This paper is intended to stimulate debate amongst stakeholders in the international research community on the topic of returning individual genetic research results to study participants. Pharmacogenetics and disease genetics studies are becoming increasingly prevalent, leading to a growing body of information on genetic associations for drug responsiveness and disease susceptibility with the potential to improve health care. Much of these data are presently characterized as exploratory (non-validated or hypothesis-generating). There is, however, a trend for research participants to be permitted access to their personal data if they so choose. Researchers, sponsors, patient advocacy groups, ethics committees and regulatory authorities are consequently confronting the issue of whether, and how, study participants might receive their individual results. Noted international ethico-legal guidelines and public policy positions in Europe and the United States are reviewed for background. The authors offer 'Points-to-Consider' regarding returning results in the context of drug development trials based on their knowledge and experience. Theses considerations include: the clinical relevance of data, laboratory qualifications, informed consent procedures, confidentiality of medical information and the competency of persons providing results to participants. The discussion is framed as a benefit-to-risk assessment to balance the potential positive versus negative consequences to participants, while maintaining the integrity and feasibility of conducting genetic research studies.

Rapid changes in the science and technology related to genetic research are challenging scientists, health care providers, ethicists, regulators, patient groups, and the pharmaceutical industry to keep pace with ethically grounded, workable guidelines for both the research and clinical applications of human genetics. We describe the genetic research being conducted by one pharmaceutical company (GlaxoSmithKline) and how the company is addressing the ethical, legal, and social issues surrounding this research; discuss an industry working group's attempt to advance pharmacogenetic research by openly addressing and disseminating information on related ethical, legal, and regulatory issues; identify scientific and ethical differences among various types of genetic research; discuss potential implications of family consent on subject privacy and autonomy, data collection, and study conduct; and suggest points to consider when study sponsors, investigators, and ethics committees evaluate research proposals. Public and expert opinion regarding informed consent in genetic research is evolving as a result of increased education, discussion, and understanding of the relevant issues. Five years ago, there was strong support for anonymity in genetic research as a privacy safeguard. Now, an increasingly popular school of thought advocates against anonymity to preserve an individual's ability to withdraw and, if desired, access research results. It is important to recognize this evolution and address consent issues in a reasoned, practical, and consistent way, including input from patients and their families, health care providers, ethicists, scientists, regulatory bodies, research sponsors, and the lay community. Responsibility for assessing issues related to family consent for research should remain with local investigators, ethics boards, and study sponsors. A "one-size-fits-all" perspective in the form of new regulations, for example, would likely be a disservice to all.

Pharmacogenetics is changing the way medicines are discovered, developed and delivered to patients. In this article, we present the 'prescription' perspective--how the results of pharmacogenetic research will help minimize the risk of costly adverse drug reactions and treatment failures, by providing predictive tools to enable healthcare providers to prescribe the right medicine for the right patient. We discuss the challenges of this research and its clinical application; its implications for drug development; evolving concepts of informed consent; related ethical, legal and social issues; changing definitions of 'genetic testing'; and the creation of an international Pharmacogenetics Working Group.