Dear Washington Post Editorial Team,

I recently came across your article, 🔗 “Women are still underrepresented in clinical trials” by Erin Blakemore (June 27, 2022), discussing the underrepresentation of women in clinical research. Although it was published some time ago, the issues it raises remain ongoing and continue to be discussed today, underscoring how relevant this topic remains in the context of current participant experiences. It is clear that one perspective is often missing—the experience of participants themselves. I wanted to share a perspective based on participant-reported experiences and observed discussion trends.

As the founder of the Healthy Volunteers Alliance (HVA), a registered nonprofit advocacy organization representing clinical trial participants and healthy volunteers, I monitor participant discussions related to clinical research participation and observe recurring concerns that emerge across those discussions. These concerns consistently reflect that women are often excluded from studies due to childbearing potential, despite actively seeking opportunities to participate. From this perspective, underrepresentation is not always a matter of willingness—it is often a matter of eligibility.

Many early-phase trials understandably exclude women of childbearing potential, which limits participation for a large portion of younger women. At the same time, older women who are seeking to participate as healthy volunteers and are no longer of childbearing potential are often excluded due to arbitrary age limits that can be restrictive or inconsistent.

This creates a gap where women are often willing to participate but are unable to meet eligibility criteria. Addressing these structural barriers is an important step toward improving representation and ensuring that research reflects real populations.

These challenges are not limited to women. Information compiled from publicly available research, policy materials, and industry analyses—including sources such as the American Geriatrics Society, NIH, and industry publications—highlights the importance of inclusion across age, sex, and diverse populations to ensure that clinical research is applicable and reflective of real-world participants.

Through HVA, we are working to document and bring awareness to a broad range of issues affecting clinical trial participants, including the lack of participant representation and meaningful avenues for recourse, as well as gaps in informed consent, compensation concerns, eligibility barriers, and participant treatment across the research system. The patterns discussed here—particularly age-based exclusions and eligibility limitations—represent one example of these broader challenges.

As an advocacy organization, HVA is actively working to bring greater visibility to the real-world experiences of clinical trial participants—perspectives that are often missing from broader research narratives. While efforts to raise these concerns through traditional channels have not led to meaningful resolution, these issues continue to affect participants across the research system. We believe the media can play an important role in helping to bring these realities forward, and we welcome the opportunity to contribute participant-informed insights, documented patterns, and ongoing concerns to support more complete and accurate reporting.

 If helpful, additional information and supporting materials can be found through our website, including specific documentation and discussion around age and eligibility considerations.

Thank you for your time and for continuing to highlight important issues within clinical research.

Dear Mr. Ornstein,

The Healthy Volunteers Alliance (HVA) is a newly established, registered nonprofit advocacy organization formed after participant-driven research identified a critical gap in clinical research: healthy volunteers in Phase I trials have little to no meaningful representation and no clearly defined pathway for recourse when concerns arise.

Since its formation, HVA has engaged directly with participants and has worked to follow established channels by communicating with research sites, Institutional Review Boards (IRBs), and major regulatory oversight entities. These efforts were undertaken with the expectation that existing oversight systems would provide guidance, clarification, accountability, and resolution when concerns were raised.

Instead, a consistent and concerning pattern has emerged. When concerns are submitted through appropriate channels, responses are often limited, non-specific, or absent, and do not provide the clarity, accountability, or resolution these systems are intended to deliver. In addition, some participants have reported experiencing site-level restrictions on future participation after raising concerns through formal channels, even when safety or health-related issues are involved. This creates a potential disincentive for individuals to report concerns through the very systems intended to protect them.

Through months of research and outreach efforts, HVA has documented multiple instances in which concerns were raised in good faith, supported with documentation, and directed through recognized pathways, yet did not result in clear responses or visible resolution. These efforts include documented email correspondence, formal submissions, and certified outreach letters to research organizations and regulatory entities. HVA finds this pattern highly concerning, as it reflects a system in which processes exist, but do not consistently produce outcomes that participants can access, trust, or rely on.

This raises a broader concern about how participant protection systems function when they are relied upon. Clinical research operates within established frameworks intended to protect participants, including informed consent requirements, IRB oversight, and regulatory entities such as the Food and Drug Administration. However, when participants attempt to use these structures to raise concerns, including situations involving potential deviations from informed consent - there is often no clear or accessible path to obtain answers, clarification, or resolution. While certain oversight bodies, such as the Office for Human Research Protections, have defined jurisdictional limitations, participants are not provided with clear direction when concerns fall outside those boundaries, further contributing to gaps in accountability.

A clear distinction also exists between participant populations. Individuals participating in clinical trials as patients, who are receiving investigational treatments for medical conditions, often have access to advocacy organizations, support networks, and structured channels for representation. In contrast, healthy volunteers -who play a critical role in early-phase research and assume both time and medical risk - do not have equivalent representation or clearly defined avenues for recourse.

We believe this reflects a broader gap in participant-facing accountability and transparency within the clinical research system. This issue affects a large and growing population of healthy volunteers, numbering in the thousands, whose experiences remain largely absent from public discussion and meaningful support.

