Precision medicine [NEW TOPIC PAGE] Ethical, Legal and Social Issues (ELSI)

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Landscape of granted US patents in personalized diagnostics for oncology from 2014-2018. Ouellette Steven B et al. Expert opinion on therapeutic patents 2019 Feb Similar articles in PubMed
Perspectives on communication and engagement with regard to collecting biospecimens and family health histories for cancer research in a rural Alaska Native community. Dirks Lisa G et al. Journal of community genetics 2019 Jan Similar articles in PubMed
Molecular Tumor Boards: Ethical Issues in the New Era of Data Medicine. Stoeklé Henri-Corto et al. Science and engineering ethics 2018 24(1) 307-322 Similar articles in PubMed
Enabling precision medicine via standard communication of HTS provenance, analysis, and results. Alterovitz Gil et al. PLoS biology 2018 Dec 16(12) e3000099 Similar articles in PubMed
Ethical conundrums in pediatric genomics. Rotz Seth J et al. Hematology. American Society of Hematology. Education Program 2018 Nov 2018(1) 301-306 Similar articles in PubMed
FDA takes new action to advance the development of reliable and beneficial genetic tests that can improve patient care FDA Press Release, December 4, 2018
FDA approves ‘precision medicine’ drug for different cancers with same mutation L McGinley, Washington Post, November 26, 2018
Thought leader perspectives on benefits and harms in precision medicine research. Beskow Laura M et al. PloS one 2018 13(11) e0207842 Similar articles in PubMed
Impact of Precision Medicine on Drug Repositioning and Pricing: A Too Small to Thrive Crisis. Tiriveedhi Venkataswarup et al. Journal of personalized medicine 2018 Nov 8(4) Similar articles in PubMed
Will precision medicine be available for all patients in the near future? Gómez René Maximiliano et al. Current opinion in allergy and clinical immunology 2018 Nov Similar articles in PubMed
FDA guidance for next generation sequencing-based testing: balancing regulation and innovation in precision medicine. Luh Frank et al. NPJ genomic medicine 2018 328 Similar articles in PubMed
ClinGen advancing genomic data-sharing standards as a GA4GH driver project. Dolman Lena et al. Human mutation 2018 Nov 39(11) 1686-1689 Similar articles in PubMed
Precision medicine in diabetes and diabetic kidney disease: Regulatory considerations. Mol Peter G M et al. Diabetes, obesity & metabolism 2018 Oct 20 Suppl 319-23 Similar articles in PubMed
Distributive justice, diversity, and inclusion in precision medicine: what will success look like? Cohn Elizabeth G et al. Genetics in medicine : official journal of the American College of Medical Genetics 2017 19(2) 157-159 Similar articles in PubMed
Community Partnership in Precision Medicine: Themes from a Community Engagement Conference. Jones Loretta et al. Ethnicity & disease 2018 28(Suppl 2) 503-510 Similar articles in PubMed
South Korea: in the midst of a privacy reform centered on data sharing. Kim Hannah et al. Human genetics 2018 Aug 137(8) 627-635 Similar articles in PubMed
Precision medicine and sharing medical data in real time: opportunities and barriers. Yang Y Tony et al. The American journal of managed care 2018 Aug 24(8) 356-358 Similar articles in PubMed
Genomic medicine must reduce, not compound, health inequities: the case for hauora-enhancing genomic resources for New Zealand. Robertson Stephen P et al. The New Zealand medical journal 2018 Aug 131(1480) 81-89 Similar articles in PubMed
Orphan Cancer Drugs in the Era of Precision Medicine C Nabhan et al, JAMA Oncology, August 23, 2018
Biobanks and the Moral Concerns of Donors: A Democratic Deliberation. De Vries Raymond G et al. Qualitative health research 2018 Aug 1049732318791826 Similar articles in PubMed
Effort to Diversify Medical Research Raises Thorny Questions of Race  M Miller, Scientific American, August 10, 2018
Machine learning and genomics: precision medicine versus patient privacy. Azencott C-A et al. Philosophical transactions. Series A, Mathematical, physical, and engineering sciences 2018 Sep 376(2128) Similar articles in PubMed
