Literature DB >> 25506378

The unintended implications of blurring the line between research and clinical care in a genomic age.

Benjamin E Berkman1, Sara Chandros Hull1, Lisa Eckstein2.   

Abstract

While the development of next-generation sequencing technology has had a paradigm-changing impact on biomedical research, there is likely to be a gap between discovery of therapeutic benefits in research and actual adoption of the new technology into clinical practice. This gap can create pressure on the research enterprise to provide individualized care more typical of the clinic setting because it is uniquely accessible in research. This blurring of the line between research and clinical care is understandable, and perhaps even inevitable. But even if the gap is only transitory, such a blurring can have lasting implications, both by expanding obligations imposed on researchers, but also by challenging long-held ethical views. We explore this idea, focusing on how the dissolving distinction between research and clinical care has influenced the vigorous debate around how researchers should manage genetic findings (sometimes separated into primary and incidental or secondary findings) resulting from research.

Entities:  

Keywords:  ancillary care; incidental findings; legal liability; research ethics; secondary findings; whole-genome sequencing

Year:  2014        PMID: 25506378      PMCID: PMC4262832          DOI: 10.2217/pme.14.3

Source DB:  PubMed          Journal:  Per Med        ISSN: 1741-0541            Impact factor:   2.512


  52 in total

1.  Shattuck lecture--medical and societal consequences of the Human Genome Project.

Authors:  F S Collins
Journal:  N Engl J Med       Date:  1999-07-01       Impact factor: 91.245

2.  What makes clinical research ethical?

Authors:  E J Emanuel; D Wendler; C Grady
Journal:  JAMA       Date:  2000 May 24-31       Impact factor: 56.272

Review 3.  Disclosure of individual genetic data to research participants: the debate reconsidered.

Authors:  Annelien L Bredenoord; Hester Y Kroes; Edwin Cuppen; Michael Parker; Johannes J M van Delden
Journal:  Trends Genet       Date:  2010-12-27       Impact factor: 11.639

4.  Mandatory extended searches in all genome sequencing: "incidental findings," patient autonomy, and shared decision making.

Authors:  Lainie Friedman Ross; Mark A Rothstein; Ellen Wright Clayton
Journal:  JAMA       Date:  2013-07-24       Impact factor: 56.272

5.  First FDA authorization for next-generation sequencer.

Authors:  Francis S Collins; Margaret A Hamburg
Journal:  N Engl J Med       Date:  2013-11-19       Impact factor: 91.245

6.  Secondary variants--in defense of a more fitting term in the incidental findings debate.

Authors:  Gabrielle M Christenhusz; Koenraad Devriendt; Kris Dierickx
Journal:  Eur J Hum Genet       Date:  2013-05-22       Impact factor: 4.246

7.  Returning genetic research results: study type matters.

Authors:  Amy L McGuire; Jill Oliver Robinson; Rachel B Ramoni; Debra S Morley; Steven Jofe; Sharon E Plon
Journal:  Per Med       Date:  2013-01       Impact factor: 2.512

8.  Understanding incidental findings in the context of genetics and genomics.

Authors:  Mildred K Cho
Journal:  J Law Med Ethics       Date:  2008       Impact factor: 1.718

9.  Return of research results from genomic biobanks: cost matters.

Authors:  Marianna J Bledsoe; Ellen Wright Clayton; Amy L McGuire; William E Grizzle; P Pearl O'Rourke; Nikolajs Zeps
Journal:  Genet Med       Date:  2012-08-30       Impact factor: 8.822

Review 10.  Exome sequencing: the sweet spot before whole genomes.

Authors:  Jamie K Teer; James C Mullikin
Journal:  Hum Mol Genet       Date:  2010-08-12       Impact factor: 6.150

View more
  15 in total

1.  Leaves imitate trees: Minnesota Hmong concepts of heredity and applications to genomics research.

Authors:  Kathleen A Culhane-Pera; MaiKia Moua; Pachia Vue; Kang Xiaaj; May Xia Lo; Robert J Straka
Journal:  J Community Genet       Date:  2016-11-07

2.  Mapping the Ethics of Translational Genomics: Situating Return of Results and Navigating the Research-Clinical Divide.

Authors:  Susan M Wolf; Wylie Burke; Barbara A Koenig
Journal:  J Law Med Ethics       Date:  2015       Impact factor: 1.718

Review 3.  Points to Consider: Ethical, Legal, and Psychosocial Implications of Genetic Testing in Children and Adolescents.

Authors:  Jeffrey R Botkin; John W Belmont; Jonathan S Berg; Benjamin E Berkman; Yvonne Bombard; Ingrid A Holm; Howard P Levy; Kelly E Ormond; Howard M Saal; Nancy B Spinner; Benjamin S Wilfond; Joseph D McInerney
Journal:  Am J Hum Genet       Date:  2015-07-02       Impact factor: 11.025

4.  Privacy and ethical challenges in next-generation sequencing.

Authors:  Nicole Martinez-Martin; David Magnus
Journal:  Expert Rev Precis Med Drug Dev       Date:  2019-04-08

5.  Strategies to Guide the Return of Genomic Research Findings: An Australian Perspective.

Authors:  Lisa Eckstein; Margaret Otlowski
Journal:  J Bioeth Inq       Date:  2018-05-16       Impact factor: 1.352

6.  Ethical Considerations for the Return of Incidental Findings in Ophthalmic Genomic Research.

Authors:  Emmanuelle Souzeau; Kathryn P Burdon; David A Mackey; Alex W Hewitt; Ravi Savarirayan; Margaret Otlowski; Jamie E Craig
Journal:  Transl Vis Sci Technol       Date:  2016-02-09       Impact factor: 3.283

7.  Improving the informed consent process in international collaborative rare disease research: effective consent for effective research.

Authors:  Sabina Gainotti; Cathy Turner; Simon Woods; Anna Kole; Pauline McCormack; Hanns Lochmüller; Olaf Riess; Volker Straub; Manuel Posada; Domenica Taruscio; Deborah Mascalzoni
Journal:  Eur J Hum Genet       Date:  2016-02-10       Impact factor: 4.246

8.  Participant Engagement in Translational Genomics Research: Respect for Persons-and Then Some.

Authors:  Janet E Childerhose; Candice R Finnila; Joon-Ho Yu; Barbara A Koenig; Jean McEwen; Stacey L Berg; Benjamin S Wilfond; Paul S Appelbaum; Kyle B Brothers
Journal:  Ethics Hum Res       Date:  2019-09

9.  Practices and Attitudes toward Returning Genomic Research Results to Low-Resource Research Participants.

Authors:  Megan B Raymond; Kayla E Cooper; Lisa S Parker; Vence L Bonham
Journal:  Public Health Genomics       Date:  2021-07-06       Impact factor: 2.132

10.  Navigating the research-clinical interface in genomic medicine: analysis from the CSER Consortium.

Authors:  Susan M Wolf; Laura M Amendola; Jonathan S Berg; Wendy K Chung; Ellen Wright Clayton; Robert C Green; Julie Harris-Wai; Gail E Henderson; Gail P Jarvik; Barbara A Koenig; Lisa Soleymani Lehmann; Amy L McGuire; Pearl O'Rourke; Carol Somkin; Benjamin S Wilfond; Wylie Burke
Journal:  Genet Med       Date:  2017-08-31       Impact factor: 8.822

View more

北京卡尤迪生物科技股份有限公司 © 2022-2023.