Types of Harm
There are various types of harm that can occur while participating in a study such as: psychological harm, physical harm, legal harm, social harm, and economic harm.
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 adverse situation 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 a Certificate 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 circumstances 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 see Risk Sensitive Participants for 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 Modifying Consent for Ethnographic Studies.
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 participation confidential and private, even to the level that your meeting together is done privately. 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 see Paying a Participant and Participants in Dire Economic and Social Situations.