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

Chapter: Appendix C: Equity in Innovation within NIH and FTC: Examination of Agency Approaches and Implementation

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Suggested Citation:"Appendix C: Equity in Innovation within NIH and FTC: Examination of Agency Approaches and Implementation." 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 C

Equity in Innovation within NIH and FTC: Examination of Agency Approaches and Implementation


A white paper for the Committee on Creating a Framework for Emerging Science, Technology, and Innovation in Health and Medicine

Alexis Walker, PhD, Assistant Professor, Columbia University

September 2022

This paper describes how two U.S. government agencies—the National Institutes of Health (NIH) and the Federal Trade Commission (FTC)—have approached “equity in innovation”1 in recent years, including successes and barriers, as well as potential remedies. It is based on a literature and legal review, as well as interviews with 19 current and former leaders within these agencies. After an executive summary and a background section, the report covers each of the two agencies separately, first addressing the agency’s approaches and test cases of how it is responding to an emerging technology (polygenic risk scores at NIH and artificial intelligence at FTC), and then addressing successes and barriers, plus potential improvements.

EXECUTIVE SUMMARY

Although of late there has been increasing attention to “equity” outcomes in American policy making, within the U.S. federal government, the term is not well defined. A recent Executive Order2 focuses on equity in the federal government and provides one definition of the term, but this definition is neither well known nor universally accepted across govern-

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1 As tasked by the National Academies Committee on Creating a Framework for Emerging Science, Technology, and Innovation in Health and Medicine.

2 EO 13985, “On Advancing Racial Equity and Support for Underserved Communities Through the Federal Government,” 2021.

Suggested Citation:"Appendix C: Equity in Innovation within NIH and FTC: Examination of Agency Approaches and Implementation." 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.
×

ment agencies, especially by individuals doing equity work (see the section on Definitions, below). Different genealogies of the terms “equity” and “equality,” as well as political battles over these terms and related goals, have led different groups and individuals to operate with different definitions—or none at all. And while the 2021 Executive Order referenced above also required agencies to develop Equity Action Plans (EAPs), these plans have not been broadly publicized within NIH and FTC. NIH does not have its own EAP; administratively NIH left the obligation of developing an EAP to its umbrella agency the Department of Health and Human Services (HHS), whose plan makes little mention of NIH.

At FTC, equity work has been controversial, with commissioners from different political parties disagreeing on whether and how this goal ought to be pursued. There is explicit opposition by some of the agency’s commissioners, who argue that such work “unfairly privileges” some groups and is a form of government overreach. The latter framing is a technocratic construal of an issue that has long been the object of strong party divides: the size and role of the federal government. These debates create major barriers to equity work at FTC, but individuals working on these issues at FTC have nonetheless advanced significant and innovative approaches to equity in innovation and emerging technology, especially regarding artificial intelligence (AI) and algorithmic bias.

As an agency, NIH has attempted to focus its equity work on ostensibly apolitical scientific approaches, which makes it difficult for NIH to address the social dynamics of equity that are integral to science.3 For example, NIH has relied far more on the “scientific” stage of its grant review (in terms of resources, time, weight in decision making, etc.) than on the parts of its review and award process that could make equity more central (e.g., existing processes of council review and discretion of institute directors, adding new and revised processes). There are clear disparities in grant funding (by race as well as other features of applicants) at NIH, but there is disagreement within the agency as to the cause of these disparities, making it difficult to address the underlying issues. The institutes and centers (ICs) that make up NIH have great autonomy, which can make it hard to introduce common equity approaches across the agencies and push all ICs forward. On equity, the National Human Genome Research Institute (NHGRI) has been among the leading ICs in implementing extensive stakeholder involvement, as well as engaging with alternative forms of knowledge and expertise.

NIH has focused primarily on health disparities and workplace diversity rather than equity per se. And while NIH has made a great deal of resources available in these arenas, an explicit focus on equity (including a formal definition) would help equity workers advance these efforts, as would a shift toward approaching equity as part of the scientific process rather than treating it as an “add on” or even as an element that is at odds with objective science (e.g., the distinction some parties make between equity and excellence, which NIH has tried to address through a focus on “inclusive excellence”).

See Table C-1 for an overview of approaches that NIH and FTC have taken to advancing equity in the scientific process as well as barriers those organizations have faced.

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3 That is, science is inherently a human endeavor, and the funding, design, implementation, analysis, etc., of any scientific project is shaped by social assumptions and priorities, and thus these assumptions and priorities also shape the dynamics that drive equity and inequality (what projects matter, who has relevant expertise, etc. [see the Science Studies Reader (Biagioli, 1999) for more on this]).

Suggested Citation:"Appendix C: Equity in Innovation within NIH and FTC: Examination of Agency Approaches and Implementation." 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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TABLE C-1 NIH and FTC’s Approaches Taken and Barriers Faced to Promoting Equity in Science

NIH FTC
How does this agency approach equity? Mostly focused on health disparities and workplace diversity. NHGRI is a leader re: attention to equity (e.g., stakeholder engagement, engaging with alternative forms of knowledge and expertise). Many within the agency (including commissioners and other leadership) are explicitly hostile to equity work. A small group of innovative equity workers are leading significant and innovative efforts on equity in AI, etc.
Barriers to equity (1) Divergence among ICs re: equity understandings and approaches, (2) focus on scientific stage of review with little resources or process for prioritizing equity concerns in later stages of review and awarding, (3) definitional and goal confusion (1) Extremely limited financial and human resources for equity work, (2) perception of equity as a progressive/liberal agenda item, (3) debates over FTC jurisdiction and overreach (a technocratic framing of explicitly party politics on government size and scope)
 

NOTES: AI = artificial intelligence; FTC = Federal Trade Commission; IC = institutes and centers; NHGRI = National Human Genome Research Institute; NIH = National Institutes of Health.

BACKGROUND: “EQUITY” LANGUAGE IN FEDERAL GOVERNMENT

Legal scholar Martha Minow argues that, in recent years, debate over the terms “equality” and “equity” has become a battleground of American politics, where equality refers to uniform or “equal” treatment versus “equity,” which focuses on equality of outcomes—addressing past oppression through compensatory justice and remedies for those who have been most discriminated against (Minow, 2021). The Biden administration’s use of the term “equity” in several Executive Orders4 breaks with the language primarily used in Executive Orders, laws, regulations, and other official communications of the U.S. federal government in this area over the last several decades; on related topics, such statements have previously used terms such as “equal” and “fair,” or “discrimination” and “disparity.”

With regards to labor practices, for example, President Truman’s Executive Order of 1948 (“Regulations Governing Fair Employment Practices Within the Federal Government”) prohibited discrimination in federal employment on the basis of race, color, religion, or national origin and required all federal government departments to appoint a Fair Employment Officer (emphases added); the Equal Employment Opportunity (EEO) Act of 1972 (emphasis added) extended broader antidiscrimination employment provisions of the Civil Rights Act to federal employees (Hadden and Gallegos, 2008), following on the EEO in the Federal Government Executive Order (11478) of 1969. These led to regulations directing federal agencies to establish Special Emphasis Programs (SEPs) promoting employment from underrepresented groups (Office of Civil Rights), which were subsequently defined by the Federal Equal Opportunity Recruitment Program (established by the Civil Service Reform Act of 1978). Today, three of these SEPs are still required of federal agencies5: the

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4 See EO 13985, EO 14035, EO 14031, and EO 14036.

5 There were at least two additional government-wide SEPs in the past: the Minority Outreach and Upward Mobility Program and the Veterans Employment Program, as noted by a 1980 General Accounting Office report, How to Make Special Emphasis Programs an Effective Part of Agencies’ EEO Activities. But by 1982, a congressional investigation on federal EEO activities found that the budgets of SEPs had been eviscerated, especially those of the Minority Outreach and Upward Mobility Program, whose budget was cut by all reporting agencies, and slashed by 76.2 percent at HHS between fiscal years (FY) 1981 and 1982; these actions “effectively emasculate the programs,” according to the chairwoman of the House Subcommittee on the Civil Service (Schroeder, 1982, p. 86).

Suggested Citation:"Appendix C: Equity in Innovation within NIH and FTC: Examination of Agency Approaches and Implementation." 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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Hispanic Employment Program,6 the Federal Women’s Program,7 and the People with Disabilities Program.8

Apart from such terms as “fair” and “equal,” equity as a legal doctrine has a long history, where it differs significantly from colloquial use. In law (other than in the financial sense), “equity” refers to the authority to impose sentences that are nonmonetary; this is how it is used in the U.S. Constitution (Harrison, 2022). But with today’s sense of equity as social justice, the term does not appear to have been in frequent use by the federal government in the years immediately prior to the Biden administration. The Department of Defense’s 1969 Human Goals Charter used the term, describing its goal “to provide equity in civilian employment regardless of race, color, sex, religion, national origin, disability, age, or sexual orientation, and to provide an environment that is accessible to and usable by all,” but by the late 1990s, a subsequent secretary of defense had removed the term “equity” from the charter’s discussion of diversity (emphasis added; Military Leadership Diversity Commission, 2011).

The Reagan administration, however, made several Executive Orders focused on equity in this sense of justice (including one establishing the Task Force on Legal Equity for Women to identify discriminatory federal laws and work toward “equal treatment from Federal activities”); President Reagan also signed into law several bills focusing on “equity,” including the Educational Opportunity and Equity Act of 1982 (which provided a federal income tax credit for private school tuition) and the Retirement Equity Act of 1984 (which focused on ensuring “that working women are receiving their fair share of private pension benefits”; Donovan, 1985).

