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IRB Concerns: Harm

Of the various concerns that IRBs keep in mind when reviewing research for legal and ethical soundness, harm is one of the most important. Research that involves more than a minimal risk of harm receives extra IRB scrutiny, may take longer to be approved, and, in some cases may not be approved at all. The threshold "minimum risk of harm" is defined by the federal government as follows: "The probability and magnitude of harm or discomfort anticipated in the research are not greater than the harm or discomfort encountered in daily life or while taking routine physical or psychological tests."

This definition, while helpful, only includes two of the three elements of harm (probability of harm occurring and magnitude/amount/degree of harm); the IRB also pays attention to the type of harm or harms that a particular research project might involve. The most common are:

  • Psychological (stress, anxiety, sadness, depression, guilt, shame, regret) as a result of (for example) questions about traumatic events, offensive or threatening questions, exposure to disturbing material, or certain kinds of manipulation of the participant's environment; deception studies can also be psychologically stressful in some circumstances
  • Harm to reputation or social standing (if others knew the participant were participating in the research or if something about the participant that emerged during the research became public knowledge; this can include stigmatizing a group in which an individual participant is a member) as a result of being asked to participate in or report on activities that violate social norms, that could result in retaliation from others, or that otherwise signal that a person should not receive respectful treatment
  • Academic risk (risk of failing a course, of suspension or expulsion or another academic penalty) as a result of the participant being asked to participate in or report on activities that violate college policies
  • Legal risk (risk of civil liability, such as a lawsuit) as a result of the participant being asked to participate in or report on illegal activities
  • Criminal risk (risk of criminal liability, such as being arrested); same types of situations as immediately above
  • Economic/financial risk (risk of job loss or difficulty obtaining a job; risk of insurance loss or raising of insurance premiums) as a result of participants engaging in research in which information is revealed about them with economic or financial implications
  • Political risk (risk of attack or any other kind of retaliation from political leaders, political rebels, or anyone else engaged in political activities in the state, region, or country in question) as a result of participants engaging in research in which information is revealed about them with political implications
  • Physical (pain, injury, physical discomfort) as a result of being asked to participate in activities beyond the participant's capabilities (either because they are not properly warmed up or because they are being asked to engage in athletic behavior and they are not an athlete or because they are being asked to undergo a physical experience that is beyond anyone's normal capability to withstand); also, research that might invoke physical retaliation from someone else, such as a former partner convicted of domestic assault, could fall into this category

Potential participants should always be made aware during the consent process of potential harms that might come to them as a result of participating in a research study. Any research in which the potential risk of harm is more than minimal will not be approved by the IRB unless the researcher can demonstrate that the consent process provides clear information about potential harm and potential benefits such that the participant is well equipped to decide whether they want to participate or not.

Fortunately, there are steps that can be taken to mitigate harm or address it should it happen, even beyond having a good consent process:

  • For psychological harm, researchers can provide information about resources such as counselors that a participant can contact after participating in order to obtain psychological support.
  • For harm to reputation or social standing, the most important protection is often careful preparation and practice to make sure that the participant's identifying information remains confidential so that no one outside the study can tie the person to the research. This is also often the case with academic, legal, criminal, and economic/financial risk.
  • For physical harm, researchers can screen potential participants for risk factors and make sure that a given participant has no contra-indications that would make their risk any greater than absolutely necessary.

Beyond the above, researchers have no legal guarantee of confidentiality in the matter of illegal behavior. If a researcher collects information about illegal activities, the police may subpoena the researcher's data. A researcher who refuses to comply with such a subpoena may face contempt of court and jail time. A researcher who anticipates that he or she may collect information about illegal activities should inform participants whether the researcher will or will not comply with subpoenas for identifying information.

While the IRB's primary concern is potential harm to participants, we are also mindful of harm that investigators and institutions (including Colorado College) may face, and may elect to communicate with researchers when such harm might be a concern.