Exempt Human Subjects Research

Expect update in early 2018.

Contents

 

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” and, on page 01-1, choose “Exempt Human Subjects Research.” From there on, use the “Continue” button and let the eResearch ‘system logic’ lead you through the system-required pages. The main sections for an Exempt application are 05-3 and one of the sub-pages under 12 (e.g. 12-1 if you choose “Exemption 1” at page 12). After filling out all required sections, please “Submit” (listed PI only) the application.

Exempt study applications most often are 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). IMPORTANTLY, default 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 6 categories of “human subjects research” as “exempt from this policy.” [45 CFR 46.101(b)] These are described further 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 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 46.101(b) 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 Exempt #4, involves access to Protected Health Information (PHI) and probably should request a waiver of HIPAA authorization.

Restrictions on all Exemptions

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

Exemptions do not apply to any research with prisoners [footnote 1 to 45 CFR 46.101(i)].

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

Federal Exemptions

Federal Exemption Categories

  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.

Click here for details on Exemption 1.

  1. 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.

Click here for details on Exemption 2.

  1. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not eligible for Exemption 2, 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.

Click here for details on Exemption 3.

  1. 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.

Click here for details on Exemption 4.

  1. 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.

Click here for details on Exemption 5.

  1. 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 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.

References

U-M 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. U-M has adopted several “U-M Exemption Categories” as a "flexibility initiative."

Restrictions on “U-M Exemption Categories”

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

  • Study activity posing greater than minimal risk
  • Prisoners as subjects
  • Sponsor or other contractual restrictions
  • Federal funding or federal training grants
  • Receipt of an NIH-issued Certificate of Confidentiality to protect identifiable research data
  • FDA regulated components or clinical interventions (including clinical behavioral interventions)

U-M Exemption Categories

U-M Exemption 2A

 

Minimal risk research with adults that involves a non-invasive intervention followed by data collection via survey, interview (including focus groups), test, observation, and/or recording of physiological measurements, 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.

 

Non-invasive interventions include, but are not limited to:

  • Reading a story or vignette
  • Playing an economic game
  • Using a computer program or website
  • Watching a video
  • Using a robot arm or mechanical object, if it remains outside of the body
  • Being exposed to stimuli such as color, light or sound (within safe limits)

 

Exemption 2A is an extension of Federal Exemption 2.

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.

Exemption 7

Research in which study activity is limited to analysis of a single data set containing identifiable data. For the purpose of this research study, all research subject interactions and interventions have been completed and the data continues to retain subject identifiers or links.

This exemption is an extension of Federal Exemption 4. IRBMED applies this Exemption only as a “transitional Exemption,” i.e. a regulated study may become eligible for Exemption 7 later in the "lifecycle" of the study.

 

References

 

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Updated 1/9/2018
Created 1/4/11