The “Cure” for This Administration’s Scientific Priorities: Defend Responsible, Ethical Research and Respect Academic Freedom

By Jennifer Troyer, Jenna Norton and Alice Popejoy (all opinions our own)

The only thing more dangerous than leadership lacking knowledge is leadership lacking intellectual curiosity. Unfortunately, the latter reflects the situation at the U.S. National Institutes of Health (NIH) under the current administration. NIH Director Jayanta Bhattacharya and Deputy Director Matthew Memoli publicly claimed in December that they “cured” DEI. These authors have been handed authority and could be mistaken for experts. However, Bhattacharya and Memoli (and the policies they are implementing) demonstrate a clear lack of expertise, or even a basic understanding of the subject matter, as well as a failure to seek out relevant information before making key decisions. They constantly conflate several distinct concepts and activities, lumping them together under a single banner of “DEI” (diversity, equity, and inclusion). Any policies or programs they oppose politically are flagged with this undefined label to justify termination, despite their scientific merit.

This administration has mis-used the term ‘DEI’ to eliminate policies and practices that were intended to broaden the diversity of human study participants included in biomedical research, support studies focused on health disparities or health equity, and foster the inclusion of people with diverse backgrounds and perspectives in the scientific workforce. These are entirely different types of activities and areas of scientific investigation, each of which NIH has addressed through separate policies and programs across the research ecosystem. The breadth of different NIH activities that are now being lumped into one “DEI” bucket were implemented individually over time, and all of them were enacted to increase the quality and relevance of the science being supported.

Bhattacharya and Memoli seem unaware of why these different policies and practices were put into place at NIH in the first place, and worse, they are entirely uninterested in finding out. As a result, weaponization of the DEI label is disrupting the merit-based prioritization of cutting-edge scientific research. This does not bode well for the future of our health, healthcare workforce, or the biomedical research enterprise.

The mission of NIH is “to seek fundamental knowledge about the nature and behavior of living systems and to apply that knowledge to enhance health, lengthen life, and reduce illness and disability.” NIH policies to promote study inclusion, health disparities and health equity research, and workforce diversity were implemented to advance scientific discovery and innovation within this mission. The broad concepts of diversity, equity, and inclusion are thus essential to achieving these goals, and the political censorship we are seeing today undermines them. The need for high-quality science has not changed. Our ability to deliver it should not be derailed by the whims of the current administration.

Diversity as the basis for scientific observation and inquiry

Variation has always been a central aspect of biological research; scientists notice patterns of similarities and differences within and across natural populations, then design studies to investigate them. When everything is the same, scientists create differences in an experimental setting to see what downstream changes occur. It turns out that studying wild mice with natural genetic diversity in their populations reveals much more about what genes do than similar studies in which lab mice have been bred to be nearly identical. The variation across animals that come from different places in the wild provides “reservoirs of functional genetic diversity” that can lead to new discoveries.

At the NIH (and elsewhere), diversity in human populations is used in many contexts and is not confined to, nor fully captured by, race, sex, or gender. In a broad sense, human diversity can apply to, among other things: ancestral origins; nationality; language; self-identified race and/or ethnicity; geographic region including rural or urban locations; sex; sexual preference; gender; age; socioeconomic status; educational background, attainment, and area(s) of expertise; physical environment, including climate, exposure to pollutants; and access to healthcare.

Drawing on multiple dimensions of natural human diversity makes for more innovative and valuable science. Including broadly diverse study populations and cohorts is paramount to robust research results that lead to better downstream health outcomes for everyone. When people are left out of research due to systemic and structural barriers, without programs or policies to address known gaps in inclusion, effectiveness suffers, not just for those who are left out, but for everyone. Research based on the full breadth and depth of human biology makes for more robust outcomes than sampling based on convenience, which often happens in the absence of funded programs to support enhanced diversity in research.

