Continuing Review of an Approved and Ongoing Study Posing More Than Minimal Risk

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  • New Projects First Canonical ON or AFTER January 21, 2019
  • Studies that were Outset approved BEFORE January 21, 2019, and are ONGOING
  • Transitioning Studies Get-go Approved Before January 21, 2019, and are ONGOING
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Studies that were First approved BEFORE January 21, 2019, and are ONGOING

Going forward, whether or not your inquiry is FDA regulated will be very important in determining which regulations the IRB will utilise to your research.
This is because the FDA has not yet harmonized their regulations with the 2018 Common Dominion.

Terminology:	Pre-2018 Mutual Rule	Federal Homo Subjects Regulations in upshot prior to January 21, 2019
	2018 Common Rule	Federal Human Subjects Regulations in effect on or after Jan 21, 2019

________________________________________________________

• Studies that are Not FDA regulated will continue to be reviewed and conducted nether the Pre-2018 ("Old") Common Rule (regardless of funding or support.)
  • You lot are non required to transition these studies to the 2018 Mutual Rule
  • You MAY transition your study to the 2018 Mutual Rule if that would be benign–see:Transitioning Studies First Canonical Earlier January 21, 2019 and are ONGOING.
    • If you choose to transition your study to the 2018 Mutual Dominion and information technology is Non under FDA regulations the post-obit changes will apply to your study
      • New consent requirements including adding the Key Data section and other wording changes will be required
      • Standing Review volition not be required if your study was originally approved by expedited review (minimal take a chance research) or if your study was originally reviewed past the total board as a more than-than-minimal take a chance study but it has reached the point of data analysis or clinical follow-up simply.
      • The requirement to post a consent certificate to a federal public website will utilize if your written report meets the definition of a clinical trial
• Studies that are FDA regulated and practise NOT take any federal funding will proceed to exist reviewed and conducted under FDA regulations.
  • The FDA will still require Continuing Review for all studies regardless of risk or status of the written report
  • No changes in how Modifications or REFs are reviewed
  • The FDA does not crave the Fundamental Information section or other wording changes required in the 2018 Common Rule. However these changes do not conflict with any FDA regulations, so you may add the new consent items if you so cull.
  • You will NOT be immune to transition these studies to be reviewed under the 2018 Mutual Rule
• Studies that are BOTH FDA regulated and take federal funding or back up volition continue to exist reviewed and conducted under both sets of regulations.
  • The most restrictive rules utilise where the ii rules conflict.
  • The FDA regulations will still require Continuing Review for all studies regardless of adventure or status of the written report
  • No changes in how Modifications or REFs are reviewed
  • Y'all MAY transition your study to the 2018 Mutual Rule if that would be beneficial – see:Transitioning Studies Outset Approved BEFORE January 21, 2019 and are ONGOING.
    • If you choose to transition your study to the 2018 Common Rule and it is besides nether FDA regulations
      • The new consent requirements of the 2018 Common Rule including adding the Key Information department and other wording changes will be required
      • FDA regulations will require that Continuing Review still exist conducted
      • The new 2018 Common Rule requirement to post a consent document used in a clinical trial will exist required

click diagram to enlarge

Annotation: "Equivalent Protections" in the diagram above indicates the IRB has some flexibility when a study is neither FDA regulated nor Federally funded or supported to utilize flexibility in review if the protections put in place are equivalent to those required in the 2018 Common Dominion and/or the FDA regulations.

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Source: https://hrpo.wustl.edu/research-toolkit/2018-common-rule/studies-that-were-first-approved-before-january-21-2019-and-are-ongoing/

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