Now Available: Revised process for dbGaP/NDAR certifications (August 2013)
The process for requesting dbGaP/NDAR certifications has been revised. Please see the new IRB Policy 45 (PDF) and the dbGaP/NDAR Certification Form (DOC) for more information. Note that the GWAS Supplement that was part of the initial application forms has been retired and replaced with the dbGaP/NDAR Certification Form. For sample consent form language to be used for dbGaP and NDAR studies, please see the revised Language Resource Text (DOC).
IRB Best Practices for Common Problems presentation available
PowerPoint presentation available for the Clinical Research Forum: IRB Best Practices for Common Problems (March 28, 2013). PDF version also available.
Now available: Emergency Use Materials (March 2013)
IRB Policy #29 for Emergency Use of Drugs, Biologics and Devices (PDF) has been revised. Please email the Emergency Use Report Form (DOC) to the designated IRB representative (usually the IRB chair; see the policy) before calling, if possible, so the IRB representative can reference the form during the call.
Now available: Expanded application for exempt and other statuses, not requiring IRB approval
Our previous application for exempt status is now revised to allow a mechanism for research teams to submit to the IRB for an expanded number of determinations that do not require IRB approval (these actions do require IRB review in order to make a determination, but do not require further review or approval from the IRB).
The new application (DOC) includes all of the following determination categories:
- Not Research
- Research, But Not Involving Human Subjects
- Exempt Human Subjects Research
- Non-Engagement in Human Subjects Research
Researchers should submit this new application when making such requests for IRB determination.
Other form updates
The request forms for Modifications (DOC) and Consultations have been updated, as well as the IRB-ITHS Application (short/long).
- At submission, please attach both tracked changes and clean versions of revised documents along with the modification request form.
- Consultations are now recommended for questions or studies involving multiple institutions.
- Study team signatures are no longer required in the updated SFI section of the IRB-ITHS Application form.
If you have any questions about the application process, please contact the Human Subjects Protection Program for assistance.
- Does my research require IRB approval?
- What happens after I submit my IRB application?
- What if there are changes to my study after I receive IRB approval?
- How do I renew or close a study?
- What if my research involves other sites besides Children’s, many with their own IRB?
- View all FAQs