566. Exempt Review and Approval
Updated Oct. 4, 2019
All human subject research in which University or affiliate faculty or staff are engaged must be approved or acknowledged by the University Research Integrity (RI) or IRB. The University allows certain categories of research to be exempted from DHHS requirements for IRB review and approval (i.e., the Common Rule).
Research activities in which the only involvement of human subjects is in one of the DHHS categories exempted at 45 CFR 46.104 or that meet the criteria for Exempt Review under the University’s IRB-Flexibility policy may be submitted for Exempt Review. (For information about the conditions for Exempt Review under DHHS or Flex-Exempt categories, see IRB policy Review Types. Information about FDA exemptions is provided elsewhere.)
The University grants exclusive authority to RI for review and approval of exempt research. This authority allows qualified RI staff and IRB members to review applications for exempt research.
Requirements for Exempt Review
In no case will a research project be reviewed by an individual with a real or perceived conflict of interest relevant to that project.
- Risk to participants is no greater than minimal.
- Participant selection is equitable.
- Recruitment and consent procedures are designed to be free from coercion and undue influence.
- For research involving interaction with participants, participants are told the activity involves research and that participation is voluntary, are provided with a description of the research procedures, and are given the researcher’s name and contact information.
- The research is designed to minimize harms to participants and maximize research benefits.
- Individual privacy is protected.
- Provisions are adequate to maintain the confidentiality of the data.
Reviewers also assess for compliance with applicable federal, state and local laws including HIPAA, FERPA, PPRA, and state-mandated requirements for reporting abuse and communicable diseases.
Reviewers use the Exempt Review Worksheet to assess projects submitted for Exempt Review.
Reviewers may seek clarification from the investigator or request additional information, changes, or researcher forms before making an exempt determination.
The assigned reviewer completes the review in IRBNet by making a Recommendation, adding the review worksheet and notes (if any), and marking the review complete.
Exempt Review Results
Exempt reviews result in one of five outcomes:
- Project does not constitute human subject research.
- Project meets requirements for exempt determination.
- Information is needed before exempt determination may be granted.
- Project requires Expedited Review.
- Project requires Full Committee Review.
Exempt determinations are for the life of the project.
Documentation of Exempt Review and Approval
For projects that meet the requirements for exempt determination, the reviewer or RI staff will complete the project in IRBNet by
- Selecting Exempt Review for Review Type
- Selecting Exempt for Project Status
- Selecting Exempt for Action
- Noting the date the exempt determination was finalized as the Effective Date
- Leaving the Expiration Date field blank
- Ensuring Minimal Risk is selected for Project Risk Level
- Noting the applicable exempt category (i.e., one of six DHHS categories, or Flex-Exempt) as a Project Note.
Notifications of Exempt Research Determinations
RI staff will generate and publish an exempt determination letter in IRB. The PI and contact person (if applicable) will be notified that the letter is available for review. Exempt notification letters specify the exempt category.
For projects that do not meet the requirements for exempt determination, RI staff will notify the investigators either the project was acknowledged and may proceed as “not human subject research” or the project requires Expedited or Full Committee Review.
Information about exempt determinations is available to IRB members and institutional authorities upon request.
Notifying RI of Closure of an Exempt Research Project
Investigators may notify RI of a closed exempt project by submitting a closure request via IRBNet or sending an email requesting closure and noting the reason for the closure to IRBNet@unr.edu.
Other Considerations for Review of Exempt Research
Situations for Reviewer Discretion to Request Additional Researcher Forms
For exempt research involving children or that will take place outside of the US, the designated reviewer may require the PI to submit the Population: Children or Research: International researcher forms, respectively.
Is Online Research Eligible for Exempt Review?
RI will assess minimal risk online research on a case-by-case basis to determine the appropriate level of review, either Exempt or Expedited Review.
- With adequate protections for ensuring individual privacy and data confidentiality, online research may be exempt under DHHS category 2. This exempt research requires the researcher form Exempt: Tests, Surveys, Interviews, or Observation of Public Behavior.
Is Research Involving Audio or Video Recordings, or Photography Eligible for Exempt Review?
RI will assess minimal risk research involving audio or video recordings, or photographs on a case-by-case basis to determine the appropriate level of review, either Exempt or Expedited Review.
- With adequate protections for ensuring individual privacy and data confidentiality, research involving recordings or photography may be exempt under DHHS category 2. This exemption requires the application Exempt: Tests, Surveys, Interviews, or Observation of Public Behavior.
- Non-federally funded, minimal risk research involving recordings or photography may meet the criteria for IRB-Flex Exempt Category 7. This exemption requires the application: Exempt: Minimal Risk, Non-Federally Funded Research.
How Do HIPAA, FERPA or PPRA Regulations Apply to Exempt Research?
- Exempt research involving medical records must comply with HIPAA requirements.
- Exempt research involving educational records must comply with FERPA requirements.
- If minimal risk, nonfederally funded research involving surveys or interviews with children* meets the criteria for exempt review, the research must comply with PPRA requirements.
*Researchers are advised to contact RI before submitting an exempt application for research involving children.