Ethical, legal, and social issues related to genomics and cancer research: the impending crisis.
Cancer research is a multibillion-dollar enterprise validated by the clinical trial process and increasingly defined by genomics. The continued success of the endeavor depends on the smooth functioning of the clinical trial system, which in turn depends on human subject participation. Yet human subject participation can exist only in an atmosphere of trust between research participants and research sponsors, and the advent of genomics has raised a multitude of ethical, legal, and social issues that threaten this trust. The authors examine 6 of these issues: (1) informed consent; (2) privacy, confidentiality, and family disclosure dilemmas; (3) property rights in genomic discoveries; (4) individual and institutional conflicts of interest; (5) insurance and employment issues; and (6) litigation under the federal False Claims Act. The authors conclude that failure to resolve these issues may lead to a sufficient impairment of trust in genomics-based clinical trials on the part of potential research participants that the clinical trial system may implode for lack of willing participants, thus threatening the future of cancer research.
Ellerin
Bruce E
BE
Department of Radiation Oncology, New York University School of Medicine, New York, NY 10016-6497, USA. bee2@nyu.edu
Schneider
Robert J
RJ
Stern
Arnold
A
Toniolo
Paolo G
PG
Formenti
Silvia C
SC
D003219:Confidentiality; D016265:Conflict of Interest; D005817:Genetic Counseling / Q000941:ethics / Q000331:legislation & jurisprudence; D036281:Genetic Research / Q000941:ethics / Q000331:legislation & jurisprudence; D005820:Genetic Testing / Q000941:ethics / Q000331:legislation & jurisprudence; D023281:Genomics / Q000941:ethics* / Q000331:legislation & jurisprudence*; D033161:Government Regulation; D006801:Humans; D007373:Interinstitutional Relations; D009369:Neoplasms / Q000235:genetics* / Q000628:therapy; D012107:Research Design; D012941:Social Responsibility; D014481:United States