The Revised Common Rule: What Happens Now After the Compliance Date?

The revised Common Rule, released by the U.S. Department of Health and Human Services (DHHS), is the first major change to these regulations in more than 25 years. Human research protection professionals are subject to following the revised Common Rule provisions, with a compliance date of January 21, 2019. This report reviews the complexity of getting to these changes; a summary of major changes, and highlights specific changes with examples of implementation approaches. We also provide considerations for working with both sets of regulations (pre-2018 and 2018) and transitioning studies.

The journey of these changes dates back to an Office of Human Research Protections (OHRP) regional conference held at Case Western Reserve University in Cleveland, Ohio on September 16, 2015.  The title of that conference was “Innovations in Research: Collaborations & Transformations”. OHRP representatives announced, for the first time publically, and discussed the proposed changes to the Common Rule at this event.  Following this event, there was a publication of the Notice of Proposed Rulemaking (NPRM), but then in response to concerns raised during the public comment period an extensive subsequent review process resulted in major changes the from the originally-proposed rule.  The extent of complexity to have the Common Rule changed was unpredictable at that time. 

All of the effort and work resulted in the following key changes to the Common Rule:

  1. Requires use of a single Institutional Review Board (IRB) for most Federally funded multi-institution research studies (effective January 2020);
  2. Elimination of grant congruency review by the IRB;
  3. New/revised definitions including “clinical trial,” “human subject,” and “research”;
  4. Requires additional content in the informed consent documents;
  5. New options for the use of “broad consent” documents for research involving identifiable data or identifiable bio-specimens;
  6. New categories of “exempt” human research;
  7. New criteria for limited IRB review required for certain exempt categories;
  8. Elimination of continuing review requirements for certain human research studies; and
  9. Requires posting of consent documents for certain federally funded trials to public websites.
A summary of Key IRB Changes

 

We stated previously that many of these changes are welcome in an attempt to reduce regulatory burden for investigators. For example, having more studies qualify as exempt under the regulations or having fewer studies that require continuing review all point toward reduced management burden by those involved in clinical research[1].

However, getting to these welcome changes and reductions in regulatory burdens was far more complicated than expected.  For example, just trying to figure out the compliance dates brought unanticipated challenges and anxiety with regulatory compliance.  The general compliance date for the 2018 Requirements was January 21, 2019; however, the regulations are still referred to as “pre-2018” and “2018” even though the compliance date is January 21, 2019.  Any study initiated on or after January 21, 2019 is required to comply with the 2018 Requirements.  Any study initiated before January 21, 2019 is required to comply with the pre-2018 Common Rule, unless an institution voluntarily elected to transition such studies to comply with the 2018 Requirements.  That is still complicated enough that it warrants further explanation in Table 1 below.

 

Table 1:  Revised Common Rule Background Terminology and Dates

Terms

Definition

Pre-2018 Rule

Current set of Common Rule regulations that IRBs followed prior to January 21, 2019

2018 Rule; 2018 Requirements; Revised Rule; Revised Common Rule

Updated Common Rule, effective January 21, 2019 (except for collaborative research, effective January 20, 2020)

Interim Final Rule

Formal rulemaking which delayed the 2018 Rule until July 19, 2018

Final Rule

Final Rule to Delay for an Additional 6 Months the General Compliance Date of Revisions to the Common Rule While Allowing the Use of Three Burden-Reducing Provisions; delayed compliance date to January 21, 2019

 

As a default, studies initiated (i.e., initially approved by an IRB, or determined to be exempt) before January 21, 2019 will continue to be subject to the pre-2018 Requirements.  Research initiated (i.e., initially approved by an IRB, or determined to be exempt) on or after January 21, 2019 must be conducted in compliance with the 2018 Requirements.  Any pre-2018 studies that transition to comply with the 2018 Requirements on or after January 21, 2019 must be conducted in compliance with the 2018 Requirements beginning on the transition date (i.e., the date the transition determination is documented, on or after January 21, 2019) for its duration.

