IRB 101: Risks to Research Participants

In my first post in this IRB 101 series, I described what IRBs are and why they exist.  IRBs exist to protect research participants.  In this second post, I focus on risks to research participants. 

Risk Meter Pointing to Minimal Risk

What are risks to research participants?

Risk is the probability that harm will occur.  All research involves some level of risk to research participants (never say a study has no risk to research participants!).  Most visitor studies research and evaluation can be classified as minimal risk.  Minimal risk is defined in the Common Rule as: “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.” Assessing whether your study is of minimal risk requires you to: (a) think about both the probability as well as the magnitude of harm; and (b) consider the probability and magnitude of harm against what a research participant may encounter in everyday life.

What types of risks might research participants face?

The Belmont Report defines types of potential risks to help researchers assess the risk level of their proposed study. Potential risk types include: physical, psychological, social, legal, and economic.  Below are the descriptions of these type of risks.  For visitor studies research and evaluation, risks typically fall within psychological and social risks. It is important to be aware of all types of risks though.

  • Psychological risks can include anxiety, sadness, regret and emotional distress, among others. Psychological risks exist in many different types of research in addition to behavioral studies.
  • Social risks exist whenever there is the possibility that participating in research or the revelation of data collected by investigators in the course of the research, if disclosed to individuals or entities outside of the research, could negatively impact others’ perceptions of the participant. Social risks can range from jeopardizing the individual’s reputation and social standing, to placing the individual at risk of political or social reprisals.
  • Physical risks may include pain, injury, and impairment of a sense such as touch or sight. These risks may be brief or extended, temporary or permanent, occur during participation in the research or arise after.
  • Legal risks include the exposure of activities of a research subject that could reasonably place the subjects at risk of criminal or civil liability.
  • Economic risks may exist if knowledge of one’s participation in research, for example, could make it difficult for a research participant to retain a job or to find a job, or if insurance premiums increase or loss of insurance is a result of the disclosure of research data

How do you weigh risks to research participants against study benefits?

The IRB’s official function is to weigh the risks to research participants against the benefits of the study. There is no clear formula to do so.  Risk assessment requires multiple perspectives and interpretations. That is why IRBs include multiple people with different expertise on a review panel. 

As researchers and evaluators, we are always aiming to minimize risks to research participants.  It is our duty under the principles of the Belmont Report.  From my perspective, visitor studies research and evaluation should always be of minimal risk to participants.  I don’t mean to diminish the importance of museum work. But, I cannot envision a study benefit that would rationalize researchers proposing a study of more than minimal risk.

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