The Ethical, Legal and Regulatory Issues Associated with Pharmacogenomics: Systematically Quantifying the Literature. Hewitt Jayne E et al. Journal of law and medicine 2018 Apr 25(3) 782-793 Similar articles in PubMed
Accelerating evidence gathering and approval of precision medicine therapies: the FDA takes aim at rare mutations. Issa Amalia M et al. Genetics in medicine : official journal of the American College of Medical Genetics 2018 Jul Similar articles in PubMed
Science Wants Your Data MK Baker, Five Thirty Eight, June 25, 2018
Personalized reproductive medicine: regulatory considerations. Jarow Jonathan P et al. Fertility and sterility 2018 Jun 109(6) 964-967 Similar articles in PubMed
I handed over my genetic data to the NIH. Here’s why you should, too E Dishman, All of uS, StatNews, June 13, 2018
"I don't want to be Henrietta Lacks": diverse patient perspectives on donating biospecimens for precision medicine research. Lee Sandra S-J et al. Genetics in medicine : official journal of the American College of Medical Genetics 2018 Jun Similar articles in PubMed
Data Sharing For Precision Medicine: Policy Lessons And Future Directions. Blasimme Alessandro et al. Health affairs (Project Hope) 2018 May 37(5) 702-709 Similar articles in PubMed
Recent updates and challenges on the regulation of precision medicine: The United States in perspective. Chang Lin-Chau et al. Regulatory toxicology and pharmacology : RTP 2018 Apr Similar articles in PubMed
NIH seeks health data of 1 million people, with genetic privacy suddenly an issue L Bernstein, Washington Post, May 2, 2018
Ethical considerations of neuro-oncology trial design in the era of precision medicine. Gupta Saksham et al. Journal of neuro-oncology 2017 Aug 134(1) 1-7 Similar articles in PubMed
Ethics of Genomic Data Sharing: An Interview with Bartha Maria Knoppers Global Alliance for Genomics and Health, Apr 2018
Accurate Filtering of Privacy-Sensitive Information in Raw Genomic Data. Decouchant Jérémie et al. Journal of biomedical informatics 2018 Apr Similar articles in PubMed
FDA finalizes guidances to accelerate the development of reliable, beneficial next generation sequencing-based tests, FDA, April 12, 2018
Enhance Diversity Among Researchers to Promote Participant Trust in Precision Medicine Research. Sierra-Mercado Demetrio et al. The American journal of bioethics : AJOB 2018 Apr 18(4) 44-46 Similar articles in PubMed
Beyond Consent: Building Trusting Relationships With Diverse Populations in Precision Medicine Research. Kraft Stephanie A et al. The American journal of bioethics : AJOB 2018 Apr 18(4) 3-20 Similar articles in PubMed
Fairness in Precision Medicine Kadija Ferryman and Mikaela Pitcan, Data and Society, Feb 26, 2018
Epistemology, Ethics, and Progress in Precision Medicine. Hey Spencer Phillips et al. Perspectives in biology and medicine 2016 59(3) 293-310 Similar articles in PubMed
Ethical Challenges in Biomarker-Driven Drug Development. Hey Spencer Phillips et al. Clinical pharmacology and therapeutics 2018 Jan 103(1) 23-25 Similar articles in PubMed
When Personal Feels Invasive: Foreseeing Challenges in Precision Medicine Communication. Ratcliff Chelsea L et al. Journal of health communication 2017 Dec 1-9 Similar articles in PubMed
What Is Trust? Ethics and Risk Governance in Precision Medicine and Predictive Analytics. Adjekum Afua et al. Omics : a journal of integrative biology 2017 Dec 21(12) 704-710 Similar articles in PubMed
Intellectual property considerations for molecular diagnostic development with emphasis on companion diagnostics. Glorikian Harry et al. Expert opinion on therapeutic patents 2017 Dec 1-6 Similar articles in PubMed
Power to the People: Data Citizens in the Age of Precision Medicine. Evans Barbara J et al. Vanderbilt journal of entertainment and technology law 2017 19(2) 243-265 Similar articles in PubMed
