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

BackgroundEfforts 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.MethodsWe 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.ResultsOf 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.ConclusionsOur 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.

“As Long as You Ask”: A Qualitative Study of Biobanking Consent—Oncology Patients’ and Health Care Professionals’ Attitudes, Motivations, and Experiences—the B-PPAE Study

“…Our findings corroborate international research showing that consent to biobanking has a significant social (intersubjective, familial, communal, and societal) dimension and involves complex trust relationships, which strongly mediate donors’ perceptions of risk and sense of altruism . Many participants felt that biobanking was of such small personal risk and obvious public good that it was a simple decision to make.…”

Recall and Retention of Consent Procedure Contents and Decisions: Results of a Randomized Controlled Trial

“…This trial now demonstrates that patients are also much less aware of important details of the procedure. Comparable to earlier research, we thus found that a combination of verbal and written information leads to better recall than procedures with only verbal or only (short) written information [15][16][17]. In the opt-out procedure, most patients are unaware that their tissue can be used for medical research, that they can control whether their tissue samples will be used, and what the default situation is when they do not act.…”

Nationwide comprehensive gastro-intestinal cancer cohorts: the 3P initiative

“…To maximize information retention of the informed consent procedure of the 3P initiative, information is provided through multiple sources including: the treating physician, a research nurse or physician assistant, study websites, an online patient movie, brochures, and small executive summary folders. Cervo et al studied a similar multisource informed consent procedure and showed that these patients retain much more information (!95% of the questions about the informed consent answered correctly) [28] compared to 56-88% without the provision of multisource information [27].…”