HHS seeks to delay enforcement of human testing rule

HHS wants to delay implementing several planned changes to federal policy that governs research on people and human biological specimens.

In January 2017, HHS finalized several changes to the so-called "Common Rule," which has been in place in its current form since 1991. Although the changes were supposed to kick in on July 19, HHS is now proposing to move the effective and compliance date to Jan. 21, 2019.

Last year's rule required researchers to work with a single institutional review board across multiple study sites. These panels are made of lay people who decide if clinical trials with humans can go forward.

HHS hoped having a single review board would ensure that studies weren't subject to different or conflicting review board decisions about patient protections.

The rule also altered consent form requirements to ensure potential study participants better understood the risks and benefits of the clinical trial.

"Given the degree of complexity involved with implementing the revised rule, we believe the delay we are proposing in this action is both an appropriate action to take at this juncture, and a reasonable time period to allow the regulated community to be prepared for compliance," the CMS said in the proposed rule posted Thursday.

The CMS specifically cited a request sent last summer by the Association of American Medical Colleges, which argued stakeholders would need more time to implement the rule than the agency proposed.

"The primary reason for requesting the delay was there was no guidance to implement any provisions of the new rule," said Heather Pierce, AAMC's senior director of science policy and regulatory counsel. "That's pretty essential for effective implementation."

Pierce noted that the delay did not reference any forthcoming guidance, but she is hopeful HHS will release more information in the coming months.

American Medical Informatics Association officials called the proposed timeline disappointing, as they feel most researchers are ready to make the switch, and the new date will extend the life of out-of-date policies. Instead, the AMIA proposed an effective date of July 19, 2018, and a compliance date of Jan. 21, 2019.

"This would give those more-prepared researchers and institutional review boards an opportunity to proceed with the 2018 requirements, while giving others additional time to comply," said Jeff Smith, AMIA's vice president of public policy. "Further delay … leaves in place a legacy rule that neither serves research participants, nor the research community."

Comments on the proposed delay are due May 20.