One of the most serious problems healthy volunteers face is the lack of any clear, reliable way to obtain information or resolve concerns.

At most Phase I clinics, recruiting is the only point of contact provided to participants. Recruiters typically do not have access to administrative records, participant-tracking systems, or decision-making authority, and are often unable to explain eligibility determinations, exclusions, or bans.

When volunteers attempt to escalate concerns beyond recruiting, emails and calls frequently go unanswered. Attempts to contact reviewing IRBs often result in silence as well. This leaves volunteers without a safe, consistent, or effective pathway to seek clarification, correct errors, or raise concerns—particularly when the issue directly affects future participation.

Healthy volunteers report being excluded or banned from individual research sites or ownership networks without written explanation, documentation, or an opportunity to appeal. These decisions are often communicated only when a volunteer contacts recruiting again and is told they are no longer eligible.

There is typically no designated administrative contact to review these decisions, explain how they were made, or correct inaccurate records. As a result, volunteers may lose future participation opportunities based on misunderstandings, clerical errors, or undocumented judgments that cannot be challenged.

Volunteers have reported being excluded or restricted based on positive drug screening results that were never confirmed through reliable analytical testing. Preliminary screening tests are known to produce false positives due to legally prescribed medications, over-the-counter products, supplements, or food-related cross-reactivity.

Despite these limitations, screening results are often treated as final. Participants are not given the opportunity to contest results, provide documentation, or request confirmatory testing before long-term or permanent consequences are imposed. In many cases, these exclusions occur even when no investigational drug was administered.

Healthy volunteers may face eligibility restrictions based solely on screening activity, even when they did not enroll in a study and did not receive any investigational product.

Screening outcomes or status may still be recorded and later used to deny future screening opportunities. These consequences are not always clearly disclosed in advance, leaving volunteers unaware that a routine screening visit can affect future eligibility.

Participant-tracking systems play a decisive role in eligibility decisions, yet volunteers generally have no ability to access, verify, or correct the information recorded about them.

In some cases, clinics do not promptly release volunteers from screening status in these systems. When a volunteer later attempts to screen elsewhere, outdated or inaccurate information may result in automatic exclusions or bans. Participants often learn of these issues only after traveling or presenting for screening, with no prior notice and no meaningful way to resolve the problem.

Volunteers frequently encounter age limits, BMI cutoffs, washout periods, and other eligibility criteria that vary widely across studies and sites. These standards are often not clearly explained and may lack transparent scientific justification.

When eligibility criteria are inconsistently applied or poorly disclosed, volunteers are left uncertain whether exclusions are based on safety, science, or administrative convenience.

Informed consent documents often fail to disclose how screening results, administrative determinations, or participant-tracking systems may affect future eligibility.

When volunteers are not clearly informed about these downstream consequences, they cannot fully understand the risks associated with screening or participation—even when no drug is administered.

Healthy volunteers and advocacy organizations report repeated attempts to seek clarification from research organizations and reviewing IRBs that go unanswered.

This lack of response undermines confidence in oversight mechanisms and discourages participants from raising concerns. Many volunteers report that attempts to question decisions or contact oversight bodies go unanswered, leaving serious issues unreported, unresolved, and without any clear path forward.

Many healthy volunteers hesitate to raise concerns or ask questions out of fear that doing so may lead to retaliation, exclusion from future studies, or negative records being placed in participant tracking-systems.

The lack of clear protections and anonymous reporting pathways creates a culture where issues often go unreported-not because they are unimportant, but because participants fear losing eligibility, income opportunities, or their standing within the research system.