Section VIII:

Review Types/Process

WPP #: VIII-6

Title 6:

Review of Revisions Prior to Final Approval and Calculation of Approval/Expiration Dates

Effective Date:

05-13-14

Revision History:

06-07-04; 06-21-06; 02-05-07; 9-1-09; 03-01-11

Policy Statement

Revisions to new and continuing human research applications may be required in order to ensure that all criteria for IRB approval as outlined in 45 CFR 46.111 are met. Correspondence is sent to the investigator detailing requests for revisions, clarification, or additional information as well as information regarding continuing review. The principal investigator must prepare revisions requested by the IRB and submit within the required timeline. Additionally, the principal investigator must monitor approval and expiration dates established by the VCU IRB.

Description and Procedures

Revisions to new and continuing human research applications may be required. For full board reviews written correspondence is sent to the investigator detailing requests for revisions, clarification, or additional information as well as information regarding continuing review. For exempt and expedited reviews, the correspondence is via phone conversations or email.

  1. Investigator Response Window:

    The investigator has 60 days to respond to the revisions requested. If the investigator does not respond in 60 days, the application is withdrawn. If the investigator wishes to conduct a new study that has been withdrawn, he/she must submit a new application, incorporating comments from the prior IRB review.

  2. Approved on Condition:

    When confirmations of assumptions or specific changes are requested in the protocol, consent document(s), and/or other supporting documentation, these are reviewed for compliance by the chair or his/her designee before final approval is given.

  3. Tabled:

    In instances where modifications or additional information are requested during a full board review, the revised documents are returned to the full board for its review and approval. The application receives final approval when all questions and/or requests for clarifications have been submitted and approved.

  4. Final Approval:

    Upon final approval, the ORSP provides stamped approved Informed Consent Document(s) to the principal investigator. These documents are provided to the principal investigator along with a letter of approval indicating the type of review, date of next continuing review, and a summary of investigator responsibilities.

  5. Calculation of Approval Dates and Expiration Dates:
    1. Approval Dates:
      1. Full Board Reviews -- Approval Dates are set as follows:
        1. For submissions that gain approval at a convened meeting, the approval date will be the date of the convened meeting.
        2. For studies approved on condition, the approval date will be the date a designated reviewer confirms that the condition(s) have been met.
      2. Expedited Reviews: Approval Dates are set as the date the reviewer approves the research study.
      3. Exempt Reviews: Approval dates are set as the date the reviewer approves the research study.
    2. Expiration Dates:
      1. The expiration date means the last day that the review is approved, up until midnight in the local Eastern Standard Time zone.
      2. The VCU IRB has the authority to set approval dates or other limitations as it deems necessary in order to ensure adequate monitoring of the research, so long as the approval period does not exceed one year.
      3. Research (qualifying for an expedited review) approved for an annual review cycle: Expiration date will be set as the last day of the month, 11 months forward from the 'approval date'.
      4. Research approved at a convened meeting for an annual review cycle: Expiration date will be set at 364 days from the 'approval date.'
      5. Research reviewed at a convened meeting and 'approved with conditions' for an annual review cycle: Upon subsequent confirmation by the designated reviewer that the conditions have been met, the expiration date will be set at 364 days forward from the date of the convened meeting at which the study was 'approved with conditions.'

References

OHRP Guidance on IRB Approval of Research with Conditions
45 CFR 46.111