Dr. Bhattacharya frequently focuses on replication and reproducibility, and has elevated this to an agency-wide initiative. Often, the lack of replication or reproducibility of results from a previously published human study is due to the lack of diversity in the initial study population. This has caused real harm to patients as a result of missing diversity. For example, genetic studies of hypertrophic cardiomyopathy, a serious and potentially life-threatening heart condition, failed to include diverse control populations, producing a result that looked real in relatively homogeneous European ancestry cohorts, but was in fact a false-positive. This unreplicated finding led to unnecessary, invasive clinical interventions of unaffected African American patients–demonstrating the importance of considering diversity among control populations for discovery, as well as in replication studies. Furthermore, research areas with the greatest need for replication of prior studies include clinical drug trials, which have had limited diversity among study participants and require more (not less) prioritization on the basis of background diversity.

Research study inclusion

As Bhattacharya and Memoli assert, “everyone wants science that benefits their health.” They also state that the 100-year mission of the NIH “unites all Americans of every race, color and creed,” but history shows this is a highly idealized misrepresentation.

Throughout much of its 100-year history, NIH implicitly focused on the health of white men. (This may well be related to the fact that, for much of its history, NIH was also run disproportionately by white men…but we will get to the workforce diversity issue later on.) NIH did not consider women’s health in any systematic way until 1990, and did not require funded researchers to consider sex as a biological variable until 2016. This historical lack of inclusion led to underfunding of ovarian, uterine, and cervical cancers and other diseases, such as lupus, that primarily impact women. Failure to study the impact of social and biological differences among the genders and sexes, respectively, meant that symptoms of heart disease and autism in women and girls were often missed because they differed from symptoms in men and boys. Dr. Bhattacharya acknowledged at an NICHD Council meeting that the NIH still has a long way to go in supporting research on women’s health. It is unclear how cutting the programs that focus on inclusion will get us there.

Many NIH-funded studies excluded, abused, and/or exploited people from marginalized populations, leaving a long trail of harm and resulting mistrust that still has not been repaired. Among the most infamous cases is the agency’s widespread use of “immortal” cancer cell lines harvested from Henrietta Lacks (nicknamed “HeLa”) in 1951 without her or family’s consent. The NIH’s and federally funded researchers’ use of HeLa cells continued without consent for several decades until an agreement with the Lacks family was reached in 2013. No monetary benefits have reached the Lacks family, despite Henrietta’s cells being the material foundation for profitability of the modern biomedical research enterprise. When we ignore this history, it becomes easier to attack “DEI” in theory. In practice, inclusion is critical for the future of science.

It was not until 1993, when an act of Congress mandated the inclusion of women and minorities in federally funded biomedical research, that investigators were required to collect and report demographic information on study participants. Today, data collected in this way show that most groups traditionally excluded from clinical research are still underrepresented, and more than half of clinical trials did not meet planned enrollment targets. Other aspects of diversity have taken longer for inclusion. Sex and Gender Minorities (SGM) were officially recognized as a group designated for inclusion in NIH research in 2016, and only since 2019 have NIH studies been required to consider people across the entire lifespan, from childhood to old age, in their research proposals.

Over the course of its long history, NIH has intentionally moved towards recognizing and studying the health of all people, progressively taking into consideration more aspects of inclusion and expanded definitions of diversity. Until NIH research truly represents its entire constituency and produces results that impact “Americans of every race, color, and creed,” this focus on inclusion will continue to be a necessary element of publicly funded health research, in order to provide health solutions that work for everyone.

Health disparities and health equity research

In 1990, the Office of Minority Programs (OMP) was established to investigate and improve conditions that influence racial and ethnic differences in morbidity and mortality. Ten years later, Congress mandated the National Center on Minority Health and Health Disparities (NCMHD), which became an Institute (NIMHD) in 2010. Congress charged NIMHD with systematically supporting health disparities research by examining differences in the prevalence and outcomes among racial and ethnic groups for many chronic diseases. Bhattachaya and Memoli assert that “chronic disease does not discriminate,” however, unfortunately–the reality is that striking disparities in both prevalence and outcomes exist for many chronic diseases, including some of the leading causes of death in the US, such as heart disease, diabetes, and kidney disease.

