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

BMC Medical Ethics

Agostino Steffan¹  Paolo De Paoli²  Vincenzo Canzonieri¹  Tiziana Perin³  Renato Talamini⁴  Jane Rovina¹  Silvia Cervo¹ 

[1] CRO-Biobank, Centro di Riferimento Oncologico, IRCCS, Aviano, Italy;Scientific Directorate, Centro di Riferimento Oncologico, IRCCS, Aviano, Italy;Division of Pathology, Centro di Riferimento Oncologico, IRCCS, Aviano, Italy;Department of Epidemiology and Biostatistics, Centro di Riferimento Oncologico, IRCCS, Aviano, Italy

关键词: Empowerment;    Patient education;    Biobank;    Awareness;    Understanding;    Patients;    Informed consent;   

Others  :  799923
DOI  :  10.1186/1472-6939-14-30

 received in 2012-07-26, accepted in 2013-05-17,  发布年份 2013

【 摘 要 】

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.

【 授权许可】

   
2013 Cervo et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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