HVA’s work is supported by documented outreach, detailed timelines, and repeated attempts to engage through established channels, which collectively reflect a consistent pattern rather than isolated incidents.

We would welcome your consideration of this issue and the opportunity to provide additional information or documentation. We believe further investigation and media attention could help bring visibility to a population that has long been unrecognized and to systemic gaps that directly affect participant protection and trust.

This outreach also reflects the perspective of HVA’s founder, who remains anonymous due to the nature of participation in clinical research, and who has been an active healthy volunteer participant since the early 1990s. This includes decades of direct, ongoing experience within the clinical research system, which has informed HVA’s work and understanding of the issues described above.

Thank you for your time and consideration of bringing awareness to this important issue.

Warm regards,

This article is about the FDA removing draft guidance that was meant to improve diversity in clinical trials. Diversity, Equity, and Inclusion (DEI) means making sure studies include a wider range of people across age, sex, and ethnicity, so research better reflects the people these drugs and treatments are meant for.

In January 2025, shortly after President Donald Trump issued an executive order affecting diversity, equity, and inclusion (DEI) programs and federal recognition of gender identity, the FDA removed its previously issued draft guidance on diversity in clinical trials from its website. This was done without public notice or explanation, and was first observed publicly around January 23, 2025, raising concerns about the agency’s position on clinical trial diversity requirements and what this means for sponsors moving forward.

One important part of this article is that the guidance was not just a suggestion. It was meant to push sponsors to create Diversity Action Plans. These plans were supposed to show how they would include people who have often been underrepresented in clinical trials.

Now that the FDA has removed that draft guidance, it creates confusion about what is expected moving forward. It also raises concerns about whether the FDA is still committed to improving diversity in trials and whether clear standards are still in place.

The article also points out that this creates uncertainty for sponsors about compliance and expectations. At the time the article was written in January 2025, the FDA was expected to finalize this guidance by June 2025, including requirements for Diversity Action Plans 🔗 outlining how studies would include more representative populations. Now that that deadline has passed, and the draft guidance has been removed without clear explanation, it raises questions about whether that requirement was ever finalized and what standards are currently in place moving forward. When rules and expectations are unclear at the top, it can affect how studies are designed and who is allowed into them.

We also looked for updated information to see whether the FDA has finalized this guidance or provided any clarification since the June 2025 deadline. Based on publicly available information at the time of this writing, there is still limited clarity on where things currently stand. This lack of clear, updated guidance adds to the uncertainty for both sponsors and participants, and makes it more difficult to understand what standards are actually being followed in clinical trials today.

From a participant standpoint, this matters a lot. We already see many people excluded from studies because of age, sex, childbearing potential, ethnicity, or other eligibility criteria that are not always clearly explained. When guidance meant to improve inclusion is removed, it raises concerns that these same barriers may continue or even get worse.

The article also highlights the history of underrepresentation in clinical trials and why that matters. If certain groups are left out, research does not fully reflect real populations. That affects not just fairness, but also how meaningful and reliable the results are for the people who may eventually use these drugs or treatments.

At HVA, we see these issues reflected in participant experiences all the time. People often do not understand why they are excluded, why standards seem to change, or why one study says one thing while another says something different. That is why transparency, consistency, and clear guidance are so important.

These are the same issues we talk about throughout the HVA website, including age limits and inconsistent eligibility standards. Many participants are willing to take part in research but are excluded based on criteria that are not always clearly explained or applied the same way across studies.

This is also why HVA continues to focus on awareness, education, and transparency. Participants deserve to understand why these decisions are being made and how they affect their ability to participate.

This is not just a policy issue. It affects real people who are trying to participate in research and deserve to understand how and why these decisions are being made.

Dear Applied Clinical Trials Editorial Team,

The Healthy Volunteers Alliance (HVA) is a registered nonprofit advocacy organization representing healthy clinical trial participants in Phase I clinical research across the United States. Our work focuses on documenting real participant experiences and identifying patterns in how clinical trials are conducted, especially where transparency, consistency, and participant understanding and perspectives are lacking.

We are submitting this response to the April 11, 2025 article by Rebecca Johnson, PhD, titled "The Impact of DEI Ban on Clinical Research Ecosystem." We are providing a participant-focused perspective on how these developments are affecting clinical trial participation for the individuals directly involved. In doing so, we also considered related reporting on this issue, including the ​January 31, 2025 article by Giuliana Grossi, "FDA Quietly Removes Draft Guidance on Diversity in Clinical Trials Following Executive Order on DEI," which further highlights the concerns surrounding the removal of this guidance. 

We agree that improving diversity in clinical trials is necessary and that efforts to make research more inclusive have become increasingly important. Expanding representation across age, sex, ethnicity, and other underrepre​sented groups is critical to ensuring that research reflects the populations these treatments are intended for.

As outlined in the article, efforts to improve diversity in clinical trials have been building over several years. The Food and Drug Omnibus Reform Act of 2022 required sponsors to develop Diversity Action Plans for certain studies, and the FDA began working on guidance to explain how those plans would be created and applied. That FDA Draft Guidance was released in June 2024 and was expected to be finalized by June 2025, providing clearer direction to sponsors and research sites on how to improve inclusion across clinical trials.

