Exempt Review (for research initiated prior to 21-Jan-2019)
Exempt means that all the research activities fall under one or more of the exemption categories defined by the federal regulations. The significance of qualifying as exempt is that the research activity is not subject to continuing IRB oversight. Exemption does not lessen the ethical obligations to subjects as articulated in the Belmont Report and in codes of professional conduct. Depending on the circumstances, investigators performing exempt studies may need to obtain informed consent, protect confidentiality, minimize risk, and address problems and complaints.
Exempt determinations are made by the Research Integrity office through application to the IRB. Please note that once exemptions are granted by the IRB, investigators are required to submit amendments to the IRB before making changes to the research activity. Significant changes can affect the eligibility of the research to continue to qualify as exempt.
When research includes any of the following, it does not qualify for exemption:
- It is FDA-regulated (see Human Subjects Research Determination Worksheet)
- The research involves prisoners and is conducted or funded by DHHS or Dept. of Defense (DoD)
- The research involves prisoners and is inappropriate for the prison population being studied or involves interactions with prisoners.
The following types of research may qualify as exempt:
- Research conducted in established or commonly accepted educational settings, involving normal educational practice. (Both the procedures involve normal educational practices and the objectives of the research involve normal educational practices.)
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
- information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects and
- any disclosure of the human subjects' responses outside the research could reasonably place the human subjects at risk of criminal or civil liability or be damaging to the human subjects' financial standing, employability or reputation. In addition,
- (N/A if the research does not involve children or is not conducted, funded, or otherwise subject to regulation by these agencies.) if the research involves children and is conducted, funded, or subject to regulation by DHHS, Dept. of Defense (DoD), Dept. of Education (ED), or Environmental Protection Agency (EPA), the procedures are limited to:
- the observation of public behavior when the investigator(s) do not participate in the activities being observed and
- the use of educational tests.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior that is not exempt under section 2 above if:
- the human subjects are elected or appointed public officials or candidates for public office, or
- federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
- Research involving the collection or study of existing data, documents, records, pathological specimens or diagnostic specimens, if these sources are publicly available or the information is recorded by the investigator in such a manner that the subjects cannot be identified directly or through identifiers linked to the subjects. (For research conducted, funded, or otherwise subject to regulation by any federal agency, "existing" means "existing at the time the research is proposed." Otherwise, it means "existing at the time the research is proposed or will exist in the future for non-research purposes.")
- Research and demonstration projects which are conducted by or subject to the approval of department or agency heads and which are designed to study, evaluate or otherwise examine:
- public benefit or service programs,
- procedures for obtaining benefits or services under those programs,
- possible changes in or alternatives to those programs or procedures or
- possible changes in methods or levels of payment for benefits or services under those programs.
In addition, all of the following must be true:
- The program under study delivers a public benefit or service
- The research or demonstration project is conducted pursuant to specific federal statutory authority
- There is no statutory requirement that the project be reviewed by an IRB
- The project does not involve significant physical invasions or intrusions upon the privacy of subjects
- The funding agency concurs with the exemption
- Taste and food quality evaluation and consumer acceptance studies, if:
- wholesome foods without additives are consumed or
- a food is consumed that contains a food ingredient at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the Dept. of Agriculture
The following requirements apply to exempt research:
- The research involves no more than Minimal Risk to participants.
- Selection of subjects is equitable.
- If there is recording of identifiable information:
- There are adequate provisions to maintain the confidentiality of the data.
- There are interactions with subjects:
- There will be a consent process.
- The consent process will disclose that the activities involve research.
- The consent process will disclose the procedures to be performed.
- The consent process will disclose that participation is voluntary.
- The consent process will disclose the name and contact information for the investigator.
- There are adequate provisions to maintain the privacy interests of subjects.
Policy: Exempt Determinations