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UMKC Implementation: Exemption Changes

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"Exempt" human subjects research is a sub-set of research involving human subjects that does not require comprehensive IRB review and approval because the only research activity involving the human subjects falls into one or more specific exemption categories as defined by the Common Rule. Research activities in which the only involvement of human subjects will be in one or more of the exempt categories defined by the Federal regulations, will be given an exempt determination, rather than an IRB approval.

What is exempt human subjects research?

  • Exempt projects are not subject to continuing review
  • Amendments are required only if changes to the project could alter the exempt determination
  • An exempt determination does not lessen the investigator's ethical obligations, including the completion of human subjects protections training 
Review the (revised) Final Rule on exempt research:  45 CFR 46.104

 

UMKC Implementation: Exemption Changes

Effective January 21, 2019, the current federally-defined exemption categories for human subjects research and the UMKC exempt determination process will change, with:

  • Modification to most existing categories
  • Expansion in scope to several existing categories
  • Addition of new categories
  • New exempt determination processes applicable in specific circumstances:
    • Limited IRB Review

These changes reflect the recent trends in research oversight to reduce administrative burden on investigators and IRBs for minimal-risk research.  

If you have questions regarding the applicability of an exemption category to your proposed research, contact the UMKC IRB for assistance prior to completing the IRB application.


Exempt Research with Prisoners

  • Final Rule changes the pre-2018 rule to allow the exemptions to apply to Subpart C for research involving a broader subject population if the research only incidentally includes prisoners.
  • Permits the exempt secondary research of information or biospecimens from subjects who are prisoners, if that research is not seeking to examine prisoners as a subpopulation.
  • Final Rule also allows subjects to continue in exempt research if they become prisoners during a study.


Exempt Research with Children

  • Final Rule allows research with children to be exempt for categories 1, 4, 5, 6, 7, and 8. 
  • Final Rule does not permit the exemption of research with children that includes identifiable information and is reviewed under a limited IRB review.
  • Consistent with pre-2018 rule, observation of the public behavior of children under Category 2 is allowed only if the researcher does not participate in the activities being observed.
  • Consistent with pre-2018, surveying and interview procedures with children may not be exempt.

Overview of Exemption Category Changes

The following lists the high-level changes for each exemption category.

A new ineligibility criterion will be added to this interaction/intervention exemption for research that involves possible "adverse effects" on student learning of the required education content and/or on the assessment of educators.

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.

The scope will be expanded to include the collection of sensitive and identifiable data.  However, the following is not allowed:

  • Interventions
  • The collection of biospecimens
  • Linking to additional personally-identifiable data
  • Research with children (except for educational tests or some public observation)
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 §__.111(a)(7).

A "benign intervention" is defined as one that is brief in duration, harmless, not physically invasive, painless, not embarrassing or offensive, and not likely to have a lasting adverse impact.

This new exemption permits data collection via an interaction (e.g., survey, interview, audio/visual recording) from adult subjects with prospective agreement.  However, the following is not allowed:

  • Research with children
  • Deception, unless prior agreement obtained
  • Physiological data collection methods (e.g., EEG; wearable devices, such as FitBitTM; blood pressure monitors)
  • Linking to additional personally-identifiable data
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 §__.111(a)(7).

The scope of this exemption will be expanded to allow:

  • Prospective data review
  • Research that is conducted by, or on behalf of, a Federal department/agency or using government-generated or government-collected information obtained for non-research activities

A Determination is required; however, if PHI is used then a Privacy Board review (HIPAA) is conducted with the Determination.

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 re-identify 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 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); 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 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.

A new eligibility criterion for this interaction/intervention exemption will be that the project must be published on a federal website.

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.

Unchanged.

This new exemption allows for the storage of data and/or specimens in a repository, with identifiers maintained, that were collected under an approved IRB protocol with "Broad Consent" for future secondary use research. 

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 §__.111(a)(8).

UMKC will not implement Exemption #7 at this time

This new exemption allows forsecondary research use/analysis of identifiable data/biospecimens that were collected under an approved IRB protocol with "Broad Consent".

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 §__.116(a)(1) through (4), (a)(6), and (d);

(ii) Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §__.117;

(iii) An IRB conducts a limited IRB review and makes the determination required by §__.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.

UMKC will not implement Exemption #8 at this time