Guidance

Exempt Human Subjects Research

IRBMED
Jan 16, 2019 5:00 pm

This page contains information regarding human subjects research that falls within the federal exemption categories or U-M exemption categories. Exempt human subjects research does require an application and determination in the eResearch system before any research activity or analysis takes place. U-M's exemption processing changed significantly with the eResearch 4.3 update in June 2018.

  • Requesting an Exempt Determination

    eResearch application

    Open a new project application in eResearch Regulatory Management (eResearch or eRRM) system.

    Specific pointers on filling out an Exempt study application:

    After you fill out the study team, project summary, &c on page 01, click “Continue.” On page 01-1, based on your research design, choose either ".. Interaction/Intervention" or "Secondary Research Uses." Fill out all system-required sections, use the “Continue” button and let the eResearch ‘system logic’ lead you through the system-required pages. After filling out all required sections, please “Submit” (listed PI only) the application. Some exemptions (1, 2, 3) may permit "self-determination" as an alternative to "Submit to IRB"; this option is not presented for studies involving PHI access.

    The opportunity to select exemptions 1, 2, 3, 5, and 6, appear on page 01-1 after selecting "Research Involving Subject Interaction/Intervention" if certain conditions are met. If none of the exemption categories seem to apply, you can indicate that on 01-1 and eResearch will route you for comprehensive IRB review and approval. Qualification for Exemption 4 is determined as part of the Secondary research application type.

    Exempt study applications submitted to the IRB are most often processed in less than two weeks. IRB staff will contact you through the eResearch system with any questions or required clarifications. You’ll receive an “Exempt” determination through the eResearch system when all required reviews are complete.

    IRB-HSBS (UM Central Campus IRB) processes some Exempt human research study applications submitted by UMHS or Medical School faculty (requests for Exemption 1, 2, or 3 that do not involve PHI access and do not require limited IRB review process under the 2018 Revised Common Rule). IMPORTANTLYdefault IRB jurisdiction for UMHS faculty is unchanged: if you normally submit to IRBMED (by choosing "IRBMED" in question 1.9 of an HUM application), please continue to do so.

    Questions?

    Contact your IRB with questions or concerns. Email:

  • What is an Exemption?

    “Exempt human subjects research” is a specific sub-set of “research involving human subjects” that does not require ongoing IRB oversight, because the only involvement of human subjects falls into one or more specifically defined “Exempt categories.”

    • Federal regulations governing human subjects protection specify categories of “human subjects research” that are “exempt from this policy.” [45 CFR 46.104(d)] These are described further in the "Federal Exemptions" below.
    • U-M recognizes additional exemptions as a “flexibility initiative”. These are available only for research that is not federally funded, nor subject to other additional regulations. These are described further in the "U-M Flexibility Initiative Exemption Categories" below.

    Exempt human subjects research generally poses “no more than minimal” risk, involves simple, well-understood study designs, and does not involve subjects likely to be vulnerable to coercion or undue influence. Research that involves both exempt and non-exempt activities is not exempt.

    Exempt status does not lessen researchers’ ethical obligations to subjects as articulated in the Belmont Report, in disciplinary codes of professional conduct, and in U-M policies such as Human Research Protection Program (HRPP) Operations Manual (OM) Part 1, section IV and SPG Policy for Research with Human Participants).

    How is Exemption different from Not Regulated determination?

    “Exempt human subjects research” meets the regulatory definitions for “research” [45 CFR 46.102(d)] and for “involving human subjects” [45 CFR 46.102(f)], and also meets criteria for exemption [45 CFR 46.104(d) or a “U-M Exemption Category”]. By U-M policy, exempt research must be submitted for IRB review before the research begins; if an Exemption determination is finalized, no further IRB oversight is necessary so long as the research activity remains within the scope of the exemption category.

    “Activities not regulated as human subjects research” do not meet the regulatory definition of “research,” and/or do not meet the regulatory definition of “involving human subjects.” Not Regulated projects do not require IRB oversight at any point, although an eResearch application is still indicated if Privacy Board review is required.

    See also UM HRPP OM Part 4

    How are Exempt studies regulated?

