- DOI:
-
https://doi.org/10.57187/4812
Original article
Vol. 156 No. 6 (2026)
General consent: a mixed-method and patient-inclusive approach to explore and optimise information strategies
-
Cite this as:
-
Swiss Med Wkly. 2026;156:4812
-
Published
-
11.06.2026
Summary
STUDY AIMS: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
References
- 1. D'Abramo F. Biobank research, informed consent and society. Towards a new alliance? J Epidemiol Community Health. 2015;69(11):1125-8. Epub 20150210. doi: 10.1136/jech-2014-205215. PubMed PMID: 25669218.
- 2. Anderson EE, Newman SB, Matthews AK. Improving informed consent: Stakeholder views. AJOB Empir Bioeth. 2017;8(3):178-88. Epub 20170802. doi: 10.1080/23294515.2017.1362488. PubMed PMID: 28949896; PubMed Central PMCID: PMCPMC5749407.
- 3. Ballard LM, Horton RH, Dheensa S, Fenwick A, Lucassen AM. Exploring broad consent in the context of the 100,000 Genomes Project: a mixed methods study. Eur J Hum Genet. 2020;28(6):732-41. Epub 20200109. doi: 10.1038/s41431-019-0570-7. PubMed PMID: 31919452; PubMed Central PMCID: PMCPMC7253456.
- 4. Barazzetti G, Bosisio F, Koutaissoff D, Spencer B. Broad consent in practice: lessons learned from a hospital-based biobank for prospective research on genomic and medical data. Eur J Hum Genet. 2020;28(7):915-24. Epub 20200221. doi: 10.1038/s41431-020-0585-0. PubMed PMID: 32086443; PubMed Central PMCID: PMCPMC7316733.
- 5. Bosisio F, Barazzetti G, Koutaissoff D, Spencer B. Patients' decision to contribute to a biobank in the light of the patient-recruiter relationship-a qualitative study of broad consent in a hospital setting. J Community Genet. 2021;12(1):15-25. Epub 20200810. doi: 10.1007/s12687-020-00479-z. PubMed PMID: 32779150; PubMed Central PMCID: PMCPMC7846645.
- 6. Cheah PY, Jatupornpimol N, Hanboonkunupakarn B, Khirikoekkong N, Jittamala P, Pukrittayakamee S, et al. Challenges arising when seeking broad consent for health research data sharing: a qualitative study of perspectives in Thailand. BMC Med Ethics. 2018;19(1):86. Epub 20181107. doi: 10.1186/s12910-018-0326-x. PubMed PMID: 30404642; PubMed Central PMCID: PMCPMC6223036.
- 7. Bochud M, Currat C, Chapatte L, Roth C, Mooser V. High participation rate among 25 721 patients with broad age range in a hospital-based research project involving whole-genome sequencing - the Lausanne Institutional Biobank. Swiss Med Wkly. 2017;147:w14528. Epub 20171020. doi: 10.4414/smw.2017.14528. PubMed PMID: 29063527.
- 8. Humanforschungsgesetz. Die Bundesversammlung der Schweizerischen Eidgenossenschaft. Bundesgesetz über die Forschung am Menschen. https://www.admin.ch/opc/de/classified-compilation/20061313/index.html#2014
- 9. Sanderson SC, Brothers KB, Mercaldo ND, Clayton EW, Antommaria AHM, Aufox SA, et al. Public Attitudes toward Consent and Data Sharing in Biobank Research: A Large Multi-site Experimental Survey in the US. Am J Hum Genet. 2017;100(3):414-27. Epub 20170209. doi: 10.1016/j.ajhg.2017.01.021. PubMed PMID: 28190457; PubMed Central PMCID: PMCPMC5339111.
- 10. Griessbach A, Bauer A, Jorger Lebet F, Grossmann R. The concept of General Consent in Switzerland and the implementation at the University Hospital Zurich, a cross-sectional study. Swiss Med Wkly. 2022;152:w30159. Epub 20220414. doi: 10.4414/smw.2022.w30159. PubMed PMID: 35429239. doi: https://doi.org/10.4414/SMW.2022.w30159
- 11. Bosmani C, Carboni S, Samer C, Lovis C, Perneger T, Huttner A, et al. REPRESENT: REPresentativeness of RESearch data obtained through the 'General Informed ConsENT'. BMC Med Ethics. 2023;24(1):10. Epub 20230213. doi: 10.1186/s12910-022-00877-7. PubMed PMID: 36782161; PubMed Central PMCID: PMCPMC9926654.
- 12. Gerber DE, Rasco DW, Skinner CS, Dowell JE, Yan J, Sayne JR, et al. Consent timing and experience: modifiable factors that may influence interest in clinical research. J Oncol Pract. 2012;8(2):91-6. Epub 20111206. doi: 10.1200/JOP.2011.000335. PubMed PMID: 23077435; PubMed Central PMCID: PMCPMC3457835.
