CC researchers develop new consent template for cancer trials

Episode # 28
Uploaded: Sept. 10, 2009
Running Time: 5:02

MARTINO: From the National Institutes of Health in Bethesda, Maryland, this is CLINICAL CENTER RADIO. About 14 percent of NIH intramural studies are Phase I studies meaning they evaluate a new drug or treatment’s safety, determine a safe dosage range, and identify side effects. A team including Dr. Christine Grady, acting head of the CC Department of Bioethics, recently developed a shorter and simpler consent form for patients participating in Phase I oncology trials.

GRADY: Informed consent is very important for ethical research because people who are participating in research need to know that research is different than the regular care that they might be get elsewhere. They need to know why it is being done, what it entails, and what the risks and benefits are. The way I view informed consent, the more far removed the research study is from what a person might expect in regular clinical care, the more stringent the sort of conditions of understanding should be.

MARTINO: Dr. Grady said the informed consent process is especially important for individuals enrolled in phase one oncology trials because of the nature of those trials and the individuals that are enrolled.

GRADY: Phase one cancer research for example is a very controversial kind of research because it is done for the purpose of determining safety and toxicity yet it involves people who are sick, have advanced cancer and have exhausted usually all available treatments for their cancer. So there is this confluence of potentially vulnerable people, with a study that is designed for purposes that are not to benefit them, and so you want to be sure that people understand that.

MARTINO: The new consent template was published in the July-August issue of IRB: Ethics & Human Research. In addition to Grady, the research team included Dr. Shlomo Koyfman from the Department of Radiation at the Cleveland Clinic; Mary S. McCabe, director of the Cancer Survivorship Program at Memorial Sloan Kettering Cancer Center; and Dr. Ezekiel Emanuel, chief of the CC Department of Bioethics and now special advisor for health in the White House Office of Management and Budget. The idea behind creating a simplified consent form grew out of a study completed by the CC bioethics department several years ago when after collecting phase 1 oncology trial consent forms from around the country for the purposes of analyzing content, the study team realized that some of the consent forms were different than others.

GRADY: The problem has been over the last 15 years or so, especially but maybe even longer, consent forms in general have gotten much more complicated, longer, more detailed, more legalistic, more difficult to read than they used to be. And so to the extent that they are important for someone to understand what is going on in a research trial, they are becoming less effective

MARTINO: After reviewing more than 200 consent forms specifically designed for Phase I oncology trials, the CC, Cleveland Clinic, and Sloan Kettering team developed the improved consent template in both an English and Spanish version. The forms meet the recommended eighth grade maximum reading level for consent forms, but as Grady describes, that is not the only way in which they are different from the other forms the team reviewed.

GRADY: By design it is supposed to be shorter, simpler in terms of reading level but also design, the format of the actual written consent form with question headings so the form actually talks to the person that is reading it, more white space, more divisions by topic, less repetition, more tables… those are the main features that distinguish it from other consent forms used for phase one oncology.

MARTINO: Since its publication this summer, the form is available to investigators who wish to use it, accessible on the IRB: Ethics & Human Research journal website. Grady hopes to put the consent form on the CC’s Web site for access and easy adaptation. Researchers are developing a randomized controlled trial to evaluate the revised form's effect on patient understanding and satisfaction.

GRADY: I think there are a lot of people who would like to see consent forms be more carefully written with the goal of making of them as readable as possible for people who will read them. Yet there are lots of examples of consent forms where we have a long way to go to get there. So this is one step in that big puzzle.

MARTINO: To learn more about the ethical issues surrounding patient consent, or to receive updates from the Clinical Center, including news about the medical research going on here every day, log on to http://clinicalcenter.nih.gov.  From America’s Clinical Research Hospital, this has been CLINICAL CENTER RADIO.  In Bethesda, Maryland, I’m Nicole Martino at the National Institutes of Health, an agency of the United States Department of Health and Human Services.

Back to Clinical Center Radio