Table 3.

Research Needs

Defining/Identifying “Risk”	Communicating Risks	Managing Risks
How do potential participants and families/surrogates, investigators, and IRB members define risk? What risks are most worrisome to potential participants? What benefits matter most to potential participants, surrogates, and society? How do IRBs make decisions regarding risks and how do they compare risks and benefits?	What techniques are most effective for improving participant understanding of research risks? For example, what practices6 Help individuals to sort and manage significant amounts of information? Help individuals understand numbers and probabilities? Reduce cognitive biases? Improve understanding of health information? Facilitate communication of information typically provided in writing? Enhance retention and recall of information? Promote the exchange of information that matters most to potential participants? What variables affect understanding and appreciation of risk information?	What “toolkits” may investigators employ to help develop and implement effective and comprehensive risk management strategies? What are effective ways to train research staff to manage risk, particularly in higher risk studies? Are there risk management strategies that should be used when clinicians also serve as investigators? How do participants, researchers, and IRBs respond to different risk management plans?

Note: In answering research questions about the views and assessments of participants or populations of potential participants, it is important to attend to individual differences.