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Opt-out plus, the patients’ choice: preferences of cancer patients concerning information and consent regimen for future research with biological samples archived in the context of treatment
  1. E Vermeulen1,
  2. M K Schmidt1,
  3. N K Aaronson1,
  4. M Kuenen1,
  5. P van der Valk2,
  6. C Sietses2,
  7. P van den Tol2,
  8. F E van Leeuwen1
  1. 1Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands
  2. 2Vrije Universiteit Medical Centre Amsterdam, Amsterdam, The Netherlands
  1. Flora E van Leeuwen, Department of Epidemiology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands; f.v.leeuwen{at}nki.nl

Abstract

Aims: The aims of this study were to determine: (1) which consent procedures patients prefer for future medical research with tissue stored following surgery; (2) the percentage of patients who choose not to provide consent for research with their stored tissue; (3) the reasons given for denying such tissue use.

Methods: Patients (n = 103) from the Vrije Universiteit Medical Centre, an academic hospital in The Netherlands, who had recently undergone surgery for breast or colorectal cancer were mailed a questionnaire about preferences for consent regimens.

Results: Seventy-six patients (74%) completed the questionnaire. Only two patients (3%) chose not to provide consent for research with their stored tissue. The majority of patients (60%) preferred an “opt-out plus” procedure that included receiving active, verbal information to “one-time general consent” (11%) or to an “opt-out” procedure without verbal notification (5%). Only 3% indicated a wish to be asked for consent for each new research project and 21% did not know what they preferred or had no preference. There were no significant associations observed between preference for the various consent regimens and age, sex, educational level or personal sense of ownership of the stored tissue.

Conclusion: Patients prefer an opt-out plus procedure that includes the provision of explicit, verbal and written information. Less than 5% of patients decline to consent to the use of their stored tissue for research purposes.

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Footnotes

  • Funding: We acknowledge the Dutch Cancer Genomics Centre for funding this research. The Cancer Genomics Centre had no role in the development of the study design, the collection, analysis and interpretation of data, the writing of the manuscript, or the decision to submit the manuscript for publication.

  • Competing interests: None.

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