When Is Research Exempt from IRB Review?
DHHS 46.101, 1991
1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, e.g., research on the effectiveness of or the comparison among instructional techniques
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
a) Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
b) Any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation
c) The research is with children and involves survey or interview procedures or observations of public behavior. [Such research with minors is allowed for the observation of public behavior only if the investigator does not participate in the activities being observed.]
3. Research on elected or appointed public officials or candidates for public office
4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if they information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. To qualify for this exemption, the data must be in existence before the project begins. A protocol is not exempt if specimens or data will be drawn after the start date of a project, even if the reasons are unrelated to the research.
5. Procedures for obtaining benefits or services and changes in procedures for public benefit or service programs
6. Taste and food quality evaluation and consumer acceptance studies
Expedited review procedures can be used for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. An expedited review may be carried out by the IRB chairperson or by a member designated by the chair. The reviewer cannot disapprove the research. A research can only be disapproved only after review by the full IRB. All members must be advised of research proposals which have been approved under the procedures.
For Additional Information:
• Guidance Regarding Expedited and Exempt Research
• Decision Chart for Human Subject Research Exempt from IRB Review