Education has been a primary battleground over “equity” versus “equality”; the federal Elementary and Secondary Education Act of 1965 focused explicitly on “equity” as redistribution (Thomas and Brady, 2005), although federal government approaches in the 1990s shifted toward a focus on “adequacy” of education rather than “equity” therein (Houck and Debray, 2015). In spite of this trend, in 2016, the Department of Education changed the title of the “Desegregation Assistance Centers” mandated by the 1964 Civil Rights Act (to aid in the processes of school integration) to “Equity Assistance Centers.”

DEFINITIONS

The term “equity” is not well defined within the federal government. The 2021 Executive Order “On Advancing Racial Equity and Support for Underserved Communities Through the Federal Government”9 provides one definition of “equity”:

Equity means the consistent and systematic fair, just, and impartial treatment of all individuals, including individuals who belong to underserved communities that have been denied such treat-

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6 Federal Personnel Manual Letters (FPM) 713-23 of 1974; renamed as such in FPM 713-41 of 1978.

7 EO 11478 of 1969; codified in 5 U.S.C. 7201; 38 U.S.C. 4214; Title 5 CFR, Subpart B, 720.204.

8 Rehabilitation Act of 1973, renamed from “Handicapped” in an Amended Act of 1992. These have all been reinforced by subsequent Executive Orders and laws focused on the federal workplace: EO 13583, “Establishing a Coordinated Government-wide Initiative to Promote Diversity and Inclusion in the Federal Workforce” (August 2011); EO 13548, “Increasing Federal Employment of Individuals with Disabilities” (July 2010); EO 13171, “Hispanic Employment in the Federal Government” (October 2000), EO 13163 “Increasing the Opportunity for Individuals With Disabilities to be Employed in the Federal Government” (July 2000). These are in addition to Executive Orders and laws focused on the broader U.S. workforce, such as EO 13078, “Increasing Employment of Adults With Disabilities” (March 1998). And while the Veterans Employment Program does not appear to be a federally mandated SEP any longer, EO 13518 (November 2009) established the Veterans Employment Initiative, which requires most agencies to employ at least one full-time officer for a Veterans Employment Program.

9 EO 13985.

Suggested Citation:"Appendix C: Equity in Innovation within NIH and FTC: Examination of Agency Approaches and Implementation." 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.
×

ment, such as Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons; persons with disabilities; persons who live in rural areas; and persons otherwise adversely affected by persistent poverty or inequality.

However, some at FTC have argued that this definition is closer to the notion of “equality” than “equity” (Interview C). Many leaders at NIH had not heard of any NIH-wide definition of “equity” or even “health equity,” and those doing equity-focused work emphasized that an NIH-wide definition of equity would be extremely helpful in their efforts. Currently, many NIH institutes and centers use a definition of health equity drawn from the U.S. Centers for Disease Control and Prevention (CDC, 2022):

[Equity is] the state in which everyone has a fair and just opportunity to attain their highest level of health...

Achieving this requires focused and ongoing societal efforts to address historical and contemporary injustices; overcome economic, social, and other obstacles to health and healthcare; and eliminate preventable health disparities.

This language is drawn from the National Partnership for Action to End Health Disparities, a 2007–2011 stakeholder engagement program of the HHS Office of Minority Health that conducted widespread community conversations in order to produce the National Stakeholder Strategy for Achieving Health Equity (OMH, 2011).

These recent definitions of “health equity” may be of use in developing an updated definition of equity at NIH as well as other agencies. Recently, many scholars of health and equity have come to believe that there is no such thing as “health equity” independent of broader social and economic equity—only the latter would allow for real equity in health (Creary, 2021). Based on this scholarship, definitional work would likely be better focused on equity than on health equity.

Through EO 13985, the Biden administration tasked the heads of all executive departments and agencies (referred to thereafter collectively as “agencies”) with identifying barriers to “full and equal” participation in federal programs “for people of color and other underserved groups.” The Executive Order also requires each agency head to develop a plan for addressing those barriers, as well as barriers in procurement opportunities, and makes reference to “advancing equity for all, including people of color and others who have been historically underserved, marginalized, and adversely affected by persistent poverty and inequality…[a]ffirmatively advancing equity, civil rights, racial justice, and equal opportunity.” It does not make any reference to “protected classes” or to the “special emphasis” programs per se, instead calling attention to “equity with respect to race, ethnicity, religion, income, geography, gender identity, sexual orientation, and disability.”

NATIONAL INSTITUTES OF HEALTH

Within the U.S. federal government, NIH is a mid-size agency, with approximately 19,000 employees and a FY2022 budget of $45 billion (NIH Office of Budget, n.d; NIH Workforce Demographics, 2022).10 An agency’s size and budget impact its ability to main-

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10 Compare with the U.S. Postal Service’s 580,000 employees, Office of Management and Budget’s 450 employees, Department of the Air Force’s FY2021 budget of $204 billion, the Small Business Administration’s FY2021 budget of $0.8 billion, and NASA’s FY2021 budget of $23.3 billion (CRS, 2022, 2023; DoD 2021; OMB 2021).

Suggested Citation:"Appendix C: Equity in Innovation within NIH and FTC: Examination of Agency Approaches and Implementation." 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.
×

tain personnel for portfolio analysis, for recruitment and retention of employees from various demographics, and for other work toward improving the equity focus and efforts of the agency. NIH has much more expansive resources for this as compared with smaller agencies, such as FTC (see below).

Each of NIH’s 27 ICs operates largely autonomously, with separate congressional budget appropriations (excepting rare cases; NIH Office of Budget, n.d.), and able to set its own research agenda—although NIH Director Francis Collins did expand the Office of the Director (OD) substantially during his tenure from 2009 to 2021, and centralized more activities there (Interview A, Interview E). The autonomy of ICs means that they vary significantly in how they understand and approach equity issues. Institutes set their own priorities, sometimes guided by directives from Congress. So the National Institute on Deafness and Other Communication Disorders, for example, decides whether it will continue to see deafness as an impairment and fund work that addresses deafness as pathophysiology (as it does currently on the latter point), even if some other institutes have increasingly adopted the idea that deafness, at its heart, is part of human richness and variation rather than inherently an impairment.

As noted above, there is little clarity at NIH as to what “equity” means exactly. NIH has much more frequently focused on research to address “health disparities” (including creating the National Institute on Minority Health and Health Disparities) and efforts to increase workforce diversity. NIH’s Equity Committee, founded in 2017, focuses entirely on issues in the workforce (diversity metrics including those regarding hiring and promotion). It was established in response to a report that year by NIH’s Gender Inequality Action Task Force, which highlighted gender inequities in tenure and promotion, salary, and the like.

NIH Grant Review

NIH’s Center for Scientific Review (CSR), which implements approximately 75 percent of peer review for NIH’s extramural programs across ICs, has a two-stage process for reviewing grant applications from academic and other nonfederal scientists and scholars: (1) a scientific review by a panel of non-NIH academic scientists (coordinated by scientific review officers [SROs]), and (2) further review by the funding IC’s national advisory council or board. This system is rooted in the original 1944 text of the Public Service Act, which vastly expanded NIH’s grants program across the ICs (NIH, 2004; NIH Central Resource for Grants and Funding Information, 2021; NIH CSR, 2023).

For nearly 40 years, NIH has had some form of public involvement in grant review. In 1985, an amendment to the Public Health Act formalized the advisory council system by requiring that each IC have such a council, with one-third of the membership drawn from the “general public”—to include “leaders in fields of public policy, law, health policy, economics, and management.”11 The amendment authorized these councils to conduct additional review of grant proposals and to make recommendations regarding the institute’s research priorities and programs. More recent regulations on federal peer review, such as the 2004 rule on “Scientific Peer Review of Research Grant Applications and Research and Development Contracts” (69 FR 275), likewise make no mention of demographics of peer reviewers, nor do they mention other social positioning as part of requirements for peer-review participants, beyond technical expertise and conflict-of-interest issues. Notably, the example categories for public representation given in the 1985 amendment do not include patient advocates, health equity activists, tribal leaders, or members of underserved or marginalized communities. It

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11 42 U.S.C. 284(a).

Suggested Citation:"Appendix C: Equity in Innovation within NIH and FTC: Examination of Agency Approaches and Implementation." 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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may be important to update guidelines for participation in IC advisory councils and their role in review.

Scientific Review

NIH’s scientific review is based on an overall “impact score,” meant to take into account five criteria12: significance (how important is the problem it addresses or the knowledge it will produce), innovation, approach (appropriateness and feasibility), environment, and investigator team (strength and appropriateness). NIH established these categories in 1997, based largely on a report by the agency’s Committee on Improving Peer Review (specifically the subcommittee on the Rating of Grant Applications), itself a response to perceptions that peer review had become overly focused on “details of technique and methodology” rather than broader impact (NIH, 1997).13 NIH has an extensive process for engaging non-NIH scientists in reviewing each grant application in detail.

Advisory Council Review

After reviewers score all applications, advisory councils in each IC (with “public representation”) then make funding recommendations based on impact scores from the scientific review. However, they do not generally review the full pool of applications (which is typically large, so advisory councils do not have capacity to review all applications fully). And as noted before, the public representation is drawn from a narrow set of stakeholders.

Directors’ Discretion

Leadership of each institute makes final decisions on what applications are funded, and they have authority to fund grants “out of order”that is, not based simply on the scores from scientific review or even from the advisory council. Directors of some ICs have used this authority to choose grants to fund because they align with the ICs priorities, including for diversifying topic area, methods, and investigators (Interview E). However, this is burdensome for these busy directors, and often results in pushback from both applicants (who can see their scores) and NIH staff (for whom this creates more work). Interviewees reported that there is growing recognition within NIH of overreliance on peer-review scores in guiding funding distributions, but not much direction on how to address this.

