Final Rule – Changes to the Common Rule

 

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Final Rule – Changes to the Common Rule

Just a reminder that the Final Rule changes to the Common Rule are coming January 21st, 2019. These changes apply to studies that were submitted but have not been approved prior to the January 21st, 2019 deadline. What this means is studies that have been deferred by the Institutional Review Board (IRB) or were conditionally approved need to get their response in and the study approved before January 21st, 2019.

Here is a brief overview of the major changes that will be coming in January 2019. It is important to note that ongoing research studies that were initially approved by an IRB or determined to be exempt before the effective date will not be required to comply with the changes.

  • Exempt research contains many new requirements, primarily due to added regulations when using human-derived biospecimens in research
  • Exempt categories have been expanded. There are more types of research that now qualify for the expanded exempt categories.
  • Elimination of continuing review for expedited studies (unless the reviewer justifies that it would enhance the protection of subjects). Expedite studies would still need a “status report” every 2 years.
  • Addition of “key Information” to the informed consent form (see recent “blast” regarding key information)
  • Greater than minimal risk research initially reviewed by the convened IRB, now does not require continuing review when the research involves either one or both of the following:
    • Data analysis, including analysis of identifiable private information or identifiable biospecimens; or
    • Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical car

​​​​​​​For more detailed information about these changes, please go to the following link: https://research.stonybrook.edu/officenews/2516

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