Research activities in which the only involvement of human participants will be in one or more of the following categories:
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Research in Established or Commonly Accepted Educational Settings
Research, conducted in established or commonly accepted educational settings, that specifically 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.
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Educational Tests, Surveys, Interviews, Observations of Public Behavior
Research that includes only interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of 3 criteria are met:
i. The information obtained is recorded by the investigator 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 subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; OR
iii. The information obtained is recorded by the investigator in such a manner that the identity of human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited review to make the determination required by 45 CFR 46.111(a)(7) (which relate to there being adequate provisions for protecting privacy and maintaining confidentiality) AND the research is not subject to subpart D.
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Benign Behavioral Interventions in Conjunction with the Collection of Information from Adult Subjects
Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
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The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects;
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Any disclosure of the 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, employability, educational advancement, or reputation; or
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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 identifiers linked to the subject, and an IRB conducts a limited IRB review to make the determination required by 45 CFR 46.111(a)(7)
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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:
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The identifiable private information or identifiable biospecimens are publicly available; or
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The information is recorded by the investigator in such a way that the identity of the subjects cannot readily be ascertained directly or through identifiers linked to the subjects, and the investigator does not contact subjects, and the investigator will not re-identify subjects; or
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The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under HIPAA (i.e., the use is regulated for purposes of “health care operations” or “research” or for “public health activities and purposes” as those terms are defined at 45 CFR part 164) ; or
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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 information that is or will be maintained on information technology that is subject to and in compliance with certain federal statutes.
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Research and Demonstration Projects Conducted or Supported by a Federal Department or Agency
Applies to 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. Applies to activities that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including, but not limited to: procedures for obtaining benefits or services under those programs; possible changes in or alternatives to those programs or procedures; or possible changes in methods or levels of payment for benefits or services under those programs.
Each federal department/agency conducting or supporting research and demo projects must establish, on a publicly accessible federal website or in another appropriate manner, a list of the research and demo projects the federal department/agency conducts or supports under this provision. The project must be published on this list before beginning the research involving human subjects. Department/agency heads can determine what sort of information will be included on this list and maintain its oversight. HHS will develop a resource that all Common Rule departments and agencies can use to satisfy this requirement.
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Taste and Food Quality Evaluation and Consumer Acceptance Studies
This exemption applies if wholesome foods without additives are consumed, or if 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 FDA or approved by the EPA or the USDA’s Food Safety and Inspection Service.
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Storage or Maintenance for Secondary Research Use for which Broad Consent is Required
Exemption Category 7 applies to storing and maintaining identifiable private information/specimens for secondary research use.
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Secondary Research Use of Identifiable Private Information or Identifiable Biospecimens for which Broad Consent is Required
Exemption Category 8 applies to the secondary research use of identifiable private information/specimens for specific secondary research studies.
Exemption Category 8 applies to secondary research studies that involve use of identifiable private information/specimens, provided the following criteria are met:
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Broad consent for storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with 45 CFR 46.116(a)(1)-(4), (a)(6), and (d);
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Documentation of informed consent or waiver of documentation of consent was obtained in accordance with 45 CFR 46.117;
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An IRB conducts a limited IRB review to make the determination required by 45 CFR 46.111(a)(7), and to make the determination that the research to be conducted is within the scope of the broad consent; and
iv. The investigator does not include returning individual research results to subjects as part of the study plan. However, it is permissible under the exemption to return individual research results when required by law regardless of whether or not such return is described in the study plan.
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