Final Rule 'modernizes' protections for clinical trial participants

By Melissa Fassbender contact

- Last updated on GMT

(Image: iStock/BernardaSv)
(Image: iStock/BernardaSv)
The HHS issued a final rule updating outdated regulations to provide enhanced protection for clinical research participants – and the FDA may follow suit.

Today, the US Department of Health and Human Services (HHS) and 15 other federal agencies published a final rule to update regulations that had been in place since 1991.

The new rule seeks to enhance protections for clinical trial volunteers, while also ensuring that the oversight system is not overly burdensome. 

According to the HHS, most provisions in the new rule will go into effect in 2018.

The Industry responds

Dr. Richard L. Schilsky, MD, FASCO, FACP, Chief Medical Officer of the American Society of Clinical Oncology (ASCO) told us the organization appreciates finalization of updates to the Common Rule, “which will modernize protections for human subjects in biomedical research across all federal agencies​.”

These updates will advance efforts to safeguard human subjects while streamlining reporting requirements for researchers​,” he said.

We’re glad to see that the final rule improves processes for obtaining informed consent, provides clarity on the use of single institutional review boards (IRBs) for multi-site studies, and enables more prompt review of low-risk research​,” Schilsky explained.

John J. Lewis, Senior Vice President, Policy and Public Affairs at the Association of Clinical Research Organizations (ACRO) expressed similar feelings: “We applaud OHRP for requiring a single IRB in most cases and for limiting the application of the rule to cover only clinical trials that are federally-funded, as should be the case​,” he told us.

Lewis said ACRO is “particularly pleased to see the proposed burdensome and impractical consent requirements for research involving biospecimens have been removed​” – as is ASCO.

Preparing for a potential FDA adoption

Unlike the draft regulations published under the Notice of Proposed Rule Making (NPRM), the Final Rule does not expand the reach of the Common Rule regulations to research beyond trials conducted with government funding.

As such, industry-sponsored research remains under Food and Drug Administration (FDA) regulations, which were not changed as a result of the new rule.

However, David Borasky MPH, CIP, WIRB-Copernicus Group Vice President, Quality Management, told us that throughout the rulemaking process the FDA indicated it would move to harmonize with any revised Common Rule. Although this would require the FDA to go through its own rulemaking process.

Borasky added, “It should be noted that the recently passed 21st Century Cures Act requires the FDA to work to harmonize regulations with the US Department of Health and Human Services​.”

If the FDA is able to harmonize on a more aggressive timeline – the HHS rulemaking process began in July 2011 – then the FDA may be able to adopt some of the regulatory flexibility that is in the Common Rule but absent in the FDA regulations​,” he explained.

For example, under current FDA regulations, there is a limited ability to waive informed consent even for research that qualifies for such a waiver under the new Common Rule.

In order to prepare for any impending changes moving forward, Borasky said regulatory activity by the FDA should be monitored to see how quickly the agency will move to adopt the revisions to the Common Rule.

For more information, visit https://www.federalregister.gov/d/2017-01058​.  

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