Disparities in NIH Funding

There are substantial disparities in funding rates for NIH grants based on applicant demographics, even when controlling for many cofounding factors (NIH Office of the Director, 2022). In 2011, economist Donna Ginther and colleagues (2011) published results demonstrating that the success rate of applications from Black investigators was half that for White investigators. This publication led the NIH Advisory Committee to the Director (specifically the Working Group on Diversity in the Biomedical Research Workforce) to begin an investigation, including public listening sessions: (1) on diversity and peer review, (2) with representatives of historically Black colleges and universities on expanding participation

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12 Unless otherwise noted in a funding announcement.

13 That same year, the National Science Foundation (NSF) made “broader impacts” a formal criterion (National Science Foundation, 2014). NIH representatives have in recent years been in conversation with NSF regarding the benefits and drawbacks of the “broader impacts” criterion (Interview B).

Suggested Citation:"Appendix C: Equity in Innovation within NIH and FTC: Examination of Agency Approaches and Implementation." 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.
×

in conducting biomedical research, and (3) including a broader public meeting to collect stakeholder perspectives (NIH Working Group on Diversity in the Biomedical Research Workforce, 2012).14 The Working Group’s report recommended efforts “across the pipeline” to address the funding gap, but in large part the 2012 report called on NIH to collect more detailed and appropriate data to allow for analysis of the factors underlying grant funding disparities.

A 2019 paper by NIH staff demonstrates that one of the main factors driving NIH’s racial funding disparities is research topic area: Black investigators more often propose research on community and population level issues, which have lower funding rates than “mechanistic investigations” (e.g., molecular biology) (Hoppe et al., 2019). This suggested that peer reviewers may discount structural interventions compared with popular conceptions of “innovation” as including “micro,” “nano,” or digital. Katz and Matter (2020) found that independent investigator awards were apportioned in increasingly “unequal” ways from 1985–2015;15 an additional NIH-led analysis confirmed that inequalities by career stage, gender, and race grew during the period when NIH’s budget was doubled between 1998 and 2003 (Lauer and Roychowdhury, 2021). See Figure C-1 for an overview of the NIH peer-review process.

However, some NIH leaders (even in diversity administration) now argue that it is not topic choice, but rather the ICs of choice or assignment for Black investigators that primarily drives lower rates of funding, going as far as stating “peer review is not the problem” (Interview B).16 These parties point to a reanalysis of the data from the 2019 paper published by a group of NIH staff,17 which argued that “the lower rate of funding for [‘African-American/Black preferred’] topics was primarily due to their assignment to ICs with lower award rates, not to peer-reviewer preferences” (Lauer et al., 2021, p. 1). While the 2019 paper did find these differences as well, they found that topic choice had a greater effect size, especially when using advanced natural language processing techniques for analysis, as the Office of Portfolio Analysis is capable of doing.

In spite of multiple factors of causality, it is clear that increasing funding to research at the community and population level (across ICs and especially at the ICs with lower funding rates) not only would benefit the most underserved populations through research outcomes, but also would do a great deal to address racial funding disparities. CSR has also investigated disparities in award rates based on demographic features including age/career stage, gender, and race and ethnicity; they found that anonymizing grants did not improve the scores of Black investigators but did diminish the bump in scores that well-known researchers appear to receive (Interview B).

Perspectives on the causes of funding disparities are thus mixed among NIH leadership, which may challenge the agency’s ability to address these issues. However, NIH has made efforts to diversify peer-review boards and has recently implemented mandatory implicit bias training for peer reviewers. CSR’s scientific review officers select and train members of peer-review panels, offer guidance in scoring and writing reviews, and oversee review meetings; these officers have a great deal of influence in bringing together perspectives and determining exactly what mix of expertise and demographics are crucial for a review panel.

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14 NIH has substantial experience with stakeholder engagement.

15 The authors did not look at race and ethnicity, but rather resource concentration in “elite universities” and “elite investigators.”

16 While applicants can designate an IC of choice, often IC assignment is done internally at NIH.

17 Only one author worked on both of the two papers: Michael Lauer, the current director of NIH’s Office of Extramural Research.

Suggested Citation:"Appendix C: Equity in Innovation within NIH and FTC: Examination of Agency Approaches and Implementation." 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.
×
Image
FIGURE C-1 National Institutes of Health (NIH) peer-review process with key equity moments.
NOTE: IC = NIH Institute/Center.

Portfolio Analysis

The expansion of the Office of the Director under Francis Collins helped support ICs through central initiatives with important equity implications; for example, the Office of Portfolio Analysis (OPA) was established in 2011 as part of the Division of Program Coordination, Planning, and Strategic Initiatives within the Office of the Director (NIH OPA, 2023). OPA focuses entirely on analyzing the distribution of NIH-funded research, based on variables including topic area (e.g., how much money funds projects on health disparities), and characteristics of the individuals and institutions receiving grants (e.g., gender, race, ethnicity, career stage, urban/rural, R1/R2/other). OPA is well funded and has grown from 5 to 30 employees in the last decade.

However, while OPA analyzes portfolio distribution, it does not determine the features of grants that NIH tags, or the classifications available for this, which is the responsibility of the Office of Research Reporting and Analysis within NIH’s Office of Extramural Research (OER), in addition to the Research, Condition, and Disease Categorization (RCDC) system that was developed by OER’s Electronic Research Administration. In 2006, Congress passed the NIH Reform Act, which required NIH to develop such a system (NIH RePORT, n.d.).18 Notably, the RCDC system does not tag based on methods such as “ethnography” or even categories such as “ethics,” which would allow the agency to evaluate and prioritize such forms of expertise, in order to generate more textured knowledge about the nature of inequity and justice.

RCDC categorization is conducted by automated text mining of project front matter (title, abstract, specific aims, investigator’s stated public health relevance). Any one project may be tagged in multiple RCDC categories, and the entirety of the project budget will then be included in the total for each of those categories. However, 3 out of RCDC’s 280+ categories are based on study “populations tracked by gender or ethnicity”: Women’s Health, Minority Health, and Health Disparities. NIH reports that the databases tracking these demographics “are complex and not yet compatible with the RCDC system” (NIH RePORT, n.d. “Frequently

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18 That provision followed on two reports by the National Academy of Sciences (in 1998 and 2003) recommending this type of system.

Suggested Citation:"Appendix C: Equity in Innovation within NIH and FTC: Examination of Agency Approaches and Implementation." 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.
×

Asked Questions), but the agency has been trying to bring categorization of these grants into alignment with RCDC’s standard process.

For example, prior to 2019, ICs assigned funding to the category of Women’s Health based on the gender breakdown of each study’s participants. Administrators were thus dividing or prorating project budgets when they tallied this category, as opposed to other categories that did not use prorating (i.e., the entire grant budget is attributed to any of the multiple topic categories the project falls under). In FY2019, internal subject matter experts across NIH agreed on a system to define women’s health–related projects more concretely and apportion the project budgets to this category (not simply by number of participants). NIH subject matter experts now manually categorize projects to be tallied under Women’s Health and Health Disparities, although there is automated support to identify relevant applications for this review. Reporting for the latter is prorated based on enrollment percentage of “minority subjects, as defined by the Office of Management and Budget or of other NIH-designated populations experiencing health disparities, including less privileged socio-economic status populations, underserved rural residents, and sexual and gender minorities” (NIH RePORT, 2022).

Using the data to analyze NIH’s portfolio, OPA is able to draw attention to funding disparities.19 However, there is little agreement on what the correct balance of funding for various topics and methods ought to be. This is one place that NIH may be able to increase equity and address the needs of a diverse population by altering the funding mix that it is targeting. However, interviewees noted that an important goal for the agency is staying out of the news headlines;20 there have been past occasions when lawmakers have drawn attention to specific grants or programs as ridiculous, which is attention that most at NIH prefer to avoid. Beyond NIH’s own authority in setting research priorities, Congress could also intervene to set goals, as it has done in the past (e.g., goals for AIDS research funding). Certainly Congress already sets priorities to a certain extent by determining funding levels for ICs.

NIH Benefits from a Large Base of Expertise

NIH has a large body of in-house expertise across domains, employing almost 6,000 researchers at the postdoctoral career level or higher, with funding of almost $5 billion for intramural research annually (NASEM, 2019). In addition to intramural research programs through the National Institute of Minority Health and Health Disparities, NIH’s central bureaucracy has offices of Research on Women’s Health (ORWH), Tribal Health Research (THRO), and Sexual & Gender Minority Research (SGMRO), all of which employ multiple PhD-level experts.21

This domain expertise, held by individuals in both research and administrative positions, allows NIH to draw on significant theoretical and practical resources to inform its approaches to equity. But while NIH’s intramural programs have 79 principal investigators in the Behavioral and Social Sciences, the vast majority of this work is nonetheless rooted in biomedical and molecular analysis (e.g., biological markers of stress, brain circuits that control behavior), rather than qualitative work that delves into the deep experiences and knotty dynamics of injustice and power. The focus on biological analysis is also a trend in

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19 OPA was responsible for the 2019 topic choice paper (Hoppe et al., 2019).

20 One equity leader noted, “Our job is to take money from Congress and send it out to the states through research awards. As long as we’re not on the Washington Post, Congress is okay with what we’re doing.”

21 ORWH was established in September 1990, and, in the NIH Revitalization Act of 1993, Congress mandated a significant role for the office. That same act mandated establishment of the Office of Behavioral and Social Sciences Research (see https://orwh.od.nih.gov/sites/orwh/files/docs/ORWH%20Leadership%20Role.pdf). THRO and SGMRO were established in 2015 and have not been given explicit guidance by congressional mandate.

