Request for Exemption: Eligibility Criteria

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.

Limitations

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.

Addition

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.

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.

3.

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.