Literature DB >> 22382800

Return of individual research results and incidental findings in the clinical trials cooperative group setting.

Michael Ferriere1, Brian Van Ness.   

Abstract

The National Cancer Institute (NCI)-funded cooperative group cancer clinical trial system develops experimental therapies and often collects samples from patients for correlative research. The cooperative group bank (CGB) system maintains biobanks with a current policy not to return research results to individuals. An online survey was created, and 10 directors of CGBs completed the surveys asking about understanding and attitudes in changing policies to consider return of incidental findings (IFs) and individual research results (IRRs) of health significance. The potential impact of the 10 consensus recommendations of Wolf et al. presented in this issue are examined. Reidentification of samples is often not problematic; however, changes to the current banking and clinical trial systems would require significant effort to fulfill an obligation of recontact of subjects. Additional resources, as well as a national advisory board would be required to standardize implementation.

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Year:  2012        PMID: 22382800      PMCID: PMC3712634          DOI: 10.1038/gim.2012.14

Source DB:  PubMed          Journal:  Genet Med        ISSN: 1098-3600            Impact factor:   8.822


  1 in total

Review 1.  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

  1 in total
  8 in total

1.  Returning a Research Participant's Genomic Results to Relatives: Perspectives from Managers of Two Distinct Research Biobanks.

Authors:  Gloria M Petersen; Brian Van Ness
Journal:  J Law Med Ethics       Date:  2015       Impact factor: 1.718

2.  Intentions to receive individual results from whole-genome sequencing among participants in the ClinSeq study.

Authors:  Flavia M Facio; Haley Eidem; Tyler Fisher; Stephanie Brooks; Amy Linn; Kimberly A Kaphingst; Leslie G Biesecker; Barbara B Biesecker
Journal:  Eur J Hum Genet       Date:  2012-08-15       Impact factor: 4.246

3.  Return of individual research results from genomic research: A systematic review of stakeholder perspectives.

Authors:  Danya F Vears; Joel T Minion; Stephanie J Roberts; James Cummings; Mavis Machirori; Mwenza Blell; Isabelle Budin-Ljøsne; Lorraine Cowley; Stephanie O M Dyke; Clara Gaff; Robert Green; Alison Hall; Amber L Johns; Bartha M Knoppers; Stephanie Mulrine; Christine Patch; Eva Winkler; Madeleine J Murtagh
Journal:  PLoS One       Date:  2021-11-08       Impact factor: 3.240

4.  Mapping the inputs, analyses, and outputs of biobank research systems to identify sources of incidental findings and individual research results for potential return to participants.

Authors:  Heather R Bemmels; Susan M Wolf; Brian Van Ness
Journal:  Genet Med       Date:  2012-03-01       Impact factor: 8.822

5.  Informed consent for next-generation nucleotide sequencing studies: Aiding communication between participants and investigators.

Authors:  Rhonda G Kost; Stephen M Poppel; Barry S Coller
Journal:  J Clin Transl Sci       Date:  2017-02-07

6.  A Systematic Review of the Management of Incidental Findings in Genomic Research.

Authors:  Cornelius Ewuoso
Journal:  BEOnline       Date:  2016-11-22

Review 7.  Providing trial results to participants in phase III pragmatic effectiveness RCTs: a scoping review.

Authors:  Hanne Bruhn; Elle-Jay Cowan; Marion K Campbell; Lynda Constable; Seonaidh Cotton; Vikki Entwistle; Rosemary Humphreys; Karen Innes; Sandra Jayacodi; Peter Knapp; Annabelle South; Katie Gillies
Journal:  Trials       Date:  2021-05-24       Impact factor: 2.279

8.  Finding people who will tell you their thoughts on genomics-recruitment strategies for social sciences research.

Authors:  A Middleton; E Bragin; M Parker
Journal:  J Community Genet       Date:  2014-02-18
  8 in total

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