Table 2.

Strategies for the Savvy Researcher

Defining/Identifying Risks	Communicating Risks	Managing Risks
Identify possible concerns about risk or decisional capacity that might affect a study prior to submitting a proposal Use tools such as RePeat to identify risks and benefits systematically Address anticipated concerns about risk and decisional capacity in research proposals Describe potential research benefits and compare those to the risks explicitly Describe for sponsors and IRBs the process for communicating and managing risks	Plain language Interactive informed consent processes Interactive process to assess decisional capacity Provide risk information in different formats Be as specific as possible and avoid vague risk and benefit language Periodically review relevant risk information with participants	Use research ethics consultation services or other opportunities to discuss research risks with individuals not affiliated with the study but knowledgeable about research ethics Plan for ongoing staff training Ensure availability of senior investigators who may help research staff address emerging issues in a study Devise a risk management plan that includes detailed information on how different anticipated risks will be managed, how safety will be monitored, what will happen when a participant drops out of a study, the roles and responsibilities of different members of the study team with respect to risk management, and how the effectiveness of the risk management plan will be evaluated during a study.