Subject: IRB Committee Determinations/Motions

Procedure:

1. Investigator Responsibilities.
   1. Approved:
      1. The Investigator shall begin research activities only after the written notification of approval from the IRB is received.
   2. Deferred:
      1. New Studies:
         1. The Investigator shall not begin the research activities until after the written notification of approval from the IRB is received.
         2. The Investigator shall make the requested changes or justify why the changes do not need to be made in the deferral response before the IRB will reconsider the application.
         3. The Investigator shall include in the response a copy of any revised documents- including protocol and consent form - in their entirety.
      2. Modifications:
         1. The Investigator shall not begin any proposed new research activities until after the written notification of approval from the IRB is received.
         2. The Investigator shall continue to conduct the research activities as previously approved by the IRB.
         3. The Investigator shall make the requested changes or justify why the changes do not need to be made in the deferral response before the IRB will reconsider the application.
         4. The Investigator shall include in the response a copy of any revised documents- including protocol and consent form - in their entirety.
      3. Continuing Review:
         1. The Investigator may not continue the research activities beyond the expiration date until after the written notification of approval from the IRB is received.
         2. The Investigator shall make the requested changes or justify why the changes do not need to be made in the deferral response before the IRB will reconsider the application. If not approved prior to the expiration date, the study will expire and the Investigator shall proceed in accordance with IRB Procedure III.I.2.^[1]
         3. The Investigator shall include in the response a copy of any revised documents- including protocol and consent form - in their entirety.
2. IRB Committee Responsibilities.

   The IRB will render decisions on research activities and will make the following determinations and/or motions as set forth in IRB Policy III.B:

   1. Approved: The IRB will approve the research activity if it meets the criteria as set forth in IRB Policy III.D^[3].
   2. Deferred: The IRB will defer the research activity if minor modifications or clarifications are required for approval of the research in accordance with IRB Policy III.D.³
   3. Tabled due to Lack of Time: The IRB will table any proposed research activities that cannot be reviewed due to lack of time. Tabled items will be placed on the next available agenda.
   4. The IRB Chair/Vice Chair or designee will review and finalize the documentation of the expedited review procedure.
3. IRB Specialist Responsibilities.
   1. The Specialist will record the determinations of the expedited review procedures.
   2. The IRB Specialist will draft the Letter to the PI (minute excerpt) documenting the review.
      1. Approval
         1. At a minimum the following information will be documented in an approved Letter to the PI (minute excerpt):
            1. Protocol identification (title, number);
            2. Investigator's name;
            3. Mayo site(s) approved
            4. List of documents being approved (protocol, consent, advertisements, etc.)
            5. Version numbers for protocol (if applicable) and informed consent document (if applicable)
            6. IRB Approval date
            7. Statement of Approval
            8. Expiration date of IRB approval
            9. Statement regarding the number of participants approved for enrollment
            10. UPIRTSO reporting expectations
            11. Protocol deviation/non compliance issues and reporting expectations
      2. Deferral
         1. The Specialist will include the reason for the Chair/Vice Chair decision to defer approval of the study in the Letter to the PI (minute excerpt).
         2. The letter shall state the changes that must be made to the protocol and/or informed consent documents before approval can be granted
         3. The Specialist will remind the Investigator to make the changes requested by filling out a Deferral Response Form and submitting the response and documentation to the IRB for review.
      3. Tabled due to lack of Time
         1. If there is insufficient time to complete review of an item on the agenda, the item may be tabled and reassigned to the next review procedure
   3. The Specialist will record the name of the reviewer for each item in the Letter to the PI.
   4. The Specialist will finalize the Letters to the PI during the review procedures.
   5. The IRB Specialist will send the approved Letter to the PI (minute excerpt) via IRBe email to the Investigator advising him/her of the outcome of the IRB review.
   6. The Specialist will ensure that all IRB approved documents, including the Consent Form (if applicable) are provided to the Investigator at the same time the Letter to the PI (minute excerpt) is distributed.
   7. The Specialist will ensure that all relevant information has been entered into the IRB database in an accurate and timely manner.
   8. The Full Committee Specialist will provide the expedited review minutes for review and approval at the next regularly scheduled meeting of a fully convened committee. Once the meeting minutes are approved, they will be filed in the IRBe electronic files.
   9. If there is a necessity to revise an approved minute, the Specialist will complete and send a “Request for Amending Meeting Minutes” form to the irbservicecenter@mayo.edu for approval. Amendments to any approved minutes (including Letter to the PI) may only be executed when approval is granted through this method.
   10. The Specialist will include all amendments made to approved minutes (including Letter to the PI) in the next meeting agenda of the committee that originally approved it.

^[1] IRB Procedure III.I.2

^[3] IRB Policy III.D