Consent to Data Processing in Biobanking: Regulatory Challenges of Data Processing in Biobanking, Using the Estonian Example
Book Chapter
Kärt Pormeister
Privacy, Data Protection and Data-driven Technologies, 2024 [Taylor&Francis]
Abstract
Under European Union (EU) data protection law, consent can generally only be relied upon as a legal basis for processing personal data if the consent has been given for one or more specified purposes. The fact is that in the world of scientific research, this is not always possible or feasible, is recognized in the recitals of the General Data Protection Regulation. Unfortunately, the European Data Protection Board has rendered this recognition in the recitals effectively moot by maintaining that even in research, a broader consent to data processing could only go as far as to cover multiple pre-defined projects, but not undefined future projects. This ‘one-size-fits-all’ stance on consent to data processing is a problem for biobanks, the existence and data processing purposes of which cannot be confined to pre-defined research projects. In the first part of this chapter, the author explores the evolution of consent to data processing for research purposes in EU data protection law and the interpretations given to it by a number of data protection institutions, and contrasts these to other emerging regulatory regimes within the EU concerning the (secondary) research use of personal data. In the second half of the chapter, the author exemplifies the previously explored theoretical problems using the Estonian Biobank as a practical example.

A Pilot Evaluation of an Educational Video to Support Consent to a Pediatric Malignancy Biobank
Research Article
Biopreservation and Biobanking, 27 May 2024
Abstract
Introduction
The collection of biological specimens is necessary to support basic and translational research. However, the complexity of biobanking introduces numerous ethical issues, particularly regarding informed consent.
Objective
To evaluate the acceptability and perceived benefits of an educational video facilitating the consent process for the Children’s Cancer Centre Biobank.
Methods
We invited individuals who had previously consented to be (or their child to be) part of the Biobank, and health professionals who were involved in obtaining consent. Participants watched the video and completed a purpose-designed online survey.
Results
A total of 16 health professionals (invited = 30) and 15 patients/caregivers (invited = 127) participated. Most patients/caregivers felt informed about the Biobank at consent, however, noted how overwhelmed they were at the time and that they did not engage with the written information. Overall, both patients/caregivers and health professionals rated the video favorably regarding the information provided and format. Participants valued that it was simple and clear, with several health professionals noting the need for linguistic translations to better support the families they work with. Most patients/caregivers agreed that the video provided enough information to begin considering participation. This aligned with the health professionals’ feedback that the video was most effective when used as a conversation starter to help formalize the written consent.
Conclusion
Our findings suggest that our video is an acceptable and beneficial tool to assist in the Biobank consenting process, from both the perspective of decision-makers and health professionals obtaining consent. It appears particularly valuable as a precursor to an interactive, formal consent discussion. Further work is required to determine whether our video has a significant impact on outcomes such as decision-making satisfaction and knowledge, and to determine the value to adolescents.

GDPR Requirements for Biobanking Activities Across Europe
Book
Valentina Colcelli, Roberto Cippitani, Christoph Brochhausen-Delius, Rainer Arnold
Springer, 2023
About this book
The book deals with the effective operation of the rules related to biomedical research and pays attention to the activities of the national legislatures of the 27 Member States in the field of scientific research. This multilevel system has an impact on biobanking activity. The book answers questions realized by operators on the main biobanks around the EU in the field of GDPR. The authors and editors used the questions born from brainstorming among members of the Association European, Middle East & Africa for Biopreservation and Biobanking (ESBB) to offer to the operators in biobanking activity and researchers quickly answer to their daily questions, but with authors highest quality. Further the book provides a comprehensive review of the rapidly expanding field of biobanking. It provides researchers and scholars working on biobanking and bio-sharing and more in general in the university hospitals and clinical trial consortiums, and companies, biomedical researchers, but also jurists and the professionals (in particular judges, lawyers, officers) an instrument rigorous but easy to use of the GDPR in the case of biobanking activities. The book identifies a methodological path to tackle the legal or ethical problem on a specific scientific-technological to verify existing solutions and give ideas for future applications. The importance of the legal solution influences the implementation of the development of the biobanking activity service itself.

GDPR Requirements for Biobanking Activities Across Europe
Book
Editors: Valentina Colcelli, Roberto Cippitani, Christoph Brochhausen-Delius, Rainer Arnold
2023 [Springer]
About this book
The book deals with the effective operation of the rules related to biomedical research and pays attention to the activities of the national legislatures of the 27 Member States in the field of scientific research. This multilevel system has an impact on biobanking activity. The book answers questions realized by operators on the main biobanks around the EU in the field of GDPR. The authors and editors used the questions born from brainstorming among members of the Association European, Middle East & Africa for Biopreservation and Biobanking (ESBB) to offer to the operators in biobanking activity and researchers quickly answer to their daily questions, but with authors highest quality. Further the book provides a comprehensive review of the rapidly expanding field of biobanking. It provides researchers and scholars working on biobanking and bio-sharing and more in general in the university hospitals and clinical trial consortiums, and companies, biomedical researchers, but also jurists and the professionals (in particular judges, lawyers, officers) an instrument rigorous but easy to use of the GDPR in the case of biobanking activities. The book identifies a methodological path to tackle the legal or ethical problem on a specific scientific-technological to verify existing solutions and give ideas for future applications. The importance of the legal solution influences the implementation of the development of the biobanking activity service itself.

