Categories of Research for Exempt Status

Individuals who plan to initiate studies involving human subjects in one or more of the six exempt categories described in the federal regulations must submit a Request for Exemption from IRB Review form, along with appropriate documentation, prior to the start of the project. An IRB subcommittee will determine whether or not a given project is EXEMPT, and their actions are reported to the full IRB. A project declared EXEMPT does not need to be reviewed on a continuing basis; however, the IRB may ask to reconsider a protocol if it deems it necessary. When this happens, the investigator will be asked to provide additional information for IRB review, and the full Board will determine whether the initial "EXEMPT" ruling should be reversed. It is also an investigator's responsibility to report to the IRB Secretary any changes in an EXEMPT protocol. The IRB subcommittee will review the changes and rule on the continuing exempt status of such projects. Requests for Exemption are reviewed as they are received, and requestors should allow two weeks for a response; however, those unsure of whether their projects will qualify for an exemption are advised to adhere to the deadline schedule set forth in this memorandum. Then, if an exemption request is denied, the project can be referred to the full IRB in a more timely fashion. The categories of potential exemption are described on the next page.

Categories of Research That May Potentially Qualify for Exempt Status

Effective August 19, 1991, the six exempt categories are listed below. These categories do not apply to research involving prisoners, fetuses, pregnant women, or human in vitro fertilization.

1. Research may be exempt if it is conducted in an established or commonly accepted educational setting and involves normal educational practices such as (a) research on regular and special education instructional strategies or (b) research on the effectiveness of, or the comparison among, instructional techniques, curricula, or classroom management methods.
2. Research involving the use of [a] educational tests (cognitive, diagnostic, aptitude, achievement), [b] survey procedures, [c] interview procedures, or [d] observation of public behavior may be exempt, unless the information obtained is recorded in such a manner that 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 subjects at risk of criminal or civil liability, or be damaging to the subjects' financial standing, employability, or reputation. NOTE: This exemption does not apply to research with children except for research involving observation of public behavior where the investigator(s) do not participate in the activities being observed.
3. Research involving the use of [a] education tests (cognitive, diagnostic, aptitude, achievement), [b] survey procedures, [c] interview procedures, or [d] observation of public behavior that would not exempt under paragraph (2) may be exempt 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.
4. Research involving the collection or study of previously existing data, documents, records, pathological specimens, or diagnostic specimens may be exempt if they are being obtained from publicly available sources 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. NOTE: If the records involved are those of Rutgers students, the project is not exempt and must be reviewed by the IRB. Such research must conform with the Family Education Rights and Privacy Act of 1974, a copy of which may be obtained from the IRB Secretary.
5. Research and demonstration projects may be exempt if they are conducted by or subject to the approval of Federal department or agency heads, and are designed to study, evaluate, or otherwise examine [a] public changes in or alternatives to those programs or procedures or [b] possible changes in methods or levels of payment for benefits or services under those programs.
6. Taste and food quality evaluation and consumer acceptance studies may be exempt if [a] wholesome foods without additives are consumed or [b] 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 Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

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