Effective January 19, 2018, now delayed until July 2018 the current federally defined exemption categories for human subjects research, and the MCHS exemption review 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
    • Self-determination
    • Limited IRB review

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

What is exempt human subjects research?

"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 human subjects falls into one of more specific exemption categories as defined by the Common Rule.

  • Exempt projects are not subject to continuing review
  • If changes to the project could alter the exempt determination a new IRB Exemption request should be submitted to the IRB
  • An exempt determination does not lesson the investigator's ethical obligations, including the completion of COI training/reporting
  • Exempt projects do not apply to research involving prisoners (45 CFR 46 Subpart C)

Review the (revised) Final Rule on exempt research 45 CFR 46.104

If  you have questions regarding the applicability of an exemption category to your proposed research, contact your MCHS IRB for assistance prior to completing the IRB Exemption request form.

Exemption Category Changes - Overview

The following lists the high-level changes for each exemption category and identifies the potential exemption review path at MCRI based on criteria for that exemption category.

  1. EDUCATION EXEMPTION
    • adds text to clarify that to be exempt, the study is: "not likely to adversely impact student's opportunity to learn required educational content or the assessment of educators who provide instruction.

2. SURVEYS, INTERVIEWS, EDUCATIONAL TESTS, AND OBSERVATION OF PUBLIC BEHAVIOR

  • Scope expanded to include the collection of sensitive and identifiable data however not allowing the following:
    • Interventions
    • Collection of biospecimens
    • Linking to additional personally-identifiable data
    • Research with children (except for educational tests or some public observation)
  • Language updated to be in the affirmative
  • Addition of "Limited IRB Review"

3. BENIGN BEHAVIORAL INTERVENTION (NEW)

  • Permits data collection via an interaction (e.g. survey, interview, audio/visual recording) from adults subjects with prospective agreement.  However doesn't allow the following.
    • Research with children
    • Deception, unless prior agreement obtained
    • Physiological data collection methods (e.g. wearable devices, such as FitBit, blood pressure monditors)
    • Linking to additional personally identifiable data.

4. SECONDARY RESEARCH (IDENTIFIABLE PRIVATE INFORMATION/BIOSPECIMENS)

  • Expand scope to allow:
    • Prospective data review
    • Maintenance of identifiers, if all study data is protected health information (PHI)
    • Research that is conducted by, or on behalf of a Federal Department/agency or using government-generated or governmentcollected information obtained for non-research activities.

5. PUBLIC BENEFIT/SERVICE PROGRAM RESEARCH (FEDERAL DEMONSTRATION PROJECT)

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

6. TASTE/FOOD QUALITY EVALUATION & CONSUMER ACCEPTANCE

  • Unchanged

Categories 7 & 8 pertain to the optional use of "BROAD CONSENT", which MCRI will not be utilzing at this time.