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Common Rule and Other Changes

The revised Common Rule applying to research supported by DHHS and other federal agencies went into effect on January 21, 2019.

This page describes the major and minor changes to the Common Rule and their implementation at UHD.

Exemptions Exemption categories have been updated and expanded the type of research qualifying for exemption. New categories have been added.
Expedited Continuing Review A continuing review for minimal risk research, including research originally reviewed by the convened IRB that now qualifies for expedited categories 8 or 9, is no longer required.
Human Subject Research The definition used by DHHS of what qualifies as human subject research has been updated to include identifiable biospecimens and to specifically exclude types of non-research activities. See the updated definitions of "human subjects" and "research."
Informed Consent Regulations now require that informed consent forms be concise, focused, and present the key information that will help potential subjects understand why they might or might not want to participate in the study. The key information must be presented first and should include the following:
  1. Identification of the project as a research study and that participation is voluntary
  2. Purpose of the research, duration of participation, and a description of research procedures
  3. Foreseeable risks or discomforts, if any
  4. Expected benefits to subjects or others, if any
  5. Alternative procedures or treatments that might benefit the subject (Note: applies primarily to clinical research)
Single IRB of Record Beginning January 20, 2020, most federally-funded multi-site/collaborative research projects occurring in the U.S. will be required to use a single IRB.

Implementation of Regulatory Changes at UHD

  • IRB forms have been updated
  • Informed consent templates are being generated
  • IRB Policies & Procedures manual is being updated

New Studies Approved on or after January 21, 2019

  • Studies approved on or after January 21, 2019 will be approved based on compliance with the New Common Rule

Studies Approved before January 21, 2019

  • Studies approved prior to January 21, 2019 will continue to follow the pre-2018 Common Rule
  • Existing exempt studies will remain exempt unless they require re-categorization
  • Expedited or Full Board Review studies will be considered for reclassification to an exempt category at the time of continuing review