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Dyrbye LN, Thomas MR. Mechnber AI, Eacker A. Harper W, Massie, Jr FS. Power DV. ShanafehTD. Medical Education Research and IRB Review: An Analysis and Comparison of the IRB Review Process at Six Institutions. Academic Medicine July 2007; 82:654-660.

Dyrbye LN, Thomas MR. Mechnber AI, Eacker A. Harper W, Massie, Jr FS. Power DV. ShanafehTD. Medical Education Research and IRB Review: An Analysis and Comparison of the IRB Review Process at Six Institutions. Academic Medicine July 2007; 82:654-660.

Reviewed by Paola Palma Sisto

What is the problem so and what is known about it so far?
Because medical students were commonly used as research subjects without their informed consent, students are now considered a vulnerable population requiring protection as subjects of research, including Institutional Review Board (IRS) review of research proposals involving students. This has led to some challenges for medical education researchers as many are not familiar with federal regulations and for IRBs, who may not be familiar with medical education protocols. Obtaining consent at multiple institutions for a collaborative research effort is problematic.

Why did the researchers do this particular study?
Most educational researchers support IRB review of educational research. However, Httle is known about how lRB committees deal with multi-institutional research involving medical student education.

Who was studied?
The IRS committees from six medical institutions (Mayo Medical School-Lead Investigator, University of Minnesota Medical School, University of Chicago Pritzker School of Medicine, University of Miami Miller School of Medicine , University of Alabama at Birmingham School of Medicine. and University of Washington School of Medicine) were included in the study. These institutions were chosen because they represent diverse public and private institutions located in different geographic areas of the United States.

How was the study done?
A research protocol was drafted outlining a mulli-school study evaluation of medical students' quality of life. The study had 2 components: a web-based survey to be administered via email to medical students at 2 time points, and focus groups to be conducted with selected students as a follow-up to the survey. The lead investigator submitted the protocol to her IRB (note: her IRB had reviewed similar protocols in recent history). Once it was approved, the other collabomting investigators submitted the protocol to their IRSs for review. The IRSs were not aware they were the study subjects (PPS nOle•--who approved rhal?). Data regarding the dates submitted, IRB communications. responses to the IRS requests, and any additional information submitted to the IRB were collected.

What did the researchers find?
There was significant variability among the six institutions' lRBs. 5/6 institutions submitted the protocol as expedited review; 215 needed to go for full review. The sixth institution recommended exempt review; however. the protocol eventually went for full review. The time to preliminary review ranged from I-II days in five institutions and 101 days at the sixth institution. Requests for further information ranged from 0-19 requests among the six institutions. There were 22 unique requests for additional information and 25 unique requested changes to the protocol. The majority of the changes requested were regarding the consent form (cover letter to the email request). The sixth institution was excluded from the study because of the extreme time delay (at 209 days from the time of original subm ission the IRB from the sixth institution requested a link to the survey's website to allow additional review; that was 2 months into the start of the survey in the other five institutions). It took 216 days from the time the primary investigator submitted the complete research protocol to her IRB institution umil the survey was administered to the students at the five remaining institutions. The power of the study was affected, as was the academic productivity of the investigator at the sixth institution. In addition, the delay ofapprovals almost impacted the funding time limit.

What were the limitations of the study?
Only a small number of lRBs were involved in the study and only one educational protocol was considered. The investigators did not report whether any of the participating IRBs had expertise on educational research, and whether that affected the time to approval.

What are the implications of the study?
Conducting medical education research is associated with many challenges. Another challenge is obtaining timely IRS approval. The authors offer a number of strategies to facilitate the approval of valid protocols, including allowing standardization of Olpplicalions across institutions for multi• institutional medical education protocols, and ensuring expertise in medical education protocols is present on the IRB committee. The authors call for the AAMC and ACGME to work with the Association for the Accreditation of Human Researeh Protection Programs (AAHRPP) to develop central or regional IRB committees to reduce the burden on collaborators and facilitate multi-institutional trials in medical education.

Ed note: This is a fascinating article with broad implications. For those of your preparing protocols, you can't get the IRB involved early enough and be prepared for a potent ially long haul. WVR

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