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Public Health Genomics and Precision Health Knowledge Base (v7.3)
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all[original query]>>Ethical, Legal and Social Issues (ELSI)[Category]
Publication
Which bioethical and bio-legal guidelines should be followed when performing pharmacogenetic and pharmacogenomic tests in psychiatry clinical trials in Colombia, to protect genetic data and the rights of research subjects?
Pacheco Padrón Ana Patricia et al. Revista colombiana de psiquiatria 2021 50(1) 57-63
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Research projects in human genetics in Switzerland: analysis of research protocols submitted to cantonal ethics committees in 2018.
Driessen Susanne et al. Swiss medical weekly 2021 Jan 151w20403
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Sharing genetic variants with the NGS pipeline is essential for effective genomic data sharing and reproducibility in health information exchange.
Lee Jeong Hoon et al. Scientific reports 2021 Jan 11(1) 2268
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Legal Challenges for IT Service Providers in Pharmacogenomics.
Meier Lea et al. Studies in health technology and informatics 2020 Jun 27247-50
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Why African Americans say "No": A Study of Pharmacogenomic Research Participation.
Nooruddin Mohammed et al. Ethnicity & disease 2020 30(Suppl 1) 159-166
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Pioneering Informed Consent for Return of Research Results to Breast Cancer Patients Facing Barriers to Implementation of Genomic Medicine: The Kenyan BRCA1/2 Testing Experience Using Whole Exome Sequencing.
Torrorey-Sawe Rispah et al. Frontiers in genetics 2020 11170
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Pharmacogenetic Testing: The Ethics of Implementing in Clinical Practice for Chronic Pain Patients.
Fredrikson Karin M et al. Journal of pain & palliative care pharmacotherapy 2020 Jan 1-8
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Evaluation of current regulation and guidelines of pharmacogenomic drug labels; opportunities for improvements.
Shekhani Rawan et al. Clinical pharmacology and therapeutics 2019 Nov
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Pharmacogenomic Testing In Pediatrics: Navigating The Ethical, Social, And Legal Challenges.
Haga Susanne B et al. Pharmacogenomics and personalized medicine 2019 12273-285
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Why home DNA tests might not be as private as you think
C Fox, World Economic Forum, August 9, 2019
FDA Approvals Provide Advances for a Range of Cancer Types
K Honey, AACR Blogs, August 6, 2019
Genetic-Testing Scam Targets Seniors And Rips Off Medicare
M Bailey, KHN News, July 31, 2019
A Review of African Americans' Beliefs and Attitudes About Genomic Studies: Opportunities for Message Design.
Scherr Courtney L et al. Frontiers in genetics 2019 10548
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Genomic malpractice: what healthcare providers need to know to reduce the risk
J McCarthy, Precision Medicine Advisor, June 10, 2019
Are privacy-enhancing technologies for genomic data ready for the clinic? A survey of medical experts of the Swiss HIV Cohort Study.
Raisaro Jean-Louis et al. Journal of biomedical informatics 2018 791-6
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FDA Approval of PARP Inhibitors and the Impact on Genetic Counseling and Genetic Testing Practices.
Buchtel Kathryn M et al. Journal of genetic counseling 2018 27(1) 131-139
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The integration of emerging omics approaches to advance precision medicine: How can regulatory science help?
Adamo Joan E et al. Journal of clinical and translational science 2018 Oct 2(5) 295-300
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Direct-to-Consumer Tests with Marketing Authorization
FDA, 2018
FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism
FDA Press Release, October 31, 2018
Pharmacogenetic Labeling of FDA-Approved Drugs: A Regulatory Retrospective.
Drozda Katarzyna et al. JACC. Basic to translational science 2018 Aug 3(4) 545-549
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FDA rejects Akcea rare-disease drug that uses gene-blocking technology
K Sheridan, Stat News, August 27, 2018
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
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Ethical Guidelines for Genetic Research on Alcohol Addiction and Its Applications.
Chapman Audrey R et al. Kennedy Institute of Ethics journal 2018 28(1) 1-22
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FDA approves olaparib for germline BRCA-mutated metastatic breast cancer
FDA, Jan 12, 2018
Applications of pharmacogenomics in regulatory science: a product life cycle review.
Tan-Koi W C et al. The pharmacogenomics journal 2017 Dec
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Implementing Precision Medicine: The Ethical Challenges.
Korngiebel Diane M et al. Trends in pharmacological sciences 2016 Dec
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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
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Public Attitudes toward an Epidemiological Study with Genomic Analysis in the Great East Japan Earthquake Disaster Area.
Ishikuro Mami et al. Prehospital and disaster medicine 2016 Mar 1-5
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FDA oversight of laboratory-developed tests will facilitate adoption of pharmacogenetic testing into routine clinical care.
Hillebrenner E et al. Journal of clinical pharmacology 2015 Jul 55(7) 728-30
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Pharmacogenomic Biomarkers: an FDA Perspective on Utilization in Biological Product Labeling.
Schuck Robert N et al. The AAPS journal 2016 Feb
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