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IRBs often struggle with determining risks of social and behavioral research studies. It’s easy to be both too cautious and too complacent.
So a subcommittee formed by Harvard Catalyst, The Harvard Clinical and Translational Science Center, has developed a variety of case studies with examples of how to assess risk in social and behavioral research.
The social, behavioral, and educational research (SBER) subcommittee includes IRB directors, managers, staff, regulatory officers, quality assurance/improvement experts, and other stakeholders in the human research protection program, says Matt Stafford, IRB manager, Boston Children’s Hospital and co-chair of the SBER subcommittee.
Risks in social-behavioral studies are a little less concrete and defined, Stafford says.
"Most people emanating from an accredited medical school will come to a common understanding of a certain kind of immediate risk to health and the long-term consequences of things that impact their body," he says. "But everything else is a little more subjective and experience-based."
The idea to create case studies developed organically as members of the subcommittee shared ideas, he notes.
"We had witnessed issues in our own institutions and thought there was a need for broader understanding of these issues," Stafford says.
For instance, Boston Children’s Hospital handles a lot of behavioral research, including behavioral interventions and preventive measures such as reinforcing positive health behaviors and discouraging negative behaviors, he says.
"We thought case studies would be an effective teaching tool," he adds. "We made the case studies versatile and worked to get a standard format for them with the goal of making them available as a resource to the research community and the public."
The case study library is available online at http://catalyst.harvard.edu/programs/regulatory/sber.html and is about half finished, he says.
So far there are case study PDFs available in these areas:
• behavioral economics;
• business research;
• end of life issues;
• gang violence;
• prisoner research;
• social anthropology;
• students in research.
Future topics will include crisis research, deception in research, illegal behaviors, edges of research, recruitment of employees, terrorism research, and the use of focus groups.
Each case study follows a format of providing a fact pattern, regulatory, cultural, and ethical issues, and a risk-benefit analysis and risk management options. While the case studies were inspired by some researchers’ and IRB members’ recollection of actual studies, the studies presented are fictional.
Once all of the case studies are complete, the subcommittee will pilot test them and present them in discussions with faculty and the research community, Stafford says.
The subcommittee, which meets for an hour each month, held some two-hour meetings to create the case studies. Each case study has an author, and the group reviewed draft copies.
"Every topic was assigned a primary author and first reviewer," he says. The first reviewer’s comments were discussed at the meetings, he adds.
"We reviewed the text of the cases, putting them on a projector and going through them," Stafford explains. "We saw some original comments on the side, and everyone contributed comments and constructive criticism until we agreed on the final details."
The new case studies could be used as part of a for-credit program for human research protection programs, Stafford says.
"We might encourage people to hear them by convincing local institutions to qualify these as continuing education," he says. "We could put the audience in the roles of IRB members and think through some of these things."
Feedback will make the case studies richer. They’re fluid and could be improved, he says.
The point is not a template, but a basis for understanding.
"In the absence of experience, the case studies provide exposure to the possibilities," Stafford explains. "It’s a Here are some things to think about,’ which I think is all it takes for an earnest researcher or ethics panel."