FDORA Diversity Action Plans: What Every Clinical Research Site Needs to Know in 2026

What is FDORA and why does it matter now?

The Food and Drug Omnibus Reform Act (FDORA), enacted December 29, 2022, fundamentally changed the regulatory landscape for clinical trials in the United States. Buried inside the Consolidated Appropriations Act, 2023, FDORA added Sections 505(z) and 520(g)(9) to the Federal Food, Drug, and Cosmetic Act—creating a legal mandate for diversity in clinical research that had never existed before.

For years, the FDA had encouraged sponsors to enroll diverse populations. Encouragement didn't work. Trial participants remained overwhelmingly white, male, and middle-aged, even as the diseases being studied affected Black, Latino, Asian, and Indigenous communities disproportionately. FDORA changed "encouraged" to "required."

The FDA's final guidance on DAPs was due by statute in June 2025 (180 days following which requirements go live). As of April 2026, sponsors are now submitting Diversity Action Plans with their Phase 3 IND applications. This is no longer a future concern for clinical research sites. It's happening now.

The practical question for any research site coordinator is: Will your site be selected for Phase 3 trials in this new environment? The answer depends almost entirely on whether you can demonstrate a credible, data-backed diversity enrollment strategy.

What Diversity Action Plans must include

Per FDA guidance, a Diversity Action Plan is a formal document submitted to the FDA alongside a Phase 3 IND application. Sponsors—not sites—are responsible for submitting DAPs. But sites are responsible for executing against them. That's where your leverage and your risk both live.

Required elements of a DAP

The FDA requires DAPs to specify the following for each pivotal clinical study:

Notice that most of these elements require the sponsor to know—in advance—that your site can execute. That's why sponsor site-selection conversations are fundamentally different in 2026 than they were in 2022. Sponsors now ask: "What's your diversity enrollment track record? What community partnerships do you have? Can you hit a 30% Black enrollment target in a cardiology study?"

The enrollment gap: why sites are already behind

Here's the hard truth about where the industry stands. Despite decades of calls for diversity in clinical research, the numbers have barely moved.

Between 2015 and 2019, 78% of clinical trial participants were white, even though only 61% of the U.S. population identifies as white. Latino patients represented just 6% of trial participants nationally, despite comprising 16.3% of the population. For kidney disease trials, Black patients—who represent 33% of kidney disease cases—made up just 9% of trial participants.

The problem isn't that patients don't want to participate. Research consistently shows that more than 50% of patients offered trial participation agree to enroll. The barrier is that diverse populations simply aren't being asked. Sites lack community connections, bilingual staff, and the outreach infrastructure to reach these patient populations where they are.

The consequence of this underrepresentation isn't just ethical—it's operational. 55% of all Phase I–IV trials that stopped between 2008 and 2017 stopped due to low accrual. Diverse recruitment isn't just a regulatory checkbox. It's the single most effective intervention for preventing trial failure.

Why most sites are unprepared

A 2024 HHS Office of Inspector General report found that most NIH-funded trials with inclusive enrollment plans still missed their diversity targets. The root causes are structural, not attitudinal:

• No community infrastructure: Sites rely on patient databases and referrals—sources that skew white and English-speaking.
• Language barriers: Consent forms, screening materials, and coordinator conversations happen in English only.
• Accessibility gaps: Clinic hours, transportation barriers, and work schedule conflicts disproportionately affect working-class and minority communities.
• Historical mistrust: Events like the Tuskegee study and Puerto Rican pill trials have created lasting, justified skepticism in Black and Hispanic communities that requires active community trust-building—not passive recruitment.
• No diversity tracking: Many sites don't systematically track enrollment by race and ethnicity, making it impossible to demonstrate performance to sponsors.

How sponsors are using DAPs to select sites

Site selection has always favored sites with strong enrollment track records. FDORA adds a new dimension: sponsors now need sites that can deliver on disaggregated enrollment targets—not just total volume.

In practice, this means sponsors are now evaluating sites on:

Historical diversity data. If you've run 10 oncology trials in the last three years and your participant pool was 90% white, that's a liability. Sponsors will calculate whether your demographic catchment area and past performance can support their DAP goals.

Community partnership documentation. Sponsors want to see that you have established relationships with community health organizations, churches, FQHC partners, and patient advocacy groups serving underrepresented populations. These relationships take years to build. Sites that have them are immediately differentiated.

Operational diversity infrastructure. Do you have bilingual coordinators? Transportation assistance protocols? Flexible scheduling for shift workers? Sites that can document these capabilities are more credible DAP partners.

Data tracking and reporting systems. Can you provide monthly reports showing race/ethnicity enrollment breakdowns against DAP goals? Sites that have implemented tracking systems get renewed sponsor contracts. Sites that can't report are dropped.

Which therapeutic areas are most affected

FDORA's DAP requirement applies to all Phase 3 pivotal drug trials and pivotal device studies requiring IDE approval. That covers most late-stage clinical research. But the urgency varies by therapeutic area based on how severe the current representation gaps are.

Consequences of non-compliance

The consequences of FDORA non-compliance operate at two levels: the sponsor level and the site level. Understanding both clarifies why this is an urgent operational issue, not a distant regulatory concern.

For sponsors

Failure to submit a Diversity Action Plan is a prohibited act under the Federal Food, Drug, and Cosmetic Act. The FDA can levy civil or criminal penalties against sponsors who don't submit DAPs for covered studies. Sponsors who miss their DAP enrollment targets must explain why to the FDA and provide mitigation strategies—and in some cases, the FDA can require post-market studies to capture data on underrepresented groups. Those post-market studies are expensive and delay commercialization.

For sites

Sites face a different, more immediate risk: loss of sponsor partnerships and future trial volume. Because sponsors are legally accountable for DAP compliance, they will systematically deprioritize sites that create enrollment risk. A site that has historically enrolled 95% white patients and has no documented diversity strategy is a liability. Sponsors will route their Phase 3 trials elsewhere.

This isn't theoretical. Sponsors have always selected sites based on performance data. FDORA added disaggregated diversity metrics to the selection criteria. Sites that don't meet those criteria will see their trial volume decline over the next 2–3 years as the market recalibrates around the new standard.

15-point FDORA readiness checklist for site coordinators

What to do next

The research sites that will win Phase 3 partnerships over the next five years are the ones building diversity infrastructure now. Not because regulators are watching, but because diversity enrollment directly predicts trial success. Sponsors know this. Site selection is increasingly a proxy for which sites can reliably deliver diverse, enrolled populations through study completion.

The checklist above is a starting point. The honest reality is that most sites will complete 4–5 of the 15 items without outside help and struggle on the rest—particularly community partnerships, language accessibility, and real-time diversity reporting. These are the hard parts. They require sustained relationship-building, operational systems, and community trust that take months or years to establish.

For sites that want to move faster than organic development allows, specialized diversity recruitment partners can provide the community infrastructure, bilingual outreach, and tracking systems that the checklist requires—without requiring your team to build everything from scratch.