It can be difficult to remember, when you’re deep into the review of a complicated new submission, that there are only eight regulatory criteria for the approval of human subject research. These criteria are listed in more detail in UAMS IRB Policy 7.1 and at 45 CFR 46.111. A summary follows:
- Risks to subjects are minimized
- Risks to subjects are reasonable in relation to anticipated benefits, if any, and the importance of the knowledge that may reasonably be expected to result
- Selection of subjects is equitable
- To the extent required, informed consent will be sought
- To the extent required, informed consent will be documented
- When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects
- When appropriate, there are adequate provisions to protect the privacy of subject and to maintain the confidentiality of data
- When appropriate, additional safeguards have been included in the study to protect the rights and welfare of subjects vulnerable to coercion or undue influence.
These criteria are derived from the ethical principles described in the Belmont Report — Respect for Persons, Beneficence, and Justice. Please keep these criteria in mind when reviewing research and drafting contingencies. Some institutions require reviewers to document the relationship to a specific criterion for each contingency they write. UAMS does not go quite that far, but we do ask that you be able to relate your proposed contingencies to one of the above requirements. Items that do not relate to one of these criteria, but that you feel may be helpful to the study team, can be documented as a “note” in CLARA rather than as a contingency. For example, you may have suggested changes to the consent form. If the proposed consent form is so deficient that criteria 4 and 5 above could not be met, those changes would be appropriately listed as contingencies. However, if you have minor editing suggestions with no impact on the overall consent process and documentation, those changes would best be listed as comments for the study team to take into account the next time the consent form is revised.