Although we talk about it a lot, patient the minimal risk concept is used in a limited set of IRB decisions.
A. Expedited Review
“46.110. Expedited review procedures for certain kinds of research involving no more than minimal risk.”
Expedited review is an option for minimal risk studies only. At E&I, an expedited reviewer who believes a study is or might be greater than minimal risk, should refer the study to consideration by the full board. The reviewer may ask questions to clarify facts before or in coordination with referral.
B. Informed Consent
For minimal risk studies, the consent form need not include information about treatment of research related injuries and compensation for the costs of that treatment. Unless specifically waived, all consent forms must have the contact for someone to call about injury.
History note: In 1978, Secretary Califano signed an interim final regulation saying that subjects should be informed about treatment of injury, compensation for costs and where to go for information about the injury policy. The policy contained a limitation; the statement would be required only for research involving greater than minimal risk.
C. Continuing Review
During review the full board can designate a study for expedited review in the future. These are studies without investigational drugs or devices that do not qualify under the listed expedited categories. The full board must determine and document that the research involves no greater than minimal risk.
45 CFR 46 Subpart D governs research with children. It identifies four categories of research using determinations of risk and benefit. Research and clinical investigations not involving greater than minimal risk have the least amount of additional requirements.
The IRB may allow consent to be waived under the Common Rule (45 CFR 46.116(d)) if four conditions are met. The first is that the research involves no more than minimal risk to the subjects.
The IRB may waive the requirement to have a consent document in two situations. For the second situation the first criterion (45 CFR 46.117(c )) is that the research presents no more than a minimal risk of harm to the subjects.
F. Bureau of Prisons
For those who conduct their research with the federal prison system, there is also a Research Review Board. The chair of that board may approve a study using the expedited process if the study “meets the minimal risk standard” plus other requirements.