Suggested Citation:"Appendix C: Equity in Innovation within NIH and FTC: Examination of Agency Approaches and Implementation." 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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NIH’s extramural funding of Behavioral and Social Science, which is substantial: $7 billion in FY2021, up from $4.5 billion in 2017 (NIH RePORT, 2022).

NIH Focus on Workforce Diversity

NIH has a longstanding and robust infrastructure for equity, diversity, and inclusion amongst NIH staff, including the investigators in its intramural program. The NIH Office of Equity, Diversity, and Inclusion (OEDI) has a history of over 20 years. Currently, the office focuses on training NIH staff on equity, diversity, and inclusion (EDI) topics, identifying EDI trends and barriers, developing strategies to overcome these barriers (along with partners in ICs), workplace conflict resolution, and offering organizational culture consulting services for parties across NIH. OEDI has not only federally mandated SEPs (portfolios on Women, People with Disabilities, and Hispanic), but also other portfolios, including Black; Native American; Sexual and Gender Minority; Asian American, Native Hawaiian, and Pacific Islander. Each portfolio is headed by a director and full-time strategist (and a larger team, in some cases).

In 2014, NIH established an additional Office of Scientific Workforce Diversity within NIH’s Office of the Director. Under cardiologist Hannah Valentine, the office

  1. established the Distinguished Scholars Program;
  2. created the NIH Equity Taskforce (which Dr. Valentine co-chaired with NIH’s deputy director for intramural research), which led to the establishment of the NIH Equity Committee;
  3. developed and implemented the first NIH Workplace Climate and Harassment Survey (a tool other institutions can also use to assess and improve in this area); and
  4. developed the Faculty Institutional Recruitment for Sustainable Transformation (FIRST) program (to hire at least 120 faculty of color in clusters of 3–4, for a total of at least 10 at any one institution, with the goal of testing whether communal support increases retention).22

Since fall 2020, Marie Bernard has led this office, as well as the UNITE program—a cross-institute committee working to “identify and address structural racism within the NIH supported and the greater scientific community” (NIH UNITE, 2022). UNITE has since launched a Common Fund initiative for transformative health disparities research and supported a request for applications on structural racism and its impact on health.

Case Study: NHGRI and Polygenic Risk Scores

The National Human Genome Research Institute (NHGRI) is one of NIH’s smaller ICs, with a budget less than one-tenth that of the National Cancer Institute (NCI).23 However, NHGRI has been the primary hub of ethics research within NIH. NHGRI has long funded a

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22 See https://commonfund.nih.gov/first (accessed July 19, 2023). Sponsored by NIH’s Common Fund, whose programs are mean to “dramatically affect biomedical research by achieving a set of high-impact goals within a defined time frame, limited to typically ten years maximum” and “also sponsors novel approaches testing new ways of supporting the entire biomedical research workforce” (NIH OSC, 2022).

23 Appropriations for NHGRI in FY2022 were $639 million, as compared to NCI at $6.9 billion (https://officeofbudget.od.nih.gov/pdfs/FY22/Approp%20History%20by%20IC%20FY%202020%20-%20FY%202022.pdf; accessed July 19, 2023).

Suggested Citation:"Appendix C: Equity in Innovation within NIH and FTC: Examination of Agency Approaches and Implementation." 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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program in Ethical, Legal and Social Issues (ELSI) in genetics and genomics; since 1991, the institute has dedicated 5 percent of its annual budget to this program.24

The categories that NIH uses to tag grants and analyze across its portfolio make it difficult to ascertain what amounts of various ICs’ budgets are dedicated to in-depth qualitative or humanistic research. However, NHGRI funds enough ethics and justice research on genomics for bioethicists to be concerned that this focus is taking away from attention to justice in other areas of health and biomedicine; some scholars have recently argued that this focus on “genetics, genomics, neuroethics, and the ethics of other emerging technologies disproportionately harms People of Color” because it does not allow for sufficient ethics and justice attention to the many other health issues of interest to underserved Americans (Fabi and Goldberg, 2022, p. 9).

Scholars in academic interpretive social science and the health humanities broadly consider NHGRI to be the NIH IC that primarily funds ethics in their research areas (Fabi and Goldberg, 2022). NHGRI has a close and long-standing relationship with the ELSI research community, a field that the institute itself largely created through its research funding (Dolan et al., 2022). This scholarly community and its relationship with NHGRI have been the basis for the institute’s extensive work in stakeholder engagement (NHGRI is a leader in this), codesign of research agendas (especially with the underserved), and policy work. For example, NHGRI has extensive programs for engaging and supporting Native American researchers, and for addressing data sovereignty.

NHGRI has had to confront significant resistance to genomics research generated by such ethical violations as the wronging of the Havasupai tribe by genetics researchers in the 1990s and early 2000s (Garrison, 2013). The Human Genome Diversity Project was also a hugely controversial venture, proposed in the early 1990s to sample “isolated and indigenous populations” globally before they “vanished” (Reardon, 2001). Indigenous groups and activists accused the project planners of biopiracy and colonialism (especially related to talk of commercializing and patenting results from the proposed project), mentalities of extraction and lack of respect for Indigenous sovereignty, and treating Indigenous peoples as “living fossils” (Reardon, 2001). These controversies have led NHGRI to develop robust ethics programs, collaborations with tribal leadership, stakeholder engagement activities, and relationships with scholars of ethics and genetics.

These long-term relationships with communities of qualitative social science and humanities researchers are a central reason why NHGRI has become a leader in key areas of equity such as engaging members of underserved groups in setting research priorities, and in valuing forms of knowledge outside of mechanistic biological research. The institute also has robust collaborations with many civil society groups representing marginalized Americans, such as nonprofits, museums, and educational institutions, and is in close contact with these groups. For example, NGHRI’s collaboration with the National Congress of American Indians (NCAI) and their joint workshops at NCAI meetings led the institute to support (financially and technically) NCAI in developing an online resource guide on genomics research for tribal leaders and citizens; this guide underlines the importance of

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24 In light of public discussions in the mid-1980s regarding the implications of sequencing the human genome, James Watson (director of the Human Genome Project [HGP]), announced in 1988 that a portion of the HGP budget would go toward addressing social issues in genetics. This promise grew into a 3 percent budget commitment by NHGRI (then still a “Center” and not an Institute), which it scaled up to 5 percent by 1991. In the 1993 NIH Revitalization Act, Congress required that “not less than five percent” of NHGRI’s budget go to such research (Dolan et al., 2022).

Suggested Citation:"Appendix C: Equity in Innovation within NIH and FTC: Examination of Agency Approaches and Implementation." 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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Indigenous knowledge.25 Health equity staff at NHGRI are well aware of the significance of such forms of knowledge, and treat traditional knowledge as an important source of value.26 Such “epistemological humility” is also evident in NHGRI’s acknowledgement that they are not experts in tribal health or engagement, and deference to NIH’s Office of Tribal Health (Fricker, 2007).

NHGRI put in place a director on health disparities two full decades ago, and has recently established a new Office of Training, Diversity and Health Equity (TiDHE)—a title that nods at efforts not only to describe disparities, but to focus on proactive work toward addressing those disparities in pursuit of equity. The institute also has four external working groups made up of health activists and social science researchers who advise NGHRI and its council on topics including Community Engagement and Genomics as well as Genomics and Society.

In recent years, genomics researchers have begun to develop polygenic risk scores (PRS), which combine the impacts of multiple different genes in order to estimate the disease risk of any one individual based on multiple genes. However, biomedical research over the past several decades has disproportionately focused on people of European descent, in large part because they are often already engaged in medical systems, making such individuals easier to recruit for research. This oversampling of people of European ancestry means that findings from existing genetic data are less reliable in people descended from populations outside of Europe (Pope and Fullerton, 2016).

However, these population categories are often misused and misrepresented as racial categories, although such authoritative groups as the American Society for Human Genetics have continued to make official public statements emphasizing that race is a social category that does not reflect underlying biology. The conflation of race and ancestry contributes to racism in medicine by reinforcing the idea that races are inherently biologically distinct (Amutah et al., 2021; Lee et al., 2008).

NHGRI has recognized PRS as an emerging technology with significant equity implications. As such, the institute has worked within the broader NIH landscape to establish a Polygenic Risk Methods in Diverse Populations Consortium; in June 2021, NHGRI announced that it set aside $33 million for research “to improve the methods and application of polygenic risk scores (PRS) in diverse populations,” in addition to $5 million toward this goal through the NCI (NHGRI, 2021, 2022a). In addition to shaping its budget thus in order to conduct research towards addressing equity in this emerging technology, NHGRI has also developed fact sheets on the limitations of PRS in non-European populations, meant to inform the public through the NHGRI website (NHGRI, 2022b).

Barriers and Challenges

In recent years, the racial funding gaps described above have lessened to some extent, which many at NIH account to the agency’s efforts providing targeted mentorship and professional development opportunities for members of underserved groups. In interviews for this report, several NIH staff argued that a lack of clarity on definitions, including that of “equity,”

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25 It notes, for example, “A meaningful ethical framework needs to be maintained by all parties seeking to work with tribes and tribal organizations. This includes a mindfulness toward traditional harms of research, cultural knowledge that is both historic and current, and acknowledgement of the worldview of each participating partner in the research proposal” (https://www.ncai.org/policy-research-center/research-data/prc-publications/NCAI_genetics_research_resource_guide_FINAL_2012_PDF.pdf, p. 98 [accessed August 8, 2023]).

26 In interviews, this staff was easily conversant on the topic and could quickly reference NHGRI’s work on the topic. This differs significantly from staff working on health disparities interviewed from other ICs.

