Guidance

Federal Exemption Categories

IRBMED
Jan 16, 2019 5:00 pm

Federal regulations governing human subjects protection specify categories of “human subjects research” that are “exempt from this policy.” [45 CFR 46.104].

The federal exemption categories are revised and expanded as part of Revised Common Rule (full implementation and general compliance date is January 21, 2019). Since June 2018, U-M piloted some of the 2018 Common Rule enhancements as a 'flexibility initiative.' For exemptions according to "Pre-2018 Requirements," see OHRP website. Refer also to OHRP Human Subjects Regulations Decision Charts 2 – 7.

  • Exemption 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.

    Notes on Exemption 1

    “Established or commonly accepted educational settings” primarily means schools, but can apply to any setting where a specified curriculum is implemented. This includes educational courses delivered through online platforms, but not general informational websites.

    “Normal education practices” are defined as activities that typically occur in a classroom or other educational setting.  May involve the use of technologies such as computer software or handheld devices. When assessing a "normal" educational practice, the IRB will consider whether the proposed research involves an educational "best practice" that should benefit students and support the curriculum already required in that setting. In most cases, randomizing students to different conditions is not an normal educational practice and the research project would likely not qualify for exemption.

    If part of the researchtest/interviews/survey questions must be uploaded. Surveys/interviews are most important because questions may go beyond the assessment of the educational practice, which would likely fall outside of Exemption 1.

    See also

    • U-MIC presentation ““Exemption Changes under the Revised Common Rule" - Exemption 1 eligibililty is clarified without significant changes to the scope
    • Exemption 1 Tip Sheet near the bottom of HRPP Exemption Changes webpage

    Comparison between Exemption 1 and Not Regulated projects

    Exemption 1 can apply to educational research. Activities in the educational setting that do not meet the regulatory definition of “research” [45 CFR 46.102(d)] require no IRB oversight. These may include teaching evaluations.

  • Exemption 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:

    1. 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;
    2. 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
    3. 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).

    Notes on Exemption 2

    This exemption is most commonly used for survey research with adult subjects. Researchers should confirm a survey respondent is an adult before proceeding with the main survey questions (i.e. as an eligibility criterion).

    For minor (child) subjects, Exemption 2(i) and 2(ii) are limited [45 CFR 46.104(b)(3)] to

    • research involving educational tests
    • research involving observation of public behavior when the investigator(s) do not participate in the activities being observed.

    Research involving surveys of children, or observation of public behavior where the investigator participates in the activities being observed, is not eligible for Exemption 2. Research involving children may not invoke Exemption 2(iii) with limited IRB review.

    Data collection methods for this exemption are explicitly limited. Studies that involve any interventions, or that link to other individual-level data, do not qualify for Exemption 2.

    Federal Exemption 2 may apply to research involving

    1. data recorded anonymously (identifiers are never stored with the research data for analysis, not even temporarily), or
    2. data with identifiers that will not place subjects at risk if disclosed (including risk of social or professional opprobrium as well as physical or legal risk), or
    3. research involving storage of identifiable data that could place subjects at risk if disclosed, so long as there is also an IRB-approved data security plan in place (IRB determines via limited IRB review that the privacy of subjects and confidentiality of data are adequately protected).

    Examples of information that might put a subject at risk include disclosure of illegal activities, sexual behaviors, sensitive genetic or medical information, or embarrassing behaviors in the workplace.

    See also

    Comparison between Exemption 2 and Not Regulated projects

    Activities involving surveys, observation, or other Exemption 2 data collection methods but that do not meet the regulatory definition of “research” [45 CFR 46.102(d)] require no IRB oversight. These may include customer service surveys.

  • Exemption 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
    • (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).

    (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 subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal 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 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.

    Notes on Exemption 3

    "Behavioral interventions" means that clinical or medical procedures, such as blood draws, even if low risk, are not included in exemption 3.

    A "benign" intervention may include ordinary, mild, transient forms of discomfort, such as the stress associated with completing a timed cognitive task, anxiety about performance, and boredom. In assessing whether the research might reasonably be offensive or embarrassing to subjects, the researcher should consider the characteristics of the subject population (e.g. are there particular cultural norms that may be active?) and the research context (e.g. how private is the setting?).

    "Brief in duration" is intended to refer to the intervention as opposed to the intervention and the data collection activities together. Thus, the data collection activities could proceed over a longer period of time.

    Data may only be collected using verbal or written responses or audiovisual recording, which excludes data collection by Fitbit, heart rate monitors, or any other devices placed on the subjects' bodies.

    A subject's "prospective agreement" must be meaningful, but it is not the same as a requirement for explicit informed consent.  For example, individuals who are simply made aware that research data will be collected as they voluntarily complete a computer task may be understood as having agreed to participate.