Chronic diseases are by nature complex and have multiple interacting causes, including environmental conditions, social context, and economic stability, a group of factors which are generally called “social determinants of health (SDOH).” Studying these conditions in a sufficiently large population with a disproportionate burden of disease and with appropriate variables, considering biological and social causes together, can yield novel insights into disease etiology that lead to the development of better interventions and/or treatments for everyone. For example, equity-focused quality of care interventions in maternal health and cancer have led to improved outcomes for all patients regardless of racial or ethnic identity, while also reducing disparities.

Workforce diversity

A large body of peer-reviewed evidence shows that diverse groups do better work, come to more accurate conclusions, and propose more inventive solutions than monolithic groups. NIH policies have thus expanded over the years to become more intentional and systematically inclusive in improving the diversity of perspectives within the scientific workforce. Increasing the diversity of teams conducting, evaluating, and funding scientific research is an evidence-based method to improve outcomes. Therefore, for projects involving many people, NIH applicants were asked to consider how they would enhance diverse perspectives. The NIH also set these goals for scientific review panels, advisory boards, and NIH staff for similar reasons. These decisions were made to enhance the ability of the US scientific workforce to reach ambitious scientific goals. This had nothing to do with political ideology.

While inclusion of diverse perspectives has been a specific focus of NIH programs, no individual characteristic such as race, ethnicity, sex, gender, geographic location, background, educational attainment, career level, area of expertise, experience, or way of knowing was ever prioritized or considered in lieu of rigorous qualifications for research funding. Diversity Training Programs and Diversity Supplements were always focused on supporting the best and the brightest scholars with the highest promise for scientific achievement. NIH diversity supplement applicants were required to include a ‘qualification statement’ focused on the individual’s untapped talent and skills, as well as unique perspective(s) that would be valuable to the field of study. In some cases, this statement may have included references to race, ethnicity, or gender-minority status, but not necessarily. For example, an individual with physical impairment received a supplemental award for special equipment they needed to accommodate their disability while studying their own disease. Another awardee was a non-traditional student who spent their young adulthood raising their younger siblings after their parents died. These individuals might not have taken the same academic or career path of other researchers, but they had the necessary qualifications and raw ingredients for success. Both of these awards were terminated, along with hundreds of other awards to early career scientists, and thousands of awards in total.

Terminations were implemented not with any scientific rationale, but because either the application itself or the funding announcement under which they applied (written and published according to NIH policy) contained words that the current administration found objectionable. These terminations were made using similar processes recently exposed in depositions concerning terminations of National Endowment for the Humanities (NEH) awards, in which DOGE (Department of Government Efficiency) employees describe being charged with the elimination of “waste, fraud, and abuse” across the government. DOGE staff canceled awards for DEI-related themes, despite being unable to define “DEI.” In this administration, politics have overtaken evidence as the currency of scientific merit, as funding is diverted from important research studies and promising young investigators to advance a political agenda of censorship.

Censorship

Each of the activities above are now subjected to political oversight, censorship and ultimately consideration for termination. The DEI screening processes initially implemented by DOGE are now embedded at US science agencies, carried out by civil servants who experience retaliation for speaking up. Any disagreement is overruled or even censured. As things stand, investigators must choose between removing “terms that may potentially be associated with misalignment with the agency’s priorities” or losing their funding. This is an impossible choice for investigators prioritizing research that intentionally includes diverse populations or advances health equity. This administration has instilled widespread fear among scientists at NIH and the institutions it supports, as leaders worry their actions may negatively impact others. As a result, many more people disagree with what is happening than feel safe to make this known to their colleagues. If this resonates–know that you are not alone.