Suggested Citation:"Appendix C: Equity in Innovation within NIH and FTC: Examination of Agency Approaches and Implementation." 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.
×

is a major roadblock in their equity efforts. Surprisingly, they did not argue that financial or other resources are currently a major impediment. Rather, they emphasized the massive resources being dedicated to equity work currently. However, as noted above, some did point to an overreliance on peer-review scores to drive funding distributions as a significant impediment to funding both a more diverse group of investigators and research that better addresses the needs of a diverse population. The lack of allotted time and budget for advisory councils to conduct thorough review of grant applications also limits NIH’s ability to pursue a program focused on equity in innovation, as does the independence of each IC to pursue its own priorities, although the former is much more likely to be changed than the latter. As described above, lower funding rates in ICs for most community- and population-level research is a major impediment to equity in innovation at NIH.

FEDERAL TRADE COMMISSION

As opposed to NIH, the Federal Trade Commission (FTC) is a very small agency, with approximately 1,200 employees and a budget of $376.5 million appropriated for FY2022 (less than 1 percent of NIH’s total budget, and less than 15 percent of NIH’s administrative operating budget). FTC is a law enforcement agency, responsible for policing business practices that are anticompetitive, deceptive, or unfair to consumers, under the FTC Act of 1914. The agency is composed of two large segments: the Bureau of Consumer Protection and the Bureau of Competition, in addition to eight regional offices and several smaller support offices. In addition to pursuing enforcement actions (legal cases) against businesses, FTC also has a mission to protect consumers through education and to pursue policy in support of these goals.

A large percentage of FTC’s staff are lawyers; therefore, American legal traditions, norms, and habitus exert significant power in the organization. And while Hispanic American men and women are underrepresented at FTC compared with the civilian labor force (as are White women), White men are overrepresented by this metric, as are Black men and women (FTC, 2017). FTC staff consistently report being extremely overburdened and lacking sufficient support to accomplish important tasks. And while the agency pursues education activities and frequently holds public workshops on significant issues in antitrust and consumer protection, it has been rather reserved in public communication about its activities on the whole.27 The U.S. Chamber of Commerce (the world’s largest business organization) recently launched a campaign promoting transparency at FTC, arguing that FTC is overreaching its authority and conducting investigations based on “secret votes” without bipartisan support. While this can be interpreted as a partisan attack, it is rooted in FTC’s less transparent approach to governance when compared with many other agencies—an approach that is likely justified in light of the agency’s mandate for policing businesses.

In addition to enforcement actions, FTC also frequently sends “warning letters” to indicate to businesses that FTC may pursue legal action if those companies continue practices identified therein. For example, in 2016 FTC sent warning letters to app developers using code from the software development kit company Silverpush, which was using audio beaconing technology to turn on consumers’ mobile phone microphones to monitor their TV viewing patterns and use this information for advertising. Silverpush is based outside of the United States, but FTC’s warning letters indicated that if the company followed these

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27 This is evident in the difficulty encountered in engaging FTC staff for this report. While this report is greatly indebted to the effort that several FTC staff made to support the project, it is clear that FTC exerts much more control over staff in speaking about their work than does NIH, in line with the private legal matters handled by FTC.

Suggested Citation:"Appendix C: Equity in Innovation within NIH and FTC: Examination of Agency Approaches and Implementation." 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.
×

practices in the United States, the FTC might bring a case against them. Technology media usually reports on such letters, which then function as warnings also to the broader industry.

But while FTC has authority to police “unfair” business practices, these have been difficult to support legally (Interview G); they require a legal weighing to demonstrate that the practices are not reasonably avoidable by consumers and that the benefits of the practice are not outweighed by the drawbacks. In the Vizio TV case settled in 2017 for $2.2 million, the company was collecting pixels aftermarket from their smart TVs to see what customers were watching and at what time, and then selling that information to analytics and advertising companies. FTC argued that this was unfair business practice, as consumers do not expect such surveillance and it was not of any benefit to them. In July 2021, FTC rescinded a 2015 policy limiting its own enforcement ability under the FTC Act (Section 5), which Democratic commissioners argued “doubled down on the Commission’s longstanding failure to investigate and pursue ‘unfair methods of competition’” (Khan et al., 2021, p. 5). By rescinding the policy, these commissioners argued that FTC could better pursue its obligations to enforce the prohibition of unfair methods of competition, extending beyond the Clayton Antitrust Act of 1914 (PL 63-212) (Khan et al., 2021).

Innovation and Emerging Tech

When asked about “equity in innovation” (and even “equity in emerging technology”), many interviewees at FTC emphasized that agency’s work is law enforcement, with no particular attention to innovation or technology. However, historian and legal scholar Chris Jay Hoofnagle has argued that FTC “has evolved into the most important regulator of information privacy—and thus innovation policy—in the world” (Hoofnagle, 2016, pp. i-iv). In recent years, FTC has held numerous workshops28 and issued reports and guidance to the companies it regulates regarding the Internet of Things (IoT), big data, data brokers, data security, online marketing, debt collection, health care, and the sharing economy, among other “equity in innovation” topics. It has brought cases in these areas as well, regarding, for example, such devices as baby monitors and connected toys.

Commissioner Edith Ramirez, who led the agency from March 2013 to January 2017, made health care and technology two of her primary areas of focus at FTC; Time magazine called her “the woman keeping silicon valley in check” (Luckerson, 2014). Along with one of FTC’s chief technologists under the Obama administration (Ashkan Soltani), Chairwoman Ramirez led the founding of FTC’s Office of Technology Research and Investigation (OTech), which “supports all facets of the FTC’s consumer protection mission, including issues related to privacy, data security, connected cars, smart homes, algorithmic transparency, emerging payment methods, fraud, big data, and the Internet of Things”29. OTech sits within the Bureau of Consumer Protection and has led FTC in increasing its tech expertise (e.g., establishing an annual PrivacyCon; establishing a fellowship program for graduate-level technologists).

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28 For example, the April 2021 FTC workshop on Bringing Dark Patterns to Light focused on internet design features that impair customer autonomy (e.g., by sneaking items into shopping carts or making it difficult to remove additional products/services); this panel specifically investigated “the especially pernicious effects of dark patterns on communities of color” (see https://www.ftc.gov/news-events/events/2021/04/bringing-dark-patterns-light-ftc-workshop; accessed July 19, 2023) Additional workshop topics have included privacy and other data risks with regards to drones, smart TVs, connected cars, Ed Tech, etc.

29 See https://www.ftc.gov/about-ftc/bureaus-offices/bureau-consumer-protection/our-divisions/office-technology-research-investigation (accessed July 19, 2023).

Suggested Citation:"Appendix C: Equity in Innovation within NIH and FTC: Examination of Agency Approaches and Implementation." 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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FTC’s Explicitly Political Structure

FTC is an explicitly bipartisan agency, led by five commissioners serving 7-year terms, who are nominated by the U.S. president and subject to Senate confirmation. No more than three of these commissioners can be from any one party at any time. The president also selects one of these commissioners to serve as chair. This explicitly political infrastructure contrasts markedly with NIH’s efforts to be a neutral, apolitical scientific agency. The bipartisan structure has at times hampered equity efforts at FTC. For example, when FTC recently released a statement on algorithmic discrimination, one commissioner immediately released an additional statement claiming that this focus overreaches FTC’s legal authority. Any new FTC policy requires approval by vote of the commissioners; “equity” has been a politically charged term, making policies in this area difficult to pass.

Public Engagement

Under Commissioner Lina Khan, FTC has made efforts to increase public involvement in the agency’s work, by, for example, holding open commission meetings with periods for public comment. In enforcement actions, FTC’s work on “vulnerable groups” has focused primarily on children and the elderly; FTC has seen these groups as particularly vulnerable to fraudulent advertising. However, FTC has in recent years paid increasing attention to racial equity—for example, through the Every Community Initiative (ECI). ECI was established in 2014 with a focus on identifying and addressing areas of fraud that particularly affect communities of color, and the disproportionate burden of fraud that falls on members of these groups (FTC, 2021). Two years later, FTC issued a congressionally mandated report, Combating Fraud in African American & Latino Communities: The FTC’s Comprehensive Strategic Plan. In addition to racial equity, FTC has long pursued enforcement actions based on advertising in Spanish, and it has increasingly done so in other languages as well.

From ECI’s early focus on fraud, the initiative has expanded to address a wide array of equity issues within FTC’s mission. ECI has worked to develop a feedback loop of contact with marginalized communities, which ECI staff see as especially important because FTC has observed in its consumer reports data that people of color less often report issues to FTC, even though it is clear that fraud falls more heavily upon them. ECI collaborates closely with FTC’s Legal Services division, and last year started an initiative to partner with legal aid organizations to expand outreach to lower-income communities to improve reporting on consumer protection issues, as well as to improve involvement in FTC’s education efforts. ECI also works closely with FTC’s Consumer and Business Education Department, which has developed long-term connections with libraries, ethnic media outlets, community and senior centers, teachers of English as a second language, and others, which allow FTC to be in closer contact with underserved communities and address issues of concern to these groups. FTC’s regional offices play a large role in this work, as they are more closely integrated with work being done “on the ground” in different parts of the country.

FTC has also engaged the public through “tech challenges,” such as its 2016–2017 Internet of Things Home Device Security Contest, which offered a $25,000 prize for the top proposal to help consumers address security vulnerabilities in IoT devices.30 Additionally, FTC publishes Analyses to Aid Public Comment on its cases.

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30 The winning app focused on analyzing whether their devices security systems are out of date and whether their networks are secure: https://www.ftc.gov/news-events/news/press-releases/2017/07/ftc-announces-winner-its-internet-things-home-device-security-contest (accessed July 19, 2023).

