You never call, you never write: why return of 'omic' results to research participants is both a good idea and a moral imperative.

The rapid emergence of whole-genome and whole-exome sequencing of research participants has helped to revive the debate about whether genetic and other 'omic' data should be returned to research participants, and if so, which data, under what circumstances and by whom. While partial disclosure of such data has been justified in cases where participants' lives and health are threatened, full disclosure appears to remain beyond the pale for most researchers and bioethicists. I argue that it should not be and that the objections to full disclosure short-sightedly favor near-term considerations over long-term benefits. Return of genomic data to those who want it, even if a difficult undertaking and even if the meaning of the data is unclear, engages participants in science and the research enterprise, and positions them to be better stewards of their own health and wellbeing.

[1]  M. Massagli,et al.  Accelerated clinical discovery using self-reported patient data collected online and a patient-matching algorithm , 2011, Nature Biotechnology.

[2]  N. Friel,et al.  Sequencing and analysis of an Irish human genome , 2010, Genome Biology.

[3]  David P Bick,et al.  Making a definitive diagnosis: Successful clinical application of whole exome sequencing in a child with intractable inflammatory bowel disease , 2011, Genetics in Medicine.

[4]  Phil Brown,et al.  Toxic ignorance and right-to-know in biomonitoring results communication : a survey of scientists and study participants , 2012 .

[5]  L. Gostin,et al.  Access to health insurance: Experiences and attitudes of those with genetic versus non‐genetic medical conditions , 2007, American journal of medical genetics. Part A.

[6]  K. Demyttenaere,et al.  Psychological distress in the 5-year period after predictive testing for Huntington's disease , 2003, European Journal of Human Genetics.

[7]  M. Khoury,et al.  Personal genomics: information can be harmful , 2010, European journal of clinical investigation.

[8]  Robert Cook-Deegan,et al.  Disclosure of APOE genotype for risk of Alzheimer's disease. , 2009, The New England journal of medicine.

[9]  Andrew C. Adey,et al.  Haplotype-resolved genome sequencing of a Gujarati Indian individual , 2011, Nature Biotechnology.

[10]  K. Kieburtz,et al.  An approach to evaluating the therapeutic misconception. , 2009, IRB.

[11]  Sharon F. Terry,et al.  Power to the People: Participant Ownership of Clinical Trial Data , 2011, Science Translational Medicine.

[12]  N. Onland-Moret,et al.  Feedback of individual genetic results to research participants: in favor of a qualified disclosure policy , 2011, Human mutation.

[13]  N. Matsumoto,et al.  Rapid detection of a mutation causing X-linked leucoencephalopathy by exome sequencing , 2011, Journal of Medical Genetics.

[14]  Eric J Topol,et al.  Consumer perceptions of direct-to-consumer personalized genomic risk assessments , 2010, Genetics in Medicine.

[15]  Jeff Richardson,et al.  The rule of rescue. , 2003, Social science & medicine.

[16]  P. Ganz,et al.  The Trajectory of Psychological Impact in BRCA1/2 Genetic Testing: Does Time Heal? , 2008, Annals of behavioral medicine : a publication of the Society of Behavioral Medicine.

[17]  Genomics: launching a revolution in medicine. , 2000, The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics.

[18]  Wylie Burke,et al.  The rules remain the same for genomic medicine: The case against “reverse genetic exceptionalism” , 2010, Genetics in Medicine.

[19]  T. Glenn Field guide to next‐generation DNA sequencers , 2011, Molecular ecology resources.

[20]  E. Clayton Incidental Findings in Genetics Research Using Archived DNA , 2008, The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics.

[21]  N. Schork,et al.  Effect of direct-to-consumer genomewide profiling to assess disease risk. , 2011, The New England journal of medicine.

[22]  Phil Brown,et al.  Disentangling the Exposure Experience , 2011, Journal of health and social behavior.

[23]  L. Jaroff GENE HUNT , 1989, Science.

[24]  L. Andrews Who Owns Your Body? A Patient's Perspective on Washington University v. Catalona , 2006, Journal of Law, Medicine & Ethics.

[25]  Amy L. McGuire,et al.  An unwelcome side effect of direct-to-consumer personal genome testing: raiding the medical commons. , 2008, JAMA.

[26]  Elie Dolgin NEWS FEATURE:個別化遺伝学研究 , 2010 .

[27]  B. Skolnick Ethical and institutional review board issues. , 1998, Advances in neurology.

