Consent monitoring proposed to improve informed consent

Supporters argue it could decrease IRB burden

Many IRBs spend countless hours of review focusing on the consent documents needed for research studies. Are they too technical? Written at too high a level of readability? Too vague? Not extensive enough in their description of potential risks?

Many The major challenge of getting a consent document right is balancing the twin needs of comprehensibility and comprehensiveness, say Thomas May, PhD, associate professor of bioethics, and Ryan Spellecy, PhD, an assistant professor of bioethics, both at the Medical College of Wisconsin in Milwaukee.

"These two goals really are at odds in many ways," May says. "If it's complete and has too much information, it starts to lack comprehensibility, or certain aspects of the consent form begin to lose their meaning for those who are reading those forms."

May and Spellecy also note that deficiencies in consent document review make up a large number of the violations cited in warning letters to IRBs from the Food and Drug Administration and Office for Human Research Protections.

They have proposed a novel solution for this problem, drawing on the example of hospital ethics boards (HECs) at academic medical centers.

They recommend that IRBs move toward a system of routine monitoring of the informed consent process to be sure that participants understand the research. They argue that that would leave the consent document to be as complete and detailed as it needed to be, while ensuring subjects' understanding of the study itself.

At the same time, they note, the new system could ease the workload of overburdened IRBs.

"I think moving the comprehensibility issue to this system that we're proposing would allow the documents to become even more complete than they currently are," Spellecy says. "Because the primary concern of the document would no longer be this dual goal of completeness and comprehensibility.

Although such a system would increase staffing costs, May and Spellecy believe that cost could be covered by funding from the National Institutes of Health. In fact, they've identified a possible funding source for a pilot consent monitoring project, through newly created NIH Clinical and Translational Science Awards (CTSA).

HECs vs. IRBs: A different focus

Both May and Spellecy have experience serving on both hospital ethics boards and IRBs; Spellecy is currently chairman of an IRB at the Medical College of Wisconsin.

"It was really our discussions about how the approach to informed consent was so different [on HECs] than it was with IRBs that really motivated a solution to this problem we see," May says.

Hospital ethics boards address ethical problems that arise in clinical treatment of patients at their institutions. In that role, they also deal with informed consent issues — for example, ensuring that a patient understands his or her treatment options, or that family members understand the ramifications of withdrawing life support from a patient.

Although these decisions often involve signing informed consent documents, May and Spellecy argue that those documents are not viewed as the ultimate proof of patient comprehension.

They note that hospitals have been successfully sued by patients who say they weren't properly informed, even when they have signed consent documents to that effect.

At many institutions, ethics consultation is offered as an arm of the HEC, and usually is conducted by members of the committee.

They are called in on particularly difficult or unusual cases, May says.

"They usually involve questions about the patient or family's understanding of the proposed procedures or approach to care, as well as matching those proposals to the values of the patient," he says. "That's really what informed consent is all about."

It's that consultation function that May and Spellecy would like to see emulated in a research setting. They suggest that teams of monitors could oversee all informed consent in studies approved by an IRB, and report back to the board as part of their duties.

Spellecy says it's possible that this type of consent monitoring could be used even before a protocol is submitted to an IRB, to help researchers with potentially thorny consent challenges.

"It could work that way, if it was a particularly difficult question," he says. "But we also envision that informed consent teams would go out and observe consent and report back to the IRB, so enabling the IRB to do its job and ensuring that informed consent really is informed, is voluntary and so forth."

Under such a monitoring system, Spellecy says the consent document itself would function much like the package insert for a drug — as a reference material that supplements the actual process of informed consent.

"It could be a useful tool for research participants to refer back to," Spellecy says. "I've got another research visit coming up; am I supposed to fast for this visit? I'm experiencing this side effect, should I be concerned? Should I report it to my study doctor?"

He says he thinks the document could become even more complete than it currently is, because IRBs no longer would have to worry about keeping the length short enough for comprehensibility.

Spellecy says IRBs still would have to receive the reports from the consent monitors to oversee consent, much as they currently receive reports from quality assurance and compliance monitors.

But he believes IRBs would prefer that to the continued burden of wrestling with consent documents. As a researcher, he also thinks investigators would welcome the change.

"One of the things that researchers often complain about is the length and complexity and cumbersomeness of these consent forms — going back and forth with the IRB with modifications," Spellecy says. "That aspect would largely diminish under our proposal. As a researcher, I would appreciate that."

Both men say that while they haven't completely worked out the details, they could see the consent monitoring system being used in social-behavioral research, as well as biomedical studies.

"With much of social-behavioral and public health research, it's going on in the field and might be harder to monitor," Spellecy says. "But there are ways around that. If you're doing focus groups or semi-structured qualitative interviews, you can just record the consent process and someone could review that."

Finding funding

A system such as the one May and Spellecy suggest obviously would require more staffing - they estimate anywhere from one to 20 staffers, depending upon the workload of a particular IRB.

May says that it would be unlikely that already under-funded, overworked IRBs could afford to try it without a new source of funding.

"I would envision that this service would be written into NIH grants and funded in this way," he says.

They have suggested that the proposal could be piloted through the new NIH CTSA initiative.

The CTSA program works through a national consortium of 12 academic health centers, with plans to increase to about 60 institutions by 2012. The institutions will be linked together to improve the discipline of clinical and translational science. Applicants at the centers can request funding for pilot projects, including those that "seek to improve clinical design, biostatistics, clinical research ethics, informatics or regulatory pathways…"

May and Spellecy describe their idea as being in its "infancy," but say that through a pilot program, it could be strengthened into a viable way for IRBs to improve consent in research studies.

"We think we've isolated this problem of the competing goals of comprehensibility and completeness that IRBs and investigators alike struggle with," Spellecy says. "And we've tried to come up with a novel solution, borrowing from hospital ethics committees and even coming up with a possible funding stream."

Reference

May T, et al. Viewpoint: IRBs, Hospital Ethics Committees and the Need for "Translational Informed Consent." Acad Med. 2007;82:670-674. CTSA Web site: www.ctsaweb.org