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Revisions to the Common Rule – Federal Policy for the Protection of Human Subjects

Common Rule Resources

  1. U.S. Department of Health and Human Services and 15 other federal departments and agencies announcement and publication of a Final Rule (82 Fed. Reg. 7149) to revise the Federal Policy for the Protection of Human Subjects (the Common Rule).
  2. Office for Human Research Protections (OHRP) information on the revisions to the Common Rule.
  3. Useful resources from Public Responsibility in Medicine and Research (PRIM&R) about the revised common rule.
  4. NIH Announcement on the Extension of Effective Date for Final Policy on the Use of Single Institution Review Board for Multi-Site Research – this policy will apply to all competing grant applications for due dates on or after January 25, 2018.
  5. The Council on Governmental Relations (COGR) submits a joint association letter to OHRP to request a delay in the Common Rule compliance date
  6. CITI Program resources help understand the revisions to the Common Rule

 

ORPC updates

  1. Common Rule Changes announcement to campus – June 2017
  2. How the Common Rule revisions impact ​social,​ ​behavioral​ ​and​ ​education​ ​research​  at UMBC – November 2017
  3. What to expect with the Common Rule revisions – January 2018
  4. Implementation and compliance date delayed to July 19, 2018 – January 2018
  5. Common Rule revisions education sessions – coming soon

The new regulations will not impact studies approved prior to July 19, 2018

For new studies, expect to see:

  •  IRB application changes
  • Informed consent template revisions
  • UMBC IRB webpage page updates
  • UMBC IRB standard operating procedure updates
  • Minor ORPC processing time changes to facilitate workload changes

ORPC forms and updates

Please return to this page often for all updated IRB related forms and documents related to Common Rule changes. Updated forms will have date next to each link as they are uploaded (e.g. 01.10.2018cr)

 

last updated January 17, 2018

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