- What Does "Exempt" Mean?
- Exemption Categories
- Procedures for Obtaining an Exemption Determination
Exempt research is a subset of research involving human subjects that falls within a short list of categories determined by federal regulations as "exempt" from federal Policy for Protection of Human Research Subjects. At UM the determination of exempt status is made by the IRB on an individual project basis. Restrictions outlined below apply and the research must fall into one or more of the following exemption categories as described in federal regulations [excerpt from 45 CFR 46.101(b)]:
- Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) 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.
- 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 paragraph (b)(2) of this section, if: (i) The human subjects are elected or appointed public officials or candidates for public office; or (ii) 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 if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
- 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: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
- Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the FDA or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
- Restrictions on Subject Population
An exemption cannot be designated for research involving the following:
- Research involving survey or interview procedures may not be exempt.
- Observation of public behavior is not exempt if the researchers interact with the children.
- In vitro fertilization
- Other Restrictions
- Studies involving FDA-regulated investigational agent (drug, device, biologic, etc.) or off-label use of FDA approved agent are not eligible for exemption.
- Most requests for exemption from IRBMED review fall into Category 4 above, and propose the use of existing data, documents, records, and/or specimens that are recorded without identifiers. This type of study often takes the form of retrospective review of existing medical information (charts, databases, specimen repositories, etc.). While personnel with authorized access to this information may view the names and other identifiers associated with the medical record, they may not transfer the identifiers to the research record, even in coded format. If this type of research project becomes prospective rather than retrospective, or the data contained in the research record is linkable to the identity of the subjects in any way, then the project no longer qualifies for exemption status.
- In addition to the criteria outlined above, further institutional restrictions may apply to certain research projects (involving cadavers or reproductive materials, for example).
Complete the new project application in eResearch.
Contact your IRB if you have questions or concerns. Email: