Returning Genetic Research Results to Individuals: Points‐to‐Consider

Bioethics 20 (1):24-36 (2006)
  Copy   BIBTEX

Abstract

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 research results in the context of drug development trials based on their knowledge and experience. These 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.

Links

PhilArchive



    Upload a copy of this work     Papers currently archived: 93,069

External links

Setup an account with your affiliations in order to access resources via your University's proxy server

Through your library

Similar books and articles

Familial Communication of Research Results: A Need to Know?Lee Black & Kelly A. McClellan - 2011 - Journal of Law, Medicine and Ethics 39 (4):605-613.

Analytics

Added to PP
2013-10-29

Downloads
46 (#355,781)

6 months
16 (#172,129)

Historical graph of downloads
How can I increase my downloads?