Framework developed for engaging community

Negotiate the details beforehand

With the creation of the Clinical and Translational Science Awards (CTSA) program, the goal of involving the community in research has drawn more support and interest.

Community engagement is a key strategic goal of the Clinical and Translational Science Awards program, and committees have been formed to develop road maps and best practices for institutions that want to partner with their communities to help increase knowledge that will promote health.

One such effort convened stakeholders — researchers, ethicists, IRB members, community partners and others — to discuss the challenges of community-engaged research (CEnR) and develop a framework for thinking about human subjects protection issues that it raises.

Lainie Friedman Ross, MD, PhD, a professor of pediatrics and clinical medical ethics at the University of Chicago, says her work with the CTSA prompted her interest in developing a more formal means of identifying and addressing ethical issues in CEnR.

"We applied for (funding from the CTSA) proposing that we would involve individuals in community-engaged research, the community partners as well as people who did different components of human subjects protection," Ross says.

Her team identified 25 stakeholders and held two meetings with them.

"We asked them to tell us about community-engaged research, tell us about the obstacles, tell us about what you see as the human subjects protection concerns," she says. "Having listened to them, we then again reviewed the entire literature and came up with a novel framework."

The framework, outlined in papers published recently in the Journal of Empirical Research on Human Research Ethics, lays out structures for developing research/community partnerships, for identifying risks to both individuals and their communities and for fulfilling the federally regulated key functions of human subjects protection in a community research context.1,2

Negotiating a relationship

Ross and her colleagues note that partnerships between researchers and communities need to be negotiated in advance of the project. A memorandum of understanding created from this negotiation might address such issues as control of and access to the data collected, intellectual property rights, returning of research results and the authority that a group such as a community advisory board (CAB) would have regarding data monitoring or even stopping a research project over human subjects protection concerns.

She says that in this process, communities may be better served by CABs than by creating their own IRBs to oversee the research.

"There was a lot of community push (in stakeholder discussions) to form their own IRBs," she says. "I thought it made much more sense for the community to create advisory boards that had greater flexibility and weren't held to specific membership, specific rules, what they can and cannot consider, and those sorts of things."

Whatever the structure, it's important for the relationship to be bi-directional — considering each issue from the perspective of both the research enterprise and the community needs and expectations, Ross says.

"For example, just like the university has conflicts of interest, so do the communities," she says.

Determining risk

Ross says CEnR may require IRBs to adjust their usual ways of considering risk. She and her colleagues lay out three different levels at which community research may introduce risk:

  • An individual level, with the possibility of physical or psychosocial risk to a subject based on his or her participation (example: an adverse effect from a medication, or becoming upset by research findings that indicate a health problem);
  • An individual risk based on association with a group, regardless of whether the person participates in the research (example: an individual who belongs to a certain ethnic group is stigmatized by research findings that draw conclusions about that group);
  • A group risk, if a community organization makes a decision to participate in research (example: conflict arises in an organization over a decision to participate in research or as a result of findings disseminated afterward).

Ross notes that IRBs are constrained by the federal regulations from considering long-term policy issues that may result from proposed research.

"That doesn't prevent them from acknowledging that there are community and group risks," she says. "They can consider the tension of what risks happen when some individuals agree to participate in research and some individuals don't.

"That's not to say that they shouldn't permit the research to go on. I just think that an appropriate review requires that you think about those additional risks."

A variety of actors

While acknowledging the important role of IRBs in helping to ensure the protection of individuals and communities in research, Ross says it's important to realize that there are many other entities that can share that responsibility, from investigators themselves to CABs and research advocates.

One of her papers outlines the various ways in which these actors can contribute to key functions of human subjects protection.

"We have to be careful of what we ask of IRBs. They're already overworked, there's already concern about IRB mission spread," Ross says. "And to some extent, we need to think about human subjects protections more broadly. It's not just about IRBs."

Ross says that the current model of community research – one that tends to group people based on geographic location or race and ethnicity may give way to a model more focused on genomic identity.

"Hopefully, at some point, we're going to get rid of using race as a surrogate marker," she says. "We're going to be able to look at genotypes and understand, for example, why some people digest drugs differently than others.

"So we'll get rid of some of our large and inaccurate group classifications and we'll be able to group people more technically accurately for the purpose of health care."

She notes that groups of people with similar types of genomic conditions are now organizing via the Internet to seek out research as a community, which will bring its own advantages – and complications.

"It's something to think about – how that kind of community social network will change how we think about doing research and IRBs and everything else," Ross says.

References

  1. Ross LF, Loup A, Nelson RM, et al. Human Subjects Protections in Community-Engaged Research: A Research Ethics Framework. J Empir Res Hum Res Ethics. 2010; 5:5-17.
  2. Ross LF, Loup A, Nelson RM, et al. The Challenges of Collaboration for Academic and Community Partners in a Research Partnership: Points to Consider. J Empir Res Hum Res Ethics. 2010; 5:19-31.