Simplify IC form is first idea — here are other strategies to follow

Don't use exculpatory language

If you believe the informed consent process truly is a process and not just a multi-page document to get someone to sign, then it's important to develop strategies for improving both the process and the IC form.

"The consenting process itself is a dialogue between the investigator and the potential subjects," says Stewart A. Laidlaw, PhD, an associate vice president for compliance at the Los Angeles Biomedical Research Institute at the Harbor-UCLA Medical Center (LA BioMed) in Torrance, CA.

"So the investigator explains what's involved in the study and explains about risks and potential benefits, and the potential subject asks questions to clarify issues that he or she is not clear on," Laidlaw says. "This theoretically goes on until it reaches a point where the potential subject decides he or she will take part in the study or will not take part in the study."

This process is complemented by the informed consent document, which ideally is simple, highly readable, and provides clarity to the points the CT coordinator or principal investigator is making about the study.

There are at least two points of view on how an ideal consent form should be written.

"There's always a dynamic tension between those who wish to simplify it and make it understandable versus those who wish to make it complete," Laidlaw notes.

If the form is simplified and readable, then it could serve its purpose.

On the other hand, sometimes it's a good idea to add short explanations of background clinical trial information in the consent form, says Robyn Shapiro, JD, a partner who specializes in health law at Drinker Biddle & Reath in Milwaukee, WI.

"I've been thinking about this, and I know it goes against the comments that are popular and valid lately that these consent forms are just too long," Shapiro says. "Nonetheless, I think it would be a good idea to do a short explanation of the various trials in clinical research so that you can help people understand."

For example, an IC form could include this boilerplate information, Shapiro suggests:

  • Phase I studies are small studies of an experimental intervention, usually the first time the intervention is used in humans, with the primary purpose to test for safety, harms, and discomforts and how these change at different doses;
  • Phase II studies are mid-size studies designed to begin a more complete evaluation of the effectiveness of the intervention-at a dose level thought to be safe, based on earlier studies-and also to continue to test for harms, discomforts, and side effects;
  • Phase III studies are large studies to gather data to prove or disprove safety and effectiveness, and reconfirm optimal doses and routes of administration.

LA BioMed uses an informed consent format that has a standard section, Laidlaw says.

"There is standard language in any consent form that relates to what an IRB will look for in an informed consent document," Laidlaw says. "This includes what will happen in the event of an emergency, contact numbers, and the fact that the participation is voluntary."

When plaintiffs suing CT investigators and sponsors prevail, it's sometimes related to informed consent claims, Shapiro notes.

For instance, in 1990 there was a case decided by the California Supreme Court regarding a leukemia patient named John Moore. His spleen cells were used to develop and patent an anti-cancer drug, but Moore claimed that he never gave permission for his cells to be used in medical research.1

The California Supreme Court ruled that a patient does not have property rights over body tissues used to develop new treatments, but that Moore had not received adequate informed consent, Shapiro says.

"He lost on the property claim, but won on the informed consent claim," she adds.

The case applied only to California law, but has had wider implications for research scientists.

After this lawsuit, CT investigators wanted IC documents to say that participants were giving up their blood and tissue samples and relinquishing all legal rights and interests to the items, Shapiro says.

"But that's the kind of exculpatory language you can't use," she says. "No informed consent written or oral can include exculpatory language if your institution is subject to the Common Rule."

This means that subjects cannot waive their legal rights or release the investigator or institution or sponsor from liability or negligence under federal regulations, Shapiro explains.

"So that precludes a lot of language that lawyers otherwise would like to put in informed consent forms," she adds.

Instead, California institutions and others might say: "The tissue we get from you in this research may be used to develop a product that could be patented and licensed. There are no plans to provide any financial compensation to you if this happens," Shapiro says.

"So far this wording has stood up because it leaves a loophole," Shapiro adds. "You're just saying, 'We're not planning at this moment' with the subtext of 'We won't pay compensate you for the tissue unless we have to in a court of law.'"

From an ethical perspective, it's important for investigators and CT staff to remember that research participants are volunteers who are putting their lives on the line for the research, Laidlaw says.

"The study is being done to answer a question of whether this treatment is effective or not or more effective than another treatment," he says. "So it's important to treat subjects with an enormous amount of respect because they are the actual heroes of the medical research enterprise."

Reference

  1. Blakeslee S. Patient's right to tissue is limited. New York Times. July 10, 1990;1.