Challenges to biobanking in LMICs during COVID-19: time to reconceptualise research ethics guidance for pandemics and public health emergencies?

Biobanking can promote valuable health research that may lead to significant societal benefits. However, collecting, storing and sharing human samples and data for research purposes present numerous ethical challenges. These challenges are exacerbated when the biobanking efforts aim to facilitate research on public health emergencies and include the sharing of samples and data between low/middle-income countries (LMICs) and high-income countries (HICs). In this article, we explore ethical challenges for COVID-19 biobanking, offering examples from two past infectious disease outbreaks in LMICs where biobanking activities contributed to the perpetuation of global inequities. We focus on how the ethical imperative to promote the common good during public health emergencies can conflict with protecting the interests of biobank participants. We discuss how conducting biobank research under a waiver of informed consent during public health emergencies is ethically permissible, provided guidance is in place to prevent biopiracy and exploitation of vulnerable communities. We also highlight the need for biobank collaborations between LMICs and HICs to promote capacity building and benefit sharing. Finally, we offer guidance to promote the ethical oversight of biobanks and biobank research during the COVID-19 pandemic or other future public health emergencies.

A serviceable Research Biobank model: Charter of Principles and Biobank Ethics Consultation Service (BECS) as a formal toolkit to promote an expert ethical guidance to biobank research

The complexity of biobank research has recently increased generating a number of novel ethical issues. In recent years the University of Insubria is committed to provide specific training programs in Bioethics, Applied Ethics and Clinical Ethics aimed to face to critical topics related to medicine, research and biobanking. Actually we design the Insubria Biobank as a research infrastructure with an appropriate Ethical Framework and responsible for the custody of biospecimens and data according to a model of Charitable Trust. So to answer certain questions is crucial: How could biobank respect the trust placed in it? What resources could promote the goals of the biobank? Do professionals require a specific ethical training? This credit of trust must be fed and confirmed by the ethical choices of the biobank and ensuring maximum transparency and traceability of decisions. The aim of the Insubria Biobank is to become an ethical subject to secure the public trust and to define the ethics criteria to be made public and to which the biobank will comply. In our model we propose the prospective involved parties that could guarantee the achievement of this goal: Informed Consent, Charter of Principles and Biobank Ethics Consultation Services (BECS). Our purpose is to offer a Charter of Principles and BECS to help scientists, health care professionals, patients, donors, institutional review board and policymakers, better navigate the ethical issues in biobanking. An exploratory survey to identify the willingness to use BECS represent our future research plan.

Scientific Citizenship’s Youngest Domain: Function Creep in Norway’s Newborn Screening Programme

Newborn screening (NBS) for inborn errors of metabolism and other serious conditions with onset during infancy is a widespread public health initiative. Like other screening programmes, it aims to discover and treat a disease before effects manifest themselves. Recently, there have been two prominent changes in NBS: a substantial increase in the number of conditions screened for and growing attention to secondary use of residual newborn blood spots. Here, we analyse how this latter change has transpired in Norway. In 2018, Norway’s parliament sanctioned the secondary use of NBS samples for epidemiological research unrelated to NBS. This broadened the programme’s scope, co-opting it for research purposes, making samples available for inclusion in Norway’s biobanking strategy. We argue that this transformation is a case of function creep, whereby the function of screening samples is expanded to serve purposes other than helping newborns. The process provided only minimal involvement from ordinary citizens, but it transformed screened infants into potential scientific citizens. Henceforth, all future generations of Norwegians must choose to stay in or opt out of biobank research when they turn sixteen. Additionally, consenting to this research may occasion a second form of function creep, as ‘actionable findings’ are fed back to participants.