    (These notes are based on the SACHRP Committee 2017 "Recommendations on Benign Behavioral Interventions.")

    Like Exemption 2(iii) above, limited IRB review for Exemption 3(i)(C) must determine that the privacy of subjects and confidentiality of data are adequately protected.

    See also

    2018 Exemption 3 resembles a retired U-M Flexibility Initiative "Exemption 2A."

    Pre-2018 Federal Exemption 3 was rarely, if ever, used at U-M.

  • Exemption 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:

    1. The identifiable private information or identifiable biospecimens are publicly available
    2. 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 re-identify subjects
    3. "HIPAA Exemption" 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)
    4. 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 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 the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.

    Notes on Exemption 4

    This is the most common IRBMED Exemption.

    4(i) “Publicly available” is defined as information shared without conditions on use. Datasets requiring a Data Use Agreement (DUA or DSA) are not “publicly available.” Per federal guidance, publicly available "can apply to secondary research use of archives in a public library, for example, or to government or other institutional records where public access is provided on request, or from a commercial entity if the information is provided to members of the public on request or if the only requirement for obtaining the information is paying a user fee, registering or signing in as a visitor to an archive. It would also apply if a commercial entity made identifiable biospecimens publicly available to anyone on request or for a fee."

    4(ii) Data recorded from non-public sources must be de-identified during data collection by the study team, such that no one could “readily ascertain” subjects' identities based on the research dataset: not the researchers, nor the data provider, nor anyone else. Research utilizing multiple datasets is not generally eligible for Exemption 4, since the researchers maintain identifiers temporarily to collate the data.

    HIPAA Exemption 4(iii) "Use" has a HIPAA-specific technical definition, meaning the sharing/access/analysis/etc. of the Protected Health Information (PHI) is confined 'inside' the covered entity (CE) that maintains the information. Interdisciplinary studies at U-M may include study team members both 'inside' and 'outside' the Michigan Medicine CE: such studies disclose as well as use PHI, and such studies are not eligible for the HIPAA Exemption. Per federal guidance, since "HIPAA also provides protections in the research context for the information that would be subject to this exemption (e.g., clinical records)..." it is not beneficial to apply the full set of IRB regulations as an additional set of protections.

    4(iv) This Exemption is expected to be used rarely, if at all, at U-M.

    See also

    Comparison between Exemption 4 and Not Regulated projects

    Analysis of publicly available datasets without identifiers does not meet the regulatory definition of “involving human subjects,” and as such requires no IRB oversight. “Publicly available” is defined as information shared without conditions on use. Datasets requiring a Data Use Agreement (DUA or DSA) are not “publicly available.” A “publicly available” dataset may still require payment of a fee to gain access.

    Analysis of non-public data/biospecimens where the investigators never obtain identifiable private information about the data/biospecimen human donors often does not meet the regulatory definition of “involving human subjects.” In these cases, no IRB oversight is required, although a Data Use Agreement (DUA or DSA) or Materials Transfer Agreement (MTA) is very likely required. DUAs and MTAs are processed through the Unfunded Agreement (UFA) system in eResearch Proposal Management (eRPM). If data received includes HIPAA identifiers (in the form of a “limited data set”), an eResearch application is required for Privacy Board review.

    See also

  • Exemption 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. 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 research and demonstration projects 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 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.

    Notes on Exemption 5

    Unlike other categories, this exemption must be granted by the HRPP Director rather than IRB staff. IRB staff provide preliminary processing of an application for Exemption 5, then forward the information to U-M Office of Research (UMOR) for additional review. The application should include explicit documentation from the federal sponsor that the activity is “public benefit or service programs” research meeting the Exemption 5 criteria, such as reference in the Notice of Award to Exemption 5 or a reference to Exemption 5 in a federal rule, such as Medicaid Section 1115 Demonstrations.

    This exemption is rarely used at U-M.

    U-M Exemption 5 is a flexibility initiative extending the applicability of Exemption 5 permitting the application of the category to State of Michigan programs.

  • Exemption 6

    Taste and food quality evaluation and consumer acceptance studies,

    1. if wholesome foods without additives are consumed or
    2. 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 FDA or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

    Notes on Exemption 6

    This is the only exemption category also recognized by FDA, per 21 CFR 56.104(d).

    This exemption is rarely used at U-M.

  • Exemptions 7 and 8 - NOT ACTIVE AT U-M

    U-M is not implementing at this time

    • Exemption 7 - "Storage/maintenance of identifiable data/biospecimens obtained with 'broad consent'"
    • Exemption 8 - "Use of identifiable data/biospecimens obtained with 'broad consent'"
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Edited By: larkspur@umich.edu
Last Updated: January 16, 2019 5:00 PM