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Introduction¹

Biomedical research² has led to numerous discoveries and the translation of those advances into the areas of medicine, health, and policy for the purposes of improving health and reducing the burden of disease. Conducting responsible biomedical research and appropriately using and applying the new knowledge gained from these investigations in society will mean integrating the basic guiding principles of bioethics³ into the translational process. Technological advances in biomedical research can lead to the appearance of new and emerging bioethical issues. The use of new technologies may also mean that existing bioethical challenges may be viewed in a new light. As scientific research, technological advances, and societal perspectives of those advances continue to evolve, ethical discussions are needed at the intersections where innovations meet the people who may

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¹ This workshop was organized by an independent planning committee whose role was limited to identification of topics and speakers. This Proceedings of a Workshop was prepared by the rapporteurs as a factual summary of the presentations and discussion that took place at the workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants and are not endorsed or verified by the National Academies of Sciences, Engineering, and Medicine, and they should not be construed as reflecting any group consensus.

² “Biomedical research” refers to research that is broad in scope and can span disciplines of biology, medicine, behavioral, and social sciences. Conducting biomedical research may imply experimental inquiries to understand events at the atomic, molecular, cellular, organismal, and population levels (Flier and Loscalzo, 2017).

³ “Bioethics” refers to the multidisciplinary study of, and response to, moral and ethical questions related to innovations in biomedicine (see What Is Bioethics at https://bioethics.jhu.edu/about/what-is-bioethics [accessed May 18, 2020]).

use them with the goal of ensuring that the benefits of research reach all individuals and that individuals are not subject to harms.

For example, as the use of digital technologies becomes ever more prevalent in daily life as well as in biomedical research and clinical care, new challenges related to informed consent, the privacy of patient information, responsible data sharing, and considerations for vulnerable and under-served populations are presented. Wearable technologies and applications on mobile devices passively collect biometric and behavioral data that can then be used for self-study or self-care, shared with health care providers, or used by the digital platform for purposes that the device owner might, or might not be, aware of. The potential ethical challenges can include issues related to health equity and health literacy (e.g., who has access to digital devices for participation in research) and a lack of data privacy protections for user-generated data that could be used to make conclusions about an individual’s health. New models of biomedical research are emerging too, including patient-led research that takes place outside of the traditional regulatory environment (and often employs digital technologies). Individuals involved in citizen science⁴ might fall into a less regulated area of research where the adherence to ethical research norms has less oversight. Another ethical challenge for the research enterprise in the United States is that certain populations have been consistently underrepresented in research (e.g., rural, low socioeconomic, and racial/ethnic minority groups), making it less likely that the benefits from research will be equitably distributed. Structural racism is a contributor to racial inequalities in health, and an examination of the origins of race can be helpful to begin to understand this important issue.

On February 26, 2020, the Board on Health Sciences Policy of the National Academies of Sciences, Engineering, and Medicine (the National Academies) hosted a 1-day public workshop⁵ in Washington, DC, to examine current and emerging bioethical issues that might arise in the context of biomedical research and to consider research topics in bioethics that could benefit from further attention. The scope of bioethical issues in research is broad, and for this workshop the independent planning committee chose to focus on issues related to the development and use of digital technologies, artificial intelligence, and machine learning in research and clinical

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⁴ The term “citizen science” does not currently have a widely accepted definition, but has been referred to as “the general public engagement in scientific research activities when citizens actively contribute to science either with their intellectual effort or surrounding knowledge or with their tools and resources” (EC, 2014). Other terms for similar nontraditional research models include personal science, do-it-yourself science, patient-led research, or participant-led research. Citizen science is discussed in further detail in Chapter 3.

⁵ The workshop agenda, speaker biographies, planning committee Statement of Task, and a list of attendees can be found in Appendixes A, B, C, and D, respectively.

practice; issues emerging as nontraditional approaches to health research become more widespread; the role of bioethics in addressing racial and structural inequalities in health; and enhancing the capacity and diversity of the bioethics workforce. Specific areas of research were outlined in the Statement of Task (see Box 1-1) as being out of scope for the workshop due to other ongoing projects in those spaces. The workshop was sponsored by the National Institutes of Health (NIH) Office of Science Policy.

CURRENT AND HISTORICAL SUPPORT FOR BIOETHICS RESEARCH

Over the past 25 years many members of the bioethics community have benefited from funding from NIH, said Jeffrey Kahn, the director of the Johns Hopkins Berman Institute of Bioethics and the chair of the workshop planning committee. For example, support for bioethics from NIH has included bioethics-focused, investigator-initiated projects and research; inclusion of bioethics as a component in biomedical research projects; the embedding of bioethics researchers within biomedical research to examine and analyze the ethical issues raised; and support for trainees in bioethics-related programs.

