Literature DB >> 27376949

Consent Issues in Genetic Research: Views of Research Participants.

Deborah Goodman1, Catherine O Johnson, Lari Wenzel, Deborah Bowen, Celeste Condit, Karen L Edwards.   

Abstract

BACKGROUND: With the arrival of large-scale population-based genomic research studies, such as the Precision Medicine Initiative (PMI), the question of how to best consent participants is significant, and in an era of patient-centered research, few studies have evaluated participants' preferences about re-consent and broad consent. Using quantitative methods, this study evaluates participants' views regarding the acceptability of re-consent and broad consent in subjects from the Participant Issues Project.
METHODS: A total of 450 participants were recruited from a cancer genetics registry, including cancer patients, their relatives, and controls. Participants completed a secure online survey.
RESULTS: Most participants endorsed re-consent when investigating an unrelated health condition or sharing their de-identified data with an investigator at a different institution. Notification rather than re-consent was preferred when studying a different gene but the same disease. Over 80% of respondents endorsed re-consent when parents of a child gave the original consent and the child has now reached adulthood. Preferences for some scenarios varied by history of cancer at baseline, gender, stage of cancer, or case versus control group. The large majority of participants preferred the option to select broad consent categories of research.
CONCLUSION: Understanding research participants' preferences, including their views on the need for re-consent, are critical to the success of the PMI.
© 2016 S. Karger AG, Basel.

Entities:  

Mesh:

Year:  2016        PMID: 27376949      PMCID: PMC4996754          DOI: 10.1159/000447346

Source DB:  PubMed          Journal:  Public Health Genomics        ISSN: 1662-4246            Impact factor:   2.000


  22 in total

1.  "Broad" consent, exceptions to consent and the question of using biological samples for research purposes different from the initial collection purpose.

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2.  A new initiative on precision medicine.

Authors:  Francis S Collins; Harold Varmus
Journal:  N Engl J Med       Date:  2015-01-30       Impact factor: 91.245

3.  Attitudes toward genetic research review: results from a survey of human genetics researchers.

Authors:  K L Edwards; A A Lemke; S B Trinidad; S M Lewis; H Starks; M T Quinn Griffin; G L Wiesner
Journal:  Public Health Genomics       Date:  2011-04-11       Impact factor: 2.000

4.  Meeting the governance challenges of next-generation biorepository research.

Authors:  Stephanie M Fullerton; Nicholas R Anderson; Greg Guzauskas; Dena Freeman; Kelly Fryer-Edwards
Journal:  Sci Transl Med       Date:  2010-01-20       Impact factor: 17.956

5.  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

6.  The Cancer Genetics Network: recruitment results and pilot studies.

Authors:  Hoda Anton-Culver; Argyrios Ziogas; Deborah Bowen; Dianne Finkelstein; Constance Griffin; James Hanson; Claudine Isaacs; Carol Kasten-Sportes; Geraldine Mineau; Prakash Nadkarni; Barbara Rimer; Joellen Schildkraut; Louise Strong; Barbara Weber; Deborah Winn; Robert Hiatt; Susan Nayfield
Journal:  Community Genet       Date:  2003

Review 7.  Participants' understanding of informed consent in clinical trials over three decades: systematic review and meta-analysis.

Authors:  Nguyen Thanh Tam; Nguyen Tien Huy; Le Thi Bich Thoa; Nguyen Phuoc Long; Nguyen Thi Huyen Trang; Kenji Hirayama; Juntra Karbwang
Journal:  Bull World Health Organ       Date:  2015-01-22       Impact factor: 9.408

8.  Subjects matter: a survey of public opinions about a large genetic cohort study.

Authors:  David Kaufman; Juli Murphy; Joan Scott; Kathy Hudson
Journal:  Genet Med       Date:  2008-11       Impact factor: 8.822

9.  Genetics researchers' and IRB professionals' attitudes toward genetic research review: a comparative analysis.

Authors:  Karen L Edwards; Amy A Lemke; Susan B Trinidad; Susan M Lewis; Helene Starks; Katherine W Snapinn; Mary Quinn Griffin; Georgia L Wiesner; Wylie Burke
Journal:  Genet Med       Date:  2012-01-12       Impact factor: 8.822