Suggested Citation:"Appendix C: Equity in Innovation within NIH and FTC: Examination of Agency Approaches and Implementation." 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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Legal Authority and Antiracism

The bounds of FTC’s legal authority with regards to equity have been a battle of late. FTC recently recruited a civil rights lawyer to advise the agency’s chairwoman, examining legal theory in order to establish the limits of FTC’s civil rights authority; the goal of this work has been thinking holistically about the intersections of civil rights and consumer protection, which have traditionally been treated quite separately from consumer protection and competition law. Some at FTC have tried to push the agency to see that equity and civil rights are important elements of both FTC’s consumer protection and antitrust work.

In the summer of 2020, amid widespread protests regarding racial equity in the United States, FTC Commissioner Rebecca Slaughter argued in a tweet that FTC must become antiracist and that antitrust laws can play an important role in racial equity (and should be explicitly antiracist) (Feiner, 2020). Prior to this, legal theory on antitrust as an equity issue was extremely limited; however, in the last 2 years, legal theory on this topic has multiplied rapidly (Interview C). In spite of public backlash from some stakeholders, Chairwoman Lina Khan has made public statements supporting antiracism in antitrust as well.

FTC Technologists

Under the leadership of Chairwoman Khan, the agency has also vastly expanded its team of technologists and has centralized many of these technical experts in an Office of the Chief Technology Officer, where they can support legal experts across the agency. Over the last decade, FTC has typically hosted chief technologists for a period of 1 year each, most often on leave from academic positions. The role of FTC technologists has been the subject of great debate in recent years. When Republican Commissioner Joe Simons was appointed FTC Chairman in 2018, he began investigating whether to establish a Bureau of Technology within FTC (Miller, 2018). However, Simons was apparently at odds with the Trump administration, which attempted to pressure FTC into pursuing cases against Twitter and other social media companies for anticonservative bias (Nylen et al., 2020).

Commissioner Rohit Chopra, who has directed the Consumer Financial Protection Bureau since October 2021, argued vehemently in late 2020 that FTC had become reactive with respect to issues in technology, following media reports rather than identifying cases proactively through its own research. Writing in a dissenting opinion on the Zoom settlement that year, which he and Commissioner Slaughter argued did not hold the company sufficiently accountable for its privacy gaps and misleading language regarding security, Chopra argued that FTC should “make a concerted effort to increase the proportion of technologists and others with technical knowledge in our investigative teams” and that the commission “has deprived our litigators and enforcement attorneys of ... needed expertise” (Victor, 2020).

Technology experts, advocacy groups, and journalists have in recent years consistently argued that FTC lacks sufficient technical expertise to hold technology companies accountable for privacy issues, and some observers have drawn attention to the impacts of this gap on equity as well (Wood, 2019). Chairwoman Khan has long been critical of “big tech” and has prioritized FTC attention in this area. In addition to ongoing attention to monopoly power in social media, search engines, eCommerce, and similar areas (and how a lack of competition can allow for known racially discriminatory features in Google searches, for example), Chairwoman Khan has helped drive FTC’s recent attention to algorithmic bias.

Suggested Citation:"Appendix C: Equity in Innovation within NIH and FTC: Examination of Agency Approaches and Implementation." 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.
×

Case Study: Algorithmic Bias

Under Chairwoman Edith Ramirez, FTC examined issues of “Inclusion” and “Exclusion” in the arena of big data and issued a report on the topic in early 2016 (FTC, 2016). During Commissioner Ramirez’s time at FTC, the agency brought several cases related to data concentration (e.g., a merger case regarding educational marketing data),31 cases in which companies have used geolocation data for advertising beyond the control of consumers,32 and numerous cases regarding insufficient security and privacy measures that endanger consumers and their data.33 FTC’s big data efforts during this period also focused on enforcing the Fair Credit Reporting Act (FCRA); FTC pursued more than 100 FCRA cases under Chairwoman Ramirez, emphasizing that when companies buy data about consumers from analytics companies or data brokers, and use that data to make eligibility determinations regarding housing, credit, employment, insurance, and the like, the company must notify consumers and give them an opportunity to correct inaccurate information.

With the new presidential administration and the departure of Chairwoman Ramirez in early 2017, some of FTC’s big data efforts slowed. However, in May of 2018, two new commissioners joined FTC, and continued to push on big data issues, including internet privacy: Commissioner Rebecca Slaughter and Commissioner Rohit Chopra. That year FTC brought a case against real estate software company RealPage, arguing that the company did not take proper steps to ensure the veracity of data it provided to landlords and property managers,34 drawing attention to this significant element of algorithmic equity: the quality of data on which algorithms are based.

In April 2020, Bureau of Consumer Protection (BCP) director Andrew Smith published a blog post titled “Using Artificial Intelligence and Algorithms,” warning that FTC could use FCRA to police the use of data and algorithms in making decisions about consumers. This guidance also emphasized that the Equal Credit Opportunity Act and the employment provision of the Civil Rights Act give FTC authority to enforce discrimination against “protected classes.” One year later, in April 2021, a lawyer in the BCP wrote a blog post titled “Aiming for Truth, Fairness, and Equity in your Company’s Use of AI” (Jillson, 2021). The post highlighted health AI as a prime site for algorithmic bias, since the data on which models are trained often reflect racial bias and then result in algorithms that perpetuate systemic racism. In a phrase that spread rapidly in the tech industry, the post cautioned companies to “hold yourself accountable—or be ready for the FTC to do it for you” (Jillson, 2021).

Throughout this period, FTC continued to hold public workshops on AI-related topics, such as voice cloning and dark patterns (see note under Innovation and Emeging Tech), as well as sessions on algorithmic bias, at PrivacyCon 2020 and 2021. Commissioner Slaughter also continued to write and speak extensively on algorithmic bias, promoting the importance of the topic to a wide array of audiences. Upon taking on the role of chairwoman in June 2021, Commissioner Khan brought in a legal advisor with extensive experience in algorithmic bias. In September of that year, FTC passed new investigation regulations regarding algorithmic and biometric bias, which allow staff to investigate allegations of such bias. While no enforcement

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31 Dun & Bradstreet Corp., Dkt. No. 9342 (filed May 7, 2010), https://www.ftc.gov/sites/default/files/documents/cases/2010/05/100507dunbradstreetcmpt.pdf (accessed July 19, 2023).

32 See Press Release, FED. TRADE COMM’N, Mobile Advertising Network InMobi Settles FTC Charges It Tracked Hundreds of Millions of Consumers’ Locations Without Permission (June 22, 2016), https://www.ftc.gov/newsevents/press-releases/2016/06/mobile-advertising-network-inmobi-settles-ftc-charges-it-tracked.

33 For example, cases against Wyndham Worldwide (whose lax security allowed hackers to place memory-scraping malware on the company’s servers, leading to financial information breaches) and TRENDnet (whose lack of security in home video security and baby monitors allowed hackers to post live feeds on the Internet).

34 RealPage settled the case for $3 million.

Suggested Citation:"Appendix C: Equity in Innovation within NIH and FTC: Examination of Agency Approaches and Implementation." 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.
×

actions on algorithmic bias are public at this time,35 many observers have taken the new investigation regulations and the April 2021 blog post as an indication that FTC is likely bringing cases in this area currently or will do so in the near future.

In August of 2022 BCP released an Advance Notice of Proposed Rulemaking regarding Commercial Surveillance and Data Security (as well as a fact sheet on the topic), requesting public comments before October 21, 2022; in September FTC also held a virtual forum for public commentary. This notice used the term “algorithmic discrimination,” asking for public comments on the following questions:

  • How prevalent is algorithmic discrimination based on protected categories such as race, sex, and age? Is such discrimination more pronounced in some sectors than others? If so, which ones?
  • How should the Commission evaluate or measure algorithmic discrimination? How does algorithmic discrimination affect consumers, directly and indirectly? To what extent, if at all, does algorithmic discrimination stifle innovation or competition?
  • How should the Commission address such algorithmic discrimination? Should it consider new trade regulation rules that bar or somehow limit the deployment of any system that produces discrimination, irrespective of the data or processes on which those outcomes are based? If so, which standards should the Commission use to measure or evaluate disparate outcomes? How should the Commission analyze discrimination based on proxies for protected categories? How should the Commission analyze discrimination when more than one protected category is implicated (e.g., pregnant veteran or Black woman)?
  • Should the Commission consider new rules on algorithmic discrimination in areas where Congress has already explicitly legislated, such as housing, employment, labor, and consumer finance? Or should the Commission consider such rules addressing all sectors?

However, the designation of “discrimination” has been difficult to support legally, and (as noted above) has raised criticism from some parties; although this recent report uses the term, FTC has considered other terminology such as “negative differential treatment” (Interview C).

FTC has thus addressed algorithmic bias through public education and engagement (e.g., public comment on rulemaking, and in open sessions), as well as through regulatory guidance. In June of this year, FTC issued another congressionally mandated report on AI; this one required FTC to investigate the use of AI in combatting predatory online behavior, such as child sexual exploitation and incitement of violence, as well as scams, fakes, and the like. However, FTC released a much broader report, drawing attention to its extensive AI work.

FTC’s Equity Action Plan

As opposed to NIH, which does not have its own Equity Action Plan (EAP) because it falls under the EAP from HHS, FTC developed an independent EAP in accordance with the Biden administration’s Executive Order 13985 of 2021 (FTC, 2022a). Few interviewees at FTC had heard about this EAP, even one administrator who was designated a team leader on one of the EAP goals. Members of the EAP team note that this kind of equity work is totally new at

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35 This statement depends on definitions. FTC’s June 2022 report to Congress highlights two recent facial recognition tech cases as relevant: one against Facebook and another against Everalbum, both holding that these companies deceived consumers about the company’s use of facial recognition technology.

