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. Per North Texas Regional IRB policy, a student cannot be the principal investigator.
- CITI certificates for ALL key personnel
- The cover letter (in lieu of informed consent) or informed consent
- Application for a Waiver of Documentation of Informed Consent, or a Waiver of Informed Consent (must meet criteria)
- 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 the IRB 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 North Texas Regional IRB located in Center of BioHealth (CBH) Suite 160, 3500 Camp Bowie Fort Worth, TX 76107. Please contact us at 817-735-0409 if you have any questions regarding research submission.
Pages in Exempt Review
This page was last modified on February 6, 2018