Integrating Rules for Genomic Research, Clinical Care, Public Health Screening and DTC Testing: Creating Translational Law for Translational Genomics.

Susan M Wolf Pilar N Ossorio Susan A Berry Henry T Greely Amy L McGuire Michelle A Penny Sharon F Terry

J Law Med Ethics

Susan M. Wolf, J.D., is McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre Baker Daniels Professor of Law; and Professor of Medicine at the University of Minnesota. She is also Chair of the University's Consortium on Law and Values in Health, Environment & the Life Sciences. She is a Principal Investigator on an NIH-supported project on "LawSeq: Building a Sound Legal Foundation for Translating Genomics into Clinical Application" (NHGRI/NCI # R01HG008605; Wolf, Clayton, Lawrenz, PIs). Pilar N. Ossorio, Ph.D., J.D., is Professor of Law and Bioethics at the University of Wisconsin-Madison, where she is on the faculties of the Law School and the Department of Medical History and Bioethics at the Medical School. She is Ethics Scholar-in-Residence at the Morgridge Institute for Research, Co-Director of UW's Law and Neuroscience Program, a faculty member in the UW Masters in Biotechnology Studies program, and Program Faculty in the Graduate Program in Population Health. Susan A. Berry, M.D., is Division Director for Genetics and Metabolism in the Department of Pediatrics at the University of Minnesota. She is a Professor in the Departments of Pediatrics, Ophthalmology and Genetics, Cell Biology and Development. She is a member of the Minnesota Department of Health Newborn Screening Advisory Committee, a Fellow of the American Academy of Pediatrics, and a Fellow of the American College of Medical Genetics. Henry T. Greely, J.D., is the Deane F. and Kate Edelman Johnson Professor of Law and Professor, by courtesy, of Genetics at Stanford University. He chairs the California Advisory Committee on Human Stem Cell Research and the steering committee of the Stanford University Center for Biomedical Ethics, and directs the Stanford Center for Law and the Biosciences and the Stanford Program in Neuroscience and Society. Amy L. McGuire, J.D., Ph.D., is the Leon Jaworski Professor of Biomedical Ethics and Director of the Center for Medical Ethics and Health Policy at the Baylor College of Medicine. She served on the National Advisory Council for Human Genome Research 2011-15 and is immediate past-President of the Association of Bioethics Program Directors. Michelle A. Penny, Ph.D., is Head of the Translational Genome Sciences Group at Biogen. She is Co-Chair of the National Academy Roundtable on Genomics and Precision Health and the Industry Pharmacogenomics Working Group. Sharon F. Terry, M.A., is President and Chief Executive Officer of Genetic Alliance and co-founder of the Genetic Alliance Registry and Biobank. She has served in a leadership role on organizations including the Precision Medicine Initiative Cohort Advisory Panel; Cures Acceleration Network Review Board and Advisory Council, National Center for Accelerating Translation Science, NIH; National Academy Roundtable on Genomics and Precision Health; Global Alliance for Genomics and Health; and International Rare Disease Research Consortium Executive Committee. Organizations are listed here for author identification only.

Published: March 2020

Human genomics integrates research, clinical care, public health, and consumer testing, but legal frameworks vary significantly across these areas.
Conflicts may arise when genomic practices overlap, particularly concerning consent, liability, analysis quality, and privacy protection.
The paper proposes a unified legal approach to resolve these conflicts while ensuring individuals' rights and interests are safeguarded in translational genomics.

Human genomics is a translational field spanning research, clinical care, public health, and direct-to-consumer testing. However, law differs across these domains on issues including liability, consent, promoting quality of analysis and interpretation, and safeguarding privacy. Genomic activities crossing domains can thus encounter confusion and conflicts among these approaches. This paper suggests how to resolve these conflicts while protecting the rights and interests of individuals sequenced. Translational genomics requires this more translational approach to law.

