Institutional Review Board Instructions, Forms, and Samples

There are currently three IRB panels constituted at the Health Center that meet on a monthly basis. Panel 01 meets for the first convened meeting of the month, Panel 02 meets for the second convened meeting of the month and Panel 3 meets for the third convened meeting of the month. With one exception studies requiring full board review are initially assigned to Panel 01, 02 or 03 based on submission date of the application. The one exception is that any study proposing to involve prisoners as subjects (including via chart reviews) must be reviewed by Panel 02 which has a prisoner advocate as a member. Once a study has been assigned to a panel it remains under that same panel's oversight for the life of the study. IRB Panel 4 meets on an as needed basis and only reviews studies involving research with embryonic stem cells.

All documents submitted to the IRB must be typed. Cells on the forms will expand to accommodate text. If you cannot access the documents, experience a problem with the formatting, or have general questions about preparing a submission to the IRB contact any of the following individuals for assistance:

For each submission, save the relevant documents to your hard drive and complete accordingly. Always refer back to the web site or the shared Institutional Review Board e-mail folder when submitting forms to the IRB to ensure you are using the most recent version of the document. The IRB reserves the right to return outdated forms. A log describing changes that have been made is available at the bottom of the page.

Human Subjects Training

All key personnel associated with a study, including those authorized to obtain consent, must complete human subjects training. Completion of this training will be verified by the IRB Office. New investigators and research personnel who have not yet completed training or whose training is more than 3 years old are also required to complete the CITI Basic Course Requirement and submit the completion certificate to the Human Subjects Protection Office. Biomedical investigators whose initial CITI training is expiring must complete the CITI GCP course. Social and behavioral investigators whose initial CITI training is expiring must complete the CITI social and behavioral refresher course.

Starting the IRB Process

Your research protocol should be well formulated before you being the process of preparing an IRB application. The first step is to determine whether you study will require review by the full board or whether it will qualify for expedited review or exempt status. To make this determination first review the categories of research that may qualify for an exempt status. If the research does not appear to qualify for exempt status, review the categories of research that may be permitted under expedited review. If the research does not appear to qualify for exempt status or expedited review, full board review will be required and the submission deadlines will apply. Once you determined the type of review that is required you should review the Checklist for Initial and Continuing review and prepare/provide those documents that are relevant to your study. The checklist also tells you how many copies of each document must be provided. Use this checklist to communicate with the IRB if you need to convey information about your submission. If items on the checklist do not pertain to your study indicate NA. Once all of your material is complete it is submitted in hard copy format to the IRB office. It can be addressed to the IRB, 2nd floor Munson Building at MC-3926 and sent via interoffice mail or through the courier service, or it can be hand delivered. The IRB staff will the screen the submission and communicate with you via e-mail regarding any needs for additional information or clarifications.

All documents are in Word format unless otherwise noted.

*Also review sections for routine IRB forms, HIPAA forms and vulnerable populations for additional forms that may be required (e.g., checklist, HIPAA authorization, appendices, etc.)