Literature DB >> 23875796

Return of individual research results and incidental findings: facing the challenges of translational science.

Susan M Wolf1.   

Abstract

The debate over return of individual research results and incidental findings to study participants is a key frontier in research ethics and practice. This is fundamentally a problem of translational science-a question of when information about an individual that is generated in research should be communicated for clinical attention, particularly as technologies such as whole-genome sequencing and whole-exome sequencing are increasingly used in clinical care. There is growing consensus that investigators should offer participants at least those individual findings of high clinical importance and actionability. Increasing attention to what information biobanks and secondary researchers owe people who provide data and specimens offers an opportunity to treat these source individuals as research partners. Cutting-edge issues include return of results in pediatric populations and return to kin and family, both before and after the death of the proband, as well as how to manage incidental findings in clinical sequencing. Progress will require an understanding of the continuum linking research and clinical care and developing standards and models for return.

Entities:  

Mesh:

Year:  2013        PMID: 23875796      PMCID: PMC4452115          DOI: 10.1146/annurev-genom-091212-153506

Source DB:  PubMed          Journal:  Annu Rev Genomics Hum Genet        ISSN: 1527-8204            Impact factor:   8.929


  62 in total

1.  The ancillary-care responsibilities of medical researchers. An ethical framework for thinking about the clinical care that researchers owe their subjects.

Authors:  Henry S Richardson; Leah Belsky
Journal:  Hastings Cent Rep       Date:  2004 Jan-Feb       Impact factor: 2.683

2.  Medicine. The ultimate genetic test.

Authors:  Radoje Drmanac
Journal:  Science       Date:  2012-06-01       Impact factor: 47.728

3.  "Human non-subjects research": privacy and compliance.

Authors:  Kyle Bertram Brothers; Ellen Wright Clayton
Journal:  Am J Bioeth       Date:  2010-09       Impact factor: 11.229

Review 4.  CT colonography reporting and data system: a consensus proposal.

Authors:  Michael E Zalis; Matthew A Barish; J Richard Choi; Abraham H Dachman; Helen M Fenlon; Joseph T Ferrucci; Seth N Glick; Andrea Laghi; Michael Macari; Elizabeth G McFarland; Martina M Morrin; Perry J Pickhardt; Jorge Soto; Judy Yee
Journal:  Radiology       Date:  2005-07       Impact factor: 11.105

5.  Incidental findings on pediatric MR images of the brain.

Authors:  Brian S Kim; Judy Illes; Richard T Kaplan; Allan Reiss; Scott W Atlas
Journal:  AJNR Am J Neuroradiol       Date:  2002 Nov-Dec       Impact factor: 3.825

6.  Research ethics. Research practice and participant preferences: the growing gulf.

Authors:  S B Trinidad; S M Fullerton; E J Ludman; G P Jarvik; E B Larson; W Burke
Journal:  Science       Date:  2011-01-21       Impact factor: 47.728

Review 7.  Managing incidental findings in human subjects research: analysis and recommendations.

Authors:  Susan M Wolf; Frances P Lawrenz; Charles A Nelson; Jeffrey P Kahn; Mildred K Cho; Ellen Wright Clayton; Joel G Fletcher; Michael K Georgieff; Dale Hammerschmidt; Kathy Hudson; Judy Illes; Vivek Kapur; Moira A Keane; Barbara A Koenig; Bonnie S Leroy; Elizabeth G McFarland; Jordan Paradise; Lisa S Parker; Sharon F Terry; Brian Van Ness; Benjamin S Wilfond
Journal:  J Law Med Ethics       Date:  2008       Impact factor: 1.718

8.  The Informed Cohort Oversight Board: From Values to Architecture.

Authors:  Ingrid A Holm; Patrick L Taylor
Journal:  Minn J Law Sci Technol       Date:  2012

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

10.  Taxonomizing, sizing, and overcoming the incidentalome.

Authors:  Isaac S Kohane; Michael Hsing; Sek Won Kong
Journal:  Genet Med       Date:  2012-02-09       Impact factor: 8.822

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  62 in total

1.  Automatic Placement of Genomic Research Results in Medical Records: Do Researchers Have a Duty? Should Participants Have a Choice?

Authors:  Anya E R Prince; John M Conley; Arlene M Davis; Gabriel Lázaro-Muñoz; R Jean Cadigan
Journal:  J Law Med Ethics       Date:  2015       Impact factor: 1.718

2.  Whole Genome Sequencing as a Genetic Test for Autism Spectrum Disorder: From Bench to Bedside and then Back Again.

Authors:  Michael J Szego; Ma'n H Zawati
Journal:  J Can Acad Child Adolesc Psychiatry       Date:  2016-05-01

3.  Preferences for the Return of Individual Results From Research on Pediatric Biobank Samples.

Authors:  Kurt D Christensen; Sarah K Savage; Noelle L Huntington; Elissa R Weitzman; Sonja I Ziniel; Phoebe L Bacon; Cara N Cacioppo; Robert C Green; Ingrid A Holm
Journal:  J Empir Res Hum Res Ethics       Date:  2017-04       Impact factor: 1.742

4.  Patients' Choices for Return of Exome Sequencing Results to Relatives in the Event of Their Death.

Authors:  Laura M Amendola; Martha Horike-Pyne; Susan B Trinidad; Stephanie M Fullerton; Barbara J Evans; Wylie Burke; Gail P Jarvik
Journal:  J Law Med Ethics       Date:  2015       Impact factor: 1.718

5.  Return of Genetic Research Results to Participants and Families: IRB Perspectives and Roles.

Authors:  Laura M Beskow; P Pearl O'Rourke
Journal:  J Law Med Ethics       Date:  2015       Impact factor: 1.718

6.  Canadian Research Ethics Board Leadership Attitudes to the Return of Genetic Research Results to Individuals and Their Families.

Authors:  Conrad V Fernandez; P Pearl O'Rourke; Laura M Beskow
Journal:  J Law Med Ethics       Date:  2015       Impact factor: 1.718

7.  INTRODUCTION: Return of Research Results: What About the Family?

Authors:  Susan M Wolf
Journal:  J Law Med Ethics       Date:  2015       Impact factor: 1.718

8.  Pediatric Cancer Genetics Research and an Evolving Preventive Ethics Approach for Return of Results after Death of the Subject.

Authors:  Sarah Scollon; Katie Bergstrom; Laurence B McCullough; Amy L McGuire; Stephanie Gutierrez; Robin Kerstein; D Williams Parsons; Sharon E Plon
Journal:  J Law Med Ethics       Date:  2015       Impact factor: 1.718

9.  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

10.  Research Participants' Attitudes towards Receiving Information on Genetic Susceptibility to Arsenic Toxicity in Rural Bangladesh.

Authors:  Lizeth I Tamayo; Hannah Lin; Alauddin Ahmed; Hasan Shahriar; Rabiul Hasan; Golam Sarwar; Hem Mahbubul Eunus; Habibul Ahsan; Brandon L Pierce
Journal:  Public Health Genomics       Date:  2020-02-18       Impact factor: 2.000

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