Major Changes to the Common Rule
After years of effort, the Office of Human Research Protection (OHRP) has published the Federal Policy for the Protection of Human Subjects; Final Rule known as the Common Rule. On January 21, 2019 the revisions to the Common Rule will be effective. OHRP has developed educational materials and a list of frequently asked questions to assist the research community in understanding, implementing, and complying with the revised Common Rule. These resources are available at:
Collaborative Institutional Training Initiative (CITI Program) has also created resources to help the research community understand the revisions to the Common Rule. These resources are available at: https://about.citiprogram.org/en/final-rule-resources/.
Please note: The resources listed above provide a general overview of the revisions to the Common Rule.
Specific Impact on UMass Amherst Researchers is discussed under the following links and also available as a Resource Document:
- New/Revised Definitions
- Changes to the Continuing Review Procedures
- Changes to the Exempt Categories
- Changes to the Informed Consent
UMass IRB/HRPO will also provide customized guidance on Common Rule changes in specific protocol reviews (via comments in the electronic protocol system).
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