Risk: The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Federal regulations define only “minimal risk.”
Minimal Risk: A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed 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. EXAMPLE: survey research that measures the participants’ attitudes on an issue.
The definition of minimal risk for research involving vulnerable participants (e.g., fetuses, pregnant women, children/minors, prisoners, and the mentally disabled) differs somewhat from other research participants.
Greater Than Minimal Risk: In research presenting more than minimal risk, a consent form is required. Potential participants must be informed of the availability of treatment and compensation in the case of research-related harm, including who will pay for the treatment and the availability of other financial compensation.
Types of Risks: The risks to which research participants may be exposed have been classified as physical, psychological, social, and economic:
- Physical Harm: Research may involve exposing participants to minor pain, discomfort, or injury from invasive procedures, or harm from possible side effects of the intervention. All of these should be considered “risks” for purposes of IRB review. Some of the adverse effects that result from medical procedures or drugs can be permanent, but most are transient. Procedures commonly used in medical research usually result in no more than minor discomfort (e.g., temporary dizziness, the pain associated with venipuncture). Some research is designed only to measure more carefully the effects of therapeutic or diagnostic procedures applied in the course of caring for an illness. Such research may not entail any significant risks beyond those presented by medically indicated interventions. On the other hand, research designed to evaluate new drugs or procedures may present more than minimal risk, and, on occasion, can cause serious or disabling injuries.
- Psychological Harm: Participation in research may result in undesired changes in thought processes and emotion (e.g., episodes of depression, confusion, or hallucination resulting from drugs, feelings of stress, guilt, and loss of self-esteem). These changes may be either transitory, recurrent, or permanent. Most psychological risks are minimal or transitory, but IRBs should be aware that some research has the potential for causing serious psychological harm.
Stress and feelings of guilt or embarrassment may arise simply from thinking or talking about one’s own behavior or attitudes on sensitive topics such as drug use, sexual preferences, selfishness, and violence. These feelings may be aroused when the subject is being interviewed or filling out a questionnaire. Stress may also be induced when the researchers manipulate or stage the participants’ environment in order to observe how passersby respond. More frequently, however, IRBs will confront the possibility of psychological harm when reviewing behavioral research that involves an element of deception, particularly if the deception includes false feedback to the participants about their own performance.
Invasion of privacy is a risk of a somewhat different character. In the research context, it usually involves either covert observation or “participant” observation of behavior that the participants consider private. The IRB must make two determinations: (1) is the invasion of privacy involved acceptable in light of the participants’ reasonable expectations of privacy in the situation under study; and (2) is the research question of sufficient importance to justify the intrusion? The IRB should also consider whether the research design could be modified so that the study can be conducted without invading the privacy of the participants.
Deception often involves intentionally misleading participants about the purpose of the study. This may involve the use of confederates to mislead participants about research purposes and tasks, and confederates may knowingly provide false feedback about the subject’s own behavior, as a way to manipulate their feelings and thoughts. If deception is used, the researchers must debrief the research participants afterwards. The researchers must explain the true purpose of the study and explain the reasons for the deception.
Refer to the IRB Policy on Deception (Links to an external site.) for more information.
Breach of confidentiality is sometimes confused with invasion of privacy, but it is really a different problem. Invasion of privacy concerns access to a person’s body or behavior without consent; confidentiality of data concerns safeguarding information that has been given voluntarily by one person to another.
Some research requires the use of a subject’s hospital, school, or employment records. Access to such records for legitimate research purposes is generally acceptable, as long as the researcher has the consent of the participant and protects the confidentiality of that information. The IRB must be aware, however, that a breach of confidentiality may result in psychological harm to individuals (in the form of embarrassment, guilt, stress, and so forth) or in social harm (see below).
- Social and Economic Harm: Some invasions of privacy and breaches of confidentiality may result in embarrassment within one’s business or social group, loss of employment, or criminal prosecution. Areas of particular sensitivity are information regarding alcohol or drug abuse, mental illness, illegal activities, and sexual behavior. Some social and behavioral research may yield information about individuals that could label or stigmatize the participants. Confidentiality safeguards must be strong in these instances. (EXAMPLE: Disclosing a research subject’s criminal history, HIV status, or mental illness diagnosis could adversely affect the subject’s present or future employment, eligibility for insurance, and standing in the community.) A researcher’s plans to contact such individuals for follow-up studies should be reviewed with care.
- Other Harms or Costs: Participation in research may result in additional actual costs to individuals, including legal risks and risks to participants’ social relationships. Any anticipated costs to research participants should be described to prospective participants during the consent process.
If harm is anticipated, the researchers must debrief (Links to an external site.) the participants after the participants have completed the research activity.
BENEFITS IN RESEARCH
The benefits of research fall into two major categories: benefits to participants and benefits to society. Research that involves the evaluation of a procedure may benefit the participants by ameliorating their conditions or providing a better understanding of their disorders. Patients and healthy individuals also may agree to participate in research that is either not related to any illnesses they might have or that is related to their conditions but not designed to provide any diagnostic or therapeutic benefit. Such research is designed principally to increase our understanding and store of knowledge about human physiology and behavior. Research that has no immediate therapeutic intent nonetheless may benefit society as a whole. These benefits take the form of increased knowledge, improved safety, technological advances, and better health. The IRB should clearly identify the anticipated benefits to the research participants, if any, and the knowledge researchers expect to gain from the research. If benefits to the participants are not anticipated, the researchers should acknowledge that there is no direct benefit to the participants other than knowledge gained from participating in the research.
Direct payments or other forms of remuneration (e.g., extra credit points for academic coursework, gift cards, etc.) offered to potential participants as an incentive or reward for participation should not be considered a “benefit” to be gained from research. In addition, although participation in research may be a personally rewarding activity or a humanitarian contribution, these subjective benefits will not enter into the IRB’s assessment of benefits and risks.
For more information, see here for a longer discussion from Salem State.