Responsible Data Sharing to Respond to the COVID-19 Pandemic: Ethical and Legal Considerations (v 3.0)

The Perspective of the Regulatory and Ethics Work Stream of the Global Alliance for Genomics and Health

Notice to the GA4GH community: This is a living document and we are seeking contributions. We will be releasing version 4.0 on July 15. Please submit comments/contributions by July 10.

If you would like to contribute, the Regulatory and Ethics Work Stream kindly requests that you download a copy of the document, annotate it, and then email it to Adrian Thorogood and Michael Beauvais ([email protected] ; [email protected]).

Text in dark grey is new to version 2.0.

Text in navy is new to version 3.0.

Executive summary

An effective and equitable response to the COVID-19 pandemic requires rapid and sustained international collaboration and data sharing. The Global Alliance for Genomics and Health (GA4GH)’s focus on the creation of technical standards and regulatory/ethics guidance to enable the responsible sharing of human genomic and health-related data means that the GA4GH community is in a unique position to help move forward research into COVID-19. The Regulatory and Ethics Work Stream (REWS) has prepared this overview to assist researchers and others, such as research ethics committee (REC) / institutional review board (IRB) members, in navigating ethical and legal issues during the COVID-19 public health emergency. This is a living document, and we call on the GA4GH community to provide feedback, and to share their experiences and success stories.

Legal and regulatory

For the jurisdictions examined to-date (Australia, Canada, EU, UK, and USA), privacy and data protection law already contains provision for the processing of data for public health purposes provided certain conditions are satisfied. Where research is undertaken as a public health measure (typically under the supervision of a public health authority), privacy law provides avenues for data processing. Engaging in international transfers of personal data may also require a distinct basis in law.

Intellectual property (IP) can be licensed under generous terms for the purposes of responding to COVID-19 through licenses such as the Open COVID License. Some countries (e.g., Germany, Israel, Chile, and others) have also taken measures to more generously license patented technologies relevant to COVID-19.

Genomic tests such as PCR testing are likely to be regulated as in vitro diagnostic medical

devices (IVDs). These tests must present scientific validity, analytical performance, and clinical performance for approval. Certain countries such as Canada have permitted temporary authorizations to be sought, which may allow test developers to rely on a preexisting foreign approval of the device.

Data sharing policy

The exigencies of the pandemic further highlight the need for open science. Sharing interim results and research methods insofar as the integrity of the research allows is essential. To this end, registering research hypotheses or projects in a public database before participant recruitment or data analysis is invaluable. Preprint publishing and other forms of knowledge sharing and exchange are also encouraged. At the same time, responsible use of such data is essential. This means carefully considering preliminary data’s limitations, especially where decisions affecting individuals may be made on the basis of such data.

Ethics

Public health ethics must be distinguished from biomedical ethics. The principle of justice is the bedrock of the former, with its emphasis on the interaction of individuals and communities, on collective responsibilities and common goods. The purposes for which the research is conducted will determine which set of principles are to be given greater weight. There is potential for the inclusion of research infrastructure such as biobanks within the public health system. To ensure such inclusion is done effectively and ethically, ethicists and policymakers should consider how to balance the ethical implications of public health measures with biomedical research.[1]

Timely Research Ethics Review and Data Access

Research is an integral part of outbreak response, but “despite [the] sense of urgency, research during an epidemic is still subject to the same core scientific and ethical requirements that govern all research on human subjects.”[2] Researchers should explore creative ways to obtain informed consent via digital means or through a legally authorized representative, where appropriate. Standard exceptions to consent requirements for secondary use of health data may have stronger ethical justification for research directed at pandemic responses. RECs/IRBs have been encouraged to adapt processes to facilitate the robust and timely review of research. Preliminary information from the GA4GH community suggests that RECs and data access committees (DACs) are anticipating some type of expedited review for COVID research.

Introduction

In the midst of a global pandemic, now, more than ever, we need sustained international collaboration and data sharing. Only by coming together to share data and collaborate in research can we as a global community respond effectively to the COVID-19 pandemic and develop solutions that can benefit humanity. As part of this effort, the Global Alliance for Genomics and Health (GA4GH) has signed onto the Wellcome statement Sharing research data and findings relevant to the novel coronavirus (COVID-19) outbreak. The GA4GH community also has various initiatives underway, from COVID beacons to platforms like COVIDaware that facilitate the anonymous collection of user-submitted symptom information. (Information regarding these initiatives can be found here: https://www.ga4gh.org/home/covid-19/).

The founding ethos of GA4GH centres around a human rights approach to responsible data sharing. The current pandemic has brought to the fore the human rights of everyone to obtain the highest attainable standard of health, to non-discrimination, and to the benefits of scientific progress. We note that many of the issues and principles raised in this context are not new; rather, the way in which these principles are weighed and balanced must be applied in an unprecedented public health context and tailored to the current pandemic situation. As citizens, we must also ensure that restrictions on fundamental rights and freedoms must be justified, proportionate, reviewable and temporary.

Responding to the pandemic requires an unprecedented level of collaboration from governments, international organizations, policy makers, scientists, industry, and the public. We consider that research, “whether epidemiological, genetic, preclinical, microbiological, behavioural or operational – can generate new knowledge about an outbreak in rapidly changing situations.”[3] In the context of COVID-19, this includes, for example, studies about clinical practice and process optimization, diagnostic tests, clinical trials, the virus’ interaction with the human body, validation of serological tests, etc., are all important to better respond to the outbreak.[4] These types of research implicate three broad types of data: pathogen genomic data, human (host) genomic data, and other types of human clinical data. The ethical and legal issues associated with sharing human data have been documented in the literature. Data governance policies may vary between data types, taking into consideration their scientific value (e.g., reproducibility), connection to the COVID-19 pandemic, as well as their ethical and legal implications.

The GA4GH Regulatory and Ethics Workstream (REWS) holds that the goal of responsible, open, and rapid dissemination of data and knowledge should still conform with ethical and legal principles, security standards, and applicable laws, and also recognizes that dissemination should encourage such sharing to improve responses in the context of public health emergencies. In recognition of the role that bioethics, public health ethics, and law have to play, we have outlined some of the specific issues the COVID-19 pandemic raises, including any relevant responses from regulatory authorities.

Description of the Audience, Goals and Structure of this Document

This document is primarily directed towards the human genomic research community interested in supporting the global effort to combat COVID-19. The goal of the document is to summarize key regulatory pathways and ethical considerations. In particular, we provide information on the kinds of modifications that are being implemented for genomics researchers to contribute in the context of a public health emergency, noting that these will differ between jurisdictions. This document is best read in conjunction with the recommendations and guidelines of the Research Data Alliance’s COVID-19 working group.

We envisage this as a living document, which we will aim to update regularly in response to rapidly changing research, legal and policy contexts. We envisage this document as a beginning of a conversation. To promote community learning, we encourage members of the GA4GH community to fill out a (very) brief survey regarding the existence of any new large-scale genomics or biobanking projects as part of their country’s response to the pandemic. Please see https://forms.gle/AUefrySNgJXZBdd77. We have shared some interim results in section 4 of this document.

1. Legal and regulatory

Law and regulation in the midst of a legitimate public health emergency may present new avenues by which research can be done in conformity with ethico-legal principles and norms. In this section, we detail three principal legal and regulatory areas of interest: privacy and data protection, intellectual property, and medical devices. We have given specific attention to responses in