It’s Official: The New Common Rule will become Effective January 21, 2019

The Office(s) of the Vice President for Research will be CLOSED as follows during this holiday season:
Monday and Tuesday, December 24 and 25 - Christmas Holiday
Monday and Tuesday, December 31 - January 01, 2019

It’s Official: The New Common Rule will become Effective January 21, 2019

What does it mean to you as an investigator conducting human research? It means:

  • A new definition of research; specifically a new section that speaks to activities that are specifically not deemed research
  • New exemption criteria, including one involving ‘benign behavioral interventions’
  • Removal of a continuing review requirement for certain research (with the caveat that a progress report will still need to be submitted for administrative reasons)
  • New consent process and consent form template (beginning with a ‘concise and focused presentation of the key information that is most likely to assist a prospective subject or LAR in understanding the reasons why one might or might not want to participate in the research’.  A ‘reasonable person’ standard is required for the consent process.

We will be sending you educational updates to explain these, and other, changes so that you are set to go on 1/21/19. We will also be working to ensure that our SOPs, our applications and other documents are also updated to comply with the new rule.

If you have any questions or comments about any aspect of our HRPP, please feel free to contact Margaret McNurlan, Interim AVP for Research Compliance, 2-9036, Margaret.mcnurlan@stonybrookmedicine.edu

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