Subject: Institutional Review Board Committee Review Responsibilities

Policy:

It is the policy of Mayo Clinic's Office for Human Research Protection – Institutional Review Board (IRB) – to review all human subjects research activities under Mayo Clinic's IRB jurisdiction.

1. IRB review of research
   1. The IRB will review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy.
   2. The IRB will require that information given to subjects as part of informed consent is in accordance with IRB Policy IV.A. ^[1] The IRB may require that information, in addition to that specifically mentioned in IRB Policy IV.A ¹ be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights and welfare of subjects.
   3. The IRB will require documentation of informed consent or may waive documentation in accordance with IRB Policy IV.B ^[2]and C. ^[3] In cases where the requirement for documentation of informed consent is waived; the IRB may require the Investigator to provide subjects with a written statement regarding the research.
   4. The IRB will notify Investigators and the institution in writing of its decision to approve or disapprove the proposed research activity or of modifications required to secure IRB approval of the research activity (deferral). ^[4] If the IRB decides to disapprove a research activity, it will include in its written notification a statement of the reasons for its decision and give the Investigator an opportunity to respond in person or in writing.
   5. The IRB will conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year, and will have authority to observe or have a third party observe the consent process and the research. ^[5], ^[6]
   6. The IRB may, for some or all subjects find that the requirements in Section II of IRB Policy IV.C ^[7] for an exception from informed consent for emergency research are met. If the IRB determines that it cannot approve the research because it does not meet these requirements, the IRB will promptly notify the Investigator and the Sponsor of the research in writing. The written notification will include a statement of the reasons for the IRB's determination. The IRB will provide to the Sponsor a copy of information that has been publicly disclosed under Section II of IRB Policy IV.C. ⁷, ^[8]

^[1] IRB Policy IV.A

^[2] IRB Policy IV.B

^[3] IRB Policy IV.C

^[4] IRB Policy III.B

^[5] 45 CFR 46.109

^[6] 21 CFR 56.109

^[7] Section II of IRB Policy IV.C

^[8] 21 CFR 56.109(c)(2), (e) and (g)