Subject: Activities Subject to IRB Jurisdiction

Policy:

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

1. Jurisdiction of the IRB
   1. All research ^[1] projects involving human subjects ^[2] fall under the jurisdiction of the IRB. This includes any clinical investigation under the jurisdiction of the Food and Drug Administration. ^[3]
2. Review and Approval of Human Subjects Research
   1. No intervention or interaction with human subjects in research, including advertising, recruitment, and/or screening, may begin until the IRB has reviewed and approved the research. ^[4], ^[5]
   2. It is the responsibility of the IRB Chairperson or his/her designee or the full IRB to determine what activities constitute "human subjects research".
   3. Mayo Clinic's FWA ^[6] with the Federal government defines it's jurisdiction over the review of human subjects research. Regardless of sponsorship, the IRB must review all human subjects research when Mayo Clinic's IRB is the IRB of Record. ^[7]
3. Failure to Submit a Project for IRB Review
   1. If research involving human subjects is conducted without prior IRB review and approval, the matter will be referred to the IRB in accordance with IRB Policy Chapter II. ^[8]

^[1] 45 CFR 46.102(d)

^[2] 45 CFR 46.102(f)

^[3] 21 CFR 56.102 (c)

^[4] 45 CFR 46.101(a)(2)

^[5] 21 CFR 56.103 (c)

^[6] Mayo Clinic's Federalwide Assurance

^[7] IRB Policy I.D

^[8] IRB Policy II.B