Exempt studies
Exempt: Studies are exempt from full review if they have the following characteristics as described under the Protection of Human Subjects Title 45 Code of Regulation part 46 (45 CFR 46.104).
1. Research, conducted in established or commonly accepted educational settings, that specificallly involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness or or the comparison among instructional techniques, curricular or classroom management methods.
2. Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), or survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least of of the following criteria is met:
(i) The information obtained is recorded by the inverstigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
(ii) Any disclosure of the human subjects' responses outside the research would not reasonably place the subject at risk of crminal or civil liability or be damaging to the subjects' financial standing, employability, education advancement, or reputation; or
(iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifires linked to the subjects, and the IRB conducts a limited IRB review to make a determination required by 46.111(a)(7).
3. (i) Research involving benign behaviroal interventions in conjuction with the collection of information from an adult subject through verbal or written responses (including data entry) or audivisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
(A) The information obtained is recorded by the investigator in such a manner that the identity of the huan subjects cannot be ascertained, directly or through identifiers linked to the subjects;
(B) Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employablity, educational advancement, or repuation; or
(C) The information obtained is recorded by the investigator in such a manner that teh identity of the human subjects can readily be ascertained, directly or through identifiers linked ot the subjects, and the IRB conducts a limited IRB review to make the determination required by 46.111(a)(7).
(ii) For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjets will find interventions offensive or embarrassing. Provded all such criteria are met, examples of such benign behavioral interventions woul dinclude having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a noinal amount of received cash between themselves and someone else.
(iii) If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unles the subject authorizes the deception through a prospective agreement to particiapte in research in circumstances in which the subject is informed that he or she will be unaware or misled regarding the nature or purposes of the research.
4. Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
(i) The identifiable private information or identifiable biospecimens are publicaly available;
(ii) Information, which may include information about biospecimens, is recorded by the investigator in such a manner that teh identitiy of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact teh subjects, and the investigator will not re-identify subjects;
(iii) The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of "health care operations" or "research" as those terms are defined at 45 CFR 164.501 or for "public health activities and purposes" as described under 45 CFR 164.512(b); or
(iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private informatino that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of teh activity will be maintained in systems of records subject to the Privacy Act of 1974, 5U.S.C. 552a, and, the information used in the research was collected subject to the Paperwork Reducation Act of 1995, 44U.S.C 3501 et seq.
5. Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other surbodniate agencies that have been delegated authority to conduct the research and demonstration projcet), and that are designated to study, evaluate, improve or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under these programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or leves of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arangments, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.
(i) Each Federal department or agency conducting or supporting the researchn and demonstration projcets must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstrtion projcts that the Federal department of agency conducts or supports under this provision. The research or demonstraition project must be published on the list prior to commencing the research involving human subjects.
(ii) [Reserved]
6. 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 the 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 the Food Safety and Inspection Service of the U.S. Department of Agriculture.
7. Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by 46.111(a)(8).
8. Secondary research for which broad consent is required: Research involfing the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria is met:
(i) Broad conent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with 46.116(a)(1) through (4), (a)(6), and (d);
(ii) Documentation of informed consent or waiver of documentation of consent was obtained in accordance with 46.117;
(iii) An IRB conducts a limited IRB review and makes the determination required by 46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraphs (d)(8)(i) of this section; and
(iv) The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investgator from abiding by any legal requirement to return individual research results.