Consent and Privacy in the Era of Precision Medicine and Biobanking Genomic Data

Conboy, Colleen

doi:10.1177/0098858820933493

Cited by 3 publications

(2 citation statements)

References 28 publications

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“…Biobanking raises important ethical and legal considerations regarding informed consent, privacy, and data protection [ 67 ]. It is crucial to ensure that appropriate ethical guidelines are followed and that consent is obtained from patients prior to sample collection and usage.…”

Section: Challenges and Considerations In Neuro-urology Biobankingmentioning

confidence: 99%

Neuro-Urology and Biobanking: An Integrated Approach for Advancing Research and Improving Patient Care

Botter,

Kessler

2023

IJMS

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Understanding the molecular mechanisms underlying neuro-urological disorders is crucial for the development of targeted therapeutic interventions. Through the establishment of comprehensive biobanks, researchers can collect and store various biological specimens, including urine, blood, tissue, and DNA samples, to study these mechanisms. In the context of neuro-urology, biobanking facilitates the identification of genetic variations, epigenetic modifications, and gene expression patterns associated with neurogenic lower urinary tract dysfunction. These conditions often present as symptoms of neurological diseases such as Alzheimer’s disease, multiple sclerosis, Parkinson’s disease, spinal cord injury, and many others. Biobanking of tissue specimens from such patients is essential to understand why these diseases cause the respective symptoms and what can be done to alleviate them. The utilization of high-throughput technologies, such as next-generation sequencing and gene expression profiling, enables researchers to explore the molecular landscape of these conditions in an unprecedented manner. The development of specific and reliable biomarkers resulting from these efforts may help in early detection, accurate diagnosis, and effective monitoring of neuro-urological conditions, leading to improved patient care and management. Furthermore, these biomarkers could potentially facilitate the monitoring of novel therapies currently under investigation in neuro-urological clinical trials. This comprehensive review explores the synergistic integration of neuro-urology and biobanking, with particular emphasis on the translation of biobanking approaches in molecular research in neuro-urology. We discuss the advantages of biobanking in neuro-urological studies, the types of specimens collected and their applications in translational research. Furthermore, we highlight the importance of standardization and quality assurance when collecting samples and discuss challenges that may compromise sample quality and impose limitations on their subsequent utilization. Finally, we give recommendations for sampling in multicenter studies, examine sustainability issues associated with biobanking, and provide future directions for this dynamic field.

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Section: Challenges and Considerations In Neuro-urology Biobankingmentioning

confidence: 99%

Neuro-Urology and Biobanking: An Integrated Approach for Advancing Research and Improving Patient Care

Botter,

Kessler

2023

IJMS

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“…Identification of risk often relies on categorization of potential harm as sufficiently likely and sufficiently severe (Mikkelsen et al 2019 ). However, severity or likeliness can change, for instance, in the case of genomic identifiability (Malin et al 2011 , Kasperbauer et al 2018 ) due to proliferation of publicly available online genomic data, which has raised privacy concerns regarding research infrastructures, as well as recreational websites, and big data practices such as data mining (Gymrek et al 2013 , Erlich and Narayanan 2014 , Erlich et al 2018 , Conboy 2020 ). At the same time, risks are interpreted very differently by individuals and these interpretations do not always align with the clinical or epidemiological risk rationalities (Lupton 2013 , Quinn et al 2013 ), nor are they always seen relevant by the individual in making their decision (Helgesson 2012 ).…”

Section: Introductionmentioning

confidence: 99%

Biobanking and risk assessment: a comprehensive typology of risks for an adaptive risk governance

