Patient Preferences for Use of Archived Biospecimens from Oncology Trials When Adequacy of Informed Consent Is Unclear.
Biobank
Cancer trials
Informed consent
Patient survey
Research ethics
Journal
The oncologist
ISSN: 1549-490X
Titre abrégé: Oncologist
Pays: England
ID NLM: 9607837
Informations de publication
Date de publication:
01 2020
01 2020
Historique:
received:
13
05
2019
accepted:
17
07
2019
pubmed:
8
9
2019
medline:
15
12
2020
entrez:
8
9
2019
Statut:
ppublish
Résumé
Oncology research increasingly involves biospecimen collection and data sharing. Ethical challenges emerge when researchers seek to use archived biospecimens for purposes that were not well defined in the original informed consent document (ICD). We sought to inform ongoing policy debates by assessing patient views on these issues. We administered a cross-sectional self-administered survey to patients with cancer at an academic medical center. Survey questions addressed attitudes toward cancer research, willingness to donate biospecimens, expectations regarding use of biospecimens, and preferences regarding specific ethical dilemmas. Among 240 participants (response rate 69%), virtually all (94%) indicated willingness to donate tissue for research. Most participants (86%) expected that donated tissue would be used for any research deemed scientifically important, and virtually all (94%) expected that the privacy of their health information would be protected. Broad use of stored biospecimens and data sharing with other researchers increased willingness to donate tissue. For three scenarios in which specific consent for proposed biobank research was unclear within the ICD, a majority of patient's favored allowing the research to proceed: 76% to study a different cancer, 88% to study both inherited (germline) and tumor specific (somatic) mutations, and 70% to permit data sharing. A substantial minority believed that research using stored biospecimens should only proceed with specific consent. When debates arise over appropriate use of archived biospecimens, the interests of the research participants in seeing productive use of their blood or tissue should be considered, in addition to addressing concerns about potential risks and lack of specific consent. This survey evaluated views of patients with cancer regarding the permissible use of stored biospecimens from cancer trials when modern scientific methods are not well described in the original informed consent document. The vast majority of patients support translational research and expect that any biospecimens they donate will be used to advance knowledge. When researchers, policy makers, and those charged with research oversight debate use of stored biospecimens, it is important to recognize that research participants have an interest in productive use of their blood, tissue, or data, in addition to considerations of risks and the adequacy of documented consent.
Sections du résumé
BACKGROUND
Oncology research increasingly involves biospecimen collection and data sharing. Ethical challenges emerge when researchers seek to use archived biospecimens for purposes that were not well defined in the original informed consent document (ICD). We sought to inform ongoing policy debates by assessing patient views on these issues.
MATERIALS AND METHODS
We administered a cross-sectional self-administered survey to patients with cancer at an academic medical center. Survey questions addressed attitudes toward cancer research, willingness to donate biospecimens, expectations regarding use of biospecimens, and preferences regarding specific ethical dilemmas.
RESULTS
Among 240 participants (response rate 69%), virtually all (94%) indicated willingness to donate tissue for research. Most participants (86%) expected that donated tissue would be used for any research deemed scientifically important, and virtually all (94%) expected that the privacy of their health information would be protected. Broad use of stored biospecimens and data sharing with other researchers increased willingness to donate tissue. For three scenarios in which specific consent for proposed biobank research was unclear within the ICD, a majority of patient's favored allowing the research to proceed: 76% to study a different cancer, 88% to study both inherited (germline) and tumor specific (somatic) mutations, and 70% to permit data sharing. A substantial minority believed that research using stored biospecimens should only proceed with specific consent.
CONCLUSION
When debates arise over appropriate use of archived biospecimens, the interests of the research participants in seeing productive use of their blood or tissue should be considered, in addition to addressing concerns about potential risks and lack of specific consent.
IMPLICATIONS FOR PRACTICE
This survey evaluated views of patients with cancer regarding the permissible use of stored biospecimens from cancer trials when modern scientific methods are not well described in the original informed consent document. The vast majority of patients support translational research and expect that any biospecimens they donate will be used to advance knowledge. When researchers, policy makers, and those charged with research oversight debate use of stored biospecimens, it is important to recognize that research participants have an interest in productive use of their blood, tissue, or data, in addition to considerations of risks and the adequacy of documented consent.
Identifiants
pubmed: 31492767
pii: theoncologist.2019-0365
doi: 10.1634/theoncologist.2019-0365
pmc: PMC6964122
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
78-86Informations de copyright
© AlphaMed Press 2019.
Références
BMC Med Ethics. 2015 Sep 09;16:60
pubmed: 26354520
Genet Test Mol Biomarkers. 2013 Apr;17(4):327-35
pubmed: 23406207
Eur J Hum Genet. 2014 Aug;22(8):964-8
pubmed: 24281371
N Engl J Med. 2015 Dec 10;373(24):2293-6
pubmed: 26509903
Life Sci Soc Policy. 2016;12:3
pubmed: 26968989
Genet Med. 2010 Feb;12(2):116-21
pubmed: 20098329
Soc Sci Med. 2016 Aug;162:79-87
pubmed: 27343817
PLoS Biol. 2017 Jul 25;15(7):e2002654
pubmed: 28742850
PLoS Genet. 2008 Aug 29;4(8):e1000167
pubmed: 18769715
Genet Med. 2016 Jul;18(7):663-71
pubmed: 26583683
PLoS One. 2017 Feb 24;12(2):e0172957
pubmed: 28235011
Oncologist. 2019 Dec;24(12):1577-1583
pubmed: 31182655
Soc Sci Med. 2010 Jan;70(2):217-20
pubmed: 19853341
Genet Med. 2017 May;19(5):505-512
pubmed: 27735922
Nat Biotechnol. 2007 Sep;25(9):973-6
pubmed: 17846619
PLoS One. 2015 Jul 08;10(7):e0129893
pubmed: 26154134
Lancet. 2001 Nov 24;358(9295):1772-7
pubmed: 11734235
Health Aff (Millwood). 2018 Aug;37(8):1313-1320
pubmed: 30080467
Eur J Med Genet. 2016 Jun;59(6-7):295-309
pubmed: 27130428
Cell Tissue Bank. 2008 Mar;9(1):55-65
pubmed: 17960495
Cancer. 2016 Feb 1;122(3):464-9
pubmed: 26505269
Am J Bioeth. 2015;15(9):34-42
pubmed: 26305750
BMC Med Ethics. 2013 Apr 02;14:17
pubmed: 23547565
J Natl Cancer Inst Monogr. 2011;2011(42):1-7
pubmed: 21672889
Cancer. 2012 Oct 15;118(20):5060-8
pubmed: 22415847
Am J Bioeth. 2019 May;19(5):6-18
pubmed: 31068107
Oncologist. 2005 Sep;10(8):636-41
pubmed: 16177288
Biopreserv Biobank. 2014 Apr;12(2):106-12
pubmed: 24749877
BMC Cancer. 2015 May 17;15:413
pubmed: 25981796
Genet Med. 2009 Oct;11(10):712-5
pubmed: 19745750
Soc Sci Med. 2011 Aug;73(3):367-74
pubmed: 21726926
Eur J Hum Genet. 2015 Dec;23(12):1607-14
pubmed: 25735479
Am J Med Genet A. 2006 Apr 1;140(7):733-9
pubmed: 16523508
Cancer Invest. 2010 Aug;28(7):726-34
pubmed: 20590448