Emily Brown

by Emily Brown

Why Sponsors Should Adopt the Standards of the New Common Rule

Reams have been written about the upcoming new Common Rule and its impact on federally funded studies. Given the seemingly limited impact of the Rule, it could be tempting for industry sponsors to ignore these new provisions. The new Common Rule imposes fairly significant changes on the preparation of informed consent documents, however, and the institutions that receive federally funded studies are focused on bringing their consent form templates into compliance.

We encourage sponsors to consider adopting the new standards of the Rule now, both to facilitate collaborations with institutions and also to prepare for what we believe will eventually be the universal U.S. standard for consent documentation.

For a brief refresher on the revisions to the Common Rule, set to go into effect in January of 2018, download this recent presentation by James Riddle, Vice President of Client Services for Kinetiq, the consulting and technology division of Quorum Review IRB, and Laura Odwazny, Senior Attorney with the Office of the General Counsel, U.S. Department of Health and Human Services (HHS) from the 2017 DIA Annual Conference. (This presentation covers all the basics, so you don’t need to wait for a webinar next month to get the background!)

The new Common Rule revisions are daunting and complex, and industry sponsors may believe it’s more hassle than it’s worth to bring study materials into alignment for the sake of institutional research sites. However, the FDA is showing signs that it will adopt Common Rule-esque changes into its own regulatory lexicon, especially in light of the mandates of the 21st Century Cures Act to improve harmonization with HHS regulations. Getting an early start on compliance with the new Common Rule is a savvy step to put sponsors ahead of the pack. In effect, not only will sponsors demonstrate their willingness to be institutional partners, they will also be ready to take on research after the FDA’s changes while everyone else is scrambling to catch up.

And so, it is worth the hassle.

Sponsors who embrace the changes necessitated by the new Common Rule will:

  • Improve study startup efficiency with institutional sites
  • Embrace regulatory changes that are designed to improve the consent process
  • Ensure business continuity when, ultimately, the FDA harmonizes its regulatory requirements.

 

What Sponsors Can Do Now

Here are three steps sponsors can take now to accommodate the new Common Rule that will pay dividends in 2018 and beyond.

1. Update Your Consent Form Template

Several new standards in the Common Rule relate to informed consent, and they’re aimed at making the consent discussion more meaningful to participants. Sponsors should work to understand the new requirements and update their consent templates accordingly, specifically to support the “reasonable person” standard and the “concise summary” standard. Not only would this mean that research with institutions can start up faster, because the appropriate template is already in place, but it can also serve to guide institutions in what these new standards mean.

While volumes have been written about the nuts and bolts of the Common Rule, interpretations of what exactly the new standards mean are relatively sparse—not even the authors of the final Rule offered much insight into these standards. This means that sponsors, institutions, and research sites have the opportunity to work together to shape the standards into something that represents an improvement for the consent discussion and something that serves to support, rather than complicate, everyday research operations.

2. Train Your Staff

One way to guarantee a smooth transition into the new world of the final Rule is to adequately train the staff who will be working with institutions on the ins and outs of the Rule as it applies to institutions. The more they know, the better equipped they will be to anticipate the needs of the institution. This is also a firm investment in the future transition likely to come when the FDA adopts similar rules.

3. Keep Your Finger on the FDA Pulse

The FDA is very likely to issue changes to comply with the 21st Century Cures Act and bring its own regulations and guidance in line with the Common Rule as part of its effort to harmonize. It’s less a question of “if” and more a question of “when,” and sponsors will be in good shape if they can anticipate changes.

In the short term, it may seem easier for industry sponsors to ignore the Common Rule revisions and force institutions to use different consent form templates for industry sponsored studies as opposed to federally funded studies. In the long term, making these changes now, with the luxury of time to do so, makes good business sense. By proactively aligning with institutions, industry sponsors can streamline the study start-up process and move research forward.

 


James Riddle, VP of Client Services for Kinetiq

Special Feature: Executive Insight

James Riddle, MCSE, CIP, CPIA, VP of Client Services for Kinetiq

Institutions are struggling to make all the changes necessary to implement the new regulations before the January 19, 2018 deadline. Sponsors who are willing to work with institutions during this challenging time will build lasting relationships, better prepare their organization for impending FDA regulations, and ultimately speed their study start-up.

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