Major Changes to the Common Rule

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:

https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/index.html

https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/revised-common-rule-q-and-a/index.html#transition-provision

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:

  1. New/Revised Definitions
  2. Changes to the Continuing Review Procedures
  3. Changes to the Exempt Categories
  4. 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).

Feel free to contact us with any questions you may have: humansubjects@ora.umass.edu or 413-545-3428.