Revised Common Rule

Revised Common Rule

View slides from our Lunch 'n' Learn here.

 

Transition Guidelines

The Research Compliance department has interpreted the revised Common Rule and updated policies and business processes to accommodate the changes.

Quick Reference Guide

Definitions

In general, the new regulations do not impact studies approved prior to January 21, 2019 (grandfathered in).  However, some minimal risk research will become exempt from further review under the new regulations. The IRB will make these exempt determinations at the study’s next continuing review and will notify study teams accordingly.

Additionally, some minimal risk studies may benefit from being re-reviewed according to the new regulations (> 2018) because continuing review would no longer be required.  However, these studies would also have to comply with all document and procedural changes, which could entail more work for the study team.

The following decision chart summarizes when an existing study will transition to the new regulations (>2018):

Considerations for transitioning an existing study:

  • Timing and study status
  • Estimated end date
  • Conclusion for active data collection
  • Approaching expiration and extent of changes needed to achieve compliance
  • Collaboration
  • Whether there are multiple IRB reviews
  • Impact of transition on other sites
  • Collaborating site requirements and/or policies
  • Funding
  • Whether the funding agency requires different or additional regulatory compliance
  • Complexity of Study: number of studies/sub-studies, populations, consent documents, research tasks
  • History/age of protocol
  • Quality and completeness of submission
  • Researcher responsiveness/willingness to transition
  • Assess current/future protocol activity if possible
  • Whether future phases/design changes are anticipated
  • Previous compliance or other challenges that would or would not make the protocol a good candidate for transition.

If the PI would like to convert any other type of grandfathered study, it is recommended to meet with the IRB staff on a case-by-case basis to see if there are reasons why the study should remain under the old rule (< 2018).

Express Exemptions

Think your project qualifies for an exemption under the Revised Common Rule?  Try our new pilot process.

InstructionsRequest Form

Regulation Change Highlights

Continuing Review:

  • Minimal risk studies that qualify for expedited review after January 21, 2019 will now only require an annual check-in, rather than a full continuing review, unless the IRB determines and documents that continuing review is required. (NOTE: The requirement to submit modifications and RNIs has not changed.)
  • Justifications for keeping a full continuing review might include:
    • Study is regulated by the FDA or a sponsor who require continuing review
    • Study involves additional regulatory oversight
    • Study procedures or risks indicate that greater oversight is necessary
    • Other research specific considerations
  • The annual check-in will simply be a reminder (either via email or the eIRB) to submit modifications or RNIs as needed, follow applicable policies and procedures, and to close the study when human subject activities are complete. No other action will be required from the study team. 
  • For new studies determined to qualify for full review, annual continuing review requirements will still apply unless the study status has progressed to data analysis only or acquisition of long-term follow-up data collected as part of routine care.
  • If an expedited study has a waiver of consent, the IRB will confirm with the study team at continuing review if they still meet the criteria for the waiver.

Exemptions:

  • Research that was once reviewed as expedited may now be considered exempt. A summary of the new exemption criteria can be found in the Guidelines for Exemptions handout.
  • Ongoing expedited studies that are now eligible for exemption under the revised common rule will automatically be converted to the > 2018 rule after 1/21/2019 at continuing review and will no longer require further review.
  • A category called Benign Behavioral Interventions (BBI) has been added specifically for social-behavioral-educational research. Review of these activities is unlikely to require additional protections because the risk of harm is low and subject autonomy is respected. See the Benign Behavioral Interventions handout.

Informed Consent:

  • After 1/21/2019, consent forms will require a concise summary of study activities, risks, and benefits to be presented on the first page of the consent form:
    • A statement that the study is research and participation is voluntary
    • A summary of research including purpose, duration, and a list of procedures 
    • Reasonable, foreseeable risks or discomforts
    • Reasonable, expected benefits
    • Alternative procedures for course of treatment if any
  • Additional elements designed to facilitate a potential subject's decision to participate or not are also required to be included within the body of the consent form. An updated consent template is available in the eIRB library and on the Forms & Templates page to capture the post-2018 (> 2018) requirements.
  • The IRB will not require re-consent of grandfathered studies, except when significant changes are made involving human subjects.
  • New elements of consent have been added to inform participants about potential secondary use of their data and specimens.
  • After 1/21/2019, consent waivers for use of identifiable data and specimens can only be granted if the IRB finds that it would be impracticable to conduct the research with de-identified data. 

Single IRB (sIRB):

Effective January 25, 2018, the National Institutes of Health (NIH) mandated the use of a single IRB as a contingency for funding for multi-center NIH studies. By January 20, 2020, IRB oversight for most federally-funded collaborative research projects will be required to use a single IRB. Expect an IRB request for REDCap survey information and IRB consultation prior to study submission for multi-site research under a single IRB.

sIRB Handout

More sIRB Information

FAQs

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

After January 21, 2019, new protocol submissions to the KPNW IRB will be required to use the updated consent and waiver templates that can be found in eIRB library. These templates contain the required elements (> 2018) to help you meet the requirements. If a study was approved prior to the 1/21/2019 effective date, it will remain under the old rule (< 2018) until its next continuing review. At that point, it is eligible to transition to the new rule (>2018) if there is benefit in doing so. If a study is approved on or after 1/21/2019, it will automatically be governed by the new rule.

The IRB will determine that some studies under the new rule will no longer require continuing review. When prompted for continuing review in the eIRB system, you will either respond if needed for submitting a modification, RNI, or closure under the new regulations (> 2018), or you will submit a full continuing review per the old regulations (< 2018).

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

Existing Full Board Studies

Nothing will change for studies that were reviewed by a full board under the old rule (<2018).

Existing Expedited Studies

Some studies that were originally expedited by the IRB under the old rule (< 2018) will be eligible for less frequent review, beginning on 1/21/2019. In general, the IRB will require an annual check-in rather than a full continuing review to keep the study active, depending on the complexity of the study. A reminder for some kind of annual review will still be prompted in the eIRB system.

Existing Exempt Studies

There will be no changes to studies already determined to be exempt. 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 consent form must be posted to a publicly available federal website (i.e., clinicaltrials.gov) after the trial is closed to recruitment and no later than 60 days after the last study visit for any subject.

What about Broad Consent?

The term “Broad Consent” as defined by the new regulations applies to consent for storage and secondary use of identifiable private information or biospecimens. This concept is implemented on an institutional level and requires tracking of individuals who decline to provide broad consent. Because there is no guidance from OHRP and because of the implications of tracking individuals who do not provide consent, and therefore exclude their data from future research, KPNW generally does not recommend using Broad Consent at this time. Investigators can continue to use biospecimens that are coded or seek waiver of consent for use of biospecimens with identifiers retained following KPNW current practices.  Investigators interested in exploring the possibility of using Broad Consent should contact the RSPO for guidance.

What if my study is FDA regulated?

FDA regulations are separate from Common Rule regulations and have NOT changed. FDA still requires annual continuing review for FDA-regulated studies, including minimal risk FDA-regulated studies.

Where can I find links to the new forms?

Please consult the eIRB library for revised templates and checklists.

Who can I call if I have questions about a submission or renewal?

Please call the RSPO office at (503) 335-3945 or contact the IRB staff member with whom you have been working.