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.

Harm is understood by IRBs in relation to the potential benefits of the research (to the participants themselves, to larger communities of which they may be a part, to society as a whole, to the academic literature in the field). The IRB uses a risk-benefit calculus to determine whether a particular project offers greater benefits than risks of harm; only projects with more benefit than risk of harm are approved or exempted. Note that in this context, "benefit" does not include "benefit to the researcher" in the sense of completion of a thesis project or a course for a grade.

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 in and of themselves than those encountered in daily life or during the performance of routine physical or psychological examinations or tests." The phrase "in and of themselves" is extremely important here, as it clarifies that the issue for IRBs is how much participation in the research will increase the risk of harm for participants. If the participants are already engaged in harmful activities independent of the research, that is of no concern to the IRB. If participating in the research does not increase already-existing risks of harm to participants, the research would be considered essentially harmless by the IRB. If participating in the research adds less harm than the participant would encounter in ordinary or everyday life for that individual, the research would be considered minimal-risk by the IRB. 

Probability of harm and magnitude of harm are two different facets of harm and can exist in various relationships to one another. A research project with a very low probability of high-magnitude harm may, for example, be less risky than a research project with a very high probability of low-magnitude harm when all the harm factors are taken into account.

The IRB also pays attention to the type or types of harm 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 harm (failing a course, 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 harm (civil liability, such as a lawsuit) as a result of the participant being asked to participate in or report on illegal activities
  • Criminal harm (criminal liability, such as being arrested); same types of situations as immediately above
  • Economic/financial harm (job loss or difficulty obtaining a job; 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 harm (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
  • Moral injury as a result of being asked to participate in activities, observe activities, or consider ideas or situations that the participant would find morally problematic or deeply against their values
  • Community harm that may impact not only the participant but one or more communities (defined in the broadest possible sense) of which they are a part or with which they may interact; this can include any types of harm discussed above.

Risks of social, psychological, and moral harm are always context-specific and may change based on (for example) the age of participants, their social setting, or other situational aspects. Researchers should be thoughtful about how the context or situation a participant is in may increase or minimize the risk of harm for that participant.

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 example:

  • 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.

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 about situations in which such harm might be a concern.

Report an issue - Last updated: 08/25/2021