Download full-text PDF	Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7447150	PMC
http://dx.doi.org/10.1177/1073110520916996	DOI Listing

Publication Analysis

Top Keywords

clinical care

care public

public health

translational genomics

translational

integrating rules

rules genomic

genomic clinical

health screening

screening dtc

Similar Publications

Advances in the diagnosis and management of endometriosis: A comprehensive review.

Pathol Res Pract

January 2025

Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University, Chengdu, China; Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu, China. Electronic address:

Yingying Chen Shanza Waseem Li Luo

Endometriosis is a prevalent gynecological condition characterized by the presence of endometrial-like tissue outside the uterus, leading to chronic pelvic pain and infertility. This review aims to shed light on the latest advancements in diagnosing and managing endometriosis. It offers insight into the condition's pathogenesis, clinical symptoms, diagnostic techniques, and available treatment approaches.

View Article and Find Full Text PDF

Similar Publications

Association Between Language, Interpreter Use, and Pediatric Surgical Outcomes.

J Pediatr Surg

January 2025

Division of Pediatric General and Thoracic Surgery, Seattle Children's Hospital, 4800 Sand Point Way NE, Seattle, WA 98105, USA; Department of Surgery, University of Washington, Box 356410, 1959 NE Pacific St, Seattle, WA 98195, USA.

Nicole Chicoine Sarah Greenberg Dwight Barry Andre Dick Hannah Cockrell

Background: Inequities exist in pediatric surgical outcomes. Differential outcomes have been identified across racial groups, geography, and socioeconomic standing. However, the association between preferred language, interpreter use, and surgical outcomes is not well-studied in pediatric surgical literature.

View Article and Find Full Text PDF

Similar Publications

Trends and predictors of leaving before medically advised in US emergency departments from 2016 to 2021.

Am J Emerg Med

December 2024

Department of Health Policy & Organization, School of Public Health, The University of Alabama at Birmingham, Birmingham, AL, USA; Center for Outcomes and Effectiveness Research and Education, Heersink School of Medicine, The University of Alabama at Birmingham, Birmingham, AL, USA.

Yahya Alnashri Elena Andreyeva Theodoros V Giannouchos

Background: Leaving before medically advised (BMA) is a significant issue in the US healthcare system, leading to adverse health outcomes and increased costs. Despite previous research, multi-year studies using up-to-date nationwide emergency department (ED) data, are limited. This study examines factors associated with leaving BMA from EDs and trends over time, before and during the COVID-19 pandemic.

View Article and Find Full Text PDF

Similar Publications

Clinical and Microbiological Profile of Melioidosis in a Tertiary Care Hospital in Kerala, India.

Am J Trop Med Hyg

January 2025

Department of Microbiology, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, India.

Divya Vijayakumar Hridya Vikraman Poornima Baby Dipu Sathyapalan Amritavarshini Sreekumar

Melioidosis is a neglected tropical infection caused by the Gram-negative bacterium Burkholderia pseudomallei, which is found in soil and water across tropical countries. The infection spectrum ranges from mild localized lesions to severe sepsis. The clinical presentation, severity, and outcome are influenced by the route of infection, bacterial load, strain virulence, and specific virulence genes of B.

View Article and Find Full Text PDF

Similar Publications

How I Treat Higher-Risk MDS.

Blood

January 2025

H. Lee Moffitt Cancer Center, Tampa, Florida, United States.

Alain Mina Rami S Komrokji

Myelodysplastic syndromes/neoplasms (MDS) are a widely heterogenous group of myeloid malignancies characterized by morphologic dysplasia, a defective hematopoiesis, and recurrent genetic abnormalities. The original and revised International Prognostic Scoring Systems (IPSS) have been used to risk-stratify patients with MDS to guide treatment strategies. In higher-risk MDS, the therapeutic approach is geared toward delaying leukemic transformation and prolonging survival.

View Article and Find Full Text PDF

Similar Publications

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!