There are many types of risks to which research participants may be exposed. The U-M IRBs generally consider three broad categories of risks: psychological (including invasion of privacy), informational (confidentiality, social, legal, employability-related), and physical.
Participation in research may result in undesired changes in thought processes and/or emotions (e.g., anxiety, depression, confusion, stress, guilt, and loss of self-esteem). These changes may be momentary, temporary, or permanent; they may also occur as a single episode or be recurrent. Some research has the potential for causing serious psychological harm. In the research context, invasion of privacy usually involves either covert observation or researchers participating in situations/behavior that participants consider private.
Informational (including privacy, legal, financial, and social harm)
Confidentiality relates to safeguarding research data and information that has been given voluntarily by one person to another. Some social and behavioral research may yield information about participants that could be stigmatizing (e.g., social harm) or put them at risk of legal or financial repercussions. Genetic research may uncover information about a participant’s family or lineage that was previously unknown or may cause personal or interpersonal conflict (e.g., paternity concerns). Release of confidential research information can also result in psychological harm to individuals (e.g. embarrassment, guilt, stress).
Research includes medical procedures that may result in pain, discomfort, or loss of physical functioning. Research may dictate the course of a participant’s clinical care and may use unproven drugs or experimental procedures that could result in serious injury. Adverse outcomes can range from momentary and minimally discomforting to severe and permanently disabling.