think you can withdraw from the study if you wish?' And most people said no, they couldn't withdraw.
"So I think what this speaks to is that IRBs may spend a lot of time on informed consent forms that participants don't understand, particularly in the developing world."
He says this is an area where local review of projects in the developing world may hold particular advantages, because local RECs will better understand the literacy rates in the community and other cultural issues.
Klitzman says he also was interested in areas where IRB and REC members gave similar answers. In both countries, members were divided over how to treat participants who contracted HIV during the trial. More than half of both IRB members and REC members thought that participants should receive the best care available anywhere in the world, while about 30% of IRB members and 26% of REC members thought only the standard care available in the host country is required, with the rest opting for the best care available in the host country.
Members in both countries agreed that they need more training regarding HIV vaccine trials.
Klitzman says they also shared another surprising attribute: In both countries, most people who completed the surveys were white males.
"Both the US and South Africa have trouble getting people who really reflect the community and who are interested and have the time to participate."
Klitzman says IRBs can gain some important insights from the HVT survey, particularly when it comes to the informed consent process.
"I'm concerned about comprehension, that participants don't understand these forms," he says. "Even in this country, how many participants really understand 20-page consent forms?"
He says IRBs and RECs need to communicate more about these types of trials.
"Institutions here may assume that everybody else seems to have signed off, so we should just sign off too, we don't want to create a problem," Klitzman says. "And then of course, in South Africa they may be saying, I don't think they understand these consent forms, but the U.S. is saying OK, so we don't want to stand in the way."
And he notes that there has been limited research on the attitudes and practices of IRBs, in part because it's often hard to get the names of members or permission to sit in on IRB meetings.
"I think many IRBs and IRB members resist being studied and I think that may not be serving the field best in the long run," he says. "I think agreeing to participate in studies will help the process of IRB decision-making, the quality of decisions, and I think it also will potentially help with transparency.
"I think IRBs are trying to do the right thing and to say no, we don't want to be studied does not give that message, it's not encouraging a sense of trust on the part of researchers."