512. New Projects: Submission Requirements for Exempt Review
Updated July 1, 2019
For projects to be eligible for Exempt Review, participant risk must be no greater than minimal and research activities must be in one or more DHHS exempt categories at 45 CFR 46.101 items(b)(1)-(6) or the University's IRB-Flexibility Policy (IRB-Flex). For information about IRB-Flex, see the policy for institutional authority for human research protection. For more information about DHHS or Flex-Exempt review categories, see the online HRPP Policy Manual Review Types).
Projects for Exempt Review may be submitted at any time; meeting dates and deadlines do not apply to exempt reviews.
Mandatory Submission Requirements for Exempt Research
The following requirements apply to each New Project submitted for Exempt Review:
- Confirm the PI and all members of the study team have completed the required training.
- Create a New Project in IRBNet.
- Add Part I, Cover Sheet.
- Add one of the following exempt applications, as relevant to the research (see policy IRB Review Types for exempt research types and corollary exempt applications):
Exempt Core Application Research with Participants
Exempt Core Application Review of Existing Records or Specimens
Exempt, IRB-Flex: Minimal Risk Ethnographic and Naturalistic Field Research
Exempt, IRB-Flex: Minimal Risk, Non-Federally Funded Research
- As applicable, add study-specific materials/documents from the itemized list below.
- Share IRBNet access for all study personnel, giving PI Full Access
- Obtain PI signature electronically through IRBNet
- Submit the project for Exempt Review
Study-Specific Materials/Documents for Exempt Research
Submit the following materials/documents when relevant to an exempt research project:
- Add Protocol Review Subcommittee review: Required only for VA research.
- Add documentation of approval from agency or department head for research involving public benefit or service programs: Required only for Exempt Category 5.
- Add materials for inviting prospective participants (e.g., SONA posting flyers, emails, scripts): Required when participants will be invited to participate.
- Add materials for informing participants about the research (e.g., information sheets/scripts): Required when participants will be told about the research.
- Add study materials (e.g., surveys, assessment materials, data collection logs): Required as applicable to the research.
- Add HIPAA Authorization Template: Required to obtain authorization from participants for research involving disclosure of protected health information (PHI)
- Add HIPAA Waiver of Authorization researcher form: Required when the PI is requesting a waiver of the requirement for written authorization for research involving disclosure of PHI
- Add agency-specific researcher forms: Required for research conducted or supported by the following federal agencies: DOD, DOE, DOJ, or EPA
- Add Education Records/Classroom Survey researcher form: Required for research invoking FERPA or PPRA (e.g., research conducted in schools that receive funding from the DoEd)
- Add documentation of external institutional approval: Required when approval from an external body is necessary for the research to proceed (e.g., school district approval; approval to recruit TMCC students or employees)
NOTE: In some cases, external bodies require IRB approval before approving the research or research components (e.g., recruitment). Contact the RI with questions about obtaining approval from external institutions.
Materials that May Be Requested
At the reviewer's discretion:
- Vulnerable population researcher forms may be requested for research involving pregnant women, fetuses, or neonates; prisoners; children; or adults with impaired consent capacity.
- The Research: International researcher form may be requested for research involving foreign or culturally-different sites or populations.
Additional Requirements for Independent or External Investigators to Use the University IRB
Review IRB policy for independent or external investigators to use a University IRB and complete the following steps:
- Add principal investigator curriculum vitae.
- As applicable, add a completed and signed Declaration of Exemption form, external IRB exempt determination, or External Investigator Request to Use University IRB and relevant applications and project materials.