Consent and Research Governance in Biobanks: Evidence from Focus Groups with Medical Researchers

Whitley, Edgar A.; Kanellopoulou, Nadja; Kaye, Jane

doi:10.1159/000336544

Cited by 44 publications

(48 citation statements)

References 64 publications

(40 reference statements)

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“…In a qualitative research project, Whitley et al 27 reported that scientists noted the difficulty in predicting the future research uses of biological samples and information. Similarly, a study examining genomic researchers' attitudes on informed consent found that the majority preferred a general or broad consent approach.…”

Section: Resultsmentioning

confidence: 99%

“…Similar results were also found in a study where research ethics committees in the United Kingdom did not readily allow general consent forms permitting any future research and some committees distinguished DNA-related tests from other forms of research. 27 While it is interesting to see that exclusions are being incorporated into informed consent applications for biobanking, it remains to be seen whether they can be used to omit contentious research and sharing.…”

Section: (Participant 5)mentioning

confidence: 99%

“…15 While the bulk of research studies focus on capturing the perceptions of the general public and patients on research ethics issues related to biobanking, [16][17][18] only a few have focused on understanding the views of scientists who may manage biobanks [19][20][21][22][23][24][25] and even fewer concentrate on scientists' perceptions of informed consent. 26,27 It is important to capture the opinions of scientists as they run biobanks and are the end users of biorepository samples and information and thus have first-hand knowledge on biobank functions. In this paper, we report the results of a pilot study that involved interviewing scientists who attended the 2013 European Lab Automation conference in Hamburg, Germany.…”

Section: Introductionmentioning

confidence: 99%

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Scientists’ perspectives on consent in the context of biobanking research

2014

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Most bioethics studies have focused on capturing the views of patients and the general public on research ethics issues related to informed consent for biobanking and only a handful of studies have examined the perceptions of scientists. Capturing the opinions of scientists is important because they are intimately involved with biobanks as collectors and users of samples and health information. In this study, we performed interviews with scientists followed by qualitative analysis to capture the diversity of perspectives on informed consent. We found that the majority of scientists in our study reported their preference for a general consent approach although they do not believe there to be a consensus on consent type. Despite their overall desire for a general consent model, many reported several concerns including donors needing some form of assurance that nothing unethical will be done with their samples and information. Finally, scientists reported mixed opinions about incorporating exclusion clauses in informed consent as a means of limiting some types of contentious research as a mechanism to assure donors that their samples and information are being handled appropriately. This study is one of the first to capture the views of scientists on informed consent in biobanking. Future studies should attempt to generalize findings on the perspectives of different scientists on informed consent for biobanking.

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Section: Resultsmentioning

confidence: 99%

Section: (Participant 5)mentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Scientists’ perspectives on consent in the context of biobanking research

2014

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“…El proyecto EnCoRe utiliza una plataforma web que permite a los participantes de investigación tener una relación interactiva con los gestores del biobanco y con la comunidad de investigación 32 . Desde la plataforma web se promueve un proceso dinámico, que hace hincapié en el re-contacto continuo con los donantes del biobanco, ofreciendo a ellos información "en tiempo real" de los proyectos específicos de investigación, lo cual permite a los participantes la opción de proporcionar o revocar fácilmente su consentimiento 33 . Bajo esta metodología interactiva, utilizado herramientas de informática, el CD propone ser un modelo de continua comunicación bidireccional entre los participantes en la investigación (donantes), y los investigadores, superando así el problema ético que implica la participación pasiva, propia del consentimiento amplio 34 .…”

Section: Consentimiento Informado Dinámicounclassified

“…Es factible que al no cumplirse las expectativas de los donantes, ellos puedan asumirlo como una falta o abuso de confianza y el reclutamiento menor sería la consecuencia, por lo tanto el costo/ beneficio de un mayor contacto debe ser sopesado de manera cuidadosa 38 . El poder proveer a los donantes de los biobancos de herramientas que les permitan un mayor control y tal vez nuevos derechos sobre su contribución, es probablemente el argumento más fuerte para un modelo de consentimiento dinámico e interactivo.…”

