201. Exempt Research and Vulnerable Populations

Updated July 1, 2019

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Research may be exempt from the review of a convened IRB if the only involvement of human subjects will be in one or more of the six categories described in this section, unless prisoners or certain activities with children are involved. According to the Common Rule (45 CFR 46, Subpart A at §46.101), certain categories of research (i.e., "exemptions" or "exempt research") may not require a convened IRB review and approval. The determination of exemption may not be made by the investigator. The University recognizes RI senior staff or experienced IRB members to make exempt determinations after a complete review of the research protocol, the consent process and relevant forms, and after careful consideration of the risks, benefits, confidentiality, voluntariness, and other features of the research activity Approval of research under an exemption is given for an indefinite time period-re-review is not required unless or until the investigator proposes modifications to the project that causes the research to become nonexempt.

These six DHHS categories of research activities that are exempt from the requirements for IRB review. The University's IRB Flexibility Policy (IRB-Flex) expands the types of research activities that may be reviewed as exempt for minimal risk research that is not conducted or supported by a federal agency. (See IRB Review Types policy for details about Flex-Exempt review.)

Exempt categories for FDA-regulated research differ from the DHHS categories. Refer to the FDA policy sections for details.

NOTE: The supplemental forms for research involving pregnant women/fetuses or children are not required for exempt research. The prisoner form is required if the research activities meet the requirements for review under Flex-Exempt Review as specified below.

Exempt Research Involving Pregnant Women and Fetuses ( §46 Subpart B)

  • The six DHHS categories of exempt research may apply to pregnant women and fetuses.
  • Minimal risk research involving pregnant women or fetuses or their records, which is neither conducted nor supported by a federal agency, may meet the criteria for Flex-Exempt Review.

Exempt Research Involving Prisoners ( §46 Subpart C)

  • DHHS exempt categories 1-6 do not apply to research involving prisoners.
  • Non-federally funded, minimal risk prisoner research involving records, samples, or other materials may meet the criteria for Flex-Exempt Review with the following caveats:

o   The IRB may consult with the IRB prisoner representative before making the determination to review as Flex-Exempt.

o   The research must be appropriate for the prison population being studied.

  • Requires researcher form Population: Prisoners.

Exempt Research Involving Children ( §46 Subpart D and Footnote 1 at §46.101)

  • With adequate protections for insuring individual privacy and data confidentiality, research involving children may be exempt under DHHS categories 1, and 3-6.
  • The DHHS exemption at §401(b)(2) (Category 2) for federally-funded research involving survey or interview procedures, or observation of public behavior only applies to research with children when the investigators do NOT participate in the activities being observed.
  • Minimal risk research involving children or their records, which is neither conducted nor supported by a federal agency, may meet the criteria for Flex-Exempt Review.

Exempt Research Involving Adults with Cognitive Impairment

  • With adequate protections for ensuring individual privacy and data confidentiality, research involving adults with cognitive impairment may be exempt under DHHS categories 4 or 5.
  • Non-federally funded, minimal risk research involving clinical or medical records for adults with cognitive impairment may meet the criteria for Flex-Exempt Review.
  • Research involving interactions or interventions with adults with cognitive impairment cannot be reviewed as exempt.

Exempt Research Involving Non-English Speakers

  • Projects involving interactions with non-English speakers may be eligible for exempt review under DHHS categories 1-3, and 5-6.
  • Non-federally funded minimal risk research involving non-English speakers may meet the criteria for Flex-Exempt Review.
  • For projects involving with non-English speakers, researchers must include mechanisms to ensure participants comprehend the study purpose, what participants will experience, participant risks (if any), and research benefits.