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IRB perspectives on the return of individual results from genomic research

Return of individual research results from genomic studies is a hotly debated ethical issue in genomic research. However, the perspective of key stakeholders-institutional review board (IRB) professionals-has been missing from this dialogue. This study explores the positions and experiences of IRB m... Full description

Journal Title: Genetics in medicine 2012-02, Vol.14 (2), p.215-222
Main Author: Dressler, Lynn G
Other Authors: Smolek, Sondra , Ponsaran, Roselle , Markey, Janell M , Starks, Helene , Gerson, Nancy , Lewis, Susan , Press, Nancy , Juengst, Eric , Wiesner, Georgia L
Format: Electronic Article Electronic Article
Language: English
Subjects:
Publisher: United States
ID: ISSN: 1098-3600
Link: https://www.ncbi.nlm.nih.gov/pubmed/22241094
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recordid: cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_3493147
title: IRB perspectives on the return of individual results from genomic research
format: Article
creator:
  • Dressler, Lynn G
  • Smolek, Sondra
  • Ponsaran, Roselle
  • Markey, Janell M
  • Starks, Helene
  • Gerson, Nancy
  • Lewis, Susan
  • Press, Nancy
  • Juengst, Eric
  • Wiesner, Georgia L
subjects:
  • Article
  • Consent Forms - ethics
  • Decision Making
  • disclosure of results
  • Ethics Committees, Research - ethics
  • Ethics Committees, Research - organization & administration
  • Female
  • genetic research
  • Genetic Research - ethics
  • genomic research
  • Guidelines as Topic
  • Health Personnel - organization & administration
  • Health Personnel - psychology
  • Humans
  • Institutional Review Boards
  • Male
  • return of results
ispartof: Genetics in medicine, 2012-02, Vol.14 (2), p.215-222
description: Return of individual research results from genomic studies is a hotly debated ethical issue in genomic research. However, the perspective of key stakeholders-institutional review board (IRB) professionals-has been missing from this dialogue. This study explores the positions and experiences of IRB members and staff regarding this issue. In-depth interviews with 31 IRB professionals at six sites across the United States. IRB professionals agreed that research results should be returned to research participants when results are medically actionable but only if the participants want to know the results. Many respondents expected researchers to address the issue of return of results (ROR) in the IRB application and informed-consent document. Many respondents were not comfortable with their expertise in genomics research and only a few described actual experiences in addressing ROR. Although participants agreed that guidelines would be helpful, most were reticent to develop them in isolation. Even where IRB guidance exists (e.g., Clinical Laboratory Improvement Act (CLIA) lab certification required for return), in practice, the guidance has been overruled to allow ROR (e.g., no CLIA lab performs the assay). An IRB-researcher partnership is needed to help inform responsible and feasible institutional approaches to returning research results.
language: eng
source:
identifier: ISSN: 1098-3600
fulltext: no_fulltext
issn:
  • 1098-3600
  • 1530-0366
url: Link


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titleIRB perspectives on the return of individual results from genomic research
creatorDressler, Lynn G ; Smolek, Sondra ; Ponsaran, Roselle ; Markey, Janell M ; Starks, Helene ; Gerson, Nancy ; Lewis, Susan ; Press, Nancy ; Juengst, Eric ; Wiesner, Georgia L
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descriptionReturn of individual research results from genomic studies is a hotly debated ethical issue in genomic research. However, the perspective of key stakeholders-institutional review board (IRB) professionals-has been missing from this dialogue. This study explores the positions and experiences of IRB members and staff regarding this issue. In-depth interviews with 31 IRB professionals at six sites across the United States. IRB professionals agreed that research results should be returned to research participants when results are medically actionable but only if the participants want to know the results. Many respondents expected researchers to address the issue of return of results (ROR) in the IRB application and informed-consent document. Many respondents were not comfortable with their expertise in genomics research and only a few described actual experiences in addressing ROR. Although participants agreed that guidelines would be helpful, most were reticent to develop them in isolation. Even where IRB guidance exists (e.g., Clinical Laboratory Improvement Act (CLIA) lab certification required for return), in practice, the guidance has been overruled to allow ROR (e.g., no CLIA lab performs the assay). An IRB-researcher partnership is needed to help inform responsible and feasible institutional approaches to returning research results.
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subjectArticle ; Consent Forms - ethics ; Decision Making ; disclosure of results ; Ethics Committees, Research - ethics ; Ethics Committees, Research - organization & administration ; Female ; genetic research ; Genetic Research - ethics ; genomic research ; Guidelines as Topic ; Health Personnel - organization & administration ; Health Personnel - psychology ; Humans ; Institutional Review Boards ; Male ; return of results
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1Smolek, Sondra
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notesGRRIP Consortium: The Genetic Research Review Issues Project (GRRIP) is a collaborative, multi-site consortium examining genomic researchers’ and IRB professionals’ views, positions and perspectives on several aspects of the review and conduct of human genomic research. Additional members include: Jo Boughman, American Society of Human Genetics, Bethesda; Wylie Burke, University of Washington, Seattle; Karen Edwards, University of Washington; Seattle; William Freeman, Northwest Indian College, Bellingham; Mary Quinn-Griffin, Case Western Reserve University, Cleveland; Amy Lemke, Northwestern University, Chicago; Patricia Marshall, Case Western Reserve University, Cleveland; Pearle O’Rourke, Partners HealthCare Systems, Boston; Susan Brown Trinidad, University of Washington, Seattle.
abstractReturn of individual research results from genomic studies is a hotly debated ethical issue in genomic research. However, the perspective of key stakeholders-institutional review board (IRB) professionals-has been missing from this dialogue. This study explores the positions and experiences of IRB members and staff regarding this issue. In-depth interviews with 31 IRB professionals at six sites across the United States. IRB professionals agreed that research results should be returned to research participants when results are medically actionable but only if the participants want to know the results. Many respondents expected researchers to address the issue of return of results (ROR) in the IRB application and informed-consent document. Many respondents were not comfortable with their expertise in genomics research and only a few described actual experiences in addressing ROR. Although participants agreed that guidelines would be helpful, most were reticent to develop them in isolation. Even where IRB guidance exists (e.g., Clinical Laboratory Improvement Act (CLIA) lab certification required for return), in practice, the guidance has been overruled to allow ROR (e.g., no CLIA lab performs the assay). An IRB-researcher partnership is needed to help inform responsible and feasible institutional approaches to returning research results.
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