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How to Apply for IRB Review

Due to the subtleties and complexities of the issues involved with evaluating human subjects research, an initial IRB review will take a minimum of 2.5 weeks from the time of proposal submission, but could take longer. The time to a completed review (including notification of acceptance) depends on a number of factors, including the timeliness of the submitter in responding to feedback from the IRB. It is incumbent upon the submitter to allow for that necessary time of review, and to facilitate the review by being diligent in completing the application correctly and responding to feedback promptly.

1. If this is your first research project at Shepherd, please complete an authorized training course. Shepherd will accept its own authorized CITI training certificate. Any other certificate must be validated by the IRB Chair BEFORE you apply. Retain an electronic copy of the certificate. For more information on the CITI Shepherd course: student investigators must contact their faculty sponsors. Faculty investigators must contact the IRB Chair.
   
   If you have submitted a proposal to the Shepherd IRB previously, please make sure your authorized training course certificate is still valid (these certificates are valid for three years from the completion date). If it is not valid, you will need to renew it. Note that while the Shepherd IRB will accept the previously accepted NIH Office of Extramural Research Protecting Human Research Participants course certificate for current holders, the IRB will not accept an NIH certificate with a renewal date of September 16, 2018 or later.
2. Obtain the Shepherd IRB Application Coversheet, the Shepherd IRB Application, the Shepherd IRB Policy Manual and (if appropriate) the Online Data Collection IRB Issues document, read the IRB Policy Manual in full, and then create and submit a complete IRB application package electronically to the IRB chair.
   • All files must be attached to the email; we will not accept submissions where documents are made available through links.
   • If you are a student PI, you must CC your Faculty Sponsor on the proposal submission and any followup responses.

   Please note that the Coversheet is a fillable PDF document. Some PDF readers (most notably Preview on the Mac, but this is also true of Adobe software) don’t always handle these files well.

3. A complete IRB application package will be fully aligned with the material in the IRB Policy Manual and other supporting documents, include:
   • the Shepherd IRB Coversheet (use the most current one from the website);
   • the Shepherd IRB Application containing your responses to all items in the form (use the most current one from the website);
   • a copy of the Informed Consent form to be used (make sure all elements discussed in the IRB Policy Manual are included);
   • copies of any measurement instruments to be used;
   • copies of any participant recruiting advertisements (if used);
   • any other forms or information that will be shared with participants;
   • a copy of a valid training course certificate for each investigator;
   • a copy of the Faculty Sponsor’s valid training course certificate (if you are a student PI).
4. The IRB is in session between September and May of each year, and meets at noon on the first Friday of each of those months to consider applications requiring a “full review”. Your application materials for full review must be received by the chair of the IRB at least 10 business days before a meeting to be considered at that meeting. Applications requiring “exempt” or “expedited” reviews are considered on an ongoing basis during the Shepherd academic year; those application materials are submitted to the chair of the IRB, who then initiates the appropriate review process.
   
   The meeting schedule and submission deadlines for all applications for the current year can be found at the IRB Calendar. The IRB does not meet during the summer. Therefore, reviews for applications submitted after April 15 (for exempt or expedited reviews) or the May meeting submission deadline (for full reviews) may be delayed until the beginning of the next Fall semester.