RT Article
T1 RETURNING GENETIC RESEARCH RESULTS TO INDIVIDUALS: POINTS-TO-CONSIDER
JF Bioethics
VO 20
IS 1
SP 24
OP 36
A1 Renegar, Gaile
A1 Webster, Christopher J.
A1 Stuerzebecher, Steffen
A1 Harty, Lea
A1 Ide, Susan E.
A1 Balkite, Beth
A1 Rogalski-Salter, Taryn A.
A1 Cohen, Nadine
A1 Spear, Brian B.
A1 Barnes, Diane M.
A1 Brazell, Celia
A2 Webster, Christopher J.
A2 Stuerzebecher, Steffen
A2 Harty, Lea
A2 Ide, Susan E.
A2 Balkite, Beth
A2 Rogalski-Salter, Taryn A.
A2 Cohen, Nadine
A2 Spear, Brian B.
A2 Barnes, Diane M.
A2 Brazell, Celia
LA English
YR 2006
UL https://ixtheo.de/Record/1781879788
AB 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.
K1 Policy
K1 Guidelines
K1 exploratory
K1 results
K1 Research
K1 genetic
K1 pharmacogenetic
DO 10.1111/j.1467-8519.2006.00473.x