Literature DB >> 32342790

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

Susan M Wolf1, Pilar N Ossorio1, Susan A Berry1, Henry T Greely1, Amy L McGuire1, Michelle A Penny1, Sharon F Terry1.   

Abstract

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.

Entities:  

Year:  2020        PMID: 32342790      PMCID: PMC7447150          DOI: 10.1177/1073110520916996

Source DB:  PubMed          Journal:  J Law Med Ethics        ISSN: 1073-1105            Impact factor:   1.718


  63 in total

1.  Revisiting Wilson and Jungner in the genomic age: a review of screening criteria over the past 40 years.

Authors:  Anne Andermann; Ingeborg Blancquaert; Sylvie Beauchamp; Véronique Déry
Journal:  Bull World Health Organ       Date:  2008-04       Impact factor: 9.408

2.  Genetic testing and FDA regulation: overregulation threatens the emergence of genomic medicine.

Authors:  James P Evans; Michael S Watson
Journal:  JAMA       Date:  2015-02-17       Impact factor: 56.272

Review 3.  Emerging issues in public health genomics.

Authors:  Dana Dolinoy; Beth Tarini; J Scott Roberts
Journal:  Annu Rev Genomics Hum Genet       Date:  2014       Impact factor: 8.929

Review 4.  Living laboratory: whole-genome sequencing as a learning healthcare enterprise.

Authors:  M Angrist; L Jamal
Journal:  Clin Genet       Date:  2014-09-06       Impact factor: 4.438

5.  Adrift in the Gray Zone: IRB Perspectives on Research in the Learning Health System.

Authors:  Sandra Soo-Jin Lee; Maureen Kelley; Mildred K Cho; Stephanie Alessi Kraft; Cyan James; Melissa Constantine; Adrienne N Meyer; Douglas Diekema; Alexander M Capron; Benjamin S Wilfond; David Magnus
Journal:  AJOB Empir Bioeth       Date:  2016-03-02

Review 6.  The law of incidental findings in human subjects research: establishing researchers' duties.

Authors:  Susan M Wolf; Jordan Paradise; Charlisse Caga-anan
Journal:  J Law Med Ethics       Date:  2008       Impact factor: 1.718

7.  Customers or research participants? Guidance for research practices in commercialization of personal genomics.

Authors:  Sara L Tobin; Mildred K Cho; Sandra S-J Lee; David C Magnus; Megan Allyse; Kelly E Ormond; Nanibaa' A Garrison
Journal:  Genet Med       Date:  2012-06-14       Impact factor: 8.822

8.  ACMG policy statement: updated recommendations regarding analysis and reporting of secondary findings in clinical genome-scale sequencing.

Authors: 
Journal:  Genet Med       Date:  2014-11-13       Impact factor: 8.822

9.  ACMG recommendations for reporting of incidental findings in clinical exome and genome sequencing.

Authors:  Robert C Green; Jonathan S Berg; Wayne W Grody; Sarah S Kalia; Bruce R Korf; Christa L Martin; Amy L McGuire; Robert L Nussbaum; Julianne M O'Daniel; Kelly E Ormond; Heidi L Rehm; Michael S Watson; Marc S Williams; Leslie G Biesecker
Journal:  Genet Med       Date:  2013-06-20       Impact factor: 8.822

Review 10.  APPLaUD: access for patients and participants to individual level uninterpreted genomic data.

Authors:  Adrian Thorogood; Jason Bobe; Barbara Prainsack; Anna Middleton; Erick Scott; Sarah Nelson; Manuel Corpas; Natasha Bonhomme; Laura Lyman Rodriguez; Madeleine Murtagh; Erika Kleiderman
Journal:  Hum Genomics       Date:  2018-02-17       Impact factor: 4.639

View more
  6 in total

1.  The Future of DTC Genomics and the Law.

Authors:  Henry T Greely
Journal:  J Law Med Ethics       Date:  2020-03       Impact factor: 1.718

Review 2.  "Choice of law" in precision medicine research.

Authors:  Laura M Beskow; Leslie E Wolf
Journal:  Am J Hum Genet       Date:  2022-08-04       Impact factor: 11.043

Review 3.  Strategic vision for improving human health at The Forefront of Genomics.

Authors:  Eric D Green; Chris Gunter; Leslie G Biesecker; Valentina Di Francesco; Carla L Easter; Elise A Feingold; Adam L Felsenfeld; David J Kaufman; Elaine A Ostrander; William J Pavan; Adam M Phillippy; Anastasia L Wise; Jyoti Gupta Dayal; Britny J Kish; Allison Mandich; Christopher R Wellington; Kris A Wetterstrand; Sarah A Bates; Darryl Leja; Susan Vasquez; William A Gahl; Bettie J Graham; Daniel L Kastner; Paul Liu; Laura Lyman Rodriguez; Benjamin D Solomon; Vence L Bonham; Lawrence C Brody; Carolyn M Hutter; Teri A Manolio
Journal:  Nature       Date:  2020-10-28       Impact factor: 49.962

Review 4.  The need for polygenic score reporting standards in evidence-based practice: lipid genetics use case.

Authors:  Hannah Wand; Joshua W Knowles; Shoa L Clarke
Journal:  Curr Opin Lipidol       Date:  2021-04-01       Impact factor: 4.616

5.  Ethical Principles, Constraints and Opportunities in Clinical Proteomics.

Authors:  Sebastian Porsdam Mann; Peter V Treit; Philipp E Geyer; Gilbert S Omenn; Matthias Mann
Journal:  Mol Cell Proteomics       Date:  2021-01-14       Impact factor: 5.911

6.  Genomic medicine and the "loss of chance" medical malpractice doctrine.

Authors:  Jennifer K Wagner; Michelle N Meyer
Journal:  HGG Adv       Date:  2021-04-05
  6 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.