The ASBH 9th Annual Meeting (October 18-21, 2007) of ASBH

Sunday, 21 October 2007 - 11:00 AM

Ethics and Regulation of Predictive Health Research: A New Translational Paradigm?

Eric M. Meslin, PhD1, Scott C. Denne, MD2, Timothy Caulfield, LLM3, Barbara J. Evans, PhD, JD, LLM4, and Peter H. Schwartz, MD, PhD1. (1) Indiana University Center for Bioethics, Indianapolis, IN, USA, (2) Indiana University School of Medicine, Indianapolis, IN, USA, (3) University of Alberta, Edmonton, AB, Canada, (4) University of Houston Law Center, Houston, TX, USA

Now that the human genome has been sequenced, large projects in “Predictive Health Research” (PHR) are being undertaken that utilize “biobanks,” databases combining health data from medical records with genomic data from tissue samples. PHR is truly “translational” research – spanning the “bench” to the “bedside” – and therefore the associated ethical and policy analysis must be translational as well. As the speakers in this panel will demonstrate, ethics research in this area must address topics ranging from basic to applied, touching on all different phases of PHR research and its implementation. These investigations are necessarily collaborative, since they require input from many different areas. The panel members typify the collaborative nature of the research as well, bringing their disparate backgrounds in clinical research, ethics, philosophy, and law to their shared focus on PHR.

The first speaker will examine the ethical challenges involved in creating a biobank for research involving children. He will discuss research underway on the attitudes of health professionals towards collecting and storing samples and medical information from pediatric patients. This information is essential “basic research” for identifying ethical concerns and addressing them in the design and implementation of PHR in the pediatric population.

The second speaker will address a basic problem in PHR research ethics involving informed consent. In particular, because biobanks function as platforms for unspecific future research projects, people providing samples or medical information cannot be informed completely about the research in which they are participating. Since this violates a basic precept in current models of informed consent, the concept must be modified or the research cannot go forward in its currently planned form.

Moving from this basic conceptual work to a more applied topic, the third speaker will discuss regulatory challenges facing the safe and effective use of PHR in patient care. Genetically targeted drug therapies and prognostic tests for serious illnesses, for instance, raise concerns about safety, clinical validity, and ethics that current regulations do not adequately address. Protections will most likely need to involve the FDA, state medical practice regulators, and the medical profession itself.

The final speaker will discuss challenges facing the implementation of one key “bedside” implication of PHR: providing patients with individualized risk information. Instead of giving general descriptions of the risks of smoking, for instance, PHR may allow genetic testing that can precisely determine the risk than an individual smoker has for lung cancer. And while many claim that such specific information will better educate patients and motivate them to change their behavior, research in related areas raises worries that such information could decrease patient compliance and hinder understanding. Again, the ethical use of genetic information at the “bedside” will not be simple.

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