Patients’ willingness to provide their clinical data for research purposes and acceptance of different consent models: Findings from a representative survey of cancer patients in Germany (Preprint)

Abstract

BACKGROUND Secondary use of clinical data for biomedical research purposes holds great potential for various types of non-interventional, 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 is to learn about patients’ attitudes and expectations regarding secondary use of their clinical data in order to inform the development of an appropriate governance framework for secondary use of clinical data for research purposes. METHODS A questionnaire was developed to assess willingness of cancer patients 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 cancer patients/survivors based on a full census. RESULTS 838 participants completed the survey. Nearly all participants showed general willingness to make clinical data available for biomedical research purposes (97%); 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. The majority supported data use also by researchers in commercial companies (74%). More than half of the participants were willing to give up control over clinical data in favour of research benefits (60%). The majority expressed acceptance of the Broad Consent model (59%), followed by the Opt-Out model (50%); specific consent for every study showed the lowest acceptance rate (39%). Patients expected physicians to share their data (91%), and expected their fellow patients to support secondary use with their clinical data (81%). CONCLUSIONS While 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 re-use and sharing. The willingness to accept loss of control over clinical data in order to enhance the benefits of research should be given special consideration.

Physicians’ Attitudes towards Secondary Use of Clinical Data for Biomedical Research Purposes in Germany. Results of a Quantitative Survey

“…Our study further found a majority of physicians viewing the support of secondary use as a moral duty of peer physicians (68%). This view resonates with the results of a study we have previously conducted in which cancer patients attributed an obligation to their physicians to support secondary use (91%) (12). An ethical discussion of such a duty to support secondary use seems essential in order to resolve the tension of conflicting duties.…”