By Melinda Young, Author

The FDA’s recent move to allow a waiver of informed consent for studies involving minimal risk could be a first step toward harmonization with the existing Common Rule.

The guidance, published in July 2017, was issued without request for comment. Its stated purpose is to guide IRBs, sponsors, and investigators about the FDA’s decision to not object when an IRB waives or alters informed consent requirements for certain minimal-risk clinical investigations.1

“We are hoping and begging and praying they’re moving in that direction of harmonizing with the existing and new Common Rule so we have a clean set of regulations and requirements, rather than a divergent set,” says John Baumann, PhD, associate vice president for research compliance at Indiana University in Indianapolis.

The revised Common Rule may or may not go into effect on Jan. 19, 2018. Earlier this year, the Trump administration signaled that it would roll back new regulations. Although the revised Common Rule was issued the day before President Donald Trump’s Jan. 20, 2017, inauguration, it was not rolled back — at least through the summer. Some IRBs and organizations requested to delay implementation, but by the end of August, it was unclear whether a postponement would be issued.

“At this point, it would take overt action to stop it from going into effect on that date,” Baumann says. “We’ve seen no indication of that action taking place, and we’ve seen any number of organizations request a change to the implementation date.”

The FDA’s new guidance is an acknowledgment that it makes no sense to continue to require informed consent for certain FDA-regulated studies, says David Borasky, MPH, CIP, vice president for IRB compliance at WIRB-Copernicus Group in Princeton, NJ.

“Unlike the Common Rule, which included some flexibility, FDA regulations never included the ability to waive informed consent in any circumstances,” Borasky explains.

The FDA finally made the change because of the shift to more flexibility that is anticipated with the revised Common Rule and due to the 21st Century Cures Act, a bipartisan bill signed by President Barack Obama on Dec. 13, 2016. The act gives the FDA authority to permit an exception from informed consent requirements when they’re minimal risk. The Cures Act amended certain sections of the Federal Food, Drug, and Cosmetic (FD&C) Act.1

“The forthcoming changes in the Common Rule and 21st Century Cures Act empowered the FDA to push through this guidance until the regulations could change,” Borasky says.

“The FDA’s waiver is great — allowing some flexibility, and we can apply it across the board,” says Elizabeth Kipp Campbell, PhD, CIP, director of the office of human research ethics at the University of North Carolina (UNC) at Chapel Hill.

“For us, this change is seamless: Our application already asked those questions,” Kipp Campbell says.

The FDA guidance is a positive move that signals the agency is taking the directions from the 21st Century Cures Act seriously, says James Riddle, MCSE, CIP, CPIA, vice president of client services at Kinetiq, a division of Quorum Review IRB in Seattle.

“My personal take is this is the first step the FDA is going to take to harmonize FDA regulations and the Common Rule, which has had a waiver of consent for a long time,” Riddle adds. “The FDA, perhaps, should have considered this change previously, but didn’t because of the FD&C Act’s words, which were updated by the 21st Century Cures Act.”

The new flexibility for minimal risk studies will have a small effect on FDA regulated studies, says Shawn Axe, CIP, director of the human research protection program at Indiana University.

For example, trauma patients at an ED may require a blood draw. There isn’t time to obtain consent, and the patients do not have the capacity to provide consent at the moment of the emergency. Under the FDA’s new guidance, the IRB could possibly waive informed consent, making it simpler to use the patients’ blood draw data for an emergency medicine study, Axe explains.

“Previously, that would not be possible,” Axe says. “We have not submitted a request to the FDA yet on that scenario.”

The Indiana University human research protection program has moved forward on changes that will reflect the new Common Rule. (See story on strategies to prepare for new Common Rule in this issue.)

“We’re implementing a new consent template with the suggested changes to the consent language,” Axe says. “We’ve gotten a head start on that, but we’re planning to roll out everything else in January, including the big changes to exemptions and the new category of IRB review.”

As UNC at Chapel Hill’s IRB has been busy for the past year, preparing for reaccreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), the IRB has not been able to change its standard operating procedures and other forms to reflect and prepare for the revised Common Rule. Once the accreditation visit is complete in the fall, then the IRB can focus on revisions, Kipp Campbell says.

“We have taken a little of wait-and-see,” she says. “When the new Common Rule is implemented, we’ll need to change those.”

If the new Common Rule goes into effect on Jan. 19, the IRB will be ready. But there still is a chance it will be delayed, Kipp Campbell notes.

Another possibility is that federal officials will provide the promised revised Common Rule guidance and templates at the November PRIM&R conference, she adds. “A lot of us are pinning our hopes on that.”

Kipp Campbell anticipates that the most challenging part of implementing changes will involve the electronic systems, particularly in creating new exempt categories.

“Those of us who own homegrown systems, that’s a lot of work, a lot of investment,” she says. “It’s enormously complex and not very nimble.”

By contrast, changing the informed consent template likely will be one of the easier changes to make, she says.

The principle behind the new Common Rule is to put emphasis on what’s the greatest risk and to minimize non-risk activities, Baumann says.

“Notwithstanding some of what we’ve gone through to prepare for the change, we appreciate and agree with this principle,” he says. “As much as this is causing difficulties and stress and switching priorities and wearing many hats and extra hours and costs, we really understand and support the underlying principle behind it.”

REFERENCE

  1. IRB waiver or alteration of informed consent for clinical investigations involving no more than minimal risk to human subjects: Guidance for sponsors, investigators, and institutional review boards. Guidance published by U.S. Department of Health and Human Services, FDA, et al. July 2017:1-8. Available at: http://bit.ly/2wJD68N.