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Toward Equitable Innovation in Health and Medicine: A Framework (2023)

Chapter: Appendix A: Information Sources and Methods

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Suggested Citation:"Appendix A: Information Sources and Methods." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Appendix A

Information Sources and Methods


The Committee on Creating a Framework for Emerging Science, Technology, and Innovation in Health and Medicine was tasked with developing a governance framework for considering potential benefits and risks that emerging science, technology, and innovation in health and medicine can bring to society, informed by prior work of the National Academy of Medicine (NAM) standing Committee on Emerging Science, Technology, and Innovation (CESTI). The committee was asked to produce a framework founded on core ethical principles with a focus on equity.

COMMISSION COMPOSITION

The National Academies of Sciences, Engineering, and Medicine and the National Academy of Medicine appointed a committee of 19 experts to undertake the statement of task. The committee was composed of members with expertise in such areas as biomedical research and development in academia and industry; health equity and justice; bioethics of emerging science and technology; governance, policy, and innovation; technology assessment, economics, and behavioral economics; and community engagement. Appendix D provides biographical information for each committee member. Two National Academy of Medicine fellows also participated in the study; their biographical information is also provided in Appendix D.

MEETINGS AND INFORMATION-GATHERING ACTIVITIES

The committee deliberated from approximately May 2022 to February 2023 to gather and discuss information and draft its report. To address its task, the committee analyzed information obtained from reviewing current literature and other publicly available resources and undertook information-gathering activities, such as inviting stakeholders to share perspectives during several virtual sessions and soliciting public input online.

Suggested Citation:"Appendix A: Information Sources and Methods." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×

Input from NAM CESTI

Materials developed by CESTI and information presented during an April 2022 workshop, at which the study was announced, served to inform the study committee. The workshop included sessions on lessons learned about emerging technology governance, technology assessment models, public engagement, and overviews of CESTI’s work. Materials developed by CESTI articulated essential elements and ethical principles to inform governance of emerging science, technology, and innovation, drawing on preparation and analysis of three case study discussion papers, in the areas of regenerative medicine, neurotechnology and noninvasive neuromodulation, and telehealth and mobile health. Each case study opened with hypothetical vignettes to illustrate potential ethical issues, identified key stakeholders and how governance developed within and across sectors, and concluded with a “visioning” section on possible evolutionary trajectories the example may take that would need to be accounted for in a governance system. Publications arising from CESTI have been referenced in relevant chapters:

  • Mathews, D. J. H., C. A. Balatbat, and V. J. Dzau. 2022a. Governance of emerging technologies in health and medicine: Creating a new framework. New England Journal of Medicine 386:2239-2242.
  • Mathews, D. J. H., R. Fabi, and A. C. Offodile II. 2022b. Imagining governance for emerging technologies. Issues in Science and Technology 38(3):40-46.
  • Mathews, D., A. Abernethy, A. Butte, J. Enriquez, B. Kocher, S. Lisanby, T. M. Persons, R. Fabi, A. C. Offodile II, J. S. Sherkow, R. Sullenger, E. Freiling, and C. Balatbat. 2023a. Neurotechnology and noninvasive neuromodulation: Case study for understanding and anticipating emerging science and technology. NAM Perspectives. Discussion Paper, National Academy of Medicine, Washington, DC. Forthcoming.
  • Mathews, D., A. Abernethy, E. Chaikof, R. A. Charo, G. Q. Daley, J. Enriquez, S. Gottlieb, J. Kahn, R. D. Klausner, S. Tavazoie, R. Fabi, A. C. Offodile II, J. S. Sherkow, R. Sullenger, E. Freiling, and C. Balatbat. 2023b. Regenerative medicine: Case study for understanding and anticipating emerging science and technology. NAM Perspectives. Discussion Paper, National Academy of Medicine, Washington, DC. Forthcoming.
  • Mathews, D., A. Abernethy, A. Butte, P. Ginsburg, B. Kocher, L. Levy, C. Novelli, L. Sandy, J. E. Smee, R. Fabi, A. C. Offodile II, J. S. Sherkow, R. Sullenger, E. Freiling, and C. Balatbat. 2023c. Telehealth and mobile health: Case study for understanding and anticipating emerging science and technology. NAM Perspectives. Discussion Paper, National Academy of Medicine, Washington, DC. Forthcoming.

CESTI also developed a heatmap to serve as a visual representation of a consideration of a technology’s alignment with guiding ethical principles at a point in time. This heatmap is intended as a flexible tool that can be further customized in multiple contexts and by multiple types of stakeholders and decision makers (see Table A-1).

