##common.pageHeaderLogo.altText##

Original article

Vol. 155 No. 5 (2025)

Socio-demographic and clinical factors affecting General Consent status and choice: insights from a cross-sectional study of University Hospital Zurich patients

Cite this as:
Swiss Med Wkly. 2025;155:3685
Published
26.05.2025

Summary

BACKGROUND: Hospitals in Switzerland accumulate substantial clinical data with enormous potential for medical research. The General Consent concept allows patients to contribute their health-related data and biological samples for future research projects. However, General Consent is a complex, multi-disciplinary concept influenced by ethical and legal considerations. At the University Hospital Zurich, Switzerland, General Consent status (known/unknown) and choice (yes/no) have been documented since 2015 and have demonstrated consistent increases in coverage rates. This study investigated socio-demographic factors influencing General Consent status and choice to enhance patient communication and refine the General Consent process at the University Hospital Zurich.

METHODS: We assessed the effect of socio-demographic and clinical factors on General Consent status (known/unknown) and General Consent choice (yes/no) through logistic models and volcano plots. Patients who first visited University Hospital Zurich between January 1, 2018 and June 30, 2019 (pre COVID-19), or between July 1, 2020 and December 31, 2021 (during the COVID-19 pandemic) were included for analysis. Investigated factors included the type of visit, sex, age, nationality, religion, civil status, resuscitation preferences and living-will status, health insurance category and number of International Statistical Classification of Diseases and Related Health Problems, Version 10 (ICD-10) diagnoses. De-identified data from the University Hospital Zurichʼs clinical record system (KISIM) were used.

RESULTS: A total of 162,168 patients were included for analysis. The type of visit (in-patient or out-patient), number of diagnoses, existence of a living will and religious preference were associated with General Consent status (known/unknown). Religious preferences were also found to influence General Consent choice.

CONCLUSION: This study identified significant differences in General Consent status between in-patients and out-patients at the University Hospital Zurich, with in-patients more likely to have an unknown General Consent status. To address this, we recommend reviewing the administrative process and documentation practices related to General Consent. Our results also indicated that patients actively involved in their medical decisions and those with multiple co-morbidities were more likely to have a known General Consent status. This is likely attributable to their increased health concerns and more frequent interactions with healthcare providers. Enhancing patient and physician understanding of General Consent can improve coverage rates and promote informed consent. However, further research is needed to explore cultural differences that may influence General Consent decisions. Ultimately, streamlining administrative procedures and implementing targeted educational initiatives will improve the understandability of the General Consent process and encourage greater participation in medical research.

