United States: More Than The Leaves Are Changing: Clinical Trial Research Regulations And Policies Get A Fall Makeover

These changes represent a new season of responsibilities for those who manage and oversee clinical trials.

The Food and Drug Administration (FDA) and National Institutes of Health (NIH) have recently finalized or signaled intent to finalize numerous proposals that promise to change the landscape of clinical trial reporting, clinical researcher responsibility and Institutional Review Board (IRB) oversight. These federal agencies have been busy tidying up existing policies and implementing various requirements to promote better practices in clinical trial research. So what is shaking from the trees? This article provides an overview of the recent proposals and regulations for clinical research.

FDA Draft Guidance for Institutional Review Boards

The Office for Human Research Protections (OHRP) and the FDA have proposed new draft guidance on the written policies and procedures that an IRB should maintain. Although the draft guidance is not binding on IRBs, it provides significant insight into OHRP and FDA expectations for IRB policies and procedures and references specific statutory and regulatory requirements that should be included. The draft guidance is a user-friendly, comprehensive checklist with questions about each policy area, and IRBs are encouraged to take a fresh look at their policies and procedures with this draft guidance in mind.

Clinical Trials Registration and Results Information Submission

Almost two years after its proposed rulemaking, the U.S. Department of Health and Human Services (HHS) issued a final rule for the reporting of clinical trial information on clinicaltrials.gov. Effective January 18, 2017, clinical trial sponsors must register online within 21 days of enrolling the first trial participant. Study sponsors should be aware of this new reporting requirement, as it broadens the breadth of information they must report about the clinical trial.

One of the most critical aspects relates to reporting results about the clinical trial, if collected. Study sponsors will now be required to disclose information regarding outcomes, testing, participant characteristics and adverse events. This information also will be available regardless of whether the study results in a marketed product. The rule applies to an "applicable clinical trial," which typically includes studies on biological devices, drugs and other products subject to FDA oversight.

Revisions to the Common Rule

The clinical research community is anxiously awaiting finalized revisions to the long-standing "Common Rule" governing the protection of human subjects in research and HHS has signaled that a final rule will be released before the end of 2016. HHS and 15 other federal departments and agencies issued a proposed rulemaking on September 8, 2015.  The subject of more than 2,000 comments, the proposed rule is largely in response to recent advances in technology and the evolving use of multiple research sites for clinical trials. Public comments from researchers, institutions and the public generally disagreed with many of the rule's proposals, including a redefinition of "biospecimen" as a "human subject" and a controversial overhaul of the informed consent process. For additional information about these and other proposed changes to the Common Rule, please see the May 31, 2016, May 17, 2016, and September 28, 2015, postings to the Health Law Update blog.

Use of Single IRBs for NIH-Funded Studies

In an effort to streamline administrative processes and create greater reporting efficiency, the NIH recently finalized a new policy that requires a single IRB for purposes of all ethical reviews required by HHS regulations and policies. Applicable to studies involving NIH-funded, non-exempt human subject research conducted across multiple sites, the new policy is effective for all applications submitted on or after May 25, 2017. Under the new requirements, an applicant submitting a request for NIH funding for a multi-site study will be required to submit a plan selecting a site as the IRB of record for all study sites. An applicant may request additional funding to help it comply with the NIH requirements. The IRB of record and the other participating sites must ensure appropriate coordination regarding local regulatory requirements and contextual issues.

Investigator and Research Staff Training on Good Research Practices

In a recent notice, the NIH instituted a new policy that requires all NIH-funded clinical investigators and staff to complete training in Good Clinical Practice effective January 2017. Building on existing training for the protection of human research participants, the NIH is adding specific training on best clinical practices. Investigators and their staff may receive the training through a course, academic training program, or certification from a recognized clinical research professional organization. Participants will be required to complete the training every three years and maintain documentation evidencing such trainings. While the new policy is specific to NIH-funded clinical trials, IRBs may nevertheless consider reviewing their policies and procedures in light of this new training requirement.

Try Not to Fall Back Into Old Habits

These changes represent a new season of responsibilities for those who manage and oversee clinical trials. IRBs, clinical research organizations and investigators have an unprecedented opportunity to get an early start on implementing the new requirements to ensure compliance. So now is the time to rake up those outdated policies and procedures to make way for the new clinical research regulatory landscape.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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