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Revised Common Rule Implementation - Exemption Changes

As of January 21, 2019 with the implementation of the revised Common Rule, the current federally-defined exemption categories for human subjects research (link is external) 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.

Category Changes – Overview

#1 – EDUCATIONAL EXEMPTION

What’s New: Research that involves possible “adverse effects” on student learning of the required education content and/or on the assessment of educators is not eligible for this category.

#2 – SURVEYS, INTERVIEWS, EDUCATIONAL TESTS, AND OBSERVATION OF PUBLIC BEHAVIOR

What’s New: Expanded scope to include the collection of sensitive and identifiable data. Exclusions apply:

  • Interventions
  • Collection of biospecimens
  • Linking to additional personally-identifiable data
  • Research with children (except for educational tests or some public observation)

#3 – BENIGN BEHAVIORAL INTERVENTION (NEW CATEGORY)

What’s New: Permits data collection via an interaction (survey, interview, audio/visual recording, etc.) from adult subjects with prospective agreement. Exclusions apply:

  • Research with children
  • Deception, unless prior agreement obtained
  • Physiological data collection methods (EGG, wearable devices, such as FitBit, blood pressure monitors, etc.)
  • Linking to additional personally-identifiable data

#4 – SECONDARY RESEARCH (IDENTIFIABLE PRIVATE INFORMATION/BIOSPECIMENS

What’s New: Scope expanded 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 government-collected information obtained for non-research activities

#5 – PUBLIC BENEFIT/SERVICE PROGRAM RESEARCH (FEDERAL DEMONSTRATION PROJECTS)

What’s New: Project must be published on a federal website.

#6 – TASTE/FOOD QUALITY EVALUATION & CONSUMER ACCEPTANCE

What’s New: Unchanged

#7 – STORAGE/MAINTENANCE OF IDENTIFIABLE DATA/BIOSPECIMENS OBTAINED WITH “BROAD CONSENT” (NEW)

This category will not be implemented at UC Merced.

#8 – USE OF IDENTIFIABLE DATA/BIOSPECIMENS OBATINED WITH “BROAD CONSENT” (NEW)

This category will not be implemented at UC Merced

New Process

Limited IRB Review is a type of expedited review process required in the Common Rule. Its purpose is to ensure privacy/confidentiality protections are in place with exempt research that involves the collection or use of sensitive, identifiable data (exemptions 2, 3 and 8) and, for exemption 7, that "broad consent" was obtained and (if appropriate) documented according to an approved protocol. For exempt studies involving access to PHI (e.g., from medical records), the required Privacy Board review may be integrated with Limited IRB Review by the same assigned reviewer. UC Merced will not implement category 7 and 8.

Transition Process

EXISTING STUDIES

  • Existing exempt studies will not transition to the new categories.
  • Existing expedited studies that may fall under a new exempt category will not be transitioned unless agreed upon by the IRB and researchers associated with the study or the study obtains federal funding.

NEW STUDIES

  • New studies that qualify for an exemption submitted after January 21, 2019 will utilize the new exemption categories.