Common Rule and Other Changes

On January 19, 2017, the Department of Health and Human Services and fifteen other federal agencies issued revisions to the regulations governing human subjects research (called the Common Rule). Most of these changes go into effect on January 21, 2019.

There have been other recent regulatory updates. 
Information about these updates and the implementation at Ascension Wisconsin is outlined below.

Revised Common Rule Key Changes

The revised common rule goes into effect on 1/21/19.

Review the sections here for more details.


  • Exempt Research

    The Revised Common Rule broadens the types of research that qualify for exemption. Several exempt categories have been revised, and there are new categories of exemptions. The Exempt Review Guidance shows how the categories have changed. Note that some exemption categories require limited IRB review, which is a new type of review.

     

    Impact of Changes:

    • Research Approved before 1/21/2019: No change after 1/21/2019
    • Research Approved on or After 1/21/2019: Follows new Common Rule categories, and requires notification of closure to the IRB
  • Continuing Review

    The Revised Common Rule removes the requirement for continuing review for research that is not FDA regulated and is minimal risk research OR greater than minimal risk research ("Full board") research that is in long-term follow-up or data analysis only.


    Impact of Changes:

    • Research Approved before 1/21/2019: 
      • When the IRB conducts continuing review for ongoing research, the IRB will determine whether transition to the Revised Common Rule would be allowed and whether it would be potentially advantageous to the research.
      • This will be considered only on non-regulated research (not federally funded,not FDA regulated).
    • Research Approved on or After 1/21/2019: 
      • New minimal risk research will not automatically undergo continuing review by the IRB (unless it is FDA-regulated).
      • The IRB may require continuing review for special circumstances such as studies involving conflict of interest, IRB reliance or prior compliance concerns.

    Even when continuing review is not required, investigators remain responsible for updating the IRB about adverse events and other unanticipated problems, seeking IRB approval for changes to personnel, protocol amendments, recruitment materials, etc., and informing the IRB when the research is complete.

  • Informed Consent

    Consent forms will now require a concise summary of “key information” that is most likely to assist a prospective subject in understanding the reasons why one might or might not want to join the research.

    • This includes study activities, risks and benefits presented to research participants in the first few pages of the consent document.
    • This section must be organized in a way that facilitates understanding.
    • Consent forms of previously approved studies will not need to be updated to meet this requirement, unless federally funded and open to enrollment.
    • The Ascension WI IRB consent template has been updated to include this format.

    Additional elements of informed consent are required to be included in consent forms. The IRB Required Elements of Consent Guidance shows Common Rule revisions.

    • The Ascension WI IRB consent templates have been updated to include this format.

    The 2018 regulations require that certain clinical trial consent forms be posted on a government website. This requirement applies to studies that are conducted or supported by a federal agency and is usually done by the study Sponsor. The posting must occur no more than 60 days after the last study visit by any subject.

     

    The 2018 regulations allow for the use of informed consent. Ascension Wisconsin will not implement the new regulatory "Broad Consent" option as an informed consent process at this time. Exemptions 7 & 8, which rely on Broad Consent, also will not be implemented. This is due to the institutional management requirements outlined by the regulations.

  • Single IRB Review

    IRB oversight for most federally-funded collaborative research projects located in the U.S. will be required to use a single IRB (commercial, academic, or hospital-based) starting January 20, 2020.   See Other Regulatory Changes below for information about the NIH sIRB policy implementation.

  • What to Expect 

    For existing studies:

    The new regulations do not impact studies approved prior to the proposed implementation date of January 21, 2019.

    For existing studies, after the  implementation date the IRB may choose to apply the new rules to minimize burden for investigators. this will be done at the time of continuing review, and will likely only be considered for non-federally funded, un- regulated research.


    For new studies, expect to see:

    • Mentor & IRB application changes
    • Informed consent template revisions (already implemented) 
    • IRB SOP updates
    • Minor IRB jurisdiction changes to facilitate workload changes

     


Other Regulatory Updates


Review the sections here for more details on recent regulatory updates.

  • FDA Waiver of Informed Consent for Minimal Risk Research

    The FDA issued guidiance in accordance with the 21st Century Cures Act to allow for IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects.The FDA regulations will be updated to reflect this change.

    The Guidance allows IRBs to approve a consent procedure that does not include, or that alters or waiver the required elements of informed consent when the IRB finds and documents that:

    1. The clinical investigation involves no more than minimal risk (as defined in 21 CFR 50.3(k)
      or 56.102(i)) to the subjects;
    2.  The waiver or alteration will not adversely affect the rights and welfare of the subjects;
    3. The clinical investigation could not practicably be carried out without the waiver or
      alteration; and
    4. Whenever appropriate, the subjects will be provided with additional pertinent information
      after participation.

    This update is effective only for studies submitted to the IRB after the effective date of the FDA guidance.

  • NIH Single IRB Review Policy

    The National Institutes of Health (NIH) is implementing a variation of the Single IRB-of-Record policy beginning January 25, 2018.  The NIH sIRB policyapplies to:

    • NIH-sponsored multi-site studies, where the same protocol is used at multiple sites

    • Domestic research only