However, before that process was completed, executive orders issued by President Donald Trump placed restrictions on diversity, equity, and inclusion (DEI) related initiatives across federal agencies. These orders broadly limited how federal agencies could support or implement programs related to diversity efforts, including those aimed at improving representation in areas such as race, ethnicity, sex, gender identity, and other underrepresented populations. While not written specifically for clinical trials, these policy changes directly affected agencies like the FDA that were in the process of developing guidance to improve clarity and consistency around inclusion and exclusion practices in clinical trials. Shortly after these executive orders were issued, the FDA removed its draft guidance on diversity in clinical trials from its website without public notice or explanation.

This creates a gap in understanding what happened to that process. Guidance that had been in development, tied to federal legislation, and expected to be finalized by June 2025 was no longer available, and no clear explanation was provided about whether those expectations still applied or what would replace them.

From a participant standpoint, this is where the concern comes in. If guidance that was intended to improve inclusion was never finalized and then removed entirely, it raises real questions about how decisions are now being made across research sites and whether there is any consistent direction being followed. At the same time, many of the issues being discussed are not new. Based on HVA’s research and what we see being shared across participant forums and community groups, individuals are already facing ongoing challenges related to exclusions, inconsistent criteria, and a lack of clear explanations about why these exclusions exist.

This is why we believe a participant perspective is so important, given the direct and ongoing impact these issues have on individuals involved in clinical research. While broader policy discussions often focus on regulatory changes and industry impact, the perspective of the actual participants directly affected by these decisions is often missing. 

From a participant standpoint, the concern is not simply that eligibility criteria exist, but how those criteria are being determined and applied. In some cases, exclusions based on age, sex, or other factors may reflect general assumptions, including expectations about overall health, or site-level limitations rather than clearly explained, study-specific reasons. 

The concern is what happens when guidance tied to inclusion is removed and there is no clear follow up or accountability in place. That creates more room for inconsistency across research sites, especially in areas where participants already face exclusions based on age, sex, ethnicity, and childbearing status.

For many participants, especially those who take part in clinical research on an ongoing basis, these issues come up repeatedly. Individuals who are willing and available to participate are often excluded before even reaching the screening stage based on age, sex, ethnicity, or childbearing status, without any clear explanation as to why those decisions are being made. Over time, this creates confusion and frustration, and makes it harder for participants to understand why they are being excluded. This is why it is so important that the FDA complete this process and provide clear guidance that is applied consistently across research sites.

HVA has also raised these concerns directly with the FDA and other relevant oversight entities through certified mail and formal email correspondence sent in January 2026. While these communications were successfully delivered, HVA has not received any substantive responses addressing the concerns raised. One of the key issues we have emphasized is the need for clearer, more transparent information within informed consent forms (ICFs), including clearly stated reasons for participant exclusion. When individuals are excluded without explanation, it not only creates confusion, but also undermines trust in the research process. Clear, consistent guidance at the federal level is critical to ensuring that these standards are reflected in how studies are communicated to participants.

Despite the central role informed consent plays in protecting participants, the most recent major update to these requirements occurred with the 2018 Revised Common Rule, which introduced improvements to clarity and presentation. Since that time, there have been no comparable finalized updates addressing how inclusion and exclusion criteria are defined or communicated to participants. From our perspective, this reflects a broader gap in representation. Healthy volunteers, particularly those participating on an ongoing basis, remain largely unrepresented in formal policy discussions. As a result, recurring issues experienced at the participant level, such as unclear or inconsistently applied exclusion criteria, are not consistently brought forward in a way that leads to meaningful policy change.

Clinical trials are supposed to reflect real populations. When people are consistently excluded, whether due to age limits, sex based criteria, ethnicity, or other factors, and when those criteria are not applied consistently across different research sites, it raises real concerns about whether the research is truly reflecting the people who will ultimately be using these treatments.

If certain groups are being limited or excluded from the start, then the data being collected may not fully reflect the people who are actually using these drugs in real world settings. That creates a gap between the research and the population it is meant to serve.

From a participant standpoint, this matters because people are making decisions about their health based on that research. If they were never adequately represented in the studies to begin with, it raises valid concerns about how well those results apply to them. From a research standpoint, this also raises important questions about the integrity of the data itself, including whether these drugs are truly being tested in populations that reflect how they will be used in real world settings. This is not just a participant concern, but one that directly impacts the reliability and applicability of the research as a whole.

This is not just a regulatory issue. It directly affects individuals who are willing to participate in research but are left without clear answers about why they are excluded or what standards are being applied, reinforcing the broader concern that both participant trust and research integrity are being impacted.

At present, the perspectives of healthy volunteers remain largely absent from formal discussions, despite their direct involvement and the unique risks they assume. Through HVA, we aim to bring forward these lived experiences collectively and ensure they are recognized as a meaningful and necessary part of the conversation.

​Our organization greatly appreciates your time and consideration and would welcome the opportunity to contribute this perspective for publication, so that the voices of healthy volunteers are not only heard, but represented alongside ongoing policy and industry discussions.

​