References

  1. Griessbach A, Bauer A, Jörger 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 Apr;152(1516):w30159. 10.4414/SMW.2022.w30159
  2. Sprecher F, Talanova V. Verbesserungspotenzial des Generalkonsents. Schweiz Arzteztg. 2020 Sep;101(38):1197–200. 10.4414/saez.2020.19143
  3. Salathé M, Driessen S. Generalkonsent: Eine einheitliche Vorlage soll schweizweite Forschung erleichtern. SAMW Bulletin; 2016. p. 3.
  4. De Nardi G, Ehrensberger-Dow M, Matic I, Steiner F. Verständlichkeitsstudie Generalkonsent: Aufklärung und Einwilligung zur Weiterverwendung von biologischem Material und gesundheitsbezogenen Personendaten für die Forschung. Zürcher Hochschule für Angewandte Wissenschaften, Departement Angewantde Linguistik, Winterthur, 2018. Available from: https://digitalcollection.zhaw.ch/server/api/core/bitstreams/56e75bc2-1819-4d15-a0a8-1eacbf92379c/content
  5. Swiss Federal Council. Federal Act on Research involving Human Beings (Human Research Act, HRA). (Status as of 26 May 2021). 2014. Available from: https://www.fedlex.admin.ch/eli/cc/2013/617/en
  6. Ivashkov Y, Van Norman GA. Informed consent and the ethical management of the older patient. Anesthesiol Clin. 2009 Sep;27(3):569-80, table of contents. doi: 10.1016/j.anclin.2009.07.016.
  7. Building Trust to Reinforce Democracy. Main Findings from the 2021 OECD Survey on Drivers of Trust in Public Institutions. Building Trust in Public Institutions: OECD; 2022. doi: 10.1787/b407f99c-en. Available from: https://www.oecd.org/en/publications/building-trust-to-reinforce-democracy_b407f99c-en.html
  8. OECD skills outlook 2013: first results from the survey of adult skills. Paris: OECD Skills Outlook; 2013. Available from: https://www.oecd.org/en/publications/oecd-skills-outlook-2013_9789264204256-en.html
  9. European Commission. Summaries of Clinical Trial Results for Laypersons - Recommendations of the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use. 26. Januar 2017. Available from: https://health.ec.europa.eu/system/files/2020-02/2017_01_26_summaries_of_ct_results_for_laypersons_0.pdf
  10. Clinical Trials Expert Group. Good Lay Summary Practice. European Commission, 9. Juli 2021.
  11. Duke M. How to Write a Lay Summary. Digital Curation Centre (DCC), 2012. Available from: http://www.dcc.ac.uk/resources/how-guides.
  12. Barnes A, Patrick S. Lay Summaries of Clinical Study Results: an Overview. Pharmaceut Med. 2019 Aug;33(4):261–8. 10.1007/s40290-019-00285-0
  13. National Institute for Health Research (NIHR). Plain English summaries. April 2021. Available from: https://www.nihr.ac.uk/documents/plain-english-summaries/27363
  14. Cunningham-Erves J, Villalta-Gil V, Wallston KA, Boyer AP, Wilkins CH. Racial differences in two measures of trust in biomedical research. J Clin Transl Sci. 2019 Jun;3(2-3):113–9. 10.1017/cts.2019.378
  15. Sateren WB, Trimble EL, Abrams J, Brawley O, Breen N, Ford L, et al. How sociodemographics, presence of oncology specialists, and hospital cancer programs affect accrual to cancer treatment trials. J Clin Oncol. 2002 Apr;20(8):2109–17. 10.1200/JCO.2002.08.056
  16. Corbie-Smith G, Thomas SB, St George DM. Distrust, race, and research. Arch Intern Med. 2002 Nov;162(21):2458–63. 10.1001/archinte.162.21.2458
  17. Brandon DT, Isaac LA, LaVeist TA. The legacy of Tuskegee and trust in medical care: is Tuskegee responsible for race differences in mistrust of medical care? J Natl Med Assoc. 2005 Jul;97(7):951–6.
  18. Archibong B, Annan F. We Are Not Guinea Pigs: The Effects of Negative News on Vaccine Compliance. Global Economy and Development at Brookings; Jan 2021;10. Available from: https://www.brookings.edu/wp-content/uploads/2021/12/We-are-not-guinea-pigs_final.pdf
  19. Thompson HS, Valdimarsdottir HB, Jandorf L, Redd W. Perceived disadvantages and concerns about abuses of genetic testing for cancer risk: differences across African American, Latina and Caucasian women. Patient Educ Couns. 2003 Nov;51(3):217–27. 10.1016/s0738-3991(02)00219-7 doi: https://doi.org/10.1016/S0738-3991(02)00219-7
  20. Bundesamt für Statistik. Entwicklung der Religionslandschaft. Ständige Wohnbevölkerung ab 15 Jahren. Available from: https://www.bfs.admin.ch/asset/de/23925660
  21. Levkoff S, Sanchez H. Lessons learned about minority recruitment and retention from the Centers on Minority Aging and Health Promotion. Gerontologist. 2003 Feb;43(1):18–26. 10.1093/geront/43.1.18
  22. Corbie-Smith G, Thomas SB, Williams MV, Moody-Ayers S. Attitudes and beliefs of African Americans toward participation in medical research. J Gen Intern Med. 1999 Sep;14(9):537–46. 10.1046/j.1525-1497.1999.07048.x
  23. Tamborini CR, Kim C, Sakamoto A. Education and Lifetime Earnings in the United States. Demography. 2015 Aug;52(4):1383–407. 10.1007/s13524-015-0407-0
  24. Unger JM, Hershman DL, Albain KS, Moinpour CM, Petersen JA, Burg K, et al. Patient income level and cancer clinical trial participation. J Clin Oncol. 2013 Feb;31(5):536–42. 10.1200/JCO.2012.45.4553
  25. Zettler S, Jörger F. General Consent inpatient and outpatient Numbers from 2017 to. University Hospital Zurich, University Hospital Zurich-internal Document; 2022.