Information Disclosure in Population-Based Research Involving Genetics: A Framework for the Practice of Ethics in Epidemiology

Purpose The completion of the Human Genome Project has resulted in increased epidemiological research to identify genes and their products as risk factors for adverse health events. A parallel increase in ethical issues associated with genetic research is noted. One such issue is whether or not epidemiologists should disclose individual genetic results to research participants. Existing ethical guidelines and frameworks are not helpful for determining whether disclosure is the moral choice. The purpose of this paper was to develop a framework for use by epidemiologists, research ethics boards, and institutional review boards during the protocol development stage to ethically address the dilemma regarding disclosure of individual genetic information. Methods The core principles of research ethics were introduced and applied to the issues surrounding disclosure of genetic information. A principle-based framework was developed through analysis of the current ethical arguments for and against disclosure. Finally, examples demonstrating the use of the framework were provided. Conclusion The proposed framework will not solve all ethical dilemmas related to individual disclosure of genetic information. It is, however, a useful starting point to facilitate the consideration process.