The words “diversity,” “equity,” and “inclusion” have been scrubbed from the approved lexicon, as have references to “underrepresented” and “marginalized” groups. NIH no longer considers “health equity” among its priorities, and the concept of gender identity and its associated terminology has been entirely eliminated from use at the agency. “LatinX,” “pregnant people,” and everyone who identifies as something other than their sex at birth are no longer acknowledged as categories of people who exist (and could therefore be intentionally included in biomedical research).

NIH deployed a “computational text analysis tool” that screens all grants and applications, flagging terms like “African American,” “Black American,” and “Hispanic American,” but not “white American” or “European American.” Scientific concepts such as “vaccine hesitancy,” “mRNA vaccines,” “pandemic response,” and “climate change” are also being removed, and the development of vaccines and new cures for HIV is being scaled back with an uncertain future. While NIH policy requires manual review of grants flagged for use of this terminology, the scientific program staff doing the review report that they are often unable to overturn the original results, regardless of the scientific justification for the flagged words. These changes are being made to active projects that were written and reviewed by members of the scientific community and deemed valuable as originally proposed.

Interfering with research proposals for political reasons in the absence of scientific rationale circumvents the agreements between NIH and the institutions that receive these awards. Requiring compliance to politically-motivated changes in order to receive funding threatens the academic and intellectual freedom of investigators, and preventing NIH staff from addressing it violates their First Amendment right to free speech. Rather than eliminating waste, fraud, and abuse at NIH, the anti-DEI campaign championed by Bhattacharya and Memoli has obligated investigators, administrators and NIH staff to waste valuable time (and taxpayer dollars) discussing, rewriting and re-reviewing language that would otherwise be unchanged. The time spent on modifying the wording of countless documents has accomplished nothing except diminishing our nation’s capacity to conduct globally competitive, cutting-edge research, and perhaps moving us closer to a world of homogeneity, inequity, and exclusion–to paraphrase US District Judge William Young.

Call to Action

Despite the concerted efforts over decades to foster diversity in the scope of its research questions and study participants, and to increase inclusion and representation in the NIH workforce, one could argue these efforts have been sporadic, progressed too slowly, and remain incomplete. None of this is an argument for halting that progress.

Politically appointed leaders at the NIH have the authority to determine how Congressional priorities are implemented, but they cannot change facts with political ideology or erase the record of established evidence for what works. NIH staff are required to follow lawful directives from leadership, but their belief in scientific principles and knowledge of established evidence remain intact. Program Officers, Institutions and investigators should continue their commitment to nurturing the careers of talented and dedicated scientists, no matter who they are, promoting good research ideas no matter who they come from, and developing programs that value and integrate diverse opinions and perspectives in order to produce better research that serves more people.

We must all continue to reject demands that require investigators and recipients of federal funding to disavow DEIA (DEI + Accessibility) programs. NIH staff and reviewers must continue to ensure that studies include representative populations for the disease(s) in question and develop new programs that consider the needs of all populations, especially those experiencing health disparities.

In order to advance science, it is important that researchers adhere to ethical and rigorous consideration of diversity, equity, and inclusion in all relevant areas of their work, regardless of which words they have been allowed to use in their applications. Rather than compromising and/or complying with unreasonable (and potentially unlawful) demands, researchers and institutional leaders should stand up for their academic, intellectual, and Constitutional freedoms to conduct rigorous scientific research and publish their findings without fear of censorship, repression, or political interference.

We realize this is no small task. Alone, it is overwhelmingly daunting and can be scary. The solutions are communication, coordination and collective action. The scientific community is large and powerful. If we stand up, together, we can make necessary changes based on solid evidence for what works, while resisting politically motivated changes that seek to undermine our progress in science. Our ability to continue producing valid, scientifically sound research to improve health, lengthen life, and reduce illness and disability for ALL Americans depends on it.