Examples of Potential Risks for Human Subject Research
As part of the IRB process, the researcher is requested to identify and address the risks of harm or discomfort to which subjects may be exposed as they participate in the proposed research. The design of the research should be such that all risks are minimized as much as possible, and that any remaining risks are clearly identified to participants so that they may make an informed choice about whether or not to participate in the research.
The area of greatest concern to the federal Office of Human Research Protections is biomedical research. It is of extreme importance that research participants be protected from unknowingly participating in research that may lead to their death or permanent physical harm.
Research involving human participants at the University of Wisconsin-Superior, however, is more likely to be of a social science or behavioral nature. While the associated risks are usually less than in biomedical studies, they still exist. The examples below are not a complete list, but are provided to stimulate the researcher's thought.
- Loss of time is a discomfort for many individuals. The time needed to participate should always be identified. The estimate should be based on a pilot study of individuals actually involved in the process. It is often sensible to provide a time range, e.g, "From twenty minutes to an hour". Always err on the side of overestimation.
- Recalling traumatic or distressing events is normally a distressing activity, causing some level of suffering for your participants. The relatively short-term suffering involved within the specific time frame of your study may be followed, for some participants, by an extended period of flashbacks, nightmares, reactivation of fears, or unhappy rumination. Asking individuals to participate in research activating such memories should never be undertaken lightly.
Examples of such events might be those of being a victim of torture, rape, or other crime; suffering sexual or other harassment; recalling embarrassing moments; providing information about one's illnesses; providing information about a family member's illness or death; describing the hassles of living in poverty; describing conflicts with one's partner or spouse, etc.
When engaging in such research, it is good practice to provide the research participants with a list of community resources that can be helpful should counseling needs related to the above occur. Such resources should be those available at no or little cost to the individual, since it would be undesirable to have participants spend large amounts in counseling fees as a result of dealing with memories triggered by participation in someone's research. Some research projects (such as those by counseling, social work, or clinical psychology agencies) respond to this need by building free access to their own counseling staff into the research project.
- As a result of participation of behavioral research, some participants may falsely (or correctly) come to identify themselves as having a disorder, disturbance or inferiority. As examples, a subject responding to a "loneliness" scale may conclude that he or she is very lonely; a subject responding to a "depression" scale may conclude that he or she is depressed. The researcher needs to be aware of the risk and design the research to minimize it. Being careful of the titles given to measuring scales, and providing lists of community resources (as above) may be helpful.
- Members of minority or low-power groups are often aware that research projects have a tendency to conclude that their groups are deficient or undesirable and have no desire to participate in research which furthers such conclusions. For example, a low-income single mother might not wish to participate in research which may conclude that single parenting is detrimental to a child's school success or later romantic relationships. The best solution to this risk is to design the research so that it provides solutions to problems, rather than simply identifying a group as deficient. Failing this, subjects need to be honestly informed of the purpose of the research.
- Subjects should not be subjected without their informed consent to stimuli they might wish to avoid, such as pornography, alcohol advertisements, smoke, etc.
- Be aware of potential risks to people suffering allergies, phobias, or environmental sensitivities. Examples might be such things as the peanuts often included in candies; mold and dust of a research space; flickering lights triggering epileptic seizures; public speaking or group testing for people with agoraphobia; small laboratory cubicles for people with claustrophobia. Identify any pertinent aspects on the consent statement, and clearly request individuals who have a sensitivity to these stimuli to exclude themselves from participating in the research.
- Boredom, mental fatigue, embarrassment at poor performance, or frustration are minor but common risks. If present, they should be identified on the consent statement.
- Researchers should avoid impairing the subjects' relationships with others (e.g., asking a dating couple to discuss their conflicts; or asking employees about their dissatisfactions with their supervisors and making such information available to their employer).
- Exercise-induced or repetition-exacerbated physical harm, such as carpal tunnel syndrome, stress fractures, asthma attacks, heart attacks may be risks for certain kinds of research.
- Invasion of privacy asking about income, health habits, use of illegal substances, etc. may cause unnecessary discomfort to subjects. Refrain from such questions or provide a clear rationale to the IRB about their appropriateness for the proposed research.