Subject: IRB Approval of Research

Policy:

It is the policy of Mayo Clinic's Office for Human Research Protection – Institutional Review Board (IRB) – to review and approve research in accordance with the criteria as defined by Federal regulations.

1. Criteria for IRB Approval of Research
   1. Risks to subjects are minimized by:
   2. 1. using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and
      2. whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes;
   3. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB Committee should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB Committee should not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility;
   4. Selection of subjects is equitable considering the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations and the potential need for additional protections, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons;
   5. Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by Federal and State regulations and Institutional polices and procedures including the IRB;
   6. Informed Consent will be appropriately documented, in accordance with, and to the extent required by the Federal and State regulations and Institutional policies and procedures including the IRB;
   7. When appropriate, the research plan makes adequate provisions for monitoring the data collected to ensure the safety of subjects;
   8. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. ^[1], ^[2]
2. There are adequate provisions to protect the rights and welfare of vulnerable populations from coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. The IRB Committee must determine if additional safeguards need to be included in the study to protect the rights and welfare of these subjects. ^[3], ^[4]
3. Determining the Interval for Continuing Review

   At the time of initial approval the full IRB or expedited review committee determine the interval for continuing review will be not less than once per year. In making this determination, the full board or expedited review committee will consider the factors specified in sections I and II of this policy and may also consider factors such as:

   1. Research conducted internationally;
   2. Involvement of recombinant DNA or other types of gene transfer protocols;
   3. Previous Administrative Holds or Suspensions of the research due to compliance, record-keeping or other concerns; and/or
   4. Recommendations from other Institutional committees. ^[5], ^[6]

^[1] 45 CFR 46.111(a)

^[2] 21 CFR 56.111(a)

^[3] 45 CRF 46.111(b)

^[4] 21 CFR 56.111(b)

^[5] 45 CFR 46.103(b)(4)(ii)

^[6] 21 CFR 56.108(a)(2)