Informed Consent and Research Biobanks: A Challenge in Three Dimensions

Macilotti, Matteo

doi:10.1007/978-3-642-33116-9_9

Cited by 7 publications

(5 citation statements)

References 18 publications

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“…The problem with biobanking in relation to informed consent is the difficulty in providing adequate information for future research. It is possible that at the time when samples are collected from participants, the information on future research is still unknown (Shickle 2006;Macilotti 2013). Hence, the inability to provide specific information for future research at the time informed consent is obtained from participants.…”

Section: Introductionmentioning

confidence: 99%

A Preliminary Study to Explore the Informed Consent Approach and the Ethical Challenges in the Malaysian Biobanking for Research

Azahar

Yusof

Azhar

2022

ABR

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Since 2005, Malaysia has established several biobanks to keep in line with the advancement of biomedical research and development of biobanks in other countries such as the UK and the USA. Despite the establishment of several biobanks in Malaysia, little is known about the informed consent approach in biobanking research and its ethical challenges. This study aims to identify the approach in obtaining informed consent in the Malaysian biobanking for research and explore its ethical challenges. Using non-probability purposive sampling, an in-depth interview with the key informants was conducted in Klang Valley. Based on the interviews, broad consent is the main approach used in obtaining informed consent in biobanking for research in Malaysia and five major ethical challenges were identified. These challenges include the informants’ opinion on the current informed consent approach, understanding participants’ rights, the role of the research ethics committee, biobanking governance in Malaysia, and informants’ knowledge and awareness. In summary, there is a lack of understanding among those involved in biobanking on the ethical, legal, and social aspects of biobanking for research in Malaysia.

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Section: Introductionmentioning

confidence: 99%

A Preliminary Study to Explore the Informed Consent Approach and the Ethical Challenges in the Malaysian Biobanking for Research

Azahar

Yusof

Azhar

2022

ABR

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“…One of the most controversial issues concerns the legal nature of the subject-matter of the biobanking activity, i.e. the biological sample (Macilotti 2013 ). The latter is a “res”, a tangible good, which traditionally attracts the category of property rights.…”

Section: Introductionmentioning

confidence: 99%

Legal issues in governing genetic biobanks: the Italian framework as a case study for the implications for citizen’s health through public-private initiatives

et al. 2017

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This paper outlines some of the challenges faced by regulation of genetic biobanking, using case studies coming from the Italian legal system. The governance of genetic resources in the context of genetic biobanks in Italy is discussed, as an example of the stratification of different inputs and rules: EU law, national law, orders made by authorities and soft law, which need to be integrated with ethical principles, technological strategies and solutions. After providing an overview of the Italian legal regulation of genetic data processing, it considers the fate of genetic material and IP rights in the event of a biobank’s insolvency. To this end, it analyses two case studies: a controversial bankruptcy case which occurred in Sardinia, one of the first examples of private and public partnership biobanks. Another case study considered is the Chris project: an example of partnership between a research institute in Bolzano and the South Tyrolean Health System. Both cases seem to point in the same direction, suggesting expediency of promoting and improving public-private partnerships to manage biological tissues and biotrust to conciliate patent law and public interest.

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“…The first challenge for biobanks consists in finding an equilibrium between the scientific interests of researchers and the expectations of donors. This can be reached by better exploiting the capabilities and flexibility of current forms of informed consent ( Kaye, 2012 ; Macilotti, 2013 ; Colledge et al, 2014 ; D’Abramo, 2015 ). However, the design of an informed consent able to guarantee the sustainability of resource availability does not solve the issues related to the economic interests usually hidden behind the scientific research.…”

Section: Introductionmentioning

confidence: 99%

Samples and data accessibility in research biobanks: an explorative survey

Capocasa¹,

Anagnostou

D’Abramo

et al. 2016

PeerJ

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Biobanks, which contain human biological samples and/or data, provide a crucial contribution to the progress of biomedical research. However, the effective and efficient use of biobank resources depends on their accessibility. In fact, making bio-resources promptly accessible to everybody may increase the benefits for society. Furthermore, optimizing their use and ensuring their quality will promote scientific creativity and, in general, contribute to the progress of bio-medical research. Although this has become a rather common belief, several laboratories are still secretive and continue to withhold samples and data. In this study, we conducted a questionnaire-based survey in order to investigate sample and data accessibility in research biobanks operating all over the world. The survey involved a total of 46 biobanks. Most of them gave permission to access their samples (95.7%) and data (85.4%), but free and unconditioned accessibility seemed not to be common practice. The analysis of the guidelines regarding the accessibility to resources of the biobanks that responded to the survey highlights three issues: (i) the request for applicants to explain what they would like to do with the resources requested; (ii) the role of funding, public or private, in the establishment of fruitful collaborations between biobanks and research labs; (iii) the request of co-authorship in order to give access to their data. These results suggest that economic and academic aspects are involved in determining the extent of sample and data sharing stored in biobanks. As a second step of this study, we investigated the reasons behind the high diversity of requirements to access biobank resources. The analysis of informative answers suggested that the different modalities of resource accessibility seem to be largely influenced by both social context and legislation of the countries where the biobanks operate.

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Informed Consent and Research Biobanks: A Challenge in Three Dimensions

Cited by 7 publications

References 18 publications

A Preliminary Study to Explore the Informed Consent Approach and the Ethical Challenges in the Malaysian Biobanking for Research

A Preliminary Study to Explore the Informed Consent Approach and the Ethical Challenges in the Malaysian Biobanking for Research

Legal issues in governing genetic biobanks: the Italian framework as a case study for the implications for citizen’s health through public-private initiatives

Samples and data accessibility in research biobanks: an explorative survey

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