Kahn said the majority of bioethics-related NIH research funding has been focused in three main areas: genomics, funded through the ethical, legal, and social implications (ELSI) portfolio that is administered by the National Human Genome Research Institute (NHGRI); the ethics of biomedical research, supported by several institutes of NIH; and bioethics capacity building outside the United States, through the funding portfolio administered by the Fogarty International Center. This support for bioethics research has been essential for the development of the field of bioethics and for the careers of many researchers, but Kahn said that it has also had the predictable effect of focusing bioethics research mostly into these three areas.

More recently, Kahn said, NIH has expanded its portfolio for bioethics research, including funding from the NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, which has explored neuroethics issues. Recent bioethics funding opportunities from NIH include administrative supplements⁶ to support research on bioethical issues to inform policy development and funding from the National Center for

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⁶ See Notice of Special Interest: Administrative Supplement for Research on Bioethical Issues (Admin Supp Clinical Trial Optional), NOT-OD-20-038, https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-038.html (accessed April 29, 2020); and Notice of Special Interest: Administrative Supplements for Research on Ethical, Legal and Social Issues regarding Post-mortem Pediatric Tissue Procurement for Research Purposes (Admin Supp Clinical Trial Optional), NOT-OD- NOT-HD-20-012, https://grants.nih.gov/grants/guide/notice-files/NOT-HD-20-012.html (accessed April 29, 2020).

Advancing Translational Sciences⁷ to support the study of ethical issues in translational science research.

Although the NIH bioethics portfolio continues to expand, it is still limiting researchers in some ways, Kahn said, as there are many bioethics topics, and approaches to studying them that do not fall within the current NIH funding portfolio. This workshop is an important beginning to the discussion of how that research portfolio might be expanded further and create new opportunities, Kahn said (see Box 1-1).

It is important to note that the World Health Organization declared COVID-19 a pandemic on March 11, 2020, 2 weeks following this workshop. At the time of the workshop, there was limited evidence of community spread in several U.S. states, and widespread physical distancing efforts had not yet been implemented in the United States. As such, speaker remarks were focused broadly on bioethical issues in biomedical research and clinical care that were not related specifically to COVID-19. On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security (CARES) Act was signed into law, expanding reimbursement for telehealth and remote patient monitoring under Medicare.⁸ Other large private payers, including Aetna, Cigna, and Blue Cross Blue Shield, have also expanded coverage of telehealth in their health plans.⁹ The Office for Civil Rights at the U.S. Department of Health and Human Services (HHS) issued a statement in mid-March 2020 indicating that it would be exercising enforcement discretion about the Health Insurance Portability and Accountability Act of 1996 rules regarding remote communications technologies used for telehealth during the pandemic.¹⁰ Given this rapidly evolving landscape, there may be additional bioethical issues related to digital technologies, structural racism and health disparities, privacy, and other topics that were not expressly covered during the workshop and that warrant further discussion as well as additional funding opportunities. For example, at the time of publication,

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⁷ See Ethical Issues in Translational Science Research (R01 Clinical Trial Optional), RFA-TR-20-001, https://grants.nih.gov/grants/guide/rfa-files/RFA-TR-20-001.html (accessed April 29, 2020).

⁸ For more information about the CARES Act, see https://www.congress.gov/bill/116thcongress/house-bill/748 (accessed April 27, 2020).

⁹ For more information on private payer coverage of telehealth, see https://www.aetna.com/individuals-families/member-rights-resources/covid19/telemedicine.html, https://www.cigna.com/coronavirus, and https://www.bcbs.com/coronavirus-updates (all accessed April 27, 2020).

¹⁰ For more information on HHS enforcement discretion related to telehealth remote communications, see https://www.hhs.gov/hipaa/for-professionals/special-topics/emergencypreparedness/notification-enforcement-discretion-telehealth/index.html (accessed April 27, 2020).

NHGRI had issued a new funding opportunity for ELSI research related to COVID-19.¹¹

OVERVIEW OF TOPICS HIGHLIGHTED DURING PRESENTATIONS AND DISCUSSIONS

A number of topics were discussed throughout the workshop sessions as participants considered the range of bioethical issues that are relevant to biomedical research. While the workshop was funded by NIH, the meeting day aimed to cover material that would be of value to many groups in the fields of bioethics and biomedicine, including academic researchers and funders from the United States and around the world. While several of the presenters provide considerations for NIH, the issues raised during the discussions may also be of interest to other stakeholders. The topics highlighted below were drawn from individual speakers’ remarks and the open discussions and are addressed further in the succeeding chapters.

Ethical Norms

Several times during the workshop speakers acknowledged that data scientists and digital technology developers currently operate under a very different set of cultural norms, ethical commitments, and incentive structures than those of biomedical research and health care practice. Some speakers said that a better understanding of ethical issues is needed by digital technology developers and data scientists but that those efforts will also need to be supplemented by guidelines, regulations, system architecture, collaboration among various stakeholders, and improved incentive structures.

