Request for Exemption: Eligibility Criteria
Federal and University regulations require IRB oversight of all research activities that involve human subjects, but allow for some exemptions (45 CFR 46.101(b) and 21 CFR 56.104) from the full review process. In order for a research study to be deemed exempt, it must also pose no more than minimal risk (45 CFR 46.102(i) and FR 60364-60367) to participants. All human subjects research (even exempt studies) requires investigators to ensure and document that subjects' rights and welfare are fully protected.
It is the policy of the Pacific University IRB that investigators shall not make an exemption determination independently. Therefore, if you believe that your proposal warrants exemption from IRB review, please fill out the Request for Exemption template. Do not begin any recruitment or study procedures until you receive official notification from the IRB that the exemption is granted.
The following exemptions are found in the HHS "Policy for Protection of Human Research Subjects" (45 CFR 46.101(b)), and do not apply to research involving prisoners, fetuses, pregnant women, or human in vitro fertilization (45 CFR Part 46, Subparts B and C).
|1.||Research conducted in established or commonly accepted educational settings, involving 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 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 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.|
This does not apply to observational research involving sensitive aspects of the subjects' behavior or in settings where subjects have a reasonable expectation of privacy.
For studies involving survey or interview procedures or observation of public behavior, this exemption does not apply to research with children (45 CFR Part 46, Subpart D) except for research involving observations of public behavior when the investigators do not participate in the activities being observed.
|3.||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 2 (above), if: (a) the human subjects are elected or appointed public officials or candidates for public office; or (b) 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 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. (Note: Data protected by HIPAA or FERPA statutes requires appropriate documentation of permission for use, in addition to the exemption request form.)|
|5.||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: (a) public benefit or service programs; (b) procedures for obtaining benefits or services under those programs; (c) possible changes in or alternatives to those programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs.|
This category may be applied to service and/or program evaluations of state, city, or county programs provided that: (a) the program being studied delivers public benefits or services; (b) there is specific statutory authority over the program; (c) there is no statutory requirement that the program evaluation plan be reviewed at full committee; and (d) there is no significant intrusion or invasion of the privacy of the participants.
|6.||Taste and food quality evaluation and consumer acceptance studies, 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.|
For research studies that involve drugs or medical devices and that are governed by Food and Drug Administration regulations, only the following categories of research are exempt from full IRB review (21 CFR 56.104).
|1.||Any investigation which commenced before July 27, 1981 and was subject to requirements for IRB review under FDA regulations before that date, provided that the investigation remains subject to review of an IRB which meets the FDA requirements in effect before July 27, 1981.|
|2.||Any investigation commenced before July 27, 1981 and was not otherwise subject to requirements for IRB review under Food and Drug Administration regulations before that date.|
Emergency use of a test article, provided that such emergency use is reported to the IRB within five (5) working days. Any subsequent use of the test article at the institution is subject to IRB review.
|4.||Taste and food quality evaluations and consumer acceptance studies, if wholesome foods without additives are consumed or 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 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.|
If you believe that your proposal warrants exemption from IRB review, then please fill out the Request for Exemption template.