Healthy Volunteers Alliance
Protecting the Rights of Healthy Volunteers in Clinical Trials
RESPECT GOES BOTH WAYS
Healthy volunteers are the foundation of clinical research — and professionalism matters on all sides.
At the Healthy Volunteers Alliance (HVA), We Believe that Respect Should Go Both Ways:
Volunteers should follow study rules, arrive on time (or early when possible), and treat staff and other participants courteously. Showing up early lets staff know you’re prepared and helps keep studies running smoothly.
Clinics and sponsors should communicate clearly, treat volunteers with dignity, and handle concerns fairly.
Sometimes misunderstandings happen, and not every situation is black and white. But when everyone acts with professionalism and patience, studies run smoother resulting in positive results for everyone!
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This principle guides how HVA reviews and responds to all reported concerns!
What Happens After You Submit a Report
After a concern is submitted, HVA will review the information provided to better understand the situation and determine appropriate next steps.
What to expect:
Your submission is reviewed privately and respectfully
We may identify whether the issue involves policy, procedure, communication, or conduct
In some cases, additional clarification or documentation may be requested
when appropriate, HVA may provide guidance on possible options for next steps
Each situation is handled individually and with discretion
HVA does not share reports publicly, contact clinics or sponsors without cause, or take action without careful consideration.
While we cannot guarantee outcomes or resolutions, our goal is to help volunteers feel heard, informed, and supported -and to encourage fairness and accountability within clinical research whenever possible.
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Submitting a report does not obligate you to take further action- it simply opens the door to understanding your options!
Fairness & Accountability in Clinical Research:
Healthy volunteers play a vital role in advancing medicine — but fairness is a two-way street.
Professional conduct matters. Disruptive or disrespectful behavior can lead to restrictions, removal from a facility, or a permanent ban.
However, not all bans result from misconduct. Administrative errors or misunderstandings can also unfairly affect eligibility.
How HVA Approaches Reported Issues:
HVA does not assume fault on either side….
When a concern is submitted, our role is to approach the situation thoughtfully, objectively, and with respect for everyone involved.
Each report is reviewed on its