- 13. Braun VC. Thematic analysis. APA handbook of research methods in psychology, Vol 2: Research designs: Quantitative, qualitative, neuropsychological, and biological. psychology® Ahi, editor: American Psychological Association; 2012 2012. 14 p. doi: https://doi.org/10.1037/13620-004
- 14. Nielsen MEJ, Kongsholm NCH. Blanket Consent and Trust in the Biobanking Context. J Bioeth Inq. 2022;19(4):613-23. Epub 20220906. doi: 10.1007/s11673-022-10208-5. PubMed PMID: 36068428.
- 15. Hong SJ, Drake B, Goodman M, Kaphingst KA. Race, Trust in Doctors, Privacy Concerns, and Consent Preferences for Biobanks. Health Commun. 2020;35(10):1219-28. Epub 20190605. doi: 10.1080/10410236.2019.1623644. PubMed PMID: 31167570; PubMed Central PMCID: PMCPMC6893100.
- 16. Grande D, Mitra N, Shah A, Wan F, Asch DA. Public preferences about secondary uses of electronic health information. JAMA Intern Med. 2013;173(19):1798-806. doi: 10.1001/jamainternmed.2013.9166. PubMed PMID: 23958803; PubMed Central PMCID: PMCPMC4083587.
- 17. de Man Y, Wieland-Jorna Y, Torensma B, de Wit K, Francke AL, Oosterveld-Vlug MG, et al. Opt-In and Opt-Out Consent Procedures for the Reuse of Routinely Recorded Health Data in Scientific Research and Their Consequences for Consent Rate and Consent Bias: Systematic Review. J Med Internet Res. 2023;25:e42131. Epub 20230228. doi: 10.2196/42131. PubMed PMID: 36853745; PubMed Central PMCID: PMCPMC10015347.
- 18. Kassam I, Ilkina D, Kemp J, Roble H, Carter-Langford A, Shen N. Patient Perspectives and Preferences for Consent in the Digital Health Context: State-of-the-art Literature Review. J Med Internet Res. 2023;25:e42507. Epub 20230210. doi: 10.2196/42507. PubMed PMID: 36763409; PubMed Central PMCID: PMCPMC9960046.
- 19. Budin-Ljosne I, Teare HJ, Kaye J, Beck S, Bentzen HB, Caenazzo L, et al. Dynamic Consent: a potential solution to some of the challenges of modern biomedical research. BMC Med Ethics. 2017;18(1):4. Epub 20170125. doi: 10.1186/s12910-016-0162-9. PubMed PMID: 28122615; PubMed Central PMCID: PMCPMC5264333.
- 20. Goldschmitt M, Gleim P, Mandelartz S, Kellmeyer P, Rigotti T. Digitalizing informed consent in healthcare: a scoping review. BMC Health Serv Res. 2025;25(1):893. Epub 20250702. doi: 10.1186/s12913-025-12964-7. PubMed PMID: 40604763; PubMed Central PMCID: PMCPMC12225439.
- 21. Tosoni S, Voruganti I, Lajkosz K, Habal F, Murphy P, Wong RKS, et al. The use of personal health information outside the circle of care: consent preferences of patients from an academic health care institution. BMC Med Ethics. 2021;22(1):29. Epub 20210324. doi: 10.1186/s12910-021-00598-3. PubMed PMID: 33761938; PubMed Central PMCID: PMCPMC7992944.
- 22. Ghafur S, Van Dael J, Leis M, Darzi A, Sheikh A. Public perceptions on data sharing: key insights from the UK and the USA. Lancet Digit Health. 2020;2(9):e444-e6. Epub 20200724. doi: 10.1016/S2589-7500(20)30161-8. PubMed PMID: 32838250; PubMed Central PMCID: PMCPMC7380931.
- 23. Richter G, Borzikowsky C, Hoyer BF, Laudes M, Krawczak M. Secondary research use of personal medical data: patient attitudes towards data donation. BMC Med Ethics. 2021;22(1):164. Epub 20211215. doi: 10.1186/s12910-021-00728-x. PubMed PMID: 34911502; PubMed Central PMCID: PMCPMC8672332.
- 24. Tosoni S, Voruganti I, Lajkosz K, Mustafa S, Phillips A, Kim SJ, et al. Patient consent preferences on sharing personal health information during the COVID-19 pandemic: "the more informed we are, the more likely we are to help". BMC Med Ethics. 2022;23(1):53. Epub 20220520. doi: 10.1186/s12910-022-00790-z. PubMed PMID: 35596210; PubMed Central PMCID: PMCPMC9122733.
- 25. Trinidad MG, Platt J, Kardia SLR. The public's comfort with sharing health data with third-party commercial companies. Humanit Soc Sci Commun. 2020;7(1). Epub 20201111. doi: 10.1057/s41599-020-00641-5. PubMed PMID: 34337435; PubMed Central PMCID: PMCPMC8320359.
- 26. Lee AR, Koo D, Kim IK, Lee E, Yoo S, Lee HY. Opportunities and challenges of a dynamic consent-based application: personalized options for personal health data sharing and utilization. BMC Med Ethics. 2024;25(1):92. Epub 20240831. doi: 10.1186/s12910-024-01091-3. PubMed PMID: 39217356; PubMed Central PMCID: PMCPMC11365279.