Human Research Protections Office (HRPO)

Reviewer Checklists

The primary goals of these checklists are 1) streamline and improve the efficiency of the review process and the Committee meetings and 2) to verify and document that we are in compliance with the regulations and our own policies and procedures.

Below are the checklists that will be used for review by the IRB Members. Checklists 1A-1C, 9, 10, and 11A-D have been revised and will be implemented starting with the 4/20/06 meeting. Please note that Checklist #10 has been incorporated in to checklist #9 and checklist 11D has been incorporated in to checklist 11A. Reviewer guides have also been revised to provide more specific step-by-step instructions and to incorporate the use of the checklists in to the review process.

When you receive your assignments for your meetings, the IRB Analyst will identify which checklists are required for your review and the checklists and the reviewer guides will be attached for your convenience. The checklists will need to be printed out and completed by hand as you review your assignments

Bring the checklists, as complete as possible, to the meeting. Leave blank any items that you cannot determine or that information is unclear. As each protocol is reviewed, the Primary Reviewer will provide a summary of the protocol and then comment on areas of the checklist that are incomplete. The Secondary Reviewer will then present any additional information, including incomplete areas of the checklist that differ from those raised by the Primary Reviewer. It is these “controverted issues” that must be discussed and resolved (if possible) by the Committee. Once the discussion is completed, there will be a motion for a vote, and the completed, signed, and dated checklists will be turned in to the Committee’s QI Specialist before the next item of business begins. Finalized checklists will be verified by the QI Specialist for completeness and ultimately uploaded into BRAAN for documentation of the review and storage.

If you have questions or need assistance with the checklists, please contact the QI Specialist assigned to your meeting (see the HRPO main web page for details). Please continue to provide feedback to Carley Benham (cbenham@som.umaryland.edu) so that we can take your questions and concerns in to consideration as we continue to revise and refine this process.

New Protocol: Criteria for Approval (Checklist #1A)

Continuing Review: Criteria for Approval (Checklist #1B)

Amendment: Criteria for Approval (Checklist #1C)

Informed Consent (Checklist #9 & 10)

Waiver or Alteration of Requirement to Obtain Informed Consent (Checklist #15)

Waiver of Requirement for Written Documentation of Informed Consent (Checklist #16)

Review of Research Involving Children (Checklist #11A)

Review of Research Involving Children as Wards (Checklist #11B)

Adequate Provisions for Soliciting the Assent of Children (Checklist #11C)

Research Involving Neonates (Checklist #12)

Research Involving Pregnant Women and Fetuses (Checklist #13)

Research Involving Prisoners (Checklist #14)

IND Requirements (Checklist #8)