General consent: a mixed-method and patient-inclusive approach to explore and optimise information strategies

Little is known about the factors influencing patients' response and decision rates to requests for general consent, designed to cover the use of health-related personal data and biological samples, in tertiary university hospitals. As such, we first sought to evaluate different general consent administration modes implemented at Lausanne University Hospital between December 2012 and April 2022, based on the following indicators (i) information rates, (ii) response rates and (iii) consent rates. The second objective of the study was to assess patients' understanding, preferences, needs and expectations regarding the content, form and mode of administration of general consent.

This mixed-methods study comprised two phases. First, we analysed retrospective administrative data and general consent-related information from 178,223 adult patients who had been informed about general consent. Second, we analysed 2445 anonymised questionnaires mailed to patients as well as 4737 patient communications, and conducted 32 semi-structured telephone interviews.

The information-provision mode and clinical context influence patients' response to general consent.Oral information given by healthcare providers within medical departments is the most effective way of informing patients and making them reach a decision about granting general consent. However, 73.3% of questionnaire respondents considered that written information supported by a hotline is sufficient. Patients referred to the emergency room, following an accident for example, are less likely to respond to and grant general consent. Even though most respondents claim to fully grasp the information material, some topics seem less well understood and require additional explanations, such as the use of health-related personal data and biological samples in external institutions and the consequences of not replying to general consent.

The study provides an accurate data-driven depiction of how general consent administration methods and clinical contexts impact patients' response and decision rates, as well as an assessment of patients' understanding and needs concerning general consent information. These data allow us to confirm the validity of several practices, draw lessons and propose pragmatic recommendations to optimise general consent administration in hospitals, specifically: 1) Promote general consent information provision before or during the hospital visit or stay, 2) If a patient has not replied to general consent, repeat the information in a more favourable clinical context, 3) Diversify information channels and explore digital options for more-personalised and adapted information, 4) Simplify, clarify and illustrate general consent documentation with concrete examples of research enabled by general consent.