Thematic Analysis of Cardiac Care Patients’ Explanations for Declining Contribution to a Genomic Research-Based Biobank

Health care delivery systems increasingly ask patients to contribute biological samples for future genomic-based health research during critical care admissions, because of the requirements of genome-based research for unprecedented large sample sizes. In this report, we refer to a clinical system of collecting samples from patients for future unspecified genomic research as biobanking. Few reports exist to describe patients’ perceptions and responses to actual biobanking approaches in the clinical setting. Those studying patients’ responses did not engage patients in the clinical setting to understand their real-time perceptions.1,2 Thus, we conducted a qualitative study to explore 568 cardiac care patients’ explanations of why they declined to contribute their samples to a future genomic research biobank. Patients provided the explanations during their hospitalization. Research nurses recorded the explanations at the time the patients declined to participate. The aims of this study were to (1) identify themes emerging from explanations for declining contribution to the research bio -banking initiative and (2) determine how the content informs the stewardship conceptual framework that addresses evidence-based clinical ethics practices in genomic and genetic research biobanking. This study was guided by the stewardship conceptual framework (hereafter “framework”), which addresses ethical and social implications of genomic research biobanking in US clinical care settings.3,4 The framework proposes that protecting the sample contributors’ interests, maintaining public trust, and respecting human dignity in clinical site's biobanking practices are positive outcomes to value and achieve. Stewardship attributes in biobanking promote positive outcomes and mitigate risks of ethics violations that might arise in biobanking practices. The framework's relevance is implied by the unprecedented expectation of patients’ trust in clinical system biobanking approaches.5,6 Many current biobanking approaches do not engage in traditional informed consent processes with potential sample contributors.7 Instead, clinical systems often use “opt in” or “opt out” processes to engage and inform patients’ participation,8 including a form in admissions record-keeping systems that requires a patient to opt out of participating in a biobank to supply future research. Under the opt-out rubric, the hospital system assumes the patient agrees to their medical waste (leftover collected tissue or blood) being automatically deidentified and bio -banked with linkage to the patients’ health records, unless they overtly mark on the form that they are opting out.9 Opt-in consent, as proposed in this study's protocol, means that biobanking will not occur unless the patient overtly provides written informed consent. Although efforts are made to align clinical setting biobanking consent and collection processes with the Belmont Report standards of research ethics,9 few reports describe tailored procedures for vulnerable patients. Patients with acute symptoms, critical diagnoses, emergency admissions, diminished capacity, and treatment considerations challenge an individual's ability to comprehend standardized opt-in or opt-out biobank consent approaches.9-11 The standardized approaches’ lack of consideration for challenges to patients’ comprehension during critical care admissions presents a potential compromise of respect for human vulnerability and dignity. This study aims to understand the perspectives of patients admitted for critical care as they consider an opt-in approach to biobanking sample collection.