Editorial: Personalized Medicine: A Positional Point of View about Precision Medicine and Clarity for Ethics of Public Health. Fineschi Vittorio et al. Current pharmaceutical biotechnology 2017 18(3) 192-193 Similar articles in PubMed
Precision medicine: a matter of regulation or collaboration? Knoppers Bartha Maria et al. Journal of law and the biosciences 2016 Dec 3(3) 687-690 Similar articles in PubMed
Precision medicine, health disparities, and ethics: the case for disability inclusion. Sabatello Maya et al. Genetics in medicine : official journal of the American College of Medical Genetics 2017 Aug Similar articles in PubMed
Genomic Justice and Imagined Communities. Schwartz-Marin Ernesto et al. The Hastings Center report 2017 Jul 47(4) 30-31 Similar articles in PubMed
Genes, cells, and biobanks: Yes, there's still a consent problem. Caulfield Timothy et al. PLoS biology 2017 Jul 15(7) e2002654 Similar articles in PubMed
Equity in Precision Medicine: Is It Within Our Reach? Armstrong Katrina et al. Journal of the National Comprehensive Cancer Network : JNCCN 2017 Mar 15(3) 421-423 Similar articles in PubMed
Implementing Precision Medicine: The Ethical Challenges. Korngiebel Diane M et al. Trends in pharmacological sciences 2016 Dec Similar articles in PubMed
The Precision Medicine Initiative's All of Us Research Program: an agenda for research on its ethical, legal, and social issues. Sankar Pamela L et al. Genetics in medicine : official journal of the American College of Medical Genetics 2016 Dec Similar articles in PubMed
Precision Medicine, Diabetes, and the U.S. Food and Drug Administration. Meyer Robert J et al. Diabetes care 2016 Nov 39(11) 1874-1878 Similar articles in PubMed
The Need for a Privacy Standard for Medical Devices That Transmit Protected Health Information Used in the Precision Medicine Initiative for Diabetes and Other Diseases. Klonoff David C et al. Journal of diabetes science and technology 2016 Dec Similar articles in PubMed
Precision medicine? Welch Thomas R et al. The Journal of pediatrics 2016 Dec 1793-4 Similar articles in PubMed
Skepticism in the Genomic Era. Zacharias Rachel L et al. The Hastings Center report 2016 Nov 46(6) inside front cover Similar articles in PubMed
Has the biobank bubble burst? Withstanding the challenges for sustainable biobanking in the digital era. Chalmers Don et al. BMC medical ethics 2016 17(1) 39 Similar articles in PubMed
FDA advances Precision Medicine Initiative by issuing draft guidances on next generation sequencing-based tests FDA, July 6, 2016
Will Precision Medicine Move Us beyond Race? Bonham Vence L et al. The New England journal of medicine 2016 May 374(21) 2003-5 Similar articles in PubMed
Contrasting Medical and Legal Standards of Evidence: A Precision Medicine Case Study. Marchant Gary E et al. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics 2016 Mar 44(1) 194-204 Similar articles in PubMed
Federal Government's Proposed Expansion of Regulation of Biospecimen Research Should Be Reconsidered. Robertson Christopher T et al. Biopreservation and biobanking 2016 Mar Similar articles in PubMed
Pharmacogenomic Biomarkers: an FDA Perspective on Utilization in Biological Product Labeling. Schuck Robert N et al. The AAPS journal 2016 Feb Similar articles in PubMed
The Legal Environment for Precision Medicine. Thompson Bradley et al. Clinical pharmacology and therapeutics 2015 Nov Similar articles in PubMed
Precision medicine ethics: selected issues and developments in next-generation sequencing, clinical oncology, and ethics. Fiore Robin N et al. Current opinion in oncology 2015 Nov Similar articles in PubMed
Start me up: ways to encourage sharing of genomic information with research participants. Angrist Misha et al. Nat. Rev. Genet. 2015 Jul 17. 16(8) 435-6 Similar articles in PubMed
Drifting Away from Informed Consent in the Era of Personalized Medicine. Parens Erik et al. Hastings Cent Rep 2015 Jul 45(4) 16-20 Similar articles in PubMed
New approaches to regulating precision medicine needed, Genome Web, Feb 13 [by free subscription only]