Literature DB >> 22323073

Practical implementation issues and challenges for biobanks in the return of individual research results.

Marianna J Bledsoe1, William E Grizzle, Brian J Clark, Nikolajs Zeps.   

Abstract

Whether or not to give research results back to individuals whose specimens are used for biomedical research is a subject of considerable controversy. Much of the debate has been focused around the ethical and legal concerns with some consideration of broader social issues such as whether or not people will be affected by such information for employment or health care. Much less attention has been paid to biobanks that collect the specimens used to generate the research findings and the issues and operational requirements for implementing return of individual research results. In this article, we give the biobanks' perspective and highlight that given the diversity among the types of biobanks, it may be difficult to design and implement a blanket policy in this complex area. We discuss the variability in the types of biobanks and some important issues that should be considered in determining whether or not research results should be provided to individuals whose specimens are used in biomedical research. We also discuss challenges that should be considered in implementing any approaches to the return of research results.

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Mesh:

Year:  2012        PMID: 22323073      PMCID: PMC3388905          DOI: 10.1038/gim.2011.67

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


  28 in total

1.  Do we need a uniform regulatory system for biobanks across Europe?

Authors:  Jane Kaye
Journal:  Eur J Hum Genet       Date:  2006-02       Impact factor: 4.246

2.  UK Biobank: from concept to reality.

Authors:  William Ollier; Tim Sprosen; Tim Peakman
Journal:  Pharmacogenomics       Date:  2005-09       Impact factor: 2.533

3.  Disclosing individual results of clinical research: implications of respect for participants.

Authors:  David I Shalowitz; Franklin G Miller
Journal:  JAMA       Date:  2005-08-10       Impact factor: 56.272

4.  Public perspectives on returning genetics and genomics research results.

Authors:  J O'Daniel; S B Haga
Journal:  Public Health Genomics       Date:  2011-05-07       Impact factor: 2.000

5.  Missing part delays space mission.

Authors:  Eugenie Samuel Reich
Journal:  Nature       Date:  2011-01-20       Impact factor: 49.962

6.  Offering individual genetic research results: context matters.

Authors:  Laura M Beskow; Wylie Burke
Journal:  Sci Transl Med       Date:  2010-06-30       Impact factor: 17.956

7.  Biospecimen Reporting for Improved Study Quality.

Authors:  Helen M Moore; Andrea Kelly; Scott D Jewell; Lisa M McShane; Douglas P Clark; Renata Greenspan; Pierre Hainaut; Daniel F Hayes; Paula Kim; Elizabeth Mansfield; Olga Potapova; Peter Riegman; Yaffa Rubinstein; Edward Seijo; Stella Somiari; Peter Watson; Heinz-Ulrich Weier; Claire Zhu; Jim Vaught
Journal:  Biopreserv Biobank       Date:  2011-04       Impact factor: 2.300

8.  Communication of biobanks' research results: what do (potential) participants want?

Authors:  Tineke M Meulenkamp; Sjef K Gevers; Jasper A Bovenberg; Gerard H Koppelman; Astrid van Hylckama Vlieg; Ellen M A Smets
Journal:  Am J Med Genet A       Date:  2010-10       Impact factor: 2.802

9.  Views of female breast cancer patients who donated biologic samples regarding storage and use of samples for genetic research.

Authors:  K A Kaphingst; J M Janoff; L N Harris; K M Emmons
Journal:  Clin Genet       Date:  2006-05       Impact factor: 4.438

10.  Specimen labeling errors: a Q-probes analysis of 147 clinical laboratories.

Authors:  Elizabeth A Wagar; Ana K Stankovic; Stephen Raab; Raouf E Nakhleh; Molly K Walsh
Journal:  Arch Pathol Lab Med       Date:  2008-10       Impact factor: 5.534

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  38 in total

1.  Returning a Research Participant's Genomic Results to Relatives: Analysis and Recommendations.

Authors:  Susan M Wolf; Rebecca Branum; Barbara A Koenig; Gloria M Petersen; Susan A Berry; Laura M Beskow; Mary B Daly; Conrad V Fernandez; Robert C Green; Bonnie S LeRoy; Noralane M Lindor; P Pearl O'Rourke; Carmen Radecki Breitkopf; Mark A Rothstein; Brian Van Ness; Benjamin S Wilfond
Journal:  J Law Med Ethics       Date:  2015       Impact factor: 1.718

2.  Practical guidance on informed consent for pediatric participants in a biorepository.

Authors:  Kyle B Brothers; John A Lynch; Sharon A Aufox; John J Connolly; Bruce D Gelb; Ingrid A Holm; Saskia C Sanderson; Jennifer B McCormick; Janet L Williams; Wendy A Wolf; Armand H M Antommaria; Ellen W Clayton
Journal:  Mayo Clin Proc       Date:  2014-09-26       Impact factor: 7.616

3.  Challenges in returning results in a genomic medicine implementation study: the Return of Actionable Variants Empirical (RAVE) study.

Authors:  David C Kochan; Erin Winkler; Noralane Lindor; Gabriel Q Shaibi; Janet Olson; Pedro J Caraballo; Robert Freimuth; Joel E Pacyna; Carmen Radecki Breitkopf; Richard R Sharp; Iftikhar J Kullo
Journal:  NPJ Genom Med       Date:  2020-05-04       Impact factor: 8.617

4.  Pediatric Issues in Return of Results and Incidental Findings: Weighing Autonomy and Best Interests.

Authors:  Ingrid A Holm
Journal:  Genet Test Mol Biomarkers       Date:  2017-01-31

5.  Use of human specimens in research: the evolving United States regulatory, policy, and scientific landscape.

Authors:  Marianna J Bledsoe; William E Grizzle
Journal:  Diagn Histopathol (Oxf)       Date:  2013-09

6.  Managing the Ethical Issues of Genomic Research using Pathology Specimens.

Authors:  Nikolajs Zeps; Marianna J Bledsoe
Journal:  Clin Biochem Rev       Date:  2015-02

7.  Engaging Study Participants in Research Dissemination at a Center for Population Health and Health Disparities.

Authors:  Sarah Knerr; Sarah D Hohl; Yamile Molina; Marian L Neuhouser; Christopher I Li; Gloria D Coronado; Stephanie M Fullerton; Beti Thompson
Journal:  Prog Community Health Partnersh       Date:  2016

Review 8.  Evolving approaches to the ethical management of genomic data.

Authors:  Jean E McEwen; Joy T Boyer; Kathie Y Sun
Journal:  Trends Genet       Date:  2013-02-28       Impact factor: 11.639

9.  A role for research ethics committees in exchanges of human biospecimens through material transfer agreements.

Authors:  Donald Chalmers; Dianne Nicol; Pilar Nicolás; Nikolajs Zeps
Journal:  J Bioeth Inq       Date:  2014-06-26       Impact factor: 1.352

10.  Participant views on consent in cancer genetics research: preparing for the precision medicine era.

Authors:  Karen L Edwards; Diane M Korngiebel; Lesley Pfeifer; Deborah Goodman; Anne Renz; Lari Wenzel; Deborah J Bowen; Celeste M Condit
Journal:  J Community Genet       Date:  2016-01-22
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