title: Consent for biobanking: assessing the understanding and views of cancer patients.
abstract: Cancer patients were questioned about the consent process in a context in which they were routinely requested to donate tumor samples to research. After in-depth interviews of 19 patients, a 12-page questionnaire was designed and mailed to 745 patients who had been recently treated for colorectal cancer, breast cancer, or a hematological malignancy at a French Regional Cancer Center at which an opt-in biobanking system has existed since 2002. The response rate was 77.0% (N = 574). Among responding patients, 349 (60.8%) of the 574 were in favor of a formal and signed consent. Concordance was low (kappa = 0.23) between the number of patients who declared in the survey that they had given consent (213 of 574 [37.1%]) vs the number for whom registered consent had been recorded (267 of 574 [46.5%]). Only 2 (0.3%) of the 574 patients stated that they had signed a refusal, and only 88 (41.3%) of the 213 patients who remembered giving consent understood that their consent for biobanking also covered authorization to use their clinical data. We conclude that the opt-in consent procedure is positively perceived by most patients but should be improved for a better understanding and possibly an even better adherence to the consent process.
authors.affiliation: Université d'Aix-Marseille, Marseille, France. julien.mancini@univmed.fr
authors.forename: Julien
authors.initials: J
authors.lastname: Mancini
authors.forename: Isabelle
authors.initials: I
authors.lastname: Pellegrini
authors.forename: Frédéric
authors.initials: F
authors.lastname: Viret
authors.forename: Norbert
authors.initials: N
authors.lastname: Vey
authors.forename: Lise-Marie
authors.initials: LM
authors.lastname: Daufresne
authors.forename: Christian
authors.initials: C
authors.lastname: Chabannon
authors.forename: Claire
authors.initials: C
authors.lastname: Julian-Reynier
mesh_terms: D000328:Adult; D000368:Aged; D018070:Biological Specimen Banks; D002173:Cancer Care Facilities; D032882:Comprehension; D005260:Female; D005602:France; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D009369:Neoplasms; D010361:Patients / Q000706:statistics & numerical data*; D011639:Public Opinion; D011795:Surveys and Questionnaires