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Authored by:
Phil Cola
Associate Professor of Management, Departments of Design and Innovation and Organizational Behavior, Weatherhead School of Management
Case Western Reserve University

Madeleine Williams
Senior Director
Huron Consulting Group

On June 18, 2018, HHS released a final rule confirming the delay of the general compliance date for the revised Common Rule until January 21, 2019. The final rule follows the September 2015 publication of the Notice of Proposed Rulemaking (NPRM). In response to concerns raised during the public comment period for the NRPM, and extensive subsequent review processes, the final rule contains a number of significant changes from the originally-proposed rule. It has been interesting to watch these developments evolve over the past three years, because the Common Rule as promulgated in 1991, at 45 CFR 46, has not changed for more than 27 years. However, the past few years have brought a whirlwind of activity that has yet to be finalized. The original effective and compliance dates for the final rule was to be January 19, 2018, but this was delayed until July 19, 2018. Now, DHHS has issued another NPRM to further delay the general compliance date of the revisions to the Common Rule until January 21, 2019.

Institutional Review Boards (IRBs) in the public and private sectors have been in the process of preparing for these pending changes. Many in the field of human subject protections are excited to have updates to this regulatory framework, but others have been anxious about implementing changes to policy, procedures and resource utilization strategies. Changes to the effective and compliance dates have increased the uncertainty among IRB managers and administrators. This all comes at a time when academic medical centers and other research institutions are also in the process of implementing the NIH’s Single IRB (sIRB) policy , which represents additional uncertainty and challenges for implementation concurrently with the revised Common Rule.

The key changes to the existing Common Rule regulations include the following:

1. Required additional content for informed consent documents
2. Required use of single IRB for most multi-institutional research studies
3. New options for the use of “broad consent” documents for research involving identifiable date or identifiable bio-specimens
4. New categories of “exempt” human research
5. Elimination of continuing review requirements for certain types of human research studies
6. Required posting of consent forms for certain federally-funded trials to a public website
7. Elimination of grant congruency review by the IRB
8. New criteria for limited IRB review required for certain exempt categories

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.

Furthermore, the use of a single IRB for multi-institutional studies has been endorsed by Francis Collins, NIH Director, when he said “too many institutional review boards (IRBs) are reviewing the protocol and consent documents for the same study, often with no added benefit in terms of the protections for research participants.” This change to the Common Rule is congruent with the NIH single IRB policy, which is good to see. It is widely believed the changes listed above will streamline these processes without impacting safety of participants.

Many organizations with IRBs are asking the question of what can we do now to be prepared for the effective/compliance dates of these changes? Right now, the NPRM to further delay the general compliance date until January 21, 2019 is still under review and not final so we must operate as if the effective and compliance date of the revised Common Rule is still July 19, 2018. Since this date is fast approaching, we recommend that institutions still keep preparing for the implementation of the revised Common Rule for July 19, 2018. If you wish to begin implementing changes prior to that date, institutions may implement only those provisions of the revised Common Rule that do not conflict with the Pre-2018 Common rule. But what does this mean? DHHS has given some examples as follows:

1. Permissible – Incorporation of new elements of consent
2. Not Permissible – Elimination of Continuing Review

Institutions can use these examples to determine what other provisions are permissible or not permissible. When incorporating the new elements of consent, consider the following: 1) the new elements of consent do not replace previously existing elements of consent in the Pre-2018 Common Rule, and 2) institutions have always been allowed to incorporate local elements of consent that do not conflict with the Pre-2018 common Rule (e.g., subject injury language, state-specific requirements, or institutional monitoring requirements).

Since the NPRM to further delay the general compliance date until January 21, 2019, moved to final rule, what does this mean? In this most recent NPRM issued on April 20, 2018, HHS not only proposed a 6-month delay, but also will allow for implementation of three burden-reducing provisions during the period between July 18, 2018, and January 21, 2019. These are:

1. Early adoption of the Revised Common Rule definition of “research”
2. Elimination of grant application review
3. Elimination of continuing Review for certain non-exempt human research

In this uncertain environment, caught between old and new regulations, it is critical that organizations prepare for upcoming changes and challenges, especially around regulatory and guidance landscapes, accreditation, business management processes, staffing and technology. Managers and administrators should continue working on updating policies, procedures and review tools as guidance is released. Ensure that standard operating procedures and review tools are maintained in a way that they can easily be adjusted and re-implemented. Utilize technology in a way to ensure that work flows are able to be adjusted fluidly based on the date that the final rule is effective. Additionally, planning for ongoing trainings with IRB staff and reviewers to incorporate revisions are important.