What do I submit to the IRB for an Exempt Category Research?
This is the simplest and often the quickest process if the following are submitted and the information given is complete and clear.
- The original SIGNED and dated Exempt review application
Student investigators must have their advisor or a faculty member sign and date the Exempt application as the principal investigator. At UNTHSC, a student cannot be the principal investigator.
- CITI certificates for ALL key personnel
- Any of the data collection tools (e.g. survey, educational tests, etc.)
- Include interview/phone script
- Website address and a page print out for studies involving publicly available data (e.g. National Center for Health Statistics www.cdc.gov/nchs/about/major/nhis/hisdesc.htm)
- Recruitment/advertisement material (flyers, ads, etc.)
- Letter of collaboration or permission and/or approvals from other IRBs
- A waiver of HIPAA authorization for studies involving protected health information (call OReC staff for further guidance regarding HIPAA regulations)
In most cases, review of Exempt category research may take from 1-5 business days. Review time depends on the completeness of the packet and clarity of the information. Submit all documents to the Office of Research Compliance (OReC) located in Center of BioHealth (CBH) Suite 160, 3500 Camp Bowie Fort Worth, TX 76107. Please contact OReC at 817-735-0409 if you have any questions regarding research submission.
Pages in Exempt Review
- Exempt Category Review
- What is Exempt Category Review of Research Studies?
- Who decides whether or not a project has "minimal risk"?
- According to the federal regulations, which research studies fall under Exempt Category Review?
- Do research studies involving Children, Prisoners, Pregnant women and Fetuses qualify for Exempt Category Research?
- You are here: What do I submit to the IRB for an Exempt Category Research?
- How (and When) Will I know that a Protocol has been Approved?