Journal Article

Implementing broad consent for research with routinely collected clinical data and residual biosamples in a cancer hospital: using mixed methods approach to evaluate consent rates and patients’ perspectives

Broeks, Annegien, van Oord, Aaike, Schmidt, Marjanka K., Rebers, Susanne, van Luenen, Henri, Beusink, Miriam, Kist, Irith, van Scheijen, Sonja

2026

Overview

Background Patients are generally willing to contribute to research with routinely collected health data and residual biosamples, but transparency and being able to (to some extent) have control over data are important conditions. A broad consent procedure ensures that patients are informed, without overloading the patients with too many or repeated study-specific consents. In the context of implementation of broad consent, we investigated five aspects: response rates, whether patients felt informed and were able to reach a decision, whether the registered consent was in line with their desired consent, reasons for giving (no) consent or not responding, and suggestions to improve the procedure. Methods We analyzed consent decisions of 31,894 patients, recorded between May 2018 and December 2020 in a specialized cancer hospital. We also interviewed 64 patients selected from first-time visiting patients between October and November 2018 (25 with consent, 16 with no consent and 23 with no response). Results Consent rates were: 85.2% consented, 3.8% did not consent and 11% did not respond. The majority of the interviewees, who recalled that consent was asked, felt sufficiently informed. Those that needed more information, mostly had not (yet) read the information given to them, due to the hectic and emotional period. For the majority of our interviewees the desired consent decision matched with what was registered in the hospitals’ system. Reasons for giving consent were mostly motivational, e.g., altruism and solidarity. Reasons for not giving consent or not responding yet were mostly contextual, e.g., insufficient headspace and needing more time. Privacy concerns, e.g. mistakes resulting in data being publicly accessible, data linkage and hacking, were mentioned as well. Sometimes the reason to not give consent or not respond was based on misunderstanding, e.g. that consenting would require bureaucratic entanglements. Conclusions For high quality research with patient data and samples, broad consent from a large and representative patient population is essential, and patients must feel informed and be able to register their consent decision easily. Our novel consent procedure led to an 85.2% consent rate and desired consent decisions were mostly registered correctly. In addition, patients felt sufficiently informed.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adult / Aged / Analysis / Biological Specimen Banks / Biomedical Research - ethics / Broad consent / Brochures / Cancer / Cancer Care Facilities / Consent / CT imaging / Data Collection / Decision Making / Education / Electronic records / Ethical issues around patient confidentiality / Ethics / Female / Humans / Implementation in practice / Informed Consent - ethics / Male / Medical record linkage / Medical records / Medical research / Methods / Middle Aged / Mixed methods research / Neoplasms / Oncology, Experimental / Patient education / Patient information / Patients / Philosophy / Philosophy of Medicine / Professionals / Real-world data / Response rate / Secondary data use / Theory of Medicine/Bioethics / Web portals