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The IRB at Grand Valley State University in Allendale, MI, uses a matrix that clarifies how IRB members and staff might describe various potential harms at four levels, from no more than minimal risk to high risk.
The five-page matrix further describes the classifications of risk, including these excerpts:
• Health/physical harms. "Medical research often involves exposure to minor pain, discomfort, or injury from invasive medical procedures, or harm from possible side effects of drugs. All of these should be considered risks’ for purposes of IRB review."
• Psychological harms. "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 the subjects’ environment — as when emergencies’ or fake assaults’ are staged to observe how passersby respond. More frequently, however, is the possibility of psychological harm when behavioral research involves an element of deception."
• Invasion of privacy. "In the research context, it usually involves either covert observation or participant’ observation of behavior that the subjects consider private."
"The IRB must make two determinations:
1. Is the invasion of privacy involved acceptable in light of the subjects’ reasonable expectations of privacy in the situation under study; and
2. Is the research question of sufficient importance to justify the intrusion?"
• Breach of confidentiality. "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 protects the confidentiality of that information. However, it is important to recognize 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."
• Social and economic harms. "Some social and behavioral research may yield information about individuals that could label’ or stigmatize’ the subjects (e.g., as actual or potential delinquents or schizophrenics). Confidentiality safeguards must be strong in these instances.
"Participation in research may result in additional actual costs to individuals. Any anticipated costs to research participants should be described to prospective subjects during the consent process."