Deception. Privacy. Mood changes. These are some of the quirks of human participants in research--and therefore some of the risks behavioral scientists, federal regulators and members of Institutional Review Boards (IRBs) must consider concerning behavioral research on people. Key players from these groups gathered in May at Fordham University in New York to discuss those risks and to seek ways to work together to more accurately and consistently classify behavioral research procedures that meet federally defined minimal-risk criteria.
Preliminary surveys of researchers have shown that they feel IRBs vary greatly in their assessment of research risks for human participants and that behavioral scientists often view IRB risk assessments as overly restrictive for psychological research, says psychologist Celia Fisher, PhD, who co-chaired the conference. Indeed, most methods used in behavioral research should be classified as no greater than minimal risk because researchers are trained to carefully assess any problems their work might create for participants and procedures for limiting risk are well-established, Fisher says. In her view, IRB overevaluation of risk can delay or unnecessarily impede good and ethical research by blocking expedited review and appropriate waivers of informed consent.
"One challenge for research psychologists who conduct minimal-risk research is that IRBs have little guidance as to the types of activities and contexts that reflect the behavioral risks of daily life," Fisher says.
At the conference, co-sponsored by APA and Fordham University, psychologists conducting research across different populations and contexts--and using different methodologies--presented case examples of minimal-risk research that often trigger disagreements between investigators and their IRBs.
One of those examples involved a psychologist conducting a survey of illicit drug users. Theoretically, if police gained access to information about specific participants, the participants could face arrest, which would be considered a serious and unacceptable risk. However, if the investigator's application to the IRB details confidentiality protections that make such disclosures highly improbable, such as removing identity information from all notes, then it could be argued that the research itself poses minimal risk to participants.
"These cases and the discussions that followed provided a wealth of examples of participant protections that can be put into place to minimize risk and examples of daily life activities that can serve as a reference for judging whether a study presents no more than minimal risk to participants," Fisher says.
Conference attendees established multiple potential strategies for creating a consistent measure of minimal risk, including a flow chart that IRBs can use to consider research applications and a database of real-life research precedents for IRB reference. Implementation of specific strategies like these is not yet under way, but the presence of federal regulators and IRB representatives at the conference demonstrates that policy-makers are eager to incorporate suggestions from research psychologists to help fairly evaluate risk in behavioral research, says Sangeeta Panicker, PhD, director of the APA Science Directorate's Research Ethics Office.
"The conference allowed people from very different but interrelated backgrounds to get together to ask what is the risk of harm in research and what can be done to define it," Panicker says. "The conversations themselves go a long way to establishing consensus within the research community."