CHAPEL HILL - Investigating ethical issues surrounding recent and upcoming genetic discoveries will be the goal of a new $975,000 National Human Genome Research Institute award to University of North Carolina at Chapel Hill faculty members.
Dr. Gail Henderson and lawyer Nancy King, both professors of social medicine at the UNC-CH School of Medicine, will lead the three-year effort, sponsored by the institute's Ethical, Legal and Social Implications of the Human Genome Project program.
"When Dr. James Watson set up the Human Genome Project, he required that a certain percentage of its budget be set aside to fund studies of the genome project's ethical, legal and social implications since it raised so many questions," Henderson said. "Our work relates to how people understand genetic research in terms of the consent process.
"We're planning to investigate how benefits are described and understood in gene transfer studies, which just about everybody calls gene therapy," she said. "People think of these studies as therapy but they are not at all. They are really just early research that we hope will eventually lead to better treatments."
The Human Genome Project is a massive effort nearing completion to catalog all human genes.
Henderson, King and colleagues will conduct telephone interviews with investigators, research subjects, study coordinators and members of institutional review boards in up to 50 of the most recent gene transfer studies across the United States. The review boards, or IRBs, oversee human experimentation at each institution.
"The ultimate goal is to try and understand how people develop ideas and beliefs about possible benefits from these early research studies," Henderson said. "In some of this research there is a slight possibility of benefit, but in most it's extremely unlikely or absolutely not possible directly."
A second effort led by King will analyze consent forms not only in the 50 studies the team will investigate in depth, but in all 300 gene therapy studies done in the United States since they began in 1990.
"We will examine the various ways that investigators describe the purposes of their research in consent forms, the specific language that is used to describe experimental interventions and the extent to which consent forms include discussions of the various types of possible benefits from studies," King said. "We hope to learn things that can help investigators provide the best possible information to potential subjects."
"It's been documented in many places now that research subjects tend to over-expect benefits, particularly if they are seriously ill or have a terminal illness," Henderson said.
The concept of "informed consent" to research participation was developed to help protect subjects from unethical research, she said. Since the 1960s, public attention has focused on cases of unethical research in which patients were not told they were subjects.
However, in the past 10 to 15 years, a dramatic shift has occurred in public thinking, and many patients demand access to clinical research, Henderson said. Some activists also have lobbied the U.S. Food and Drug Administration to speed up the drug approval process. The steady and impressive march of recent scientific discoveries, coupled with news media hype about potential benefits, has resulted in unrealistic expectations, which can lead both subjects and investigators to believe that research is treatment.
"Investigators in gene transfer studies are among the most dedicated people in the world, and the hope for a genetic solution to some inherited diseases is truly breathtaking," she said. "Our project is designed to examine what investigators and subjects expect from research participation and to help clarify how it can best be discussed without either misleading anyone or destroying hope."
King emphasized that the work will address such issues as how the desperation really sick people feel influences their understanding and acceptance of what is likely to happen to them and how the complex roles of physicians who are also investigators affect their views of what research participation offers to patient-subjects.
"It's encouraging to know that the ELSI program reviewers of our project recognized the importance of examining these issues, which affect gene transfer studies but have broader implications too," King said. "By comparison with standard treatments, which often don't work either, research on possible new treatments is very highly regulated. We hope we will learn some things that will address not only research issues, but treatment issues as well -- how people understand what can and cannot be accomplished."
Others involved in the project are Drs. Larry Churchill, professor of social medicine; Daniel K. Nelson, associate professor of social medicine and pediatrics; Arlene Davis, research assistant professor of social medicine; and Michael O. Callaway, a fellow at UNC-CH's Cecil G. Sheps Center for Health Services Research. Others include Drs. Benjamin Wilfond and Sara Hull of NIH.
Note: Henderson and King can be reached at 919-843-8268 and 843-8270, respectively.
Contact: David Williamson
962-8596