Module 5

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Module 5: Identifying, Assessing, and Minimizing Risks of Social and Behavioral Research

Institutional Training for Research Involving Human Subjects

*adapted from a presentation by Jeffrey Cohen, OPRR The Institutional Review Board (IRB) - called the Committee for Research Involving Human Subjects,is responsible for reviewing and approving activities involving all research with humans at KWU. The performance of non-medical research in the social and/or behavioral arena has the potential for significant risks that go beyond invasive procedures or physical injury. These potential risks must be identified and considered by the IRB during the review and approval process.

Institutional Review Board (IRB) Responsibilities

As with other forms of research involving human subjects, KSU IRB review responsibilities include: Identify risks to human subjects Determine that risks are minimized Determine that “risks to subjects are reasonable in relation to anticipated benefits” Determine that subjects are adequately informed about any “reasonably foreseeable risks or discomforts”

Identifying Risks

Physical risks are fairly easy to identify. They would include injury, illness, or allergic reactions. However, it is important to remember that social and psychological risks are real risks too. Examples of social and psychological risks include: emotional distress, psychological trauma, an invasion of privacy, embarrassment, loss of social status, and loss of employment. IRB’s should not rely solely on investigators to identify risks. They should use investigator’s knowledge coupled with resident or consultative expertise of the IRB to identify risks.

Minimizing Risks

The three best ways to minimize risk in social and behavioral research are to incorporate precautions, to incorporate safeguards, and explore alternative methods to achieve the same goals.

Risk/Benefit Analysis

IRB’s must make a Risk/Benefit Analysis. This evaluation of a Risk/Benefit ratio is a subjective judgment. The IRB must decide whether anticipated benefit justifies asking subjects to undertake risks. IRB should take into account different subject populations and individual differences among subjects. Some people are more sensitive or “at risk” than others, and some people would benefit from participation more than others would.

Informed Consent

Consent process should empower subjects to make their own determination about risk. Therefore, risks should be explained in simple terms that subjects can relate to everyday life experiences. Risks should be stated clearly and directly, not minimized or excused away. It must be clear to the subject that they are participating in research, and they should have enough information about what is expected of them to rationally decide whether or not they choose to participate.