Levels of Review
Determination of Exemption
See also Exempt Criteria
- If the investigator feels the project meet the criteria for exempt determination, he/she should submit an Exempt application to the IRB-HSR office. The application is obtained via Protocol Builder. In order to fulfill requirements for the proper review of research, investigators cannot "self-exempt" from IRB review.
- Studies that meet the DHHS exemption criteria do not necessarily mean that the investigator is exempt from informed consent or HIPAA requirements.
- The exemption granted is only for the protocol as written at the time of the initial review when the decision to exempt was determined.
- Investigators who conduct research exempt from IRB oversight must report any changes that may alter the study in such a way that it no longer exempt from additional review (e.g. now keeping identifiers with the data)
Exempt Reviewers Responsibilities and Process
- Determination of exempt status will be performed by an experienced IRB staff member. If the study requires limited IRB review for exempt category # 2iii or 3(i)c, the review will be completed by an IRB member.
- Research will be determined to be exempt only when the sole involvement of human subjects will be in one or more of the categories listed in 45 CFR 46.104 or 21 CFR 56.104(a-d).
- Research may not be reviewed under an exempt determination if any of the following are included in the research:
- Surveys or interviews given to minors
- Observation of public behavior in minors if the investigator participates in the activities being observed unless there is a federal statute covering the activity
- Any procedures that may cause a subject either physical or psychological discomfort or are perceived as harassment above and beyond what the person would experience in daily life.
- Research involving a rare trait/disorder which if disclosed may cause harm to the subject and or research that poses risk of community or cultural harm.
- Research regulated by the FDA
- Targeted enrollment of prisoners
- Collection of date of birth from student’s information governed by the federal FERPA regulations, such as information from Student Health, the Registrar’s Office, the Office of Assessment and Studies, or the Student Information System (SIS)
- The IRB will document the review and action of the IRB staff member including the category specified in 45 CFR 46.101(b)(1-6) or 21 CFR 56.104(a-d) justifying the classification of exemption.
- The IRB will promptly notify the PI in writing/email of its decision regarding the research.
If it is determined that the research is not exempt or if modifications are required such as submission of a consent document or strengthening of protections in place to minimize risks to participants, the IRB will include in its written notification a statement of the reason for its decision and provide the PI an opportunity to respond in person or in writing. Final exempt determinations will not be granted until the study meets the criteria for an exempt determination. If the IRB staff member determines that an application does not qualify for exemption, the application will be processed either through Expedited Review or by Full Board review. The PI will be notified and instructed to return to Protocol Builder and re-answer the questions and subsequently submit a new application.
Proceed to Protocol Builder. Answer the questions appropriately. When you get to the question- "Does this study meet exempt approval criteria?" Answer the question YES. Protocol Builder will then provide you with the appropriate documents to complete.
If you need to modify the procedures in this project you must submit an email to IRBHSR@virginia.edu describing the changes. This includes any changes to recruitment/ advertising materials. The IRB-HSR will determine if the project continues to meet the criteria for exempt research.
Send an email to IRBHSRadmin@virginia.edu when this study has been closed. Include the IRB-HSR# of this study in the email. An IRB-HSR Closure Form is not required.
For additional information regarding educational resources for research see http://www.virginia.edu/vpr/irb/hsr/education.html