Swedish Law on Personal Data in Biobank Research: Permissible But Complex

This chapter describes the regulatory and organisational infrastructure of biobank research in Sweden, and how the introduction of the GDPR affects the possibilities to use biobank material in future research. The Swedish legislator has chosen a rather minimalistic approach in relation to the research exception in Article 89 GDPR and has only enacted limited general exceptions to the data protection rules. This may be partly explained by the comprehensive right to public access to official documents which gives researchers vast access to information held in registries, albeit conditioned on abiding by secrecy and confidentiality rules. The Swedish legislation implementing the GDPR includes a general exception from the data protection rules in relation to the right to access to official documents, which researchers also benefit from. However, confidentiality rules for different categories of information differ between sectors, which hinders an effective use of the registries in research. The regulatory regime for using biobank and registry data in Sweden thus involves both data protection and secrecy rules, which makes the legal landscape permissible but complex. The operationalisation of the research exception in Article 89 GDPR is analysed against this background. Special attention is given to the possibility to link personal information derived from biobanks with personal information from other data sources, including large national population based statistical registries as well as information from national clinical registers.

The Impact of the GDPR on the Governance of Biobank Research

Governance of health and genomic data access in the context of biobanking is of salient importance in implementing the EU General Data Protection Regulation (GDPR). Various components of data access governance could be considered as ‘organizational measures’ which are stressed in the Article 89(1) GDPR together with technical measures that should be used in order to safeguard rights of the data subjects when processing data under research exemption rules. In this chapter, we address the core elements regarding governance of biobanks in the view of GDPR, including conditions for processing personal data, data access models, oversight bodies and data access agreements. We conclude by highlighting the importance of guidelines and policy documents in helping the biobanks in improving the data access governance. In addition, we stress that it is important to ensure the existing and emerging oversight bodies are equipped with adequate expertise regarding using and sharing health and genomic data and are aware of the associated informational risks.

An Overview of Belgian Legislation Applicable to Biobank Research and Its Interplay with Data Protection Rules

This contribution aims to present in a clear and concise manner the intricate legal framework for biobank research in Belgium. In Part 1, we describe the Belgian biobank infrastructure, with a focus on the concept of biobank. In Part 2, we provide an overview of the applicable legal framework, namely the Act of 19 December 2008 on Human Body Material (HBM), and its amendments. Attention is given to an essential piece of self-regulation, namely the Compendium on biobanks issued by the Federal Agency on Medicine Products and Health (FAMPH). Furthermore, we delineate the interplay with relevant data protection rules. Part 3 is dedicated to the main research oversight bodies in the field of biobanking. In Part 4, we provides several examples of the ‘law in context’. In particular, we discuss issues pertaining to presumed consent, processing of personal data associated with HBM, and information provided to the donor of HBM. Finally, Part 5 and 6 addresses the impact of the EU General Data Protection Regulation (GDPR), suggests lines for further research, and outline the future possibilities for biobanking in Belgium.

Individual Rights in Biobank Research Under the GDPR

The coming into force of the General Data Protection Regulation (GDPR) on 25 May 2018 has brought about considerable changes in how data may collected, stored and used. Biobanks, which require the collection, use and re-use of large quantities of biological samples and data, will be affected by the proposed changes. In seeking to require ‘data protection by design’, the GDPR provides data subjects with certain individual rights. They are, the right to be informed, the right of access, the right to rectification, the right to erasure, the right to restrict processing, the right to data portability, the right to object and rights in relation to automated decision making and profiling.This chapter will consider each of these individual rights in turn and discuss the impact on biobank research. In particular, it will discuss the challenges that are now facing biobanks in upholding the individual rights, the limits of these rights in light of the technical realities of biobanks, and the potential impact that they may have on the collection, sharing, use and re-use of biological data and material.

Allocation of Regulatory Responsibilities: Who Will Balance Individual Rights, the Public Interest and Biobank Research Under the GDPR?

In this chapter, an analysis is undertaken of the division of legislative power in the space created by the GDPR, regarding the balancing of individual rights, the public interest and biobank research. The legislative competences of the EU, international obligations within bioethics, and the regulatory space left for Member States are all examined. The conclusion of the chapter is that in spite of the aim of the GDPR to further legal harmonisation, it is more likely that unity will be brought about through administrative cooperation and soft law tools.