Section: Consentimiento Informado Dinámicounclassified

Consentimiento Informado para Biobancos: Un debate ético abierto

Díaz¹,

Guío-Mahecha²,

Páez-Leal³

2016

revsal

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RESUMENLos Biobancos con fines de Investigación están aumentando en número e importancia, con un gran potencial que contribuye a la generación de conocimiento pertinente para la solución de problemas en salud. El reclutamiento de donantes es vital para su éxito. Sin embargo, este proceso tiene implicaciones importantes de carácter ético, legal y social. El consentimiento informado requerido para la participación del donante impone desafíos éticos importantes en torno a la privacidad, confidencialidad, uso secundario de muestras y datos para estudios futuros, retorno de resultados, intercambio de datos, distribución de beneficios entre otras. Diferentes modelos de consentimiento informado han sido propuestos para responder a algunos de estos retos éticos . Sin embargo, no se ha llegado a un acuerdo, por lo tanto la discusión continúa abierta. Este trabajo pretende contribuir con la discusión, considerando fundamental el significado y el valor del proceso de consentimiento informado para la participación en investigación biomédica. Se discuten los diferentes tipos de consentimiento que se están utilizando actualmente evaluando el nivel de control y autodeterminación por parte del donante.Palabras Claves: Consentimiento Informado, Biobanco. ABSTRACTBiobanks with Research purposes are increasing in number and importance, with great potential that contributes to the generation of knowledge relevant to solving health problems. For the Biobanks to be successful, donor recruitment is essential. However, this process has important ethical, legal and social implications. Informed consent required for the participation of the donor imposes significant ethical challenges about privacy, confidentiality, secondary use of samples and data for future studies, return of results, data exchange, and distribution of the benefits among others. Different templates of informed consent have been proposed to address some of these ethical challenges. However, an agreement has not been reached, and the discussion remains open. This work aims to contribute to the discussion, considering the meaning and value of the informed consent process for participation in biomedical research, and examines the different types of consents currently used evaluating the level of control and self-determination displayed by the donor.

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Research ethics in the post‐genomic era

Vähäkangas

2013

Environ and Mol Mutagen

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New high-throughput 'omics techniques are providing exciting opportunities in clinical medicine and toxicology, especially in the development of biomarkers. In health science research there are traditional ethical considerations that are reasonably obvious, like balancing health benefits and health risks, autonomy mainly pursued by informed consent, and protecting privacy. Epidemiological studies applying new large-scale approaches (e.g., high-throughput or high-content methods and global studies that utilize biobanking of samples and produce large-scale datasets) present new challenges that call for re-evaluation of standard ethical considerations. In this context, assessment of the ethics underlying study designs, bioinformatics, and statistics applied in the generation and clinical translation of research results should also be considered. Indeed, there are ethical considerations in the research process itself, in research objectives and how research is pursued (e.g., which methodologies are selected and how they are carried out). Maintaining research integrity is critical, as demonstrated by the relatively frequent retraction of scientific papers following violations of good scientific practice. Abiding by the laws is necessary but not sufficient for good research ethics, which is and remains in the hands of the scientific community at the level of both individual scientists and organizations. Senior scientists are responsible for the transfer of research tradition to the next generation of scientists through education, mentorship, and setting an example by their own behavior, as well as by creating systems in institutions that support good research ethics.

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Consent and Research Governance in Biobanks: Evidence from Focus Groups with Medical Researchers

Cited by 44 publications

References 64 publications

Scientists’ perspectives on consent in the context of biobanking research

Scientists’ perspectives on consent in the context of biobanking research

Consentimiento Informado para Biobancos: Un debate ético abierto

Research ethics in the post‐genomic era

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