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

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.

Genetic Data Aren't So Special: Causes and Implications of Reidentification

“…For example, Jeffrey Peppercorn and colleagues recently found that 65 percent of cancer patients in their study approved of the sharing of their leftover specimens after surgery, even without their consent. 36 Similarly, Michelle Mello et al found that 93 percent of respondents in their study, all of whom participated in clinical trials, were very or moderately willing to share both biospecimens and other health data as part of clinical trials. 37 Respondents also thought the possibility of being reidentified based on their information was very low, with few saying that identification (6.6 percent) or discrimination based on identification (5 percent) was among their biggest concerns.…”

“…Support is especially strong among those who are familiar with sharing health data. For example, Jeffrey Peppercorn and colleagues recently found that 65 percent of cancer patients in their study approved of the sharing of their leftover specimens after surgery, even without their consent 36 …”

“My Research Is Their Business, but I'm Not Their Business”: Patient and Clinician Perspectives on Commercialization of Precision Oncology Data

“…First, as appropriate for an exploratory qualitative design, the sample was small and drawn from a single precision oncology sequencing study of one disease site and might not be representative of patients with cancer generally. In addition, patients with cancer comprise a special population and might be more willing to contribute sensitive genetic data to research, given the serious nature of their disease, than other patients [22,23]. Also, we originally designed our interview instrument to assess participant feelings regarding profit investment rather than informed consent form comprehension; an explicit question or knowledge test about the consent form may have revealed such misunderstandings to be more widespread.…”

Patients’ and Members of the Public’s Wishes Regarding Transparency in the Context of Secondary Use of Health Data: Scoping Review

“…• Who: identity of data overseers [11,31,41,49,53,76,83,85,98,[100][101][102]115] and data users [11,31,33,34,36, about biobanking generally centered around the control and ownership of biological [11,31,52,[73][74][75][76][77][79][80][81]86,91,113,114,[40][41][42]49,[52][53][54]57,59,60, samples and data, especially with respect to potential misuse by insurers, the government and other third parties" (Joly et al [64] on the views of members of the public). 117,118] • "I'm just trying to say there is this framework, you know we say that there is a governance system in place which will protect the patient and we can look at them…”