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Common Rule Changes FAQs

WHAT TO EXPECT:

  1. eProtocol & IRB application changes
  2. Informed consent template revisions
  3. HRPP Operation Manual update
  4. IRB standard operating procedure updates
  5. A conservative approach as to when McLaren will be the sIRB, with IRB consultation recommended prior to application submission

FREQUENTLY ASKED QUESTIONs:

How will the changes to the Common Rule affect NEW submissions to the IRB?

After July 19, 2018, new protocol submissions to the MHC IRB will be required to use updated consent template that can be found on the IRB website. If a study is approved prior to the 7/19/18 effective date of the new rule, it will remain on the old rule until its next Continuing Review. At that point, it will transition to the new rule. If a study is approved on or after 7/19/18, it will automatically be governed by the new rule.

Some studies under the new rule may no longer require continuing review.

How will the changes to the Common Rule affect my studies at McLaren?

  • Existing Full Board Protocols - Protocols that were reviewed by a full board and are open to enrollment or still in an intervention phase will see the fewest changes under the new Common Rule. At the time of the next renewal or significant modification affecting the informed consent form that occurs after 7/19/18, you will be requested to update the consent form to meet the new requirements.
  • Existing Expedited Protocols - Most studies that were originally expedited by the IRB under the old rule will not require a continuing review, but will require a quick study status update on an annual basis. If your study currently has an expiration date, you will still be required to submit a continuing review application in 2018. At time of renewal, the IRB will assess whether additional renewals are required or not. In addition, at the time of the next renewal or significant modification affecting the informed consent form that occurs after 7/19/18, you will be requested to update the consent form to meet the new requirements. If your study does not require annual renewal, MHC IRB will require an Institutional Annual Status Report form every year to keep the study active.
  • Existing Exempt Protocols - There will be no changes to these protocols. As a reminder, if you have an exempt study that has ended, it is important to close the study with the IRB.
  • Additional requirements for federally funded studies - For each clinical trial conducted or supported by a Federal department or agency, one IRB approved informed consent form must be posted to a publicly available Federal website (yet to be specified) after the trial is closed to recruitment and no later than 60 days after the last study visit by any subject. It is recommended that you contact the sponsor of the study to determine how best meet this requirement.

What about Broad Consent?

The term “Broad Consent” as defined by the new regulations applies to consent for storage and secondary research of identifiable private information or biospecimens. This concept must be implemented on an institutional level and requires tracking of individuals who decline to provide consent. Because there is no guidance from OHRP and because of the implications of tracking individuals who do not provide consent and excluding their data from all future research, McLaren is not adopting broad consent at this time. Investigators can continue to use biospecimens that are coded or to seek waiver of consent for use of biospecimens with identifiers retained consistent with current practices.

What other changes will be made soon?

With any transition comes adjustments. As we work with the revised Common Rule, we anticipate additional changes and adaptations may be necessary. We are awaiting federal guidance on the implementation of these revised regulations. We will keep the research community apprised of any additional information.