Multidisciplinary Collaboration

Collaboration among biomedical subject-matter experts and algorithm developers was discussed as being essential for the development and assessment of safe, reliable, and useful tools for health. Importantly there was also discussion about the potential value of designing bioethics research projects that draw from multiple disciplines, including law, philosophy, sociology, history of medicine, critical medical humanities, science and technology studies, and literary theory. Some speakers felt that it would be advantageous to pair bioethics research questions directly with scientific innovation.

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¹¹ See Notice of Special Interest regarding the Availability of Urgent Competitive Revisions for Research on the 2019 Novel Coronavirus, NOT-HG-20-030, https://grants.nih.gov/grants/guide/notice-files/NOT-HG-20-030.html (accessed April 29, 2020).

Workforce Training

Training was a recurrent theme across panel discussions in terms of incorporating bioethical principles into various biomedical fields and for the purposes of preparing the bioethics workforce itself. As an example of integrating bioethics into other fields, it was discussed that the field of data science is in the early stages of addressing key ethical issues but that attention is now being paid to ethics challenges. It was mentioned that scientific conferences are devoting sessions or entire meetings to ethical issues and that colleges and universities are implementing ethics classes for data scientists. Speakers also shared their thoughts on the need for training clinicians and clinical laboratory professionals in the proper and unbiased use of algorithms. With regard to developing the bioethics workforce, it was discussed that bioethics training is reaching people too late in their careers and that there is a need to attract a more diverse group of people to the field of bioethics at an earlier age, including supporting doctoral research in bioethics. There was also discussion of the limitations of current bioethics training programs for research professionals. The importance of taking country context into account in training programs for bioethicists was also noted by speakers at the workshop as well as the value of training ethicists for transdisciplinary research.

Transparency and Choice in Data Sharing

There was much discussion about individuals’ awareness of, understanding of, and ability to consent to the sharing and uses of their health and medical data. Participants discussed the value of transparency and choice when individuals must agree to the sharing of their data in order to receive services and when shared data are not subject to appropriate governance. Participants also discussed the differences between data sharing within the context of a research collaboration (where responsibilities and ethical norms are preserved) and the sale or transfer of data (where control is often relinquished).

Racism and Structural Inequalities

The impact of racism and structural inequalities was discussed relative to issues such as the development of digital technologies and disparities that can be introduced by their use, who participates in research and why they do or do not, and who has the opportunities to be trained for careers in the biomedical and bioethics fields. For example, it was discussed that biases in the data used to train machine learning algorithms can result in structural inequalities that perpetuate inequalities. Participants also discussed some of

the historical context and current reasons why underrepresented populations often do not participate in research.

Power and Privilege

Implicit biases and structural forces assign status to people, which in turn may create differences in power and privilege. The concept of power and privilege was discussed in the context of the conduct of research—specifically, who has the right to formulate the questions, to define benefits and harms, and to define what qualifies as “success.” Workshop participants observed that professional researchers, who traditionally hold the power, often have not had the same lived experience as people from minority communities or individuals conducting self-study and often make the mistake of assuming they know what is needed by the people they are working to serve.

Research Questions for Funding or Focus

One of the objectives of the workshop was to consider potential research topics in the areas of bioethics as it relates to the use of digital technologies, data collection and use, citizen science, structural inequalities around who participates in research, and the workforce training infrastructure for bioethicists. A broad range of ideas were suggested by individual participants throughout the workshop for further attention and funding support, and these ideas are included in Chapter 6.

ORGANIZATION OF THE WORKSHOP AND PROCEEDINGS

This Proceedings of a Workshop summarizes the presentations and discussions that took place at the workshop on February 26, 2020. The first two panel sessions focused on the ethical issues associated with the use of digital health technologies, artificial intelligence, and machine learning in biomedical research and clinical care (Chapter 2). The third panel considered the different forms of innovative research models that are participant-led or patient-centered (compared with scientific investigator–led), such as citizen science, that take place outside of the traditional regulatory environment. Panelists discussed other forms of citizen science, such as personal science, and the governance of unregulated research involving mobile devices and how people pursuing these types of studies might do so ethically (Chapter 3). The next panel examined the impact of inequality on health, disease, and who participates in research. Panelists discussed race, racism, structural inequalities, the lasting impacts of historical ethical failures and harms, and the unique issues affecting sovereign tribal nations (Chapter 4).

This was followed by a discussion of bioethics workforce issues, including training needs and opportunities to ensure and maintain diversity in the workforce (Chapter 5). The workshop concluded with observations and reflections shared by panelists from a variety of agencies that fund bioethics research and from audience participants (Chapter 6).

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