At first blush, broad consent sounded like a great idea for research involving banked biospecimens and data collected during clinical care. It was discussed in the Sept. 8, 2015, Notice of Proposed Rulemaking for the revised Common Rule, and the Secretary’s Advisory Committee on Human Research Protections (SACHRP) followed up with its recommendations.1,2,3

With broad consent, patients would have an easy and speedy opportunity to opt out of future research uses of their biospecimens. But if they didn’t opt out — and most people probably would agree to the research use of their specimens — then scientific progress could proceed without the consent roadblock.

This ease of consenting greatly appealed to many investigators. But there are significant logistic problems that research institutions are recognizing and that SACHRP recently discussed at its July 2017 meeting.

“We have spent a lot of time looking at broad consent, and it raises a lot of questions,” says David Borasky, MPH, CIP, vice president for IRB compliance at WIRB-Copernicus Group in Princeton, NJ. Borasky is co-chair of SACHRP’s Subpart A Subcommittee that focuses on issues, including informed consent, related to Subpart A of the Common Rule regulations.

“When people first heard of it, there were a lot of knee-jerk reactions: Some thought it would be a nice, easy fix for how informed consent is obtained for identifiable specimens,” Borasky explains. “As we delve into it, it is a very complicated issue, and it will present significant challenges for research institutions.”

The chief problem is once someone opts out of broad consent for the use of their biospecimen data, a research institution or someone else will have to find a way notify researchers and others to not use that particular biospecimen or data, Borasky says.

“If you say ‘no’ to the broad consent, it requires institutions to track that you said, ‘no,’ so your data is never used and you’re not asked again,” says Elizabeth Kipp Campbell, PhD, CIP, director of the office of human research ethics at the University of North Carolina (UNC) at Chapel Hill.

“You can imagine what a logistical nightmare that is,” Campbell says. “You’re creating a durable confidentiality risk for a person who did not want to be in research, because you have to track this person.”

Implementation is the chief issue. “We have concerns about how difficult that will be to implement,” says John Baumann, PhD, associate vice president for research compliance at Indiana University in Indianapolis.

“Or, it would be fairly easy to implement, but very hard to track,” he adds. “We work with other medical centers that are not under our jurisdiction, and they would have to make the decision, as well, to participate in a broad consent process, and they have not been eager to assume the risk of tracking.”

SACHRP recommends that institutions wishing to use broad consent develop policies that describe the circumstances when someone can be approached for broad consent, Borasky says.

For example, if someone enters a health system for elective surgery, the person can provide or decline broad consent. Then, six months later, if the same person enters the same health system for something entirely different, is it appropriate to ask that person again about broad consent, he explains.

“The question becomes, ‘Under what circumstances is re-contact appropriate? Should there be a time delay?’” Borasky says.

“SACHRP considered what happens if someone is noncommittal toward it and does not give clear informed consent, nor clearly says, ‘No,’” he says. “What do you do with their information or specimens?”

For IRBs and research organizations considering broad consent, SACHRP’s guidance is thoughtful and could be helpful, Borasky says.

“If the Common Rule goes into effect in January, institutions can use the broad consent process,” he adds. “If they want to implement it in January 2018, then they need to lay the groundwork for that now.”

Baumann says his institution will not immediately implement broad consent, but will continue to explore possibilities with their affiliates.

“I think broad consent is one of those things that, at first, seemed like a really great idea,” Baumann says. “But once you delve deeper into its implications, you see that it’s a great idea as long as everyone says, ‘yes.’ But if someone says, ‘no,’ the risk becomes very significant.”

REFERENCES

  1. Department of Health and Human Services Office for Human Research Protections. NPRM for Revisions to the Common Rule: HHS Announces Proposal to Improve Rules Protecting Human Research Subjects. Available online at: http://bit.ly/2iDF7gx.
  2. Department of Health and Human Services Office for Human Research Protections. Attachment A: Recommendations NPRM; Recommendations on the Notice of Proposed Rulemaking entitled, “Federal Policy for the Protection of Human Subjects.” Available online at: http://bit.ly/2wEbjX4.
  3. Secretary’s Advisory Committee on Human Research Protections (SACHRP) Meeting. July 25-26, 2017. Available online at: http://bit.ly/2wlWgyO.