Suggested Citation:"Appendix C: Equity in Innovation within NIH and FTC: Examination of Agency Approaches and Implementation." 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.
×

FTC, and requires major shifts in mindsets, toward seeing equity as a significant contributor to all of FTC’s work, rather than an added requirement on top of an already overburdened workforce. In addition to attempts to navigate explicit resistance to equity work, staff also have to navigate an extremely limited budget for equity work. Furthermore, the agency does not have experience in this arena, and is “building the airplane while flying” (Interview K).

One of the primary goals of the EAP is for the BCP to develop a toolkit for “evaluating the impact of deceptive or unfair practices in the use of emerging technologies (e.g., algorithmic bias and the gig economy) on underserved communities” (FTC 2022a, p. 4). The agency plans to measure this according to the following rubric:

Short term (2-4 years out):

  1. Have we implemented the new toolkit and directed resources toward this effort?
  2. Have the efforts resulted in law enforcement actions?
  3. Are market actors responding to our efforts?

Long-term (5-8 years out):

  1. Use of the toolkit is embedded in staff’s work.
  2. Robust law enforcement, community outreach, and new policies or initiatives (e.g., rulemakings, market studies, or other initiatives) that address relative harms to different market participants, including underserved communities.
  3. Market actors affirmatively avoiding disparate harm to market participants, including underserved communities.

However, FTC has not established many metrics beyond these broad guidelines; it is still in the process of working this out. Beyond identifying equity issues in emerging technology, FTC plans to address these issues both through enforcement actions and by ensuring that members of marginalized groups receive appropriate shares of any compensation from FTC’s suits and settlements.

On the antitrust side, the EAP laid out how FTC’s Bureau of Competition (BC) will “revise its case selection and evaluation process by (1) systematically collecting information regarding the impact of proposed mergers and alleged anticompetitive conduct on communities that are already at a disadvantage in the American economy, particularly low-income communities, rural communities, and communities of color; and (2) including restrictive covenants and effects on workers, particularly low-wage workers, in BC’s merger analysis” (FTC, 2022a, p. 6). In the past, FTC has not selected antitrust cases by explicitly analyzing the impacts of competitive practices on specific demographics or on workers, beyond the categories of children and the elderly.

FTC has not established metrics for this goal for the BC. However, staff involved in developing the EAP stressed that FTC is becoming a leader on this equity issue among antitrust and consumer protection agencies globally; only the antitrust organizations of Canada, South Africa, and the United Kingdom have even started developing policies relating to equity. Building on this work, FTC’s strategic plan for 2022–2026 (released in August 2022) lists top ranking goals of “supporting equity for historically underserved communities through” both the agency’s consumer protection and competition missions (FTC, 2022b).

Suggested Citation:"Appendix C: Equity in Innovation within NIH and FTC: Examination of Agency Approaches and Implementation." 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.
×

Health Care

FTC has also pursued numerous cases and policy action in pharmaceutical antitrust and consumer protection;36 although equity has not always been a primary driver in selecting these areas of focus, this work has significant equity implications, and (as described above) FTC is increasingly acknowledging equity as a factor in case selection. For example, FTC engaged their in-house civil rights expert in a recent case brought against DaVita Dialysis, recognizing that this case would significantly impact people of color in the United States. Likewise, recent policy work on pharmacy benefits managers’ role in drug pricing has drawn some attention to impacts on low-income groups. However, these equity elements continue behind the scenes, outside of public visibility.

Limitations and Barriers

While FTC has advanced significantly in recent years on equity efforts, the terrain is still new for the organization, and many leaders in the organization oppose this very framing of work within FTC (as described above). Within FTC’s own workforce, in spite of the federal mandate requiring agencies to have a federal women’s program and Hispanic employment program, FTC runs neither of these SEPs (Interview F). Equal employment staff at FTC account this to insufficient budget. There are some obvious areas of racial inequity in consumer protection and antitrust where FTC has not taken action. For example, while racial inequities in credit reporting are well known, FTC has not pursued enforcement or policy in this area (Interview L; this contrasts with FTC’s reference to the Equal Credit Opportunity Act as a basis for antidiscrimination authority). It is unclear whether this is because of political constraints, lack of budget, or other reasons. However, it is certain that FTC staff doing equity work are often taking on these responsibilities on top of a full set of additional job responsibilities; there are extremely limited financial and human resources for this work at FTC. Specific budget set-aside for equity work could go far in supporting FTC’s “scrappy”37 efforts in this area.

FTC has been working to address equity in innovation within the bounds of current laws and regulations. However, additional congressional mandates in this arena could help the agency address political roadblocks at the level of FTC’s five commissioners (whose votes are required for policy action). While Congress asked FTC to make recommendations in its June 2022 report regarding laws that could advance the use of AI to address online harms, FTC instead argued that Congress should pass laws to ensure that AI tools do not cause additional harms. Similar equity-focused laws would likely be beneficial in other areas of emerging technology.

REFERENCES

Amutah, C., K. Greenidge, A. Mante, M.. Munyikwa., S. L. Surya, E. Higginbotham, D. S. Jones, R. Lavizzo-Mourey, D. Roberts, J. Tsai, and J. Aysola. 2021. Misrepresenting race: the role of medical schools in propagating physician bias. New England Journal of Medicine 384(9):872-878.

Biagioli, M. (ed). 1999. The Science Studies Reader. New York: Routledge.

Creary, M. 2021. Bounded justice and the limits of health equity. The Journal of Law, Medicine, and Ethics 49(2):241-256.

___________________

36 For example, the well-known Martin Shkreli “pharma bro” case, as well as numerous others in which FTC has required companies to divest from certain drug programs that would be anticompetitive.

37 That is, creative and admirable work in the face of opposition and limited resources.

Suggested Citation:"Appendix C: Equity in Innovation within NIH and FTC: Examination of Agency Approaches and Implementation." 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.
×

CDC (U.S. Centers for Disease Control and Prevention). 2022. What is Health Equity. https://www.cdc.gov/nchhstp/healthequity/index.html (accessed July 19, 2023).

CRS (Congressional Research Service). 2022. Federal workforce statistics sources: OPM and OMB. Updated June 28. https://sgp.fas.org/crs/misc/R43590.pdf (accessed July 21, 2023).

CRS. 2023. Office of Management and Budget (OMB): An overview. RS21665, June 22, 2023. https://sgp.fas.org/crs/misc/RS21665.pdf (accessed July 21, 2023).

DoD (U.S. Department of Defense). 2021. Defense budget overview. United States Department of Defense fiscal year 2022 budget request. https://comptroller.defense.gov/Portals/45/Documents/defbudget/FY2022/FY2022_Budget_Request_Overview_Book.pdf (accessed July 21, 2023).

Dolan, D., S. J. Lee, and M. K. Cho. 2022. Three decades of ethical, legal, and social implications research: Looking back to chart a path forward. Cell Genomics 2(7):100150.

Donovan, E. T. 1985. The Retirement Equity Act of 1984: A review. Social Security Bulletin 48(5):38-44. https://www.ssa.gov/policy/docs/ssb/v48n5/v48n5p38.pdf (accessed September 12, 2022).

Fabi, R., and D. S. Goldberg. 2022. Bioethics, (funding) priorities, and the perpetuation of injustice. American Journal of Bioethics 22(1):6-13.

Feiner, L. 2020. How FTC Commissioner Slaughter wants to make antitrust enforcement antiracist. CNBC, September 26. https://www.cnbc.com/amp/2020/09/26/ftc-commissioner-slaughter-on-making-antitrust-enforcement-antiracist.html (accessed September 30, 2022).

Fricker, M. 2007. Epistemic injustice: Power and the ethics of knowing. Oxford, United Kingdom: Oxford University Press.

FTC (Federal Trade Commission). 2016. Big data: A tool for inclusion of exclusion? Washington, DC. https://www.ftc.gov/system/files/documents/reports/big-data-tool-inclusion-or-exclusion-understanding-issues/160106big-data-rpt.pdf (accessed June 27, 2023).

FTC. 2017. Annual Equal Employment Opportunity Program status report. Washington DC. https://www.ftc.gov/system/files/attachments/md-715-reports/ftc_md-715_report_fy2017.pdf (accessed July 2, 2023).

FTC. 2021. Serving communities of color: A staff report on the Federal Trade Commission’s efforts to address fraud and consumer issues affecting communities of color. Washington, D.C. https://www.ftc.gov/system/files/documents/reports/serving-communities-color-staff-report-federal-trade-commissions-efforts-address-fraud-consumer/ftc-communities-color-report_oct_2021-508-v2.pdf (accessed June 29, 2023).

FTC. 2022a. Federal Trade Commission (FTC) equity action plan. https://www.ftc.gov/system/files/ftc_gov/pdf/FTCEquityActionPlanForRelease41422.pdf (accessed July 19, 2023).

FTC. 2022b. Federal Trade Commission strategic plan for fiscal years 2022-2026. https://www.ftc.gov/system/files/ftc_gov/pdf/fy-2022-2026-ftc-strategic-plan.pdf (accessed July 19, 2023).

GAO (General Accounting Office). 1980. How to make special emphasis programs an effective part of agencies’ EEO activities. Washington, DC. https://www.gao.gov/assets/fpcd-80-55.pdf (accessed June 29, 2023).

Garrison, N. 2013. Impact of the Havasupai case on genetic research. Science, Technology and Human Values 38(2):201-223.

Ginther, D. K., W. T. Schaffer, J. Schnell, B. Masimore, F. Liu, L. L. Haak, and R. Kington. 2011. Race, ethnicity, and NIH research awards. Science 333(6045):1015-1019.

Hadden, C. M., and Gallegos, D. A. 2008. The DIGEST Of Equal Employment Opportunity Law. EEOC Office of Federal Operations 19(3):Summer. https://www.eeoc.gov/federal-sector/digest/digest-equal-employment-opportunity-law-41 (accessed June 19, 2023).

