First, it is important to define risk so that it can be identified in your study.Risk is the potential for harm.It is a prediction of a probable outcome based on evidence from previous experience. The nature of risk and harm can vary in daily life, creating different dimensions of risk that are subject to the factors at play in the study. Some participants and/or study populations are inherently moresensitive to riskbecause of their situations. The lasting effects of the risks in the study should also be considered when analyzing risk levels. Researchers have an ethical obligation to do no harm, or in other words to not make a situation worse. Thus it is important to consider all the factors involved when conducting a study and where there is a potential for harm to participants.
When reviewing a study, IRB-SBS reviewers consider the probability of harm occurring ("minimal risk" versus "greater than minimal risk")and the type of harm that can occur (psychological, physical, legal, social, and economic).
Minimal Risk
“Minimal risk” is a term used in the federal regulations for human subjects research and it has become the threshold for identifying studies that require more careful scrutiny (full board review), identifying studies that do not need lengthy reviews (expedited review), and identifying studies that do not need review (exempt review). Studies that are identified as “minimal risk” are often granted exemption from further IRB review and/or receive expedited review privileges. So how is the “minimal risk” line drawn in IRB review and risk analysis?
Thefederal regulationsdefine “minimal risk” 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.” This offers some ambiguities. For example, whose “daily life” should be considered? If a study involves interviewing juvenile delinquents who deal drugs, the level of risk encountered in their daily lives could be significantly different from the average teenager. Does that mean that these participants deserve less protection than the average teenager?The Board sets the “average person” as the standard for determining “minimal risk.” If a person’s lifestyle makes them more sensitive to risk, making them a subject of a study could make the study more than “minimal risk.” In some cases, the Board may need additional information to understand what is “normal” for the “average person” in your study population. For example, the Board may not have intimate knowledge about theinternational populationyou will study. When you submit your study protocol, providing the Board with information about the study population can help them to understand the population and make an accurate determination as to the level of risk in your study. “Daily life” refers to a level of minimal harm that are normally encountered and easily ameliorated by time, bydebriefing, or both.
For studies that are greater than minimal risk, the Board is required to review them in a full board meeting. If a study is considered “risky,” it does not necessarily mean that the Board will not approve the study, but it is important that you have adequate plan in place to minimize risk and deal with situation should they arise.
Psychological Harm
Research studies, particularly psychology studies, can put participants in situations that may make them feel uncomfortable in order to learn about their reaction to a situation. The result can be psychological harm that can manifest itself through worry (warranted or unwarranted), feeling upset or depressed, embarrassed, shameful or guilty, and/or result in the loss of self-confidence. If you are collecting information from participants about upsetting and/or disturbing events, there is a potential for you to upset or disturb your participants. Asking information about painful experiences, sexual trauma, etc., could at minimum upset the participant and may bring other psychological issues to the surface. The potential for harm can increase depending on how long and often the participant is involved in the study and the capacity of the individual to handle upsetting situations. For a normal, healthy adult, temporarily being in a situation that is frightening or upsetting may not cause any lasting harm, particularly if the participant is adequately debriefed and able to process the meaning of the activity. However, if a person does not have the mental and/or emotional capacity to process a stressful situation, participation in the study may be beyond what the individual can handle. It is important that you develop an appropriate consent process which involves not only informing the participant at the beginning of the study but continuing to monitor their progress, allowing for withdrawal at any point, and an informative debriefing period after the study. You may need to consider exclusion criteria as well (i.e. participants need to meet a certain level of capacity in order to participate). The Board will want to know that you have the experience to handle an "unexpected adverse event"and that you have a plan in place to do so. It may be necessary to have additional experts on hand to assist you.
Physical Harm
While this risk tends to be less frequent with a social and behavioral science study, there are studies where considering a physical risk is still relevant. For example, if you ask your participant to exert themselves beyond their resting state and/or there is a possibility for injury as the result of participating in the study, this risk should be described in the consent form and information should be provided as to what care the participant has access to should they become injured. For some studies it may be necessary to exclude participants whose health conditions increase the likelihood of injury.
Legal Harm
Unlike doctors and lawyers, researchers cannot protect their participants’ confidences in a court of law. If you collect information about another individual, that information could be subpoenaed.If you are likely to gather information about an individual's illegal behavior (i.e. an ethnographic study of teens who are using illegal drugs) you should apply for aCertificate of Confidentiality(applicable for studies conducted in the USA only).
If you do not intend to collect information that could be a legal risk to participants but there may be a possibility that it could be divulged, in your protocol you should describe how you will handle a situation should it arise. For example, a researcher may be studying drug addicts’ access to mental health care; although she is not collecting information about the addict’s drug use, this information may come up as part of a conversation. To prevent this from happening, she should instruct her participants to not share this information with her during the consent process and then remind the participant if the subject comes up. If she was recording the conversation, the recording should be stopped and that portion erased.
There may be certain circ*mstances in which you are obligated to breach confidentiality and report illegal behaviors and activities. If a participant describes an immediate threat to hurt another individual, you may be legally required to report this information. If you learn of child abuse, you are obligated to report it. Please seeRisk Sensitive Populationsfor more information.
Perceived legal risks may be an additional hurdle in working with various communities. For example, some individuals, particularly in other countries, may be wary of signing a consent form because they are afraid of legal consequences or because this is not a common practice in their culture. In these cases, it may be appropriate to use oral consent instead of a written consent. Please see Oral Consent for more information.
Social Harm
When you are studying an individual, it is important to consider their social situation and how they function in it. Depending on the subject of your study and how well known it is in the community, even associating with you could have risks for an individual. For example, if you are studying HIV patients and a participant has not disclosed their HIV status to the community, it is important that you keep that individual’s participationconfidentialandprivate,even to the level that your meeting together is doneprivately. In some communities, inadvertently disclosing information about an individual could affect their standing in the community, in their family, and their job. In your protocol it is important that you demonstrate sensitivity to the social needs of your participants and that you describe how you will act with discretion to preserve the privacy and confidentiality of your participants.
Economic Harm
Economic risk can manifest in multiple ways depending on the study. Researchers should consider any costs participants would have to bear in order to participate in the study such as travel, child care, food, etc. Participants should be made aware of the amount of time it will take to participate in a study, particularly if it is time that they would spend away from their employment. Payment can be made to compensate for time and other expenses that the participant may incur. For more information, please seePaying a ParticipantandParticipants in Dire Economic and Social Situations.
Related Sections
- Risk-Sensitive Populations
- Full Board Protocols
- Expedited Protocols
- Exempt Protocols
- Federal Regulations
- Unexpected Adverse Event
- Certificate of Confidentiality
- Oral Consent
- Protecting Confidential
- Protecting Privacy
- Paying a Participant
- Participants in Dire Economic and Social Situations