    U-M Policy on Exempt Research requires application to, review by, and determination of “exempt” eligibility by the IRB before starting the research.  No continuing review or amendments are required as long as the research stays within the boundaries of the exemption category. Changes not requiring Amendment to an Exempt study include, but are not limited to, new study team members, formatting changes to surveys, or change between two web-based survey platforms.

    The IRB also does not review the informed consent process or document (if any).  However, study teams are strongly encouraged to utilize a consent process that provides sufficient information to participants in order to inform their decision regarding participation.

    Exempt studies may also be subject to HIPAA Privacy Rule regulation. These applications may require Privacy Board review along with IRB office review. For instance, a study involving medical record review to identify potential subjects, or medical record review to gather a dataset that would be eligible for Exemption 4, involves access to Protected Health Information (PHI) and probably should request a waiver of HIPAA authorization.

    Some Exemption applications are eligible for "self-determination," meaning that the Principal Investigator is permitted to issue a system-generated exemption determination letter based on responses to key questions within qualifying human subjects exemption categories.  The IRB does not review self-determined projects. "Self-determination" is not available to projects involving access to Protected Health Information (PHI), so will be uncommon for IRBMED studies.

    Restrictions on Exemptions

    U-M policy applies Exemption only to “no more than minimal risk” research.

    Exemptions do not apply to research with prisoners, except for research aimed at involving a broader subject population that only incidentally includes prisoners. [45 CFR 46.104(b)(2)].

    Exemption 2(iii) and Exemption 3 do not apply to research with children.

    Exemptions other than Federal Exemption Category 6 do not apply to FDA-regulated research.

     

  • Federal Exemptions

    Federal Exemption Categories

    Federal exemption categories are revised and expanded as part of Revised Common Rule (full implementation and general compliance date is January 21, 2019). The new regulatory reference is 45 CFR 46.104. For exemptions according to "Pre-2018 Requirements," see OHRP website

    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.

    Click here for details on Exemption 1.

    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).

    Click here for details on Exemption 2. Application of Exemption 2(i) and 2(ii) is limited for research involving children. Exemption 2(iii) may not be applied to research involving children.

    3. 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).

    Click here for details on Exemption 3. This exemption resembles a 'retired' U-M flexibility initiative "Exemption 2A." Exemption 3 may not be applied to research involving children.

    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. 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 [HIPAA]; or
    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,...

    Click here for details on Exemption 4.

    5. Research and demonstration projects that are conducted or supported by a Federal department or agency, ... and that  are designed to study, evaluate, or otherwise examine:

    • Public benefit or service programs; or
    • procedures for obtaining benefits or services under those programs; or
    • 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. ...

    Click here for details on Exemption 5.

    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.

    Click here for details on Exemption 6.

    U-M does not implement federal exemptions 7 and 8.

  • U-M Flexibility Initiative Exemption Categories

    "Flexibility Initiatives" (sometimes also known as "demonstration projects") permit U-M to depart from process standards incorporated in federal regulations (and associated guidance by federal regulatory agencies) for those categories of research to which those regulations need not apply. Federal regulations do not apply to research that is not federally-supported, does not fall under FDA jurisdiction, and is not held to federal regulation by contract. While continuing to apply the highest ethical standards for the protection of human subjects, flexibility initiatives decrease the administrative burden on investigators and IRB staff. In 2018 U-M piloted some of the 2018 Common Rule enhancements as a 'flexibility initiative.'

     

    Restrictions on “U-M Exemption Categories”

    Studies are not eligible for a “U-M Exemption Categories” if they involve any of the following:

    U-M Exemption Categories

    U-M Exemption 5: Research and demonstration projects sponsored by the State of Michigan

    State of Michigan-supported research and demonstration projects conducted by or subject to the approval of state department or agency heads, and that otherwise meet the following requirements:

    • The program under study must deliver a public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutritional services under the Older Americans Act);
    • It must be conducted pursuant to specific statutory authority;
    • There must be no statutory requirements that the project be reviewed by an IRB;
    • The project must not involve significant physical invasions or intrusions upon the privacy of participants.

    This exemption is an extension of Federal Exemption 5.

  • REFERENCES

Questions?

Contact us at irbmed@umich.edu or 734-763-4768 / (Fax 734-763-1234)

2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.

Edited By: larkspur@umich.edu
Last Updated: January 16, 2019 5:00 PM