The typical approach to ensuring ethical research assumes a framework of institutions, laws, and regulations that together offer ethical guidance, requirements, and oversight. But in our increasingly connected world, one in which technology, information, and other resources can travel globally and rapidly, this approach is showing its age even in traditional, familiar research.
For example, international collaborations may be subject to multiple sets of regulations, and interdisciplinary research may involve many professional ethical codes that are not always cohesive. But more strikingly, some new approaches to research occur entirely outside of any framework that makes ethical demands.
In citizen science, for example, projects may involve community monitoring of local air quality; international observations of particular species; or online-only projects with no limits to participation. This kind of research often involves collaborations between research participants from multiple countries and disciplines, with varying types and levels of training, who are often working independent of institutions. Similarly, do-it-yourself (DIY) biology or medical research may occur with just one independent researcher in a home-built lab; at the local level involving small group work within community biology labs; or at international scale on platforms such as Just One Giant Lab. DIY Bio projects have ranged from at-home Covid tests, open source epinephrine autoinjectors and accessible insulin, and even pirated gene therapies.
What these dispersed, non-traditional, or “non-establishment” approaches to research have in common is that they are ill-matched to a regulatory or ethical framework that assigns the responsibility for ethical research to centralized and monolithic institutions tied to a funding source or the laws of one nation. The poor match occurs across several dimensions. First, in many cases it is simply impossible for new research approaches to take advantage of existing institutional ethical frameworks, either because those institutions will not take on the liability of reviewing independent projects, or because such projects, run on minimal funding support, cannot afford independent review or oversight. Second, because many non-establishment research approaches stretch across international boundaries, there is no one set of national laws to adhere to, and no higher source of law (such as exists in international maritime law, for example) to which to appeal. Third, contrary to popular perception, ethical codes and regulations are not universal, so interdisciplinary or international projects must often grapple with distinct sets of ethical expectations. Given the lack of funding required to dedicate time and resources to establishing ethical guidance in these circumstances, it should not be surprising that none of these new research approaches have yet resolved how to maintain ethical standards in research.
These new approaches are not mere curiosities; they are already contributing meaningfully to the fund of knowledge (de Lorenzo and Schmidt, 2017), conducting potentially groundbreaking research, and aiming to contribute even more in the future. Some recommendations for ethics in these areas have been offered (Pauwels 2018; Guerrini et al., 2018; Pearlman and Kong, under review; Rasmussen 2019), but for the most part they have had a very narrow scope and/or tried to work within existing regulatory and institutional frameworks. We are at the very beginning of building research ethics structures that can operate independently of institutions, established funding paths, and traditional ethical frameworks, This makes it increasingly important for bioethicists and research ethicists to confront the question of how to maintain ethical standards of research in these new areas.
In this presentation, we will describe the kinds of ethical issues faced in some areas of new research, and reflect on possible approaches to ensuring that this research is conducted ethically. Presenter 1 will discuss Community Biology, and explain a facilitated approach to deriving a collectively-authored ethics code for the field. Presenter 2 will discuss an international platform for DIY Biology, the ethical challenges faced as researchers on this platform raced to address the COVID-19 pandemic, and the efforts of the platform members to address ethical issues in the process. Presenter 3 examines the challenge of establishing intellectual property resulting from research that stretches across international legal boundaries, and offers a normative framework for assessing claims to intellectual property. Finally, Presenter 4 will explore conceptual approaches to ensuring ethical research, within a framework of a “trust architecture” that establishes structures and systems that facilitate trust in the process and results of the research.
Creating a Culture of Biosafety in DIY Science during COVID-19
Professor Anna Wexler | University of Pennsylvania Perelman School of Medicine | United States
One of the most significant concerns that scholars have expressed about do-it-yourself (DIY) science movements is the potential for harm due to considerations of biosafety. Fears have been expressed that DIY science could threaten public health or lead to environmental contamination. These concerns became particularly salient during the COVID-19 pandemic, when unprecedented international DIY science efforts were devoted to creating open-source COVID-19 diagnostic tests and vaccines. To date, however, there has not been a systematic examination of how members of DIY science communities navigate biosafety-related issues.
In the present study, we conducted semi-structured interviews with 31 individuals involved in open-source science related to COVID-19 on the international Just One Giant Lab (JOGL) platform. We found that rather than a disregard for biosafety, the DIY science community created a biosafety board as well as collaboratively contributed to—and published—a comprehensive set of biosafety guidelines. Reported reasons for the establishment of biosafety guidelines include reputational protection, safety of others, creation of resources, and setting community standards. Notably, though the guidelines were the first instance of international biosafety guidelines for the DIY biology community, interviewees did not view it as a unique achievement, but rather as the culmination of a longstanding culture of biosafety, reinforced through a decade of devoted efforts to ethics training that included partnership with experts at organizations such as the Association for Biosafety and Biosecurity. Areas for improvement noted by interviewees included better dissemination of biosafety guidelines as well as the need for increased communication with outside experts.
Addressing Ethical Issues of Ownership in Biomedical Citizen Science
Assistant Professor Christi Guerrini | Baylor College of Medicine | United States
The collaborative nature of biomedical citizen science raises important questions about whether the independent scientists who support these projects have legitimate claims to their outputs. Depending on the design and objectives of a particular project, its outputs might include data sets, research findings, publications, or discoveries of new methods or technologies. Although property rights to project outputs are determined by contractual agreements, institutional policies, and statutory and common law, the rhetoric and processes employed by some projects can support the idea that participants have legitimate moral claims to access or use their outputs regardless of legal entitlements. The strength of citizen scientists’ moral claims to the outputs of the scientific activities they support might be especially strong with respect to biomedical projects that collect their personal health data or biospecimens or could provide them or their loved ones health benefits. This presentation will describe a normative framework for assessing the strength of biomedical citizen scientists’ claims of ownership given project practices based on the 3 Rs of respect, reciprocity, and reasonable expectations. This framework has practical value in helping projects promote the fairness of their ownership practices. It also has theoretical value in illuminating areas of tension in the application of traditional research ownership approaches to citizen science contexts.
Ethical Frameworks in New Research Approaches
Professor Lisa Rasmussen | University of North Carolina, Charlotte | United States
Past research abuses have driven the creation of mechanisms to guard against future abuse. But the shape of those mechanisms was driven by historical circumstances - for example, the fact that most research occurred within institutions and/or was funded by the government made a regulatory approach optimal. However, new approaches to research - for example, those not conducted within institutions or with federal funding - do not fit existing ethical mechanisms well, creating the potential for ethical abuse.
One solution might be to prohibit new research approaches, but this may be both impossible and unwise. Instead, because research must be trusted if it is to be used, we will need to find new ways to build a “trust architecture” in new areas of research. A trust architecture is a system of structures and processes that generate trust in an activity. For example, federal deposit insurance can create sufficient trust to motivate people to deposit their money in banks. Because new research approaches might not conform to either the shape or ethical values of existing research ethics structures, we will need to build new trust architectures in novel research areas. In this presentation, I will explore possible approaches to building trust architecture in novel research areas, suggest some necessary elements of a trust architecture, and summarize some lessons for bioethics in the consideration of these new research areas.