Building trust in the research partnership

Overcoming obstacles to minority enrollment

Improving the participation of minority populations in research has been a holy grail for researchers and IRBs.

Now a team from the University of Pittsburgh has begun an ambitious project to delve more deeply into the reasons that representation of minorities in research still lags behind that of whites — as well as developing and disseminating best practices that might finally help overcome this problem.

Sandra Crouse Quinn, PhD, associate dean for student affairs and education at the university, is a principal investigator for the "Building Trust Between Minorities and Researchers" project, which has received a $4 million grant from the National Center on Minority Health and Health Disparities, a part of the National Institutes of Health.

Quinn says one novel element of this effort is an emphasis on IRBs — surveying them to determine their role in the process and working with Public Responsibility in Medicine and Research (PRIM&R) to develop a curriculum for IRB members geared toward supporting recruitment and community engagement.

"IRBs have a unique perspective on this," Quinn says. "IRB members and IRB staff have a role to play in informed consent and often in monitoring enrollment. To the best of our knowledge there has not been a lot of work done on what their observations are about the process."

She says that despite numerous studies showing minority distrust of research and researchers, there are significant gaps in knowledge that she hopes to address with her study.

"What do people actually know about research — not just are they willing to participate, but what is their level of knowledge? What factors would contribute to their willingness to participate?"

She says there also has been much more work done on the attitudes of African-Americans than on those of Hispanics. And Quinn wants to hear from researchers, research staff and IRBs about their perceptions.

Surveys and interviews

The data collection for the project will have three parts:

• An online survey launched in conjunction with PRIM&R for investigators, research staff, IRB members and IRB staff. Questions will differ depending upon the participant's role in research.

Quinn says there will be some specific questions for community IRB members.

"We really do want to hear their perspectives," she says. "Because what we hear from talking to folks at PRIM&R is that community members, while they are valuable, often feel like they don't have the gravitas perhaps to be as effective on the IRB."

• A series of longer qualitative interviews with investigators who conduct different types of research, from clinical trials to community-based behavioral research.

"Those interviews are really aimed at what are the lessons they've learned, what are the best practices, what are the mistakes they've made," Quinn says. "So we can pull out of that some things that are really teachable to other investigators and research staff."

• A national telephone survey of about 3,700 African-Americans and Hispanics looking at their attitudes about and knowledge of research.

Information gleaned from these surveys and interviews will be used to come up with a curriculum for engaging minority communities in research.

"How might you engage people from your community that's being targeted for participation — maybe in a community advisory board, maybe in other ways," Quinn says.

CBPR not only answer

Quinn expects her group's recommendations to expand well beyond the community-based participatory research (CBPR) model that's often used in public health and environmental health research.

"CBPR has its place and it's valuable," she says. "But particularly when you're talking clinical trials, the fit is not good. True community-based participatory research, where the community helps develop the questions, etc., isn't a model that's applicable across all kinds of research questions."

Quinn's group will develop workshops and webinars in coordination with PRIM&R. Some of this work already has begun; she says they did a workshop last year on community research advisory boards. They plan to have several sessions at PRIM&R's December conference.

"Our goal is that we leave not just PRIM&R but the NIH Office of Bioethics and our (Clinical and Translational Science Institute) partners with a curriculum that they could use as a whole, or that they could use in pieces with investigators, research staff and IRB members," Quinn says.

In the meantime, she is hoping for a large response from IRBs during the data collection phase of the project. Interested IRB members and staff can visit the project's website http://www.healthdisparity.pitt.edu/buildingtrust.asp

"We would love to have a flood of IRB people involved in this process," she says.

The survey will be available online until June 14.