Secondary use of health care data and left-over biosamples within the ‘Medical Informatics Initiative’ (MII): a quasi-randomized controlled evaluation of patient perceptions and preferences regarding the consent process

Abstract

Background Data collected during routine health care and ensuing analytical results bear the potential to provide valuable information to improve the overall health care of patients. However, little is known about how patients prefer to be informed about the possible usage of their routine data and/or biosamples for research purposes before reaching a consent decision. Specifically, we investigated the setting, the timing and the responsible staff for the information and consent process. Methods We performed a quasi-randomized controlled trial and compared the method by which patients were informed either in the patient admission area following patient admission by the same staff member (Group A) or in a separate room by another staff member (Group B). The consent decision was hypothetical in nature. Additionally, we evaluated if there was the need for additional time after the information session and before taking the consent decision. Data were collected during a structured interview based on questionnaires where participants reflected on the information and consent process they went through. Results Questionnaire data were obtained from 157 participants in Group A and 106 participants in Group B. Overall, participants in both groups were satisfied with their experienced process and with the way information was provided. They reported that their (hypothetical) consent decision was freely made. Approximately half of the interested participants in Group B did not show up in the separate room, while all interested participants in Group A could be informed about the secondary use of their routine data and left-over samples. No participants, except for one in Group B, wanted to take extra time for their consent decision. The hypothetical consent rate for both routine data and left-over samples was very high in both groups. Conclusions The willingness to support medical research by allowing the use of routine data and left-over samples seems to be widespread among patients. Information concerning this secondary data use may be given by trained administrative staff immediately following patient admission. Patients mainly prefer making a consent decision directly after information is provided and discussed. Furthermore, less patients are informed when the process is organized in a separate room.

National standardisierter Broad Consent in der Praxis: erste Erfahrungen, aktuelle Entwicklungen und kritische Betrachtungen

“…Mit Vertreterinnen und Vertretern von Patientenverbänden wurden zu den Einwilligungsdokumenten sowie zu den Rahmenbedingungen der informierten Einwilligung 2 strukturierte Workshops gemeinsam mit der AG Kommunikation der MII durchgeführt. Zudem wurden am Standort Greifswald Patienten zu ihren Erfahrungen sowie ihrem Verständnis des Einwilligungsprozesses befragt [ 18 ]. Weitere Anfragen kamen durch vielfältige Vernetzungsaktivitäten der MII zustande, wie die enge Kooperation mit dem Netzwerk Universitätsmedizin (NUM) und hier insbesondere der Steuerungsgruppe Forschungsinfrastrukturen.…”