U-M launches $1.5M informed consent project

Updated 11:00 AM January 10, 2005

U-M launches $1.5M informed consent project

By Kara Gavin
UMHS Public Relations

Everyone who takes part in a research study, whether it's a trial of an experimental cancer drug or a psychology experiment on human behavior, has to read and sign a form saying they understand what the study will involve and they agree to take part. This signature usually comes after a talk with a researcher, and the entire process is called "informed consent."

But how well do researchers explain things to prospective participants, and make sure they truly understand what they're getting into?

And how should researchers deal with people who want to take part in studies but who don't speak English, don't understand medical terms, or are mainly motivated by the money they'll get at the end of the study? And what about those who are facing a lethal disease and fervently hope the study will help them when in fact the treatment is unproven?

A new educational initiative and research project at the U-M Health System will tackle these issues, using a $1.5 million grant from the National Institutes of Health. It will be led by Dr. Susan Dorr Goold, director of the Bioethics Program and an associate professor of internal medicine at the Medical School.

Goold says the educational effort will aim to improve an already healthy system for informed consent at U-M. She hopes it eventually will serve as a model for other hospitals and universities that do research.

Researchers at U-M already receive training in informed consent, and people who volunteer to participate in clinical research at the University have the opportunity to be educated about the study and to ask questions, and can opt out at any time.

"But we know from research on informed consent that people don't always fully understand what they're getting into, and that the consent forms they're asked to read and sign are growing in length and complexity as new regulations take effect," Goold says.

"We want to help researchers in many fields learn how to communicate this complicated information to potential study volunteers, and evaluate how well they do it." That measurement will be the basis for the project's research component.

The new effort will be based on a curriculum developed by a team from many departments and colleges, led by Goold with major input from Casey White, assistant dean for medical education at the Medical School.

Clinical researchers, from senior faculty to the research coordinators who screen and interview potential study participants, will take part. Lectures, workshops and small group discussions tailored to different learning styles will begin soon.

Researchers will be able to practice what they've learned with a "fake" study participant, called a Standardized Patient Instructor.

In addition to Goold and White, the project involves faculty and staff from the Medical School, School of Public Health, Dental School and School of Nursing, as well as from the Center for the Advancement of Clinical Research and the Institutional Review Board that oversees clinical research at the Medical School.

U-M launches $1.5M informed consent project

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