Patient Preferences for Use of Archived Biospecimens from Oncology Trials When Adequacy of Informed Consent Is Unclear

Jeffrey Peppercorn, Eric Campbell, Steve Isakoff, Nora K. Horick, Julia Rabin, Katharine Quain, Lecia V. Sequist, Aditya Bardia, Deborah Collyar, Fay Hlubocky, Debra J Mathews

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
JournalOncologist
DOIs
StateAccepted/In press - Jan 1 2019

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Patient Preference
Informed Consent
Research
Consent Forms
Information Dissemination
Neoplasms
Research Personnel
Translational Medical Research
Privacy
Administrative Personnel
Mutation

Keywords

  • Biobank
  • Cancer trials
  • Informed consent
  • Patient survey
  • Research ethics

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Patient Preferences for Use of Archived Biospecimens from Oncology Trials When Adequacy of Informed Consent Is Unclear. / Peppercorn, Jeffrey; Campbell, Eric; Isakoff, Steve; Horick, Nora K.; Rabin, Julia; Quain, Katharine; Sequist, Lecia V.; Bardia, Aditya; Collyar, Deborah; Hlubocky, Fay; Mathews, Debra J.

In: Oncologist, 01.01.2019.

Research output: Contribution to journalArticle

Peppercorn, J, Campbell, E, Isakoff, S, Horick, NK, Rabin, J, Quain, K, Sequist, LV, Bardia, A, Collyar, D, Hlubocky, F & Mathews, DJ 2019, 'Patient Preferences for Use of Archived Biospecimens from Oncology Trials When Adequacy of Informed Consent Is Unclear', Oncologist. https://doi.org/10.1634/theoncologist.2019-0365
Peppercorn, Jeffrey ; Campbell, Eric ; Isakoff, Steve ; Horick, Nora K. ; Rabin, Julia ; Quain, Katharine ; Sequist, Lecia V. ; Bardia, Aditya ; Collyar, Deborah ; Hlubocky, Fay ; Mathews, Debra J. / Patient Preferences for Use of Archived Biospecimens from Oncology Trials When Adequacy of Informed Consent Is Unclear. In: Oncologist. 2019.
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abstract = "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.",
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AU - Rabin, Julia

AU - Quain, Katharine

AU - Sequist, Lecia V.

AU - Bardia, Aditya

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AU - Mathews, Debra J

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