Guidance

Federal Exemption Categories

IRBMED
Jul 9, 2018 2:30 pm

Federal regulations governing human subjects protection specify 6 categories of “human subjects research” as “exempt from this policy.” [45 CFR 46.101(b)]. Refer also to OHRP Human Subjects Regulations Decision Charts 2 – 7.

The federal exemption categories will be revised and expanded as part of 2018 Revised Common Rule (full implementation and general compliance date is January 21, 2019). The new regulatory reference will be 45 CFR 46.104. U-M is piloting some of the 2018 Common Rule enhancements as a 'flexibility initiative'; see also the Exempt Human Subjects Research webpage, heading "U-M Exemption Categories."

  • Exemption 1

    Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as

    1. research on regular and special education instructional strategies, or
    2. 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 instruction might take place, including education delivered through online platforms.

    “Normal education practices” are defined as activities that typically occur in a classroom or other educational setting. Examples include test development, experimentation with instructional methods, evaluation of classroom or school activities, and assessment of attitudes about learning or curriculum. May involve the use of technologies such as computer software or handheld devices.

    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 ““Exemptions 1, 2, and 2A in Human Subjects Research”
    • U-MIC presentation ““Exemption Changes under the Revised Common Rule" - Exemption 1 eligibililty is clarified without significant changes to the scope

    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 involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless

    1. Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
    2. 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.

    Notes on Exemption 2

    For minor (child) subjects, Exemption 2 is limited [45 CFR 46.401(b)] 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.

    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).

    Federal Exemption 2 may apply to research involving

    • data with identifiers that cannot place subjects at risk if disclosed, or
    • data collected anonymously

    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.

    Two U-M Flexibility Initiative Exemptions extend the applicability of Exemption 2. Both will become part of the federal regulations at the full implementation and general compliance date (January 21, 2019) for the 2018 Revised Common Rule. Both apply only to adult subjects.

    • Exemption 2 with limited IRB review allows for 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.
    • Exemption 3 covers research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses

    See also

    • U-MIC presentation “Exemptions 1, 2, and 2A in Human Subjects Research”
    • U-MIC presentation “Anonymous, Coded, and De-identified Data...”
    • U-MIC presentation "Exemption Changes under the Revised Common Rule"

    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

    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:

    1. The human subjects are elected or appointed public officials or candidates for public office; or
    2. federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

    Notes on Exemption 3

    pre-2018 Federal Exemption 3 has rarely, if ever, been used at U-M. Do not confuse it with U-M Flexibility Initiative Exemption 3.

    The “public officials/candidates” phrase is interpreted literally: Exemption 3 may apply when the human subjects are high level individuals, who are elected or appointed, not public school teachers, police officers, clerks in a government building, and not staff of the elected or appointed person.

    The “federal statutes” section applies only if the confidentiality protection is without exceptions. Certificate of Confidentiality granted by a federal agency does NOT satisfy this requirement.

  • Exemption 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.

    Notes on Exemption 4

    pre-2018 Federal Exemption 4 applies only to existing data and/or specimens. “Existing” means existing before the research is proposed … to the IRB to determine whether the research is exempt. An application for Exemption 4 must include an explicit “end date” for data/specimens collection before the date of submission of the application.

    Analysis of existing, publicly available, identifiable data (like a phone book) is eligible for Exemption 4. “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.

    pre-2018 Exemption 4 applies to non-public data sources such as medical records only if both of the following are true:

    1. all data already exists at time of IRB application, and
    2. study team may view but will not record any direct or indirect identifiers.

    Data recorded from non-public sources must be de-identified during data collection by the study team, such that no one could “re-identify” based on the research dataset: not the researchers, nor the data provider, nor anyone else. A code permitting re-identification is not permitted. Research utilizing multiple datasets is not eligible for Exemption 4, since at least some identifiers must be maintained temporarily to collate the data.

    NOTE: a dataset de-identified under HIPAA definition, but retaining a code permitting re-identification, is not eligible for pre-2018 Federal Exemption 4. If criteria per OHRP Guidance on … Coded Private Information are met, such research may be eligible for “Not Regulated” determination. If criteria for a Flexibililty Initiative are met, such research may be eligible for "HIPAA Exemption."

    U-M Flexibility Initiative Exemption extends the applicability of Exemption 4 to analysis of

    • data and/or specimens that may also be generated prospectively, and
    • identifiable data regulated under HIPAA ("HIPAA Exemption").

    See also U-MIC presentation "Exemption Changes under the Revised Common Rule."

    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

    • OHRP Guidance on Research Involving Coded Private Information or Biological Specimens
      • Heading “Research not Involving Human Subjects Versus Exempt Human Subjects Research”
      • Heading “Comparison to the HIPAA Privacy Rule”
    • NIH Research Involving Human Subjects FAQ – Human Subjects Research – Human Specimens, Cell Lines, or Data
      • “What are examples of research … that would not be considered human subjects research?”
      • “What are the requirements for Exemption 4?”
      • “Is … Exemption 4 considered human subjects research?”
  • Exemption 5

    Research and demonstration projects which are conducted by or subject to the approval of federal department or agency heads, and which are designed to study, evaluate, or otherwise examine:

    1. Public benefit or service programs; or
    2. procedures for obtaining benefits or services under those programs; or
    3. possible changes in or alternatives to those programs or procedures; or
    4. possible changes in methods or levels of payment for benefits or services under those programs.

    Notes on Exemption 5

    Unlike other categories, this exemption must be granted by the HRPP Director rather than IRB staff. IRB staff will do a 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 to a federal statute which refers to Exemption 5.

    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.

     

    Page created 06/02/2015
    Updated 01/11/2018

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Edited By: larkspur@umich.edu
Last Updated: July 9, 2018 2:30 PM