Literature DB >> 19017681

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.

E Vermeulen1, M K Schmidt, N K Aaronson, M Kuenen, P van der Valk, C Sietses, P van den Tol, F E van Leeuwen.   

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.

Entities:  

Mesh:

Year:  2008        PMID: 19017681     DOI: 10.1136/jcp.2008.061069

Source DB:  PubMed          Journal:  J Clin Pathol        ISSN: 0021-9746            Impact factor:   3.411


  15 in total

Review 1.  Biobanking residual tissues.

Authors:  Peter H J Riegman; Evert-Ben van Veen
Journal:  Hum Genet       Date:  2011-08-04       Impact factor: 4.132

2.  Biobanks, consent and claims of consensus.

Authors:  Zubin Master; Erin Nelson; Blake Murdoch; Timothy Caulfield
Journal:  Nat Methods       Date:  2012-09       Impact factor: 28.547

3.  Secondary Use of Patient Tissue in Cancer Biobanks.

Authors:  Debra J H Mathews; Julia T Rabin; Katharine Quain; Eric Campbell; Deborah Collyar; Fay J Hlubocky; Steven Isakoff; Jeffrey Peppercorn
Journal:  Oncologist       Date:  2019-06-10

Review 4.  Stakeholders' perspectives on biobank-based genomic research: systematic review of the literature.

Authors:  Alma Husedzinovic; Dominik Ose; Christoph Schickhardt; Stefan Fröhling; Eva C Winkler
Journal:  Eur J Hum Genet       Date:  2015-03-04       Impact factor: 4.246

5.  Contributing to research via biobanks: what it means to cancer patients.

Authors:  Isabelle Pellegrini; Christian Chabannon; Julien Mancini; Frederic Viret; Norbert Vey; Claire Julian-Reynier
Journal:  Health Expect       Date:  2012-04-19       Impact factor: 3.377

6.  Broad consent for health care-embedded biobanking: understanding and reasons to donate in a large patient sample.

Authors:  Gesine Richter; Michael Krawczak; Wolfgang Lieb; Lena Wolff; Stefan Schreiber; Alena Buyx
Journal:  Genet Med       Date:  2017-06-22       Impact factor: 8.822

7.  Inclusion of residual tissue in biobanks: opt-in or opt-out?

Authors:  Noor A A Giesbertz; Annelien L Bredenoord; Johannes J M van Delden
Journal:  PLoS Biol       Date:  2012-08-07       Impact factor: 8.029

8.  A trial of consent procedures for future research with clinically derived biological samples.

Authors:  E Vermeulen; M K Schmidt; N K Aaronson; M Kuenen; M-J Baas-Vrancken Peeters; H van der Poel; S Horenblas; H Boot; V J Verwaal; A Cats; F E van Leeuwen
Journal:  Br J Cancer       Date:  2009-09-29       Impact factor: 7.640

9.  Cancer patient perceptions on the ethical and legal issues related to biobanking.

Authors:  Zubin Master; Jaime O Claudio; Christen Rachul; Jean C Y Wang; Mark D Minden; Timothy Caulfield
Journal:  BMC Med Genomics       Date:  2013-03-08       Impact factor: 3.063

10.  An effective multisource informed consent procedure for research and clinical practice: an observational study of patient understanding and awareness of their roles as research stakeholders in a cancer biobank.

Authors:  Silvia Cervo; Jane Rovina; Renato Talamini; Tiziana Perin; Vincenzo Canzonieri; Paolo De Paoli; Agostino Steffan
Journal:  BMC Med Ethics       Date:  2013-07-30       Impact factor: 2.652

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