Identifying and managing risks to participants is one of the most important and challenging tasks facing researchers and the HRRC. The HRRC looks for the researcher to minimize risks and evaluates the methods by which they do so in the protocol.
Risk is determined by the severity (magnitude) of harm in relation to the probability (likelihood) of that harm occurring.
Minimal risk is defined in the regulations and means "that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests." 45 CFR 46.102(i)
All greater than minimal risk research requires review and approval by the full board during a convened HRRC meeting.
Individuals have rights and expectations to privacy that may be compromised as a result of participation in research. Examples include:
An unauthorized release of personally identifiable research or health data resulting in risks of:
Harms resulting from study procedures, though more rare, may include:
Risk identification and management is discussed in more detail within Planning Your Research.
Selected relevant documents: