Giving voice to trial participants
By Prof. Gita Ramjee, HIV Prevention Research Unit, Medical Research Council, Durban, South Africa and Dr. Nyaradzo Mgodi, University of Zimbabwe-University of California at San Francisco Collaborative Research Program
Individual institutional review boards (IRBs) or ethics committees can sometimes determine the extent to which the research staff may facilitate an interaction between currently enrolled trial participants and the news media. In general, however, IRBs do not allow researchers to proactively promote contact between enrolled participants and news media. Even if an individual participant is willing to speak with a journalist, other enrolled participants may infer that the research team has broken the promise of confidentiality and might do the same to them.
Once a trial is over, however, ethics committees typically no longer govern the research team’s role in such communication. During the dissemination of results of the HPTN 035 microbicide trial in southern Africa, different sites conducting the same study had different views and experiences with linking former trial participants with news media covering the dissemination of results.
In Durban, South Africa, the research team invited a few former trial participants to the local media briefing announcing the results. These women were no longer active trial participants. After the briefing, the former participants did one-on-one media interviews with journalists upon request. The women had agreed to speak with the media before knowing the study results or even which trial arm they were in. They shared their first-hand experience of the research process with journalists and gave interviews in English and Zulu, the local language. Resulting local language and national press coverage included profiles of trial volunteers and quotes that highlighted the human story behind the research statistics.
In Harare, Zimbabwe, HPTN 035 participants did not take part in media interviews when results were disseminated. The study staff had earlier identified some women who could be interviewed by media personnel if the need arose, but never obtained local IRB permission to do so. Once results were ready for dissemination, some participants were still being followed for various outcomes (such as pregnancy). Ultimately, given the time limitations, and because participant interviews were not included in the master plan for dissemination of results, study staff did not pursue approval for such interviews from the study’s IRB.