According to 45 C.F.R 46.102(i), The Common Rule, minimal risk is defined as “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.” Simply put, risk exists in everyday interactions. Risk in human subject research is considered minimal when it is similar to ordinary or routine encounters.
Full board protocols, or those that contain more than minimal risk, are rare for an IRB at a social-behavioral institution. Therefore, it is important for reviewers and researchers to refresh their understanding of the federal definitions of risk to better determine what in a particular study may expose a participant to a risk.
There are two primary considerations for assessing risk in human subject research: (1) explicit risk (e.g., physical harm) and (2) implicit risk (e.g., misinformation).
Explicit risk information allows research participants to engage as autonomous and efficient decision-makers. In contrast, implicit risk may impair a participant’s judgment and contribute to undue stress or discomfort.
Risk levels in research are assessed throughout all IRB materials including the application, consent form document, and recruitment scripts. Fortunately, IRB reviewers in social-behavioral institutions can use minimal risk research checklists to help guide their judgments of research involving human subjects. For example, IRB reviewers should consider:
- What risks and benefits may result from the research?
- Where will the research take place?
- What is the general demographic of the target population?
- How is informed consent documented?
- Where and how is the research data stored?
- How much information is revealed during a routine survey or interview?
- Will asking a question about how someone is feeling need a referral for mental health services?
- What provisions are in place for monitoring the data collected to ensure the safety of subjects?
- What provisions are in place to protect the privacy of participants and to maintain confidentiality?
Sometimes reviewers will engage in “worst case scenario” logic when thinking through the study’s subject population and procedures. Researchers should explain possible outcomes to avoid unforeseen challenges.
At the end of the day, the IRB is responsible for the protection of the rights and welfare of human research subjects. A good portion of that job includes gauging risk levels in research.