Symposium Recap: Informed Consent in Community Participatory Research


Cindi Lewis

Not only were researchers selling the blood of study participants to Satanists, but they were using the profits to buy new vehicles, which they’d brazenly drive to follow-up visits.

At least, that was the rumor going around at some trial sites of the HIV prevention trials network, an example taken from Woodsong and Karim 2005 American Journal of Public Health publication.

“We kind of laugh at it now, but it was serious,” said Cindi Lewis, a PhD candidate in the CTSI’s Translational Biomedical Science Program. “The people really thought that ‘blood money’ was somehow involved here, and they were superstitious about it, and they were not going to participate.”

While researchers regularly spend time educating participants on the front end of their studies, informed consent can be a moving target which requires regular follow-up throughout the duration of a trial. That’s especially true when dealing with communities that may be less developed, less educated, or more vulnerable — communities wherein rumors or distrust may spread more readily among participants.

Speaking at the 2014 CTSI Symposium, Lewis outlined a continuum of strategies that researchers can employ to ensure that study participants are giving fully informed consent throughout the duration of a study, which can help prevent rumors like the one mentioned above from spreading.

“Typically, people sometimes like to think about the informed consent as a fixed point in time when you bring people in, and then the trial goes on,” said Lewis. “But it’s really a dynamic process.”


Lewis, who has worked on several research projects centered on HIV trials, spoke about the informed consent process in three phases: pre-study enrollment, enrollment, and the continuation of the study, as based on Woodsong and Karim’s proposed framework to improve informed consent in target communities.

During the pre-enrollment process, it’s vital for researchers to observe and interact with the community that they are going to be studying. This means spending time at community gatherings, such as town hall meetings or church services.

If possible, the researcher should attempt to form a partnership with individuals or groups that are already working to provide services to their community. By doing so, a researcher can form a community advisory board that truly has its finger on the pulse of the population.

“Sometimes when we look at the composition of community advisory boards, they’re not truly representative of our population,” said Lewis. “This is where, in the beginning, selecting an adequately representative community advisory board — people who are really connected to the community and are going to hear these rumors, these things that aren’t on the surface — is very important.”

An informed community advisory board can provide valuable insight into community response as the study progresses. It can also help researchers understand what suspicions may be inherent within a community from the outset, especially as the team moves into the second phase.


Though researchers need to be careful about satisfying the requirements set by the federal government and internal review boards, a creative approach to the informed consent process can help.

Lewis highlighted an example from the Carraguard Microbicide trial held in South Africa in which the research team created an image of a study participant that they named “Serena.” In early mockups, she was wearing a bandana, but as they moved through the pre-enrollment phase and learned more about their community, Serena evolved into a woman with long, curly hair. The image was meant to depict a community member and to make potential participants feel more at ease with the notion of joining the study.

Additionally, one piece of study documentation featured a visual representation of the concept of randomization, which featured a mixed group of people with pair of dice in the foreground. This helped to get the concept across to a population that may have struggled with the clinical definition.

The enrollment phase is also a good time to be proactive about addressing misconceptions — which could serve to cloud the minds of participants as the study progresses and effectively negate informed consent.

In the HIV vaccine trial group led by URMC’s Dr. Michael Keefer, Lewis is working with the group to develop materials that clearly depict key vaccine messages in the hopes of improving trial participants’ understanding of the information provided to them. For example, the fact that HIV and AIDS cannot be contracted through a vaccine — a common misconception — needs to be well-emphasized.

Continuation of study

Throughout the study period, researchers need to follow-up with the community to ensure that they remember what the study is about to begin with.

“Maybe they have an understanding right at the point where they come in to the trial,” said Lewis. “But if the trial goes on for 2 years, and I ask you 6 months down the road to tell me something about this trial and you knew nothing, but you’re still enrolled in the trial, can we really say, ethically, that this person is informed?”

Proactive efforts and steady follow-ups can help keep the participants informed. They can’t, however, prevent the emergence of every piece of misinformation. In the example referenced earlier, researchers had to work quickly to dispel the notion that they were selling the collected blood to Satanists, even limiting the amount they used the vehicles that they’d supposedly purchased with the “blood money.”

But through a concerted effort — which starts in the pre-enrollment period and continues through the end of the study and beyond — researchers can get a handle on rumors like this one, helping to ensure that their study participants are truly informed.


The 2014 CTSI Symposium, which took place on March 13, was titled “Ethics in Research: Consent Quandaries,” and was hosted by Dr. Carl T. D’Angio, Professor of Pediatrics and Medical Humanities & Bioethics at the School of Medicine and Dentistry.  To view the Symposium in its entirety, click here.

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