title: 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.
abstract: BACKGROUND
  Efforts to improve patients' understanding of their own medical treatments or research in which they are involved are progressing, especially with regard to informed consent procedures. We aimed to design a multisource informed consent procedure that is easily adaptable to both clinical and research applications, and to evaluate its effectiveness in terms of understanding and awareness, even in less educated patients.
  
  
  METHODS
  We designed a multisource informed consent procedure for patients' enrolment in a Cancer Institute Biobank (CRO-Biobank). From October 2009 to July 2011, a total of 550 cancer patients admitted to the Centro di Riferimento Oncologico IRCCS Aviano, who agreed to contribute to its biobank, were consecutively enrolled. Participants were asked to answer a self-administered questionnaire aim at exploring their understanding of biobanks and their needs for information on this topic, before and after study participation. Chi-square tests were performed on the questionnaire answers, according to gender or education.
  
  
  RESULTS
  Of the 430 patients who returned the questionnaire, only 36.5% knew what a biobank was before participating in the study. Patients with less formal education were less informed by some sources (the Internet, newspapers, magazines, and our Institute). The final assessment test, taken after the multisource informed consent procedure, showed more than 95% correct answers. The information received was judged to be very or fairly understandable in almost all cases. More than 95% of patients were aware of participating in a biobank project, and gave helping cancer research (67.5%), moral obligation, and supporting cancer care as main reasons for their involvement.
  
  
  CONCLUSIONS
  Our multisource informed consent information system allowed a high rate of understanding and awareness of study participation, even among less-educated participants, and could be an effective and easy-to-apply model for others to consider to contribute to a well-informed decision making process in several fields, from clinical practice to research.Further studies are needed to explore the effects on the study comprehension by each source of information, and by other sources suggested by participants in the questionnaire.
authors.affiliation: CRO-Biobank, Centro di Riferimento Oncologico, IRCCS, Aviano, Italy. scervo@cro.it
authors.forename: Silvia
authors.initials: S
authors.lastname: Cervo
authors.forename: Jane
authors.initials: J
authors.lastname: Rovina
authors.forename: Renato
authors.initials: R
authors.lastname: Talamini
authors.forename: Tiziana
authors.initials: T
authors.lastname: Perin
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Canzonieri
authors.forename: Paolo
authors.initials: P
authors.lastname: De Paoli
authors.forename: Agostino
authors.initials: A
authors.lastname: Steffan
mesh_terms: D000328:Adult; D000368:Aged; D001364:Awareness; D018070:Biological Specimen Banks; D035843:Biomedical Research / Q000941:ethics* / Q000592:standards; D032882:Comprehension; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000523:psychology / Q000592:standards; D008297:Male; D008875:Middle Aged; D019212:Multimedia; D009369:Neoplasms; D010361:Patients / Q000523:psychology*; D010818:Practice Patterns, Physicians' / Q000941:ethics* / Q000592:standards; D012107:Research Design; D035842:Research Subjects; D011795:Surveys and Questionnaires; D014015:Tissue Banks / Q000941:ethics / Q000592:standards
references.citation: Int J Technol Assess Health Care. 2011 Jan;27(1):31-42
references.pmid: 21262085
references.citation: Am J Public Health. 2009 Dec;99(12):2128-34
references.pmid: 19833988
references.citation: Lancet. 2012 May 5;379(9827):1677
references.pmid: 22559881
references.citation: Health Policy. 2008 Jan;85(1):1-18
references.pmid: 17645980
references.citation: Behav Sci Law. 2006;24(4):535-46
references.pmid: 16883621
references.citation: Urol Oncol. 2013 Oct;31(7):990-6
references.pmid: 22386623
references.citation: Am J Med Genet A. 2011 Apr;155A(4):737-41
references.pmid: 21572889
references.citation: Br J Cancer. 2009 Nov 3;101(9):1505-12
references.pmid: 19861997
references.citation: J Clin Epidemiol. 1991;44 Suppl 1:73S-79S
references.pmid: 2030400
references.citation: Am J Hum Genet. 2009 Nov;85(5):643-54
references.pmid: 19878915
references.citation: Curr Opin Obstet Gynecol. 2005 Dec;17(6):601-4
references.pmid: 16258342
references.citation: N Engl J Med. 2009 May 14;360(20):2050-3
references.pmid: 19439740
references.citation: PLoS Biol. 2012;10(8):e1001373
references.pmid: 22899893
references.citation: Am J Public Health. 1999 Sep;89(9):1433-4
references.pmid: 10474568
references.citation: Genet Med. 2008 Nov;10(11):831-9
references.pmid: 19011407
references.citation: Oncology (Williston Park). 1992 Oct;6(10):83-7; discussion 87-9
references.pmid: 1390017
references.citation: Health Expect. 2014 Aug;17(4):523-33
references.pmid: 22512791
references.citation: Health Policy. 2005 Sep 8;73(3):237-52
references.pmid: 16039343
references.citation: Theor Med Bioeth. 2008;29(4):267-85
references.pmid: 18855123
references.citation: Int J Health Serv. 2004;34(4):625-46
references.pmid: 15560426
references.citation: J Clin Pathol. 2009 Mar;62(3):275-8
references.pmid: 19017681
references.citation: Med Law. 2001;20(2):193-204
references.pmid: 11495203
references.citation: Am J Surg. 2009 Sep;198(3):420-35
references.pmid: 19716887
references.citation: JAMA. 2004 Oct 6;292(13):1593-601
references.pmid: 15467062
references.citation: Health Policy. 2012 Oct;107(2-3):231-42
references.pmid: 22739128
references.citation: J Clin Oncol. 1984 Jul;2(7):849-55
references.pmid: 6737023
references.citation: BMJ. 2008 Jul 10;337:a337
references.pmid: 18617495
references.citation: Lancet. 1995 Oct 21;346(8982):1060-4
references.pmid: 7564786
references.citation: Genet Med. 2012 Feb;14(2):229-35
references.pmid: 22261752
references.citation: Wien Klin Wochenschr. 2011 Jul;123(13-14):408-14
references.pmid: 21739200
references.citation: J Natl Cancer Inst Monogr. 2011;2011(42):41-2
references.pmid: 21672895
references.citation: J Natl Cancer Inst Monogr. 2011;2011(42):46-9
references.pmid: 21672897
references.citation: J Natl Cancer Inst. 2011 Jan 19;103(2):154-7
references.pmid: 21173381
references.citation: BMC Med Ethics. 2009 Jun 16;10:4
references.pmid: 19531243
references.citation: Hum Genet. 2011 Sep;130(3):357-68
references.pmid: 21814798
references.citation: Health Expect. 2011 Mar;14(1):29-37
references.pmid: 20629766
references.citation: J Med Ethics. 2005 Jul;31(7):415-8
references.pmid: 15994363
references.citation: Clin Genet. 2006 May;69(5):393-8
references.pmid: 16650074