RESUMEN
Diagnostic discrepancies occur when the diagnosis made on a biospecimen during the course of review at a biobank differs from the original clinical diagnosis. These diagnostic discrepancies detected during biobanking present unique challenges that are distinct from other types of research results or incidental findings. The proposed process for reporting diagnostic discrepancies or pathological incidental findings identified through a quality assurance evaluation at the biobank includes verification of the biospecimen identity, verification of the diagnosis within the biobank, and re-review of the case by the pathologist at the biospecimen collection site. If the pathologist at the biobank and the original pathologist do not reach agreement, an impartial and knowledgeable third party is consulted. The decision as to whether and how to notify research participants of any confirmed changes in diagnosis would be determined by institutional procedures. Implementation of this proposed process will require clear delineation of the roles and responsibilities of all involved parties in order to promote excellence in patient care and ensure that researchers have access to biospecimens of requisite quality.Genet Med 2012:14(4):417-423.
Asunto(s)
Investigación Biomédica/estadística & datos numéricos , Hallazgos Incidentales , Informática Médica/estadística & datos numéricos , Sujetos de Investigación , Investigación Biomédica/ética , Errores Diagnósticos/ética , Errores Diagnósticos/estadística & datos numéricos , Reacciones Falso Positivas , Humanos , Consentimiento Informado/ética , Informática Médica/ética , Patología Clínica/ética , Patología Clínica/normas , Patología Clínica/estadística & datos numéricos , Bancos de Tejidos/estadística & datos numéricos , Revelación de la Verdad/éticaAsunto(s)
Adenocarcinoma , Esófago de Barrett , Conducta Cooperativa , Neoplasias Esofágicas , Relaciones Interinstitucionales , Investigación Biomédica Traslacional/organización & administración , Adenocarcinoma/diagnóstico , Adenocarcinoma/epidemiología , Adenocarcinoma/terapia , Animales , Esófago de Barrett/diagnóstico , Esófago de Barrett/epidemiología , Esófago de Barrett/terapia , Bases de Datos Factuales , Neoplasias Esofágicas/diagnóstico , Neoplasias Esofágicas/epidemiología , Neoplasias Esofágicas/terapia , Humanos , Objetivos Organizacionales , Pronóstico , Factores de Riesgo , Bancos de Tejidos/organización & administraciónRESUMEN
Human biological specimens (biospecimens) are increasingly important for research that aims to advance human health. Yet, despite significant proliferation in specimen-based research and discoveries during the past decade, research remains challenged by the inequitable access to high-quality biospecimens that are collected under rigorous ethical standards. This is primarily caused by the complex level of control and ownership exerted by the myriad of stakeholders involved in the biospecimen research process. This article discusses the ethical model of custodianship as a framework for biospecimen-based research to promote fair research access and resolve issues of control and potential conflicts between biobanks, investigators, human research participants (human subjects), and sponsors. Custodianship is the caretaking obligation for biospecimens from initial collection to final dissemination of research findings. It endorses key practices and operating principles for responsible oversight of biospecimens collected for research. Embracing the custodial model would ensure transparency in research, fairness to human research participants, and shared accountability among all stakeholders involved in biospecimen-based research.