Finally, in conjunction with CESTI, a public survey was conducted in 2022 by Johns Hopkins University on the implications raised by emerging technologies, conducted in compliance with the University’s policies and procedures. The survey drew on two brief stories in areas of the case study perspectives mentioned above—focusing on genetically modified stem cells as a treatment for sickle cell disease and on the use of a noninvasive brain stimulation device—and asked participants about their views on risks and benefits associated with these areas of technology.

Suggested Citation:"Appendix A: Information Sources and Methods." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×

Commissioned Papers

The committee commissioned two white papers to inform its analysis: a historical analysis of the intersection of equity with U.S. innovation (authored by Michael McGovern and Keith Wailoo, Princeton University) and an exploration of how the National Institutes of Health and Federal Trade Commission have addressed equity (authored by Alexis Walker, Columbia University). These papers are provided in Appendixes B and C, respectively.

Literature Review and Additional Information Gathering

To supplement the expertise of committee members and information gathering through other sources, members and staff also drew on relevant articles from peer-reviewed journals, reports, statements, websites, and other literature sources. Committee members also analyzed federal agency equity action plans and gathered information on how selected federal agencies, including the National Science Foundation, the U.S. Department of Veterans Affairs, the Office of Science and Technology Policy, and others, are attending to equity.

Public Meetings and Webinars

Sessions at meetings held over the course of the study enabled the committee to obtain input from a range of additional experts. The committee’s first meeting was held virtually in May 2022 and provided an opportunity for the committee to discuss the focus, goals, and timeline of the study. The committee held additional information-gathering meetings in June, August, and October 2022. Sessions with invited speakers and experts included:

  • Discussion of study context and goals with sponsoring organizations (June 2022)
  • Presentation and discussion on the development and governance of emerging science, technology, and innovation in health and medicine (June 2022)
  • Panel discussion on equity in emerging science, technology, and innovation (June 2022)
  • Presentation and discussion on issues at the intersection of emerging technologies, ethics, and equity (August 2022)
  • Opening presentation and panel discussion on the example of artificial intelligence and algorithmic fairness (August 2022)
  • Opening presentation and panel discussion on university technology transfer and licensing (October 2022)
  • Opening presentation and panel discussion on decision making by investor communities (October 2022)

At a fifth meeting in January 2023, the committee discussed the conclusions and recommendations presented in this report and prepared its draft report for external review following National Academies policies and procedures.

Public Comments and Call for Input

To inform its deliberations, the committee invited responses to a public call for input released in summer 2022, which posed the following questions:

Suggested Citation:"Appendix A: Information Sources and Methods." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×
  • What are key gaps and needs in the current system of governance for emerging science, technology, and innovation in health and medicine? How do the gaps and needs lead to ethical or societal consequences such as inequities or unfairness?
  • In what ways does the current governance system succeed? What governance elements or strategies work well and should be preserved or built upon?
  • What is most critical stage to act, and who are the most impactful actors for enhancing governance of emerging science, technology, and innovation (STI) in health and medicine to promote societal benefits and align with ethical principles such as equity and justice?
  • What approaches or incentives are most useful for improving governance of emerging science, technology, and innovation to mitigate potential risks, enhance societal benefits, and increase alignment of emerging technologies with ethical principles?
  • Are there practical ways to enhance coordination among potential actors and at various stages in the emerging S&T life cycle?
  • Which governance pathways, emerging developments, or topics should be the focus of the study report to enable it to have the greatest impact?

We welcome any other comments relevant to the study’s task that you think the committee should consider, including relevant governance models, tools, practices, and resources of which the committee should be aware.

Approximately 80 submissions were received. Respondents commented on the context of emerging science, technology, and innovation in health and medicine and identified a variety of potential gaps and needs, including expanding stakeholder participation, the role of leadership and organizational culture, workforce considerations, issues involving data use and access, and balance and influence in the current innovation ecosystem, including access and cost issues. Submissions also noted areas in which the current U.S. system is successful, shared examples of potential models and approaches, and noted areas in which interventions in the system may be useful, including during research and early phases of technology development, when considering premarket approvals, during postmarket deployment, and in clinical care and use. The committee thanks all of the individuals and organizations that shared input as part of this process.

Information provided to the committee from outside sources or through online comment is available by request through the National Academies’ Public Access Records Office.

Website and Communications

The committee worked to make its activities transparent and accessible. The study website hosted by the National Academies was periodically updated to reflect recent and planned committee activities. Study outreach included an email address for comments and questions. A subscription to email updates was available to share further information and solicit additional comments and input to the committee.

Suggested Citation:"Appendix A: Information Sources and Methods." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×

Consulted Experts

The following individuals were invited speakers at information-gathering sessions of the committee.