Harrison, J. 2022. Federal judicial power and federal equity without federal equity powers. Notre Dame Law Review 97(5):1911-1967.

Hoofnagle, C. J. 2016. Federal trade commission privacy law and policy. Cambridge, United Kingdom: Cambridge University Press.

Hoppe, T. A., A. Litovitz, R. A. Meseroll, M. J. Perkins, B. I. Hutchins, A. F. Davis, M. S. Lauer, H. A. Valantine, J. M. Anderson, and G. M. Santangelo. 2019. Topic choice contributes to the lower rate of NIH awards to African-American/Black scientists. Science Advances 5(10):eaaw7238.

Houck, E. A., and E. Debray. 2015. The shift from adequacy to equity in federal education policymaking. The Russell Sage Foundation Journal of the Social Sciences 1(3):148-167.

Jillson, E. 2021. Aiming for truth, fairness, and equity in your company’s use of AI. Federal Trade Commission, April 19. https://www.ftc.gov/business-guidance/blog/2021/04/aiming-truth-fairness-equity-your-companys-use-ai (accessed October 1, 2022).

Katz, Y., and U. Matter. 2020. Metrics of inequality: The concentration of resources in the U.S. biomedical elite. Science as Culture 29(4):475-502.

Suggested Citation:"Appendix C: Equity in Innovation within NIH and FTC: Examination of Agency Approaches and Implementation." 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.
×

Khan, L. M., R. Chopra, and R. K. Slaughter. 2021. Statement of Chair Lina M. Khan Joined by Commissioner Rohit Chopra and Commissioner Rebecca Kelly Slaughter on the Withdrawal of the Statement of Enforcement Principles Regarding “Unfair Methods of Competition” Under Section 5 of the FTC Act. https://www.ftc.gov/system/files/documents/public_statements/1591498/final_statement_of_chair_khan_joined_by_rc_and_rks_on_section_5_0.pdf (accessed July 19, 2023).

Lauer, M. S., and D. Roychowdhury. 2021. Inequalities in the distribution of National Institutes of Health research project grant funding. eLife 10: e71712.

Lauer, M. S., J. Doyle, J. Wang, and D. Roychowdhury. 2021. Associations of topic-specific peer review outcomes and institute and center award rates with funding disparities at the National Institutes of Health. eLife 10:e67173.

Lee, S. S., J. Mountain, B. Koenig, R. Altman, M. Brown, A. Camarillo, L. Cavalli-Sforza, M. Cho, J. Eberhardt, M. Feldman, R. Ford, H. Greely, R. King, H. Markus, D. Satz, M. Snipp, C. Steele, and P. Underhill. 2008. The ethics of characterizing difference: Guiding principles on using racial categories in human genetics. Genome Biology 9(7):404.

Luckerson, V. 2014. Meet the woman keeping Silicon Valley in check. Time Magazine, July 26. https://time.com/3040669/ftc-edith-ramirez/ (accessed October 1, 2022).

Military Leadership Diversity Commission. 2011. From representation to inclusion: Diversity leadership for the 21st century military. Arlington, VA. https://issuu.com/victorybyvalorfinal/docs/mldc_final_report (accessed September 19, 2022).

Miller, A. 2018. Standalone FTC tech bureau seen as good idea, but experts spot pitfalls. FTC Watch 939, May 21. https://www.mlexwatch.com/articles/3130/standalone-ftc-tech-bureau-seen-as-good-idea-but-experts-spot-pitfalls (accessed July 19, 2023).

Minow, M. 2021. Equality vs equity. American Journal of Law and Equality 1:167-193.

NASEM (National Academies of Sciences, Engineering, and Medicine). 2019. Managing the NIH Bethesda campus capital assets for success in a highly competitive global biomedical research environment. Washington, DC: National Academies Press.

NHGRI (National Human Genome Research Institute). 2021. NIH awards $38 million to improve utility of polygenic risk scores in diverse populations. https://www.genome.gov/news/news-release/nih-awards-38-million-dollars-to-improve-utility-of-polygenic-risk-scores-in-diverse-populations (accessed August 8, 2023).

NHGRI. 2022a. Polygenic risk methods in diverse populations (PRIMED) consortium. Bethesda, MD. https://www.genome.gov/Funded-Programs-Projects/PRIMED-Consortium (accessed September 28, 2022).

NHGRI. 2022b. Polygenic risk scores. Bethesda, MD. https://www.genome.gov/Health/Genomics-and-Medicine/Polygenic-risk-scores (accessed September 28, 2022).

NIH (National Institutes of Health). 1997. Review criteria for and rating of unsolicited research grant and other applications. NIH Guide 26(22). https://grants.nih.gov/grants/guide/notice-files/not97-010.html (accessed June 29, 2023).

NIH. 2004. Scientific peer review of research grant applications and research and development contract projects. Federal Register 69(2):272-278.

NIH Central Resource for Grants and Funding Information. 2021. Peer review. Bethesda, MD: National Institutes of Health. https://grants.nih.gov/grants/peer-review.htm (accessed September 13, 2022).

NIH CSR (Center for Scientific Review). 2023. About CSR. Bethesda, MD: National Institutes of Health. https://public.csr.nih.gov/AboutCSR (accessed September 13, 2022).

NIH Office of Budget. n.d. Appropriations history. Bethesda, MD: National Institutes of Health https://officeofbudget.od.nih.gov/approp_hist.html (accessed July 21, 2023).

NIH Office of Budget. n.d. Budget request. Bethesda, MD: National Institutes of Health. https://officeofbudget.od.nih.gov/br.html (accessed September 13, 2022).

NIH Office of the Director. 2022. Racial disparities in NIH funding. Bethesda, MD: National Institutes of Health. https://diversity.nih.gov/building-evidence/racial-disparities-nih-funding (accessed September 24, 2022).

NIH OPA (Office of Portfolio Analysis). 2023. OPA home. Bethesda, MD: National Institutes of Health. https://dpcpsi.nih.gov/opa (accessed September 13, 2022).

NIH OSC (Office of Strategic Coordination- The Common Fund). 2022. Faculty institutional recruitment for sustainable transformation (FIRST) program highlights. Bethesda, MD: National Institutes of Health. https://commonfund.nih.gov/first/programhighlights (accessed June 29, 2023).

NIH RePORT (Research Portfolio Online Reporting Tools). n.d. Frequently asked questions. Bethesda, MD: National Institutes of Health. https://report.nih.gov/funding/categorical-spending/rcdc-faqs#q1 (accessed September 21, 2022).

NIH RePORT. 2022. Estimates of funding for various research, condition, and disease categories (RCDC). Bethesda, MD: National Institutes of Health.

Suggested Citation:"Appendix C: Equity in Innovation within NIH and FTC: Examination of Agency Approaches and Implementation." 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.
×

NIH UNITE. 2022. Celebrating UNITE progress to date. Bethesda, MD: National Institutes of Health. https://www.nih.gov/ending-structural-racism/celebrating-unite-progress-date-message-unite-co-chairs (accessed June 29, 2023).

NIH Workforce Demographics. 2022. Bethesda, MD: National Institutes of Health. https://www.edi.nih.gov/data/demographics (accessed July 21, 2023).

NIH Working Group on Diversity in the Biomedical Research Workforce. 2012. Draft report of the advisory committee to the director working group on diversity in the biomedical research workforce. Bethesda, MD: National Institutes of Health. https://acd.od.nih.gov/documents/reports/DiversityBiomedicalResearchWorkforceReport.pdf (accessed September 9, 2022).

NSF (National Science Foundation). 2014. Perspectives on broader impacts. Washington, DC.

Nylen, L., B. W. Swan, K. Hendel, and D. Lippman. 2020. Trump aides interviewing replacement for embattled FTC chair. Politico, August 28. https://www.politico.com/news/2020/08/28/trump-ftc-chair-simons-replacement-404479 (accessed October 1, 2022).

OMB (Office of Management and Budget). 2021. Budget of the U.S. government fiscal year 2022. The White House, May 28. https://www.whitehouse.gov/wp-content/uploads/2021/05/budget_fy22.pdf (accessed July 21, 2023).

OMH (Office of Minority Health). 2011. National stakeholder strategy for achieving health equity. Washington, DC: Department of Health and Human Services. https://www.phdmc.org/program-documents/healthy-lifestyles/dche/64-achieving-health-equity/file (accessed September 9, 2022).

Pope, A. B., and S. M. Fullerton. 2016. Genomics is failing on diversity. Nature 538(7624):161-164.

Reardon, J. 2001. The Human Genome Diversity Project: A case study in coproduction. Social Studies of Science 31(3):357-388.

Schroeder, P. 1982. Supplemental statement before the bipartisan congressional forum on Equal Employment Opportunity and Affirmative Action. In Oversight on Federal Equal Employment Opportunity Activities, Committee on Post Office and Civil Service, US House of Representatives.

Thomas, J. Y., and K. P. Brady. 2005. The Elementary and Secondary Education Act at 40: Equity, accountability, and the evolving federal role in public education. Review of Research in Education 29(1):51-67.

Victor, K. 2020. Zoom settlement stirs talk over FTC chief technologists’ role. FTC Watch 995, November 23. https://www.mlexwatch.com/articles/10011/print?section=ftcwatch (accessed October 1, 2022).

Wood, M. 2019. The FTC has no chief technologist as it weighs big tech investigations. Marketplace, April 2. https://www.marketplace.org/2019/04/02/should-we-care-ftc-doesnt-have-chief-technologist/ (accessed October 1, 2022).

Suggested Citation:"Appendix C: Equity in Innovation within NIH and FTC: Examination of Agency Approaches and Implementation." 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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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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