Research projects that include the participation of human subjects are required to gain IRB approval prior to commencement. To initiate the review process, investigators must submit the appropriate documentation and await the allotted review period. View this process in the Submission/Approval Procedure Flowchart.
»IRB Submission & Approval Process
- IRB Submission Process
- Review Process
The first step in submitting an IRB protocol application is to determine whether your research falls under one of three Categories: Exempt, Expedited, or Full Committee Review. Definitions of each category can be found on the FAQs page. If you are unsure of which category your research falls under, contact the IRB for assistance.
Once you have determined the appropriate category, download the corresponding application packet from the Forms and Instructions page. Electronically complete the application and submit to the firstname.lastname@example.org along with supplemental materials.* When submitting, title the subject field with the application name (e.g. Full Committee Application, Request for Exemption, Request for Modification). Review times vary and are based on the type of application submitted (see review schedule).
Full Committee Reviews occur once a month and must be submitted on the 15th of the month prior to the following month's review date. See schedule below.
Review Date: Submission Deadline:
August 10, 2015
September 14, 2015
October 12, 2015
November 9, 2015
December 14, 2015
January 11, 2016
February 8, 2016
March 14, 2016
April 11, 2016
May 9. 2016
June 13, 2016
August 8, 2016
September 12, 2016
July 15, 2015
August 15, 2015
September 15, 2015
October 15, 2015
November 15, 2015
December 15, 2015
January 15, 2016
February 15, 2016
March 15, 2016
April 15, 2016
May 15, 2016
July 15, 2016
August 15, 2016
Submit 4-6 weeks prior to proposed start date
Submit 3-4 weeks prior to proposed start date
Request for Continuation
Submit 45-60 days prior to expiration date
*Supplemental materials include but are not limited to: Consent/Assent forms, Surveys/Questionnaires, Interview questions, recruitment advertisements, HIPAA authorization or waivers of authorization, Certification of Human Subjects Protection training, etc.
Exempt protocols are reviewed by the IRB Administrator and the IRB Faculty Chair.
Expedited protocols are reviewed by the IRB Administrator, IRB Faculty Chair and one or two members of the Boards as needed, depending on the study details.
Full Review protocols are assigned two members of the IRB Committee as "primary reviewers". One or both of them will contact you prior to the monthly Full Committee Review meeting to request any additional information, supplemental materials, or to discuss initial concerns.
The designated reviewers will review the protocol, render a decision, and notify the Principal Investigator. The protocol will either be Approved, Approved with Modifications, Tabled for Discussion to an ad-hoc or full committee, or Not Approved.
- If Approved: the principal investigator will receive a letter of approval and the necessary documents to proceed with the research.
- If Approved with Modifications: the primary reviewers will send the requested modifications back to the Principal Investigator for revision. Once the revisions have been made and satisfy the committee, the investigator will receive a letter of approval and the necessary documents to proceed with the research.
- If Tabled for Discussion pending additional information or revisions: the IRB will return the protocol and outline the major concerns for the investigator. The protocol will be placed on the agenda of the next Full Committee Meeting as long as revisions are received in a timely manner. The IRB may also decide to convene an ad-hoc committee to review and approved the requested revisions if time is of the essence.
- If Not Approved: the IRB will notify the investigator, the Human Subjects Protection Officer (Y. Uzzell) and the Institutional Official (D. Struppa) on its decision. It is the IRB's policy to work with the investigator to make the necessary revisions needed to approve the protocol.