Remember too that there were 3 burden reduction provisions allowed between July 19, 2019 through January 20, 2019.  These were optional as follows:

  1. Implementation of the updated 2018 definition of “research”.  This included the description of activities that are deemed not to be research.
  2. Applications of the revised certification requirements that eliminate the IRB review of grant applications/proposals (i.e., no grant contingency review).
  3. Implementation of the 2018 requirements that remove the requirement for the continuing review for certain studies.  Studies that undergo expedited review and for studies that have completed study interventions and are merely analyzing study data or involve only observational follow-up in conjunction with standard clinical care.

A lingering question now is, “what do you do if you chose to apply the burden reducing provisions?” If you implemented these burden-reducing provisions to any studies, those studies must now be compliant with the 2018 Requirements.  For example, those studies that use the provision of not requiring continuing review, for example, if the additional 2018 Requirements were not applied at the time of the initial review, those studies must be re-reviewed to ensure 2018 compliance.  You must be able to keep track of all these dates and what was done in your human subject protections program during these four years of moving toward changing the common rule.  Of course, it has always been important to keep track of approval dates for human subject research studies, but now those dates are being scrutinized more than ever to ensure compliance.  For example, a common question is, “If an IRB approves a study with conditions before January 21, 2019, but verification that the conditions are satisfied occurs after January 21, 2019, is that study subject to the pre-2018 Common Rule?”

The date the IRB approves the research with conditions is the date of IRB approval.  The effective date of the IRB’s approval is the date that it is verified that the investigator has satisfied all conditions related to the approval.  This is also the date on which the research may actually begin.  For the purposes of determining whether a study is subject to the pre-2018 Common Rule or the 2018 Common Rule, the date that the IRB voted to conditionally approve the study is the date that should be used. As an example, assume that a study is approved with conditions on January 15, 2019.  Verification that all conditions have been satisfied occurs on February 1, 2019.  This study would be subject to the pre-2018 Common Rule because the date of conditional approval is before January 21, 2019.

Could this be more complex?  It seems unduly complicated, but in the world of regulations this is the new burden that is created when change does finally occur.  Therefore, what should you ensure you are doing to keep this all straight? 

  1. Decide if you will be transitioning any pre-2018 studies to the 2018 Requirements:
    1. If so, what are the criteria for deciding which studies transition?
    2. Decide how you will document those studies that transition (e.g., in IRB minutes or on checklists).
    3. Create a checklist for those studies that transition to ensure all new criteria are addressed.
    4. How will you identify those studies that are under pre-2018 and those that are under 2018 Requirements?
    5. Ensure that you still have access to pre-2018 review tools for those applicable studies.
  1. If you applied any of the burden-reducing provision, ensure that all of those studies meet all of the 2018 Requirements now.
  1. Incorporate any OHRP frequently asked question information into your updated policies, procedures, review tools, and workflows.
  1. Understand that as regulations change that simplify IRB processes, that the burden may just be shifted elsewhere in the regulatory review process (i.e., the IRB no longer has to review grants for congruence with protocols, but organizationally that is still best practice).  The workload has been shifting in this case from IRBs to Research Compliance Offices.

Transition times are definitely challenging, caught between old and new regulations, but that will pass as regulatory guidance is implemented nationally into updated policies, procedures, review tools, and workflows.  Continue utilizing technology such as IRB electronic systems as a way to ensure fluidity of workflows and continue planning for additional trainings with investigators, study coordinators, IRB staff and IRB reviewers to try to keep this information clear and as simple as possible.

 

[1] Cola, P.A. & Williams, M. (2018, June 14).  Effectively Implementing the Revised Common Rule.  Clinical Translational Science Collaborative Newsletter.  Reprinted by the Center Leading Innovation & Collaboration of the Clinical Translational Science Awards Program, U.S. Department of Health & Human Services.

This material was presented by Philip A. Cola, PhD, director of CTSC Regulatory Knowledge and Madeleine Williams, MA, Senior Director of Huron Consulting Group as part of a presentation for the April 2019 Midwest/Northeast Section meeting of the Society for Research Administrators International (SRAI).