[28]  R. Altman,et al.  The incidentalome: a threat to genomic medicine. , 2006, JAMA.

[29]  Umberto Gelatti,et al.  The world of e-patients: A content analysis of online social networks focusing on diseases. , 2010, Telemedicine journal and e-health : the official journal of the American Telemedicine Association.

[30]  Robert J Levine,et al.  The dysregulation of human subjects research. , 2007, JAMA.

[31]  Pascal Borry,et al.  Statement of the ESHG on direct-to-consumer genetic testing for health-related purposes , 2010, European Journal of Human Genetics.

[32]  R. Cowan Heredity and Hope , 2008 .

[33]  S. Treloar,et al.  Investigating genetic discrimination in the Australian life insurance sector: the use of genetic test results in underwriting, 1999-2003. , 2007, Journal of Law and Medicine.

[34]  Sharon F Terry,et al.  Answering the hard questions: the Genetic Testing Registry and its request for information. , 2011, Genetic testing and molecular biomarkers.

[35]  Issam Zineh,et al.  DNA, drugs and chariots: on a decade of pharmacogenomics at the US FDA. , 2010, Pharmacogenomics.

[36]  Steven E. Brenner Common sense for our genomes , 2007, Nature.

[37]  A. Dobalian,et al.  A review and analysis of the clinical laboratory improvement amendment of 1988: compliance plans and enforcement policy. , 2005, Health care management review.

[38]  Jay Shendure,et al.  Identification by whole-genome resequencing of gene defect responsible for severe hypercholesterolemia , 2010, Human molecular genetics.

[39]  J. Frost,et al.  Sharing Health Data for Better Outcomes on PatientsLikeMe , 2010, Journal of medical Internet research.

[40]  R. Green,et al.  The role of disease perceptions and results sharing in psychological adaptation after genetic susceptibility testing: the REVEAL Study , 2010, European Journal of Human Genetics.

[41]  H. Greely The uneasy ethical and legal underpinnings of large-scale genomic biobanks. , 2007, Annual review of genomics and human genetics.

[42]  Elizabeth T. Cirulli,et al.  Whole-Genome Sequencing of a Single Proband Together with Linkage Analysis Identifies a Mendelian Disease Gene , 2010, PLoS genetics.

[43]  Péter Kakuk,et al.  Gene Concepts and Genethics: Beyond Exceptionalism , 2008, Sci. Eng. Ethics.

[44]  Edwin Cuppen,et al.  Disclosure of individual genetic data to research participants: the debate reconsidered. , 2011, Trends in genetics : TIG.

[45]  M. Ausems,et al.  A literature review of the psychological impact of genetic testing on breast cancer patients. , 2006, Patient education and counseling.

[46]  Misha Angrist,et al.  Personal genomes in progress: from the Human Genome Project to the Personal Genome Project , 2010, Dialogues in clinical neuroscience.

[47]  Elizabeth T. Cirulli,et al.  The Characterization of Twenty Sequenced Human Genomes , 2010, PLoS genetics.

[48]  Wylie Burke,et al.  Does genomic risk information motivate people to change their behavior? , 2009, Genome Medicine.

[49]  F. Rieux-Laucat,et al.  Whole-exome-sequencing-based discovery of human FADD deficiency. , 2010, American journal of human genetics.

[50]  R. Scharfmann,et al.  Molecular Diagnosis of Neonatal Diabetes Mellitus Using Next-Generation Sequencing of the Whole Exome , 2010, PloS one.

[51]  T. Marteau,et al.  Deflating the Genomic Bubble , 2011, Science.

[52]  Muin J Khoury,et al.  Evidence-based classification of recommendations on use of genomic tests in clinical practice: Dealing with insufficient evidence , 2010, Genetics in Medicine.

[53]  B. Peshkin,et al.  Genetic Discrimination in Health Insurance: Current Legal Protections and Industry Practices , 2007, Inquiry : a journal of medical care organization, provision and financing.

[54]  R. Rao Genes and Spleens: Property, Contract, or Privacy Rights in the Human Body? , 2007, Journal of Law, Medicine & Ethics.

[55]  Debra J. H. Mathews,et al.  Geneticists' views on science policy formation and public outreach , 2005, American journal of medical genetics. Part A.

[56]  H. Jacob,et al.  A timely arrival for genomic medicine , 2011, Genetics in Medicine.