Improving consent form should be top priority

Think outside the box and go beyond regs

(Editor’s note: IRB Advisor asked IRB and human subjects protection experts from across the nation to discuss the state of human subjects protection regulations and how IRBs are interpreting federal requirements. In this issue, we discuss how IRBs and institutions can improve the informed consent process.)

If someone wants to show how IRBs and research programs have become burdened with documentation and requirements that provide no additional quality to the process of protecting subjects, then the informed consent document is Exhibit A, experts suggest.

"Informed consent documents used to be in the range of two or three pages," says Bernard Schwetz, DVM, PhD, director of the Office for Human Research Protections (OHRP).

"Now the documents are up to 10 pages or more," he says. "There are informed consent documents over 100 pages and, as people have commented, the reason you have an additional 90 pages more than what it used to be is for protecting institutions — not subjects."

While it’d be nice to return to the two-page consent forms, it might not be possible under the current regulations, says Robert M. Nelson, MD, PhD, associate professor of anesthesia and pediatrics at the Children’s Hospital of Philadelphia.

"I would challenge [Bernard Schwetz] to take the elements in the federal regulations and put them on two pages," he says.

There is no easy answer to reducing unnecessary burdens, including the lengthy informed consent forms, Schwetz notes.

"That’s one of the reasons I’m trying to bring more people to the table to talk about the function of the enterprise," he says.

Such discussions in the past usually involved IRB members, but now it’s important to bring many different parties to the table, including investigators, lawyers, research executives, and others, Schwetz says.

"I’m trying to bring a broader range of people to the table so that when we’re talking about burdens we don’t just point fingers at the people who are not at the table," he says. "I’ve sought these people out, group by group, and have talked with them about my concern for the future success of the research enterprise."

Slowly, this communication process is building bridges that may lead to better human subjects protection within an environment that is less burdensome with regard to rules and regulations, Schwetz says.

Getting a new box

In some ways, perhaps the entire informed consent process needs a radical change, Nelson proposes.

"I agree that consent forms are too long and impossible to understand, and many studies have documented that," he says. "But the more fundamental question is: What do we hope to achieve by the consent process?"

Thinking outside the box, perhaps a solution would be to create a different sort of measure showing the adequacy of the informed consent process, Nelson suggests.

"Would we be willing to tell investigators, We won’t look at your consent form, but we will check with your participants, and let’s see how much they understand of what’s going on?’" he says. "We could look at the outcomes and not spend as much time on the informed consent document."

This type of outcomes-based monitoring would be similar to what has happened in other fields, including the health care industry, Nelson notes.

"Third-party payers will relieve institutions from regulations if they meet certain guidelines, such as relieving someone of having to obtain prior authorization if they are able to discharge a patient within a certain period of time," he explains. "So are we willing to move toward that system where we relieve people of the upfront paperwork and instead use outcomes measures?"

For example, IRBs could conduct random audits and interviews of research subjects to ascertain how well they understand the research and their own participation in it.

"If the audit is random then you’re replacing an upfront review process with a back-end, random auditing process," Nelson says.

Since IRBs would have to spend less time on the upfront review process, they might have more time for a critical analysis of a protocol’s risks, he adds.

Form and process separate

If IRB members want to monitor a study’s consent process in addition to reviewing the informed consent document, then they may do so under the current regulations, says Steven Peckman, associate director for human subjects research at the Office for Protection of Research Subjects at the University of California-Los Angeles.

Peckman says he agrees with Nelson that IRBs should spend more time looking at the process of the informed consent communication because that is more important than the actual informed consent document.

"There is a place to monitor the consent document to make sure it all works, but the document is not the process," Peckman says. "And we’re going down a dangerous road if we think the document is the process when in my mind the document should serve as a summary or outline of what needs to be discussed with the subject."

True informed consent occurs during the process of an investigator and subject discussing the study, while the informed consent document explains what is discussed in a specific way, Peckman adds.

"The key word is process,’" says Mark Hochhauser, PhD, readability consultant and an IRB member at the IRB at North Memorial Healthcare in Robbinsdale, MN.

"Many IRBs focus way too much time on consent forms as a piece of paper, and there’s not enough time devoted to the consent process of the research staff," he says. "IRBs can’t be the consent process police; they don’t have the money or staff to sit in and observe what’s going on and make suggestions during the process."

Instead, the question is "Why can’t multibillion-dollar drug companies write a consent form that’s understandable?" Hochhauser asks. "It would be nice that instead of having a panel of us folks at the IRBs and those who are interested in language rewrite consent forms to have a representative from the drug company write consent forms that could be understood," Hochhauser adds.

Who will pay?

While it’s a good idea to have IRBs monitor the informed consent process, this is a costly addition to the IRB’s duties, and who would pay for it? asks Felix A. Khin-Maung-Gyi, PharmD, MBA, CIP, chief executive officer of Chesapeake Research Review Inc. of Columbia, MD, and senior policy fellow with the Center for Drugs and Public Policy at the University of Maryland in Baltimore.

"The ability of the IRB to interact with subjects in the informed consent process would be tremendously valuable, but at the present time I don’t know of any IRB that has the resources to do those things," he says.

"Informed consent and decision making are things that require time and effort, and that has to be factored into the cost of doing business," Khin-Maung-Gyi adds.

Both industry-sponsored research and federally funded research fail to provide adequate funding for this level of quality in IRB oversight, and so there are not enough resources to address these issues, he says.

The most important part of the informed consent process is not readily accessible to an audit, notes Dale Hammerschmidt, MD, FACP, associate professor of medicine at the University of Minnesota Medical School in Minneapolis.

For instance, the IRB has no control over the actual consent encounter between the principal investigator and the subject, he says.

"The other thing is the consent he may be the only retrospective document the person has to look at a month later when trying to recall something, so it remains important that it be a good document, even if it is a small part of the process," he says.

"It’s a unique quality to human life that you devote a lot of energy to tasks you can accomplish rather than to the ones you wish you could accomplish," Hammerschmidt notes.

Focus on the document

Improving the informed consent process is an issue that also concerns the Secretary’s Advisory Committee on Human Research Protection (SACHRP) for the U.S. Department of Health and Human Services, says Ernest Prentice, PhD, chair of SACHRP and an associate vice chancellor for academic affairs at the University of Nebraska Medical Center in Omaha.

"Many IRBs are requiring some kind of description of the process of consent in forms, but they don’t pay as much attention to the process as they should," he says. "What they do is concentrate on the consent document, dotting all i’s, crossing all t’s and simplifying the language."

SACHRP members have discussed alternatives, including educating investigators about how to obtain valid and informed consent and then doing quality outcome assessments, Prentice says.

But to change federal regulations to permit IRBs to forgo review of informed consent documents in exchange for providing random audits of the informed consent process, as Nelson proposes, would not be feasible, he adds.

Changing regulations is an onerous process, Prentice notes.

"In 1991, you had 17 agencies sign on to the Common Rule, and to change the Common Rule you have to get all of these agencies to agree," he explains. "The fact that we got 17 agencies to agree is remarkable — it will never happen again."

The solution is not in revising the Common Rule and regulations, but in making OHRP and the Food and Drug Administration give IRBs clear guidance as to what their expectations are, Prentice says.