Institutional Review Board (IRB) - Application & Review Process
All projects involving human subjects conducted by faculty, staff, and students of the University of Denver require IRB review and approval regardless of funding prior to the IRB meeting date.
The application submission process is done electronically though e-Protocol. First time users of the e-Protocol database system must submit a DU Research Compliance Electronic Access Request Form.
Logon to webcentral: http://webcentral.du.edu/cp/home/loginf
Go to the Student /Employee tab
Under my web (banner self service) select Student and Financial Aid forms or Employee forms
Click on DU eprotocol access form, Complete and Submit
After submitting this one-time request form, Principal Investigators will receive a username and temporary password granting them access to the database. (Link: https://eprotocol.keyusa.com/duirb/)
Additionally, you may need to include one or more attachments (A-E) if the project involves protected health information, anonymous or confidential studies and/or international research.
Review Process for "Exempt" Application Review:
Some research studies are exempt from the Code of Federal Regulations. The IRB, not the P.I., must determine that research is exempt from full board review. The review process will also be done electronically through e-Protocol. Please consult the Exempt Categories for minimal risk studies prior to submitting the application. Applications are reviewed as they come in.
Review Process for Desingated Member (Expedited) Review:
Principal Investigators applying for Designated/Expedited Review should consult the Expedited Categories prior to submitting the application. Please note that Expedited does not mean "faster" review; it simply refers to the regulatory categories. Designated members of the IRB will review your application. The review process will also be done electronically through e-Protocol.
Review Process for Full Board Review:
The IRB meeting is generally held the second Tuesday of each month. On the meeting date, members discuss and vote on each application. The following scenarios represent possible outcomes:
- Approved: Application is approved with no revisions.
- Approved contingent/pending revisions: Application is approved once specific revisions are made.
- Deferred: A decision is deferred on the application until applicant provides more specific information, or until major revisions are made.
- Denied: Application is denied without further consideration.
Once the review is complete, applicants are asked to make any revisions immediately. On projects "approved pending revisions," applicants DO NOT have a formal approval. The formal approval is required for any work to begin.
Contact us to discuss:
- Whether your project requires IRB review.
- Whether your project is exempt from Full Board review.
- Any other questions you may have about the IRB application and review process.