Subject: Modifications to Previously Approved Applications or Claims for Exemption

Policy:

It is the policy of Mayo Clinic's Office for Human Research Protection – Institutional Review Board (IRB) – to review all requests for modifications to previously approved research and exempt research.

1. For previously approved research.

   Proposed changes in a research activity during the period for which IRB approval has already been given must be promptly reported to the IRB. Such changes may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the subject. ^[1], ^[2]

2. Modifications eligible for Expedited Review.

   The IRB may use an expedited review procedure to review either or both of the following:

   1. Research that involves no more than minimal risk, and which appears on the following list: Expedited Review Categories
   2. Minor modifications in previously approved research during the period (of one year or less) for which approval is authorized. ^[3], ^[4]
3. Exempt research.

   Certain changes may disqualify the research from exempt status. Therefore, any proposed changes to an exempt study must be submitted to the IRB for review and approval prior to implementation. ^[5]

4. Re-consent or Notification of Participants.

   The IRB will determine whether the changes to the research require a change in the consent documents and therefore warrant re-consenting of currently enrolled participants or notification of participants who have completed research interventions. The IRB will ensure that the consent documents contain the information required in accordance with IRB Policy IV.A . ^[6], ^[7], ^[8]

^[1] 45 CFR 46.103(b)(4)(iii)

^[2] 21 CFR 56.108(a)(4)

^[3] 45 CFR 46.110(a), (b)

^[4] 21 CFR 56.110(a), (b)

^[5] Section III of IRB Policy III.C.

^[6] 45 CFR 46.116 (a), (b)

^[7] 21 CFR 50.25 (a), (b)

^[8] IRB Policy IV.A.