In response to the needs of Principal Investigators (PI) to receive timely approval of protocols involving human participants, the Office of the Vice President for Research has created a new position to assist Principal Investigators by offering a pre-review of the IRB Protocol Summary Form, all consent documents, advertisements, and other IRB forms that will be submitted as part of a protocol for review and approval by one of the four IRBs. While optional, this new service will allow many IRB conditions and/or concerns to be addressed in advance of the IRB meeting, thus eliminating the need for the IRB to table some research protocols. The goal of this new service will be to increase the number of full committee research protocols that are approved the first time they are submitted to the IRB and to decrease the number of protocols that are tabled. Consequently, the amount of time for obtaining final approval should be reduced.

Because a Research Compliance Administrator works so closely with the various IRBs, they are familiar with what is acceptable to the IRBs. In addition, they are able to spot inconsistencies between the protocol summary form, all of the consent documents, the research protocols and various advertisements. Because those inconsistencies often affect the risk/benefit ratio, the IRB is required to table the protocol until the Principal Investigator provides additional information and/or clarification so that the full IRB can evaluate the risk/benefit ratio at their next meeting. While an IRB meets weekly, any one specific IRB only meets on a monthly basis. Because of regulatory requirements, the IRB that places conditions (i.e., tabling a protocol) on a research protocol is the only IRB that can remove that condition. Consequently, this regulatory requirement has resulted in a monthly delay. If those concerns can be addressed in advance of the IRB meeting, the IRB would be in a position to approve the research protocol or at least approve it with minor revisions. For Principal Investigators that use this pre-review service, it is anticipated that protocols that may have been tabled by the IRB in the past will be either approved or approved with specific minor revisions that can be administratively reviewed. Obviously a decrease in the number of research protocols that have been tabled will increase the research productivity of the Principal Investigator

Investigators that wish to use this additional service will need to request “Pre-review” and to allow a few additional days for the IRB pre-reviewer to have sufficient time to conduct the pre-review. For the ease of the investigator, materials can be submitted electronically for pre-review and any duplication of IRB forms should be done after the pre-review has been completed. It is anticipated that investigators who use this new service will be able to address many of the issues identified in the pre-review before the protocol is actually submitted to the IRB for their review and approval. Because this new service is designed to facilitate the review and approval of protocols submitted for full committee review, only those protocols that must be reviewed by the full IRB are eligible for this pre-review.

The HIC is pleased to announce that Linda Aiello has been promoted to this new IRB pre-review position. For the past eight years, she has been working as a Research Compliance Administrator (IRB coordinator) and during that time she has assisted all four IRBs. Her experience with assisting investigators and individual IRBs will be extremely helpful to the investigators in getting their protocols through the IRBs and we are pleased that she is now able to devote full time to this pre-review activity.

When submitting protocols for pre-review by Ms. Aiello, the Medical/Behavioral Protocol Summary Form, Informed Consent, advertisements, questionnaires, and HIPAA forms can be emailed to Linda at laiello@wayne.edu or hand delivered to the HIC office. Please remember that IRB pre-review is optional and independent from the submission of a protocol for IRB review and approval. Therefore, the Principal Investigator should make it clear in his/her telephone conversation, emails, and/or hand delivered protocol that pre-review is being requested.

–Patti Webber