Article Figures & Data
Tables
Category Exclusion 2018 Common Rule Adoption Exclusion of activities that are deemed not research Program improvement activities Not meaningfully addressed Oral history, journalism, biography, and historical scholarship activities Oral history, journalism, biography, literary criticism, legal research, and historical scholarship deemed not researcha Criminal justice activities Deemed not researcha Quality assurance and quality improvement activities Not meaningfully addressed Public health surveillance Deemed not researcha Intelligence surveillance activities Deemed not researcha Exclusion of activities that are low risk and already subject to independent controls Educational tests, survey procedures, interview procedures, or observation of public behaviors Included in exemption categories 1, 2, and 3 Research involving the collection or study of information that has been or will be collected Partially addressed by exemption category 4 Research conducted by a government agency using government-generated or government-collected data Included in exemption category 5 Certain activities covered by HIPAA Included in exemption category 4 The following activities are excluded because they are considered to be low-risk human subjects research activities that do not meaningfully diminish subject autonomy. The secondary research use of a nonidentified biospecimen that is designed only to generate information about an individual that already is known Not meaningfully addressed aSee 45 CFR §46.102(l)(1)-(4).3
HIPAA, Health Insurance Portability and Accountability Act.
Pre-2018 Requirements12 (prior exemption category at 45 CFR §46.101) Final Rule13 (new exemption category at 45 CFR §46.104) (1) Research conducted in established or commonly accepted educational settings involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. (1) 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. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. - Table 3.
Exemption Category 2 – Surveys, Interviews, Educational Tests, and Public Observations
Pre-2018 Requirements12 (prior exemption category at 45 CFR §46.101) Final Rule13 (new exemption category at 45 CFR §46.104) (2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) 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. (2) Research that only includes 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 the following criteria is 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 the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7). IRB, institutional review board.
Pre-2018 Requirements12 (prior exemption category at 45 CFR §46.101) Final Rule13 (new exemption category at 45 CFR §46.104) (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 paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. (3)(i) 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: (A) 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; (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, employability, educational advancement, or reputation; or (C) 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 subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7). (iii) If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research. IRB, institutional review board.
- Table 5.
Exemption Category 4 – Secondary Research Uses of Identifiable Private Information or Identifiable Biospecimens
Pre-2018 Requirements12 (prior exemption category at 45 CFR §46.101) Final Rule13 (new exemption category at 45 CFR §46.104) (4) Research, involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available 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. (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 publicly available; (ii) information, which may include information about biospecimens, 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, the investigator does not contact the subjects, and the investigator will not reidentify 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 §160 and 45 CFR §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 non-research 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… the E-Government Act of 2002, if all of the identifiable private information…will be maintained in systems of records subject to the Privacy Act of 1974, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995. Note: Some sections of the 2018 regulation in the Final Rule are abbreviated in this table.
Pre-2018 Requirements12 (prior exemption category at 45 CFR §46.101) Final Rule13 (new exemption category at 45 CFR §46.104) (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 (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs. (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 subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including 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. Such projects include, but are not limited to, internal studies by federal employees and studies under contracts or consulting arrangements, cooperative agreements, or grants. (i) Each federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible federal website or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects. Note: Some sections of the 2018 regulation in the Final Rule are abbreviated in this table.
Pre-2018 Requirements12 (prior exemption category at 45 CFR §46.101) Final Rule13 (new exemption category at 45 CFR §46.104) (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 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 US Department of Agriculture. (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 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 US Department of Agriculture. - Table 8.
New Exemption Categories 7 and 8 – Storage or Maintenance of Identifiable Information or Identifiable Biospecimens / Secondary Research Requiring Broad Consent
Final Rule13 (new exemption categories at 45 CFR §46.104) (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 45 CFR §46.111(a)(8). (8) Secondary research for which broad consent is required: research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met: (i) broad consent for the 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) through (4), (a)(6), and (d); and (ii) documentation of informed consent or waiver of documentation of consent was obtained in accordance with 45 CFR §46.117; (iii) an IRB conducts a limited IRB review and makes the determination required by 45 CFR §46.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (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 investigator from abiding by any legal requirements to return individual research results. IRB, institutional review board.
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