Patients’ Willingness to Provide Their Clinical Data for Research Purposes and Acceptance of Different Consent Models: Findings From a Representative Survey of Patients With Cancer

Abstract

Background Secondary use of clinical data for biomedical research purposes holds great potential for various types of noninterventional, data-driven studies. Patients’ willingness to support research with their clinical data is a crucial prerequisite for research progress. Objective The aim of the study was to learn about patients’ attitudes and expectations regarding secondary use of their clinical data. In a next step, our results can inform the development of an appropriate governance framework for secondary use of clinical data for research purposes. Methods A questionnaire was developed to assess the willingness of patients with cancer to provide their clinical data for biomedical research purposes, considering different conditions of data sharing and consent models. The Cancer Registry of the German federal state of Baden-Württemberg recruited a proportionally stratified random sample of patients with cancer and survivors of cancer based on a full census. Results In total, 838 participants completed the survey. Approximately all participants (810/838, 96.7%) showed general willingness to make clinical data available for biomedical research purposes; however, they expected certain requirements to be met, such as comparable data protection standards for data use abroad and the possibility to renew consent at regular time intervals. Most participants (620/838, 73.9%) supported data use also by researchers in commercial companies. More than half of the participants (503/838, 60%) were willing to give up control over clinical data in favor of research benefits. Most participants expressed acceptance of the broad consent model (494/838, 58.9%), followed by data use by default (with the option to opt out at any time; 419/838, 50%); specific consent for every study showed the lowest acceptance rate (327/838, 39%). Patients expected physicians to share their data (763/838, 91.1%) and their fellow patients to support secondary use with their clinical data (679/838, 81%). Conclusions Although patients’ general willingness to make their clinical data available for biomedical research purposes is very high, the willingness of a substantial proportion of patients depends on additional requirements. Taking these perspectives into account is essential for designing trustworthy governance of clinical data reuse and sharing. The willingness to accept the loss of control over clinical data to enhance the benefits of research should be given special consideration.

Patient data for commercial companies? An ethical framework for sharing patients’ data with for-profit companies for research

“…research. [18][19][20] In other countries, acceptance rates for Reuse-ForPro range between 50% and 60%, as has been shown for Australia 21 and the UK. 22 Moreover, in the UK study in question, 44% of those participants who were not willing to share their data with for-profit companies 'earlier in the survey, agreed […] that research should be conducted by commercial organisations if, otherwise, the research would not take place.'…”

Implementation of precision medicine in healthcare—A European perspective

“…Two more recent aspects that are worth highlighting are patient and public involvement as well as equal access to precision diagnostics. We have witnessed in the last years that patients are a driving force in almost every aspect of PM: They largely support secondary research with their data [32] and are advocates for research, especially in underfunded areas [33]. Patients have a specific interest that their data also yield a benefit, that data initiatives are trustworthy, and, hence, that they are involved as patient experts in the governance of larger data initiatives.…”

Dateninfrastrukturen für die Gesundheitsforschung

“…Private forschende Unternehmen spielen generell eine große Rolle für die Forschung in Deutschland, speziell mit Blick auf die Entwicklung neuer Therapien. Dennoch sehen Patient:innen und Bürger:innen es kritischer als bei öffentlich-akademischen Forschungseinrichtungen, dass privatwirtschaftliche Unternehmen Zugang zu und Nutzungsrechte an ihren Daten haben sollen [ 14 ]. Aus ethischer Perspektive ist eine Einbeziehung von privatwirtschaftlichen Unternehmen zu medizinischen Forschungszwecken wünschenswert, wenn sie die Rechte und Sorgen der Patient:innen (und Bürger:innen) angemessen berücksichtigt und auch einen klaren Mehrwert für das öffentliche Gesundheitswesen und letztlich das Gemeinwohl schafft.…”