Getting Started

Thank you to the University of Utah Institutional Review Board, which has graciously provided this content. 

Are you new to the IRB Application Process?

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

  1. Single Site Study
     
  2. Multi-Site Study (Pitt as IRB of Record)
     
  3. 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 (http://www.hrpo.pitt.edu/content/required-ancillary-reviews)

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

5.IRB Board Review: 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 (http://www.irb.pitt.edu/sites/default/files/Overview%20Reliance%20Reques...)

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 (http://www.hrpo.pitt.edu/content/required-ancillary-reviews)

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 Board Review: 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

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 (http://www.irb.pitt.edu/sites/default/files/Overview%20Reliance%20Reques...)

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 (http://www.hrpo.pitt.edu/content/required-ancillary-reviews)

5. IRB HRPP Review:  the Reliance Team will complete the required local reviews

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

 

Thank you to the University of Utah Institutional Review Board, which has graciously provided this content.