Consent studies shed a little light on consent practices

Research about the informed consent process is beginning to trickle in, but some institutions have made this a priority.

"We've been studying informed consent as a process for the past eight years, with funding from the National Cancer Institute," says Eric Kodish, MD, professor and chairman, department of bioethics, Cleveland Clinic Foundation, Lerner College of Medicine, Case Western Reserve University in Cleveland, OH.

"We've been looking specifically at the context of childhood leukemia," Kodish adds. "So I think context is extremely important to specify when you're talking about informed consent."

The research conducted by investigators at the University Hospitals of Cleveland has involved pediatric oncology, so the informed consent studies are specific to providing information to the guardians of this group.

For example, a current study, called the Multi-institutional Study to Improve Consent (MUSIC), is examining two different interventions to improve the outcomes of informed consent, including improving the dialogue between parents and research professionals.

"One intervention is to work with parents and have them meet with a nurse prior to the consent process," Kodish says. "These nurses are trained to do an intervention, essentially using nurses as a vector to deliver the intervention to the parents."

The goal is to help the parents ask questions and gain better understanding during the informed consent process, Kodish says. The study's control arm will receive informed consent as it's usually done, and at one site, parents will be played a DVD of the nurse delivered, parent-directed intervention instead of having a one-on-one meeting with the nurse, Kodish adds.

Another intervention involves working with physicians to help them manage the informed consent process more effectively, Kodish says.

"We've developed the interventions out of a database we collected in the first study," Kodish says. "We know what's happening, and we think we have targets for improving the consent process."

When investigators decide to study the informed consent process, they can gain insights into why certain approaches do not work as well as they expect, Kodish notes.

For instance, Kodish has learned that one common response physicians give parents to a question about their children and research is ineffective.

"An important example of what parents taught me is that when you're sitting down as a physician or nurse and the parents say, 'What would you do if this was your child?' many physicians refuse to answer that question," Kodish says.

"Parents say the physician should reframe that question and see that the parents want a recommendation," Kodish says. "Parents say physicians abdicate their responsibility as a physician or nurse if they refuse to answer that question."

Before hearing this feedback from parents, Kodish would bounce this question back to the parents, saying, "I'm a parent, and I can't imagine how terrible this situation is for you, but I can't make a decision for you."

Now Kodish will offer a recommendation, but only if they ask for it explicitly.

There are many different ways to conduct informed consent, but experts say studies could help clinical trial sites select the best methods.

"People have done videos and slide shows, and they've used books, depending on who the anticipated research subjects are," says Howard Dickler, MD, director for clinical research, division of biomedical and health sciences research at AAMC.

"There are many different ways to communicate, and you want to do it in the most effective and efficient manner," Dickler adds.

One informed consent study found that comprehension increased among research participants when the clinical trial staff permitted them to take home the informed consent document for a night, says Cindy Brach, MPP, senior health policy researcher in the Center for Delivery, Organization, and Markets at the Agency for Healthcare Research and Quality (AHRQ) of Rockville, MD.

Clinical trials professionals could say to participants, "If you don't want to make a decision now, then take it home and we'll discuss it later," Brach says.