Ruha Benjamin, Princeton University

Fred Cohen, Monograph Capital Partners

I. Glenn Cohen, Harvard University

Robert Cook-Deegan, Arizona State University

Regina Dugan, CEO, Wellcome Leap

Kadija Ferryman, Johns Hopkins University

Michelle Groman, Greenwall Foundation

Andrea Hodgson, Schmidt Futures

Priti Krishtel, Initiative for Medicines, Access & Knowledge (I-MAK)

Katharine Ku, Wilson Sonsini Goodrich & Rosati

Holly Fernandez Lynch, University of Pennsylvania

Laura Maher, Siegel Family Endowment on behalf of the Public Interest Technology Infrastructure Fund

Aisling McMahon, Maynooth University, Ireland

Bradley Malin, Vanderbilt University

Lori Melichar, Robert Wood Johnson Foundation

Michelle Shevin, Ford Foundation

Susan Song, Gordon and Betty Moore Foundation

Sabriya Stukes, IndieBioNY

Herman Taylor, Morehouse School of Medicine

Kush Varshney, IBM Research

Alice Xiang, Sony AI

Ruqaiijah Yearby, St. Louis University

Draft Heatmap Developed by CESTI as a Potential Tool

As noted above, the NAM CESTI standing committee also developed the concept of a heatmap as a type of flexible visual tool that could be further adapted by stakeholders or decision makers to help characterize the alignment of a technology with foundational ethical principles. A draft of this tool is reproduced in Table A-1.1 In this draft, a particular technology at a given stage of development and in the context of specific stakeholder activities (top columns) could be evaluated against example questions (rows on the right). The specific stakeholders/rights holders, innovation activities, and other features could be adapted as relevant. This type of tool aims to provide a visual snapshot to inform governance discussions.

___________________

1 The heatmap tool is also available as a supplementary online resource (Excel file) at https://nap.nationalacademies.org/catalog/27184/.

Suggested Citation:"Appendix A: Information Sources and Methods." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×

TABLE A-1 Draft Heatmap for Characterizing the Alignment of Technology with Ethical Principles

Technology Lifecycle Stage (heatmap to be completed for a given technology and stage of development) Benefit Level Risk Level
High benefit Low benefit Low risk High risk
Example Marker of Alignment with Principles SECTOR OF DEPLOYMENT
Academia Healthcare Private sector Government Nonprofit/consumer
Within the context of the listed activity/decision process: Clinical research disease targets Clinical research recruitment Availability of geographically distributed trials Insurance coverage Investment in translational applications Targeted markets Planned business model CMS coverage Privacy protections Regulation Education/Outreach
Justice How equitable is individual access to benefits? (e.g., do marginalized groups have same access as priviliged groups?)
How equitable is distribution of burdens across individuals?
Impact on existing health disparities?
Impact on existing economic disparities?
Autonomy Does the technology interfere with an individual’s ability to make decisions about their bodies or lives?
Are individuals given the information they need to make informed decisions about their bodies and lives?
Does the technology pose risks to an individual’s personal privacy?
Fairness Is there a mechanism for stakeholder engagement and incorporation of public interests and values?
Is there an inclusive, transparent process for resolving tensions between ethical demands?
Collective Good How equitable is group access to benefits?
How equitable is distribution of burdens across groups?
What is the environmental impact of the research/technology?
Individual Good Is the technology when used in this way safe?
Does the known and estimated benefit of the technology outweigh the potential harm to an indiviudual?
Is foreseeable harm being avoided or sufficiently mitigated?
Suggested Citation:"Appendix A: Information Sources and Methods." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×
Page 157
Suggested Citation:"Appendix A: Information Sources and Methods." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×
Page 158
Suggested Citation:"Appendix A: Information Sources and Methods." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×
Page 159
Suggested Citation:"Appendix A: Information Sources and Methods." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×
Page 160
Suggested Citation:"Appendix A: Information Sources and Methods." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×
Page 161
Suggested Citation:"Appendix A: Information Sources and Methods." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×
Page 162
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Advances in biomedical science, data science, engineering, and technology are leading to high-pace innovation with potential to transform health and medicine. These innovations simultaneously raise important ethical and social issues, including how to fairly distribute their benefits and risks. The National Academies of Sciences, Engineering, and Medicine, in collaboration with the National Academy of Medicine, established the Committee on Creating a Framework for Emerging Science, Technology, and Innovation in Health and Medicine to provide leadership and engage broad communities in developing a framework for aligning the development and use of transformative technologies with ethical and equitable principles. The committees resulting report describes a governance framework for decisions throughout the innovation life cycle to advance equitable innovation and support an ecosystem that is more responsive to the needs of a broader range of individuals and is better able to recognize and address inequities as they arise.

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