Biobanking and consenting to research: a qualitative thematic analysis of young people’s perspectives in the North East of England
Research
Fabian J. S. van der Velden, Emma Lim, Lily Gills, Jasmin Broadey, Louise Hayes, Eve Roberts, Jack Courtney, Joanne Ball, Jethro Herberg, Rachel Galassini, Marieke Emonts
BMC Medical Ethics, 5 July 2023; 24(47)
Open Access
Abstract
Background
Biobanking biospecimens and consent are common practice in paediatric research. We need to explore children and young people’s (CYP) knowledge and perspectives around the use of and consent to biobanking. This will ensure meaningful informed consent can be obtained and improve current consent procedures.
Methods
We designed a survey, in co-production with CYP, collecting demographic data, views on biobanking, and consent using three scenarios: 1) prospective consent, 2) deferred consent, and 3) reconsent and assent at age of capacity. The survey was disseminated via the Young Person’s Advisory Group North England (YPAGne) and participating CYP’s secondary schools. Data were analysed using a qualitative thematic approach by three independent reviewers (including CYP) to identify common themes. Data triangulation occurred independently by a fourth reviewer.
Results
One hundred two CYP completed the survey. Most were between 16–18 years (63.7%, N = 65) and female (66.7%, N = 68). 72.3% had no prior knowledge of biobanking (N = 73). Acceptability of prospective consent for biobanking was high (91.2%, N = 93) with common themes: ‘altruism’, ‘potential benefits outweigh individual risk’, ‘frugality’, and ‘(in)convenience’. Deferred consent was also deemed acceptable in the large majority (84.3%, N = 86), with common themes: ‘altruism’, ‘body integrity’ and ‘sample frugality’. 76.5% preferred to reconsent when cognitively mature enough to give assent (N = 78), even if parental consent was previously in place. 79.2% wanted to be informed if their biobanked biospecimen is reused (N = 80).
Conclusion
Prospective and deferred consent acceptability for biobanking is high among CYP in the UK. Altruism, frugality, body integrity, and privacy are the most important themes. Clear communication and justification are paramount to obtain consent. Any CYP with capacity should be part of the consenting procedure, if possible.

Attitudes of the Public Toward Consent for Biobank Research in Japan
Masanori Oikawa, Yoshiyuki Takimoto, Akira Akabayashi
Biopreservation & Biobanking, 19 December 2022
Abstract
Background
Parallel to the rapid advancement of biological and information technologies, the role and forms of biobank research have been constantly changing. The ethical, legal, and social implications of consent in biobank research are in a state of flux. This study aimed to clarify current Japanese public preferences regarding the consent model and explore how public attitudes are determined.
Methods
We conducted an online, population-based quantitative survey among Japanese residents aged between 20 and 69 years. Statistical analyses consisted of univariate and multivariate logistic regression.
Results
Of the 1580 respondents, 60.9% preferred autonomy-based consent (specific or dynamic consent) and 23.9% preferred broad-type consent (opt-out or broad consent). Marital status, gender, and privacy concerns were significantly associated with the preference for a consent model.
Conclusions
Our results demonstrated the public’s current preference for autonomy-based consent, including dynamic consent. However, our findings also revealed that approximately half of the respondents considered broad consent as somewhat preferable.

A Preliminary Study to Explore the Informed Consent Approach and the Ethical Challenges in the Malaysian Biobanking for Research
Amnah Azahar, Aimi Nadia Mohd Yusof, Zahir Izuan Azhar
Asian Bioethics Review, 8 November 2022
Open Access
Abstract
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.

Improving the Practice of Obtaining Informed Consent for Biobanking in Clinical Settings
Laura Arregui Egido, María Villalobos-Quesada
Biopreservation and Biobanking, 29 September 2022
Abstract
Background
Biobanks form key research support infrastructures that ensure the highest sample quality for scientific research. Their activity must align closely and proportionally to the interests of researchers, donors, and society. Informed consent (IC) is a central tool to guarantee the protection of donors’ rights and interests.
Aim
This study aimed to analyze the challenges of obtaining IC for biobanking in clinical settings and ways to improve this process.
Methods
Biobank Bellvitge University Hospital HUB-ICO-IDIBELL in Barcelona received 8671 IC forms between 2017 and 2020. The mistakes that caused IC forms to be rejected by the Biobank were analyzed. In addition, interventions aimed at physicians to improve the IC process were evaluated through a calculation of the relative risk (RR). Finally, physicians who submitted samples to the Biobank, most of whom are involved in research activities, were surveyed about the barriers to collecting IC and how to improve this process.
Results
During 2017–2020, 19.6% of IC forms were rejected. The most relevant cause of rejection was the use of outdated IC forms, followed by missing patient information or mistakes having been made by the physician. Evaluation of the rejection rates before and after interventions to improve the IC process suggests significant improvement (27.7% before interventions (January 2017–May 2018) compared to 9.6% after interventions (February–December 2020), RR 0.4 95% CI 0.34–0.47; p < 0.0001). According to the physicians, the most important barrier to collecting IC is the time constraint, and they consider digitalization as a viable solution.
Conclusions
Our research offers a view of the less well-understood practical challenges that physicians and biobanks face when collecting IC in clinical settings. It suggests that, despite multiple challenges, continuous monitoring, training, and information programs for physicians are key to optimizing the IC process in clinical settings.

Blanket Consent and Trust in the Biobanking Context
Original Research
Morten Ebbe Juul Nielsen, Nana Cecilie Halmsted Kongsholm
Journal of Bioethical Inquiry, 6 September 2022
Abstract
Obtaining human genetic samples is vital for many biobank research purposes, yet, the ethics of obtainment seems to many fraught with difficulties. One key issue is consent: it is by many considered ethically vital that consent must be fully informed (at least ideally speaking) in order to be legitimate. In this paper, we argue for a more liberal approach to consent: a donor need not know all the specifics of future uses of the sample. We argue that blanket consent is ethically defensible, and that this is buttressed by considerations of (justified) trust-relations. Given robust institutional oversight, blanket consent is a permissible form of consent in the bio-banking context.