If a conflict of interest is reported to the IRB prior to its approval of the study, the IRB shall deliberate upon the conflict and resolve its management as a criterion for approval of the study. If a conflict of interest is reported to the IRB after approval of a study, the IRB shall deliberate upon the conflict and resolve its management as a criterion for permitting continuance of the study.
A key to IRB determinations shall be the IRB evaluation as to whether the conflicts could challenge, or be perceived by others to challenge, the integrity of a reasonable individual or the institution itself, whether the conflicts could result in decisions that adversely affect the production of valid scientific results and whether the conflicts might adversely affect the protection of human subjects or the credibility of the human research protection program. It shall then be the responsibility of the IRB to determine if the institution is an appropriate site for the research, whether the research should be approved and whether (and how) the conflicts shall be managed or eliminated so they no longer affect the protection of human subjects or the credibility of the human research protection program.
The IRB will determine whether the conflict is permissible in the context of the protocol or whether additional actions must be taken. Such actions may include (but are not limited to):
1. Requiring partial or complete financial divestiture
2. Requiring an independent investigator to obtain consent or conduct the research
3. Requiring an independent data safety monitoring committee or similar monitoring body
4. Requiring additional oversight or monitoring of the research
5. Requiring a second or parallel site for the study
6. Requiring modification of the role(s of particular research staff, changes in location for certain activities or prohibition of UM as a study site
7. Requiring frequent continuing review
8. Requiring separation of responsibilities for financial decisions and research decisions
9. Requiring that additional information be given to subjects as part of the informed consent process if, in the IRB's judgment, the information would meaningfully add to protection of the rights and welfare of subjects [45 CFR 46.109(b), 21 CFR 56.109(b)]
10. Disapproval of the study