Exempt Criteria 45 CFR 46.104(d)(2)
Human Subjects Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria are met*:
(i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
(ii) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or
(iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a review to make a determination of exemption **
*Clarification: The University of Pittsburgh IRB requires review for exempt determination of all human subjects research meeting any of the 3 criteria above.
**This determination is based on adequate provisions to protect privacy of subjects and to maintain the confidentiality of the data, based on the latest DHHS (Department of Health and Human Services) and local policies. Data Security Review will likely be required.
Additional Requirements & Considerations
- If any subjects are children:
- Only educational tests or passive observation of behavior with no interaction is permitted
- Investigators must provide a rationale for why a particular age range was selected, indicate their expertise in working with children, describe the adequacy of their facilities for pediatric research, and indicate whether they will have sufficient numbers of children to adequately address the research question.
- All study team members must obtain the required clearances before any interaction with children
- Prisoners may be included only if the research involves a broader subject population that only incidentally involves prisoners.
- Interventions cannot be included.
- Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes.
- Focus groups can be considered to be open-ended interviews, and may be approved for adults, provided the basic exempt criteria are met.
- Passive observation means that there is no interaction or intervention between the subjects and the study team.
- Public means that the setting or location is accessible to anyone in the general public without the need for any special permissions or privileges. Individuals being observed have no reasonable expectation of privacy.
Privacy & Confidentiality:
- “Anonymous” means that no one can identify the subject at any time.
- “Recorded Anonymously” means that recorded data are not linked to the identity of the individual subjects in any way. If there are linkage codes, data is not anonymous.
- “Coded” means that identifiers are recorded, but data are labeled with a code without identifiers. Linkage information is kept in a separate, secure location.
- Data should typically be recorded anonymously or at least coded.
- When identifiers are recorded, and information is of a sensitive nature, exempt review may not be appropriate.
- “Sensitive” information is information that has the potential to damage participants’ reputation, employability, financial standing, educational advancement, place them at risk for criminal or civil liability, etc.
- When data collection is not limited to passive observation of public behavior, subjects (and/or their parents, if subjects are minors) should be provided with an introductory script that contains basic elements of informed consent, but no formal written consent is required. See Introductory Script Sample.
- If subjects are followed over time and assessed repeatedly, exempt review may not be appropriate.
- Copies of all measures must be attached for IRB review.
- When studies are conducted in foreign countries, refer to guidance on International Research.