Akyüz

Chassang

Goisauf

et al. 2021

Life Sci Soc Policy

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Biobanks act as the custodians for the access to and responsible use of human biological samples and related data that have been generously donated by individuals to serve the public interest and scientific advances in the health research realm. Risk assessment has become a daily practice for biobanks and has been discussed from different perspectives. This paper aims to provide a literature review on risk assessment in order to put together a comprehensive typology of diverse risks biobanks could potentially face. Methodologically set as a typology, the conceptual approach used in this paper is based on the interdisciplinary analysis of scientific literature, the relevant ethical and legal instruments and practices in biobanking to identify how risks are assessed, considered and mitigated. Through an interdisciplinary mapping exercise, we have produced a typology of potential risks in biobanking, taking into consideration the perspectives of different stakeholders, such as institutional actors and publics, including participants and representative organizations. With this approach, we have identified the following risk types: economic, infrastructural, institutional, research community risks and participant’s risks. The paper concludes by highlighting the necessity of an adaptive risk governance as an integral part of good governance in biobanking. In this regard, it contributes to sustainability in biobanking by assisting in the design of relevant risk management practices, where they are not already in place or require an update. The typology is intended to be useful from the early stages of establishing such a complex and multileveled biomedical infrastructure as well as to provide a catalogue of risks for improving the risk management practices already in place.

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Attitudes of Patients With Chronic Heart Failure Toward Digital Device Data for Self-documentation and Research in Germany: Cross-sectional Survey Study

Buhr¹,

Kaufmann²,

Jörß³

2022

JMIR Cardio

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Background In recent years, the use of digital mobile measurement devices (DMMDs) for self-documentation in cardiovascular care in Western industrialized health care systems has increased. For patients with chronic heart failure (cHF), digital self-documentation plays an increasingly important role in self-management. Data from DMMDs can also be integrated into telemonitoring programs or data-intensive medical research to collect and evaluate patient-reported outcome measures through data sharing. However, the implementation of data-intensive devices and data sharing poses several challenges for doctors and patients as well as for the ethical governance of data-driven medical research. Objective This study aims to explore the potential and challenges of digital device data in cardiology research from patients’ perspectives. Leading research questions of the study concerned the attitudes of patients with cHF toward health-related data collected in the use of digital devices for self-documentation as well as sharing these data and consenting to data sharing for research purposes. Methods A cross-sectional survey of patients of a research in cardiology was conducted at a German university medical center (N=159) in 2020 (March to July). Eligible participants were German-speaking adult patients with cHF at that center. A pen-and-pencil questionnaire was sent by mail. Results Most participants (77/105, 73.3%) approved digital documentation, as they expected the device data to help them observe their body and its functions more objectively. Digital device data were believed to provide cognitive support, both for patients’ self-assessment and doctors’ evaluation of their patients’ current health condition. Interestingly, positive attitudes toward DMMD data providing cognitive support were, in particular, voiced by older patients aged >65 years. However, approximately half of the participants (56/105, 53.3%) also reported difficulty in dealing with self-documented data that lay outside the optimal medical target range. Furthermore, our findings revealed preferences for the self-management of DMMD data disclosed for data-intensive medical research among German patients with cHF, which are best implemented with a dynamic consent model. Conclusions Our findings provide potentially valuable insights for introducing DMMD in cardiovascular research in the German context. They have several practical implications, such as a high divergence in attitudes among patients with cHF toward different data-receiving organizations as well as a large variance in preferences for the modes of receiving information included in the consenting procedure for data sharing for research. We suggest addressing patients’ multiple views on consenting and data sharing in institutional normative governance frameworks for data-intensive medical research.

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Consent and Privacy in the Era of Precision Medicine and Biobanking Genomic Data

Abstract: “Big Data represents a challenge that points to the need for collective and political approaches to self-protection rather than solely individual, atomistic approaches.” – Anita Allen, “Protecting One's Own Privacy in a Big Data Economy”

Cited by 3 publications

References 28 publications

Neuro-Urology and Biobanking: An Integrated Approach for Advancing Research and Improving Patient Care

Neuro-Urology and Biobanking: An Integrated Approach for Advancing Research and Improving Patient Care

Biobanking and risk assessment: a comprehensive typology of risks for an adaptive risk governance

Attitudes of Patients With Chronic Heart Failure Toward Digital Device Data for Self-documentation and Research in Germany: Cross-sectional Survey Study

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