10.  Public preferences regarding informed consent models for participation in population-based genomic research.

Authors:  Jodyn Platt; Juli Bollinger; Rachel Dvoskin; Sharon L R Kardia; David Kaufman
Journal:  Genet Med       Date:  2013-05-09       Impact factor: 8.822

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  15 in total

1.  Authorization of tissues from deceased patients for genetic research.

Authors:  Maureen Wilson-Genderson; K Laura Barker; Heather M Gardiner; Maghboeba Mosavel; Jeffrey Thomas; Laura A Siminoff
Journal:  Hum Genet       Date:  2017-12-04       Impact factor: 4.132

2.  De-identified genomic data sharing: the research participant perspective.

Authors:  Deborah Goodman; Catherine O Johnson; Deborah Bowen; Megan Smith; Lari Wenzel; Karen Edwards
Journal:  J Community Genet       Date:  2017-04-05

3.  Translational Science, DNA Commercialization, and Informed Consent: The Need for Specific Terminology, Insights from a Review of H3Africa Projects.

Authors:  Patricia Marshall; Charmaine D M Royal; Ruth Chadwick
Journal:  Public Health Genomics       Date:  2022-01-25       Impact factor: 2.132

Review 4.  The research participant perspective related to the conduct of genomic cohort studies: A systematic review of the quantitative literature.

Authors:  Deborah Goodman; Deborah Bowen; Lari Wenzel; Paris Tehrani; Francis Fernando; Araksi Khacheryan; Farihah Chowdhury; Catherine O Johnson; Karen Edwards
Journal:  Transl Behav Med       Date:  2018-01-29       Impact factor: 3.046

5.  A comparison of views regarding the use of de-identified data.

Authors:  Deborah Goodman; Catherine O Johnson; Deborah Bowen; Megan Smith; Lari Wenzel; Karen L Edwards
Journal:  Transl Behav Med       Date:  2018-01-29       Impact factor: 3.046

6.  "I'm a Little More Trusting": Components of Trustworthiness in the Decision to Participate in Genomics Research for African Americans.

Authors:  Susan Racine Passmore; Amelia M Jamison; Gregory R Hancock; Moaz Abdelwadoud; C Daniel Mullins; Taylor B Rogers; Stephen B Thomas
Journal:  Public Health Genomics       Date:  2020-01-17       Impact factor: 2.000

7.  Importance of Participant-Centricity and Trust for a Sustainable Medical Information Commons.

Authors:  Amy L McGuire; Mary A Majumder; Angela G Villanueva; Jessica Bardill; Juli M Bollinger; Eric Boerwinkle; Tania Bubela; Patricia A Deverka; Barbara J Evans; Nanibaa' A Garrison; David Glazer; Melissa M Goldstein; Henry T Greely; Scott D Kahn; Bartha M Knoppers; Barbara A Koenig; J Mark Lambright; John E Mattison; Christopher O'Donnell; Arti K Rai; Laura L Rodriguez; Tania Simoncelli; Sharon F Terry; Adrian M Thorogood; Michael S Watson; John T Wilbanks; Robert Cook-Deegan
Journal:  J Law Med Ethics       Date:  2019-03       Impact factor: 1.718

8.  Broad consent for health care-embedded biobanking: understanding and reasons to donate in a large patient sample.

Authors:  Gesine Richter; Michael Krawczak; Wolfgang Lieb; Lena Wolff; Stefan Schreiber; Alena Buyx
Journal:  Genet Med       Date:  2017-06-22       Impact factor: 8.822

9.  A qualitative study of participants' views on re-consent in a longitudinal biobank.

Authors:  Mary Dixon-Woods; David Kocman; Liz Brewster; Janet Willars; Graeme Laurie; Carolyn Tarrant
Journal:  BMC Med Ethics       Date:  2017-03-23       Impact factor: 2.652

10.  Molecular Tumor Boards: Ethical Issues in the New Era of Data Medicine.

Authors:  Henri-Corto Stoeklé; Marie-France Mamzer-Bruneel; Charles-Henry Frouart; Christophe Le Tourneau; Pierre Laurent-Puig; Guillaume Vogt; Christian Hervé
Journal:  Sci Eng Ethics       Date:  2017-03-09       Impact factor: 3.525

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