IRB Application Process

Start by selecting the type of study that you plan to submit:

Single Site Study
Multi-Site Study (Pitt as IRB of Record)
Multi-Site Study (Pitt cedes IRB review to another IRB)

Single Site Study

Study has one participating site
Pitt is the IRB of Record

Submission process steps:

1. Prepare study documents: ensure your application is complete and through

2. Build and submit the PittPRO application: contact askirb@pitt.edu to schedule a PittPRO training course if you’re unfamiliar

3. Ancillary Reviews: Review Chapter 8 of the IRB P&P for more information

4. IRB Pre-review: This is the first IRB review. An IRB staff member will review the application for common errors and request clarifications/revisions as needed

5.IRB Review:

Full Board: protocol appears before a convened IRB and is reviewed by members who consider the approval status
Administrative Review: protocol is reviewed by a member of the Exempt/Expedited Team who will correspond directly with you to secure approval

6. Final processing: IRB staff is completing final regulatory documentation, and finalizing documents, including the approval letter

7. Ongoing review:

Modifications to an approved study must be submitted to the IRB prior to implementation
Continuing Review (i.e. renewals): Greater than minimal risk and some minimal risk protocols must be reviewed at least annually (prior to the named expiration date), per the Federal regulations. Contact askirb@pitt.edu if you are unsure if your protocol requires continuing review

Multi-Site Research where Pitt is IRB of Record

Multiple participating sites
Pitt IRB will act as IRB of Record for all sites
Contact the Reliance Team at irb.reliance@pitt.edu to discuss the submission

Submission Process Steps:

1. Complete an entry in the Reliance Request System: This is the first step in research involving reliance or a Single IRB (sIRB) mechanism for multi-site research. Learn more about the questions in the Reliance Request System

2. Prepare study documents: ensure your application is complete and through

3. Build and submit the PittPRO application: contact askirb@pitt.edu to schedule a PittPRO training course if you’re unfamiliar

4. Ancillary Reviews: Review Chapter 8 of the IRB P&P for more information

5. IRB Pre-review: first IRB review. An IRB staff member will review the application for common errors and request clarifications/revisions as needed

6. IRB Review:

Full Board: protocol appears before a convened IRB and is reviewed by members who consider the approval status
Administrative Review: protocol is reviewed by a member of the Exempt/Expedited Team who will correspond directly with you to secure approval

7. Final processing: IRB staff is completing final regulatory documentation, and finalizing documents, including the approval letter

8. Ongoing review:

Modifications to an approved study must be submitted to the IRB prior to implementation
Continuing Review (i.e. renewals): Greater than minimal risk and some minimal risk protocols must be reviewed at least annually (prior to the named expiration date), per the Federal regulations. Contact askirb@pitt.edu if you are unsure if your protocol requires continuing review

Multi-Site Research where Pitt cedes IRB Review

Multiple participating sites
Pitt IRB will cedes IRB review authority to another IRB
Contact the Reliance Team at irb.reliance@pitt.edu to discuss the submission

Submission Process Steps