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Original article

Vol. 150 No. 3334 (2020)

Uncertainties about the need for ethics approval in Switzerland: a mixed-methods study

DOI
https://doi.org/10.4414/smw.2020.20318
Cite this as:
Swiss Med Wkly. 2020;150:w20318
Published
12.08.2020

Summary

BACKGROUND

To ensure ethical oversight, researchers wanting to conduct “research” involving human beings are typically required to obtain prior approval from an independent ethics committee. However, it can sometimes be unclear if a project needs to be submitted for ethics approval. Swiss researchers can contact research ethics committees via a “jurisdictional inquiry” for clarification whether a project needs to be submitted for ethics approval.

AIMS OF THE STUDY

(1) To examine the characteristics of Swiss jurisdictional inquiries, and (2) to identify possible uncertainties regarding the correct interpretation of existing legislation in Switzerland.

METHODS

All jurisdictional inquiries submitted to Swiss research ethics committees between July and December 2017 were reviewed using qualitative content analysis. We then conducted an online survey between June 2018 and July 2018 with all researchers who had submitted a jurisdictional inquiry including a descriptive quantitative analysis.

RESULTS

The review included 271 jurisdictional inquiries. Analysis identified three groups of jurisdictional inquiries: 80.4% (218/271) sought clarification whether the project had to be submitted for ethical approval; 18.5% (50/271) requested a “declaration of no objection”; and 1.1% (3/271) asked for a clarification about which of the two ordinances was applicable to the project. Analysis identified eight distinct legal issues that appeared to be the main cause for a number of jurisdictional inquiries, with the two most frequently identified issues being whether the project will produce generalisable knowledge, and whether the project uses fully anonymised data. Overall, research ethics committees decided that 78.6% (213/271) of the jurisdictional inquiries were outside their jurisdiction and did not require ethical approval, and that 15.6% required submission for ethical approval. The online survey achieved a 56.8% response rate. The majority of respondents (94/166; 56.6%) reported that all the questions they were asked during the submission of the jurisdictional inquiry were easy to understand. Respondents reported that 88% (147/166) of all projects were started or planned to start. The vast majority (154/166; 93%) of respondents also agreed with the decisions made by the research ethics committee.

CONCLUSIONS

Jurisdictional inquiries are an important means for researchers to clarify whether their project requires ethical oversight. However, this mixed-methods study has identified some difficulties in the interpretation of legal terms, which often reflect persistent structural issues that many other countries also face. More detailed guidance may be helpful to reduce the researchers’ uncertainties and ethics committees’ workloads in relation to jurisdictional inquiries.

References

  1. Kass NE, Faden RR, Goodman SN, Pronovost P, Tunis S, Beauchamp TL. The research-treatment distinction: a problematic approach for determining which activities should have ethical oversight. Hastings Cent Rep. 2013;43(s1):S4–15. doi:.https://doi.org/10.1002/hast.133
  2. Shelley-Egan C, Brey P, Rodrigues R, Douglas D, Gurzawska A, Bitsch L, et al. Ethical Assessment of Research and Innovation: A Comparative Analysis of Practices and Institutions in the EU and selected other countries. 2016. Available from: https://satoriproject.eu/media/D1.1_Ethical-assessment-of-RI_a-comparative-analysis-1.pdf
  3. McLennan S. The ethical oversight of learning health care activities in Switzerland: a qualitative study. Int J Qual Health Care. 2019;31(8):G81–6. doi:.https://doi.org/10.1093/intqhc/mzz045
  4. McLennan S, Kahrass H, Wieschowski S, Strech D, Langhof H. The spectrum of ethical issues in a Learning Health Care System: a systematic qualitative review. Int J Qual Health Care. 2018;30(3):161–8. doi:.https://doi.org/10.1093/intqhc/mzy005
  5. Morain SR, Kass NE. Ethics Issues Arising in the Transition to Learning Health Care Systems: Results from Interviews with Leaders from 25 Health Systems. EGEMS (Wash DC). 2016;4(2):3. doi:.https://doi.org/10.13063/2327-9214.1212
  6. Fiscella K, Tobin JN, Carroll JK, He H, Ogedegbe G. Ethical oversight in quality improvement and quality improvement research: new approaches to promote a learning health care system. BMC Med Ethics. 2015;16(1):63. doi:.https://doi.org/10.1186/s12910-015-0056-2
  7. Finkelstein JA, Brickman AL, Capron A, Ford DE, Gombosev A, Greene SM, et al. Oversight on the borderline: Quality improvement and pragmatic research. Clin Trials. 2015;12(5):457–66. doi:.https://doi.org/10.1177/1740774515597682
  8. Whicher D, Kass N, Saghai Y, Faden R, Tunis S, Pronovost P. The views of quality improvement professionals and comparative effectiveness researchers on ethics, IRBs, and oversight. J Empir Res Hum Res Ethics. 2015;10(2):132–44. doi:.https://doi.org/10.1177/1556264615571558
  9. Thompson DA, Kass N, Holzmueller C, Marsteller JA, Martinez EA, Gurses AP, et al. Variation in local institutional review board evaluations of a multicenter patient safety study. J Healthc Qual. 2012;34(4):33–9. doi:.https://doi.org/10.1111/j.1945-1474.2011.00150.x
  10. Miller FG, Emanuel EJ. Quality-improvement research and informed consent. N Engl J Med. 2008;358(8):765–7. doi:.https://doi.org/10.1056/NEJMp0800136
  11. Siegel MD, Alfano SL. The ethics of quality improvement research. Crit Care Med. 2009;37(2):791–2. doi:.https://doi.org/10.1097/CCM.0b013e318194c4d6
  12. Taylor HA, Pronovost PJ, Faden RR, Kass NE, Sugarman J. The ethical review of health care quality improvement initiatives: findings from the field. Issue Brief (Commonw Fund). 2010;95:1–12.
  13. Kass N, Pronovost PJ, Sugarman J, Goeschel CA, Lubomski LH, Faden R. Controversy and quality improvement: lingering questions about ethics, oversight, and patient safety research. Jt Comm J Qual Patient Saf. 2008;34(6):349–53. doi:.https://doi.org/10.1016/S1553-7250(08)34044-6
  14. https://www.swissethics.ch/.
  15. Federal Office of Public Health. Evaluation of the Human Research Act. https://www.bag.admin.ch/bag/en/home/medizin-und-forschung/forschung-am-menschen/evaluation-humanforschungsgesetz.html Accessed 2020 January 10.
  16. Schreier M. Qualitative content analysis in practice. Los Angeles: SAGE; 2012.
  17. Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005;15(9):1277–88. doi:.https://doi.org/10.1177/1049732305276687
  18. Schweizerische Ethikkommissionen für die Forschung am Menschen. Ergebnisse der Arbeitsgruppe von swissethics zur Revision des Humanforschungsgesetz es (HFG) und der Verordnungen. 2018; https://swissethics.ch/doc/gesetzrichtl/Bericht_Arbeitsgruppe_HFG_final_Web.pdf Accessed 2020 January 10
  19. Alberta Innovates. ARECCI Ethics Guideline Tool. 2017; https://albertainnovates.ca/our-health-innovation-focus/a-project-ethics-community-consensus-initiative/arecci-ethics-guideline-and-screening-tools/ Archived at: http://www.webcitation.org/76hnxgqPG. Accessed 2020 January 10
  20. Medical Research Council Regulatory Support Centre - Health Research Authority. Is my study research? http://www.hra-decisiontools.org.uk/research/question3.html Accessed 2020 January 10

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