Motives for withdrawal of participation in biobanking and participants’ willingness to allow linkages of their data

Data repositories, like research biobanks, seek to optimise the number of responding participants while simultaneously attempting to increase the amount of data donated per participant. Such efforts aim to increase the repository’s value for its uses in medical research to contribute to improve health care, especially when data linkage is permitted by participants. We investigated individuals’ motives for participating in such projects and potential reasons for their withdrawal from participation in a population-based biobank. In addition, we analysed how these motives were related to various characteristics of the participants and their willingness to permit data linkage to their personal data for research. These questions were explored using a sample of participants in the Dutch Lifelines biobank (n = 2615). Our results indicated that motives for participation and withdrawal were premised on benefits or harm to society and to the individuals themselves. Although general values and trust both played key roles in participation, potential withdrawal and willingness to permit data linkage, they were differentially associated with motives for participation and withdrawal. These findings support and nuance previous findings by highlighting the distinctiveness and complexity of decision making regarding participation in or withdrawal from data donation. We suggest some new directions for improving recruitment, retention and safeguarding strategies in biobanking. In addition, our data provide initial evidence regarding how factors may relate with the probability that individuals will agree to data linkages, when controlling for their unique effects. Future research should further investigate how perceptions of harm and benefits may influence decision making on withdrawal of participation.

Adolescent Assent and Reconsent for Biobanking: Recent Developments and Emerging Ethical Issues

Research biobanks that enroll minors face important practical, ethical, and regulatory challenges in reconsenting participants when they reach the age of 18. Federal regulations governing research in the United States provide minimal guidance and allow for a range of practices, including waiving the requirement to obtain reconsent. Some commentators have argued that institutional review boards should indeed grant such waivers, given the low risks of biobank-based research and the impracticality of contacting all participants when they turn 18. There is also significant ethical debate about the age at which adolescents can make authentic, autonomous decisions regarding their research participation. This paper reviews these issues in detail, describes the current state of the ethical discussion, and outlines evidence-based policies for enrolling minors into research biobanks.

Protecting Genetic Privacy in Biobanking through Data Protection Law

Biobanks are critical infrastructure for medical research. Biobanks, however, are also the subject of considerable ethical and legal uncertainty. Given that biobanks process large quantities of genomic data, questions have emerged as to how genetic privacy should be protected. What types of genetic privacy rights and rights holders should be protected and to what extent? Since 25 May 2018, the General Data Protection Regulation (GDPR) has applied and now occupies a key position in the European legal framework for the regulation of biobanking. This book takes an in-depth look at the function, problems, and opportunities presented by European data protection law under the GDPR as a framework for the protection of genetic privacy in biobanking. It argues that the substantive framework presented by the GDPR already offers an admirable baseline level of protection for the range of genetic privacy rights engaged by biobanking. The book further contends that while numerous problems with this standard of protection are indeed identifiable, the GDPR offers the flexibility to accommodate solutions to these problems, as well as the procedural mechanisms to realise these solutions.

Research Biobanking, Personal Data Protection and Implementation of the GDPR in France

Since 1978 and the initial French data protection law (Loi n°78-17 du 6 Janvier 1978), consecutive modifications regarding the protection of personal health data, especially in 2004, 2016 and 2018, set up a strict legal regime for processing sensitive personal data, including for research purposes. In recent years, French law has evolved proactively and in parallel with the work of the European Union (EU) on the preparation of what became the General Data Protection Regulation (GDPR), which has been in force since May 2018. This Chapter performs a state-of-art analysis (as of 1 July 2019) of the French legal framework for research biobanks and data protection rules applying to biobanking, in particular those related to data subjects’ rights and Article 89 of the GDPR. Firstly, it provides updated information about the national landscape of active research biobanks in France (Sect. 1). Secondly, it explores how the French law embodies the developments brought by the GDPR and how it envisages individuals’ rights in the context of research biobanking (Sects. 2 and 3). Thirdly, this Chapter analyses existing and potential national exemptions to individuals’ rights, including with regard to Article 89 GDPR, and how France conceives of processing activities of ‘public interest’ (Sect. 4). Finally, the authors address ongoing debates around bioethics law in France and argue for the creation of a specific Act focused on biobanking as a means of integrating, clarifying and developing not only data protection rules but also other activities related to samples, human or not, in a unique, operational and compact act (Sect. 5).

The Italian Way for Research Biobanks After GDPR: Hybrid Normative Solutions to Balance the Protection of Individuals and Freedom of Research

The Italian context of biobanking is made up of a vast number of collections, in some cases well-organised and connected in virtuous networks and in others not identifiable as structured biobanks. From a comparative perspective, Italy can be regarded as a hybrid model, positioned between countries with full and detailed legislation concerning biobanks and those that rely only on guidelines published by national ethics committees or professional societies that have no binding legal value. In countries like Italy where the need for specific regulation is more urgent, the entry into force of the GDPR could have offered a chance to fill the gap in the legislation with regard to biobanking for medical scientific research purposes. This overview highlights the improvements made and the obstacles that persist.

Informed Consent in the Newly Established Biobank

Informed consent is an important document for every existing biobank or repository to obtain, store and use human biospecimens and associated data and information for current and future research. Biobanks have undergone great progress worldwide during the last three decades and have become an integral part of personalized medicine and health care systems and due to new scientific and social questions to be solved. Ethical, legal and social issues (ELSI) guarantee safe sample and data management, and informed consent is one of the key ELSI documents. The form and the consent given in biobank informed consent forms differs between biobank-related institutions, national biobanks, between EU states, and to find the optimal informed consent requires one to fulfil national and international laws and regulations. The Biobank in Pilsen, Czech Republic was officially opened on April the 20th 2017 as a hospital-integrated biobank, and the informed consent was one of the essential documents that had to be ready prior the opening. The process of formulating informed consent corresponding with institutional, national, and international rules and laws to share the experience, to present the challenges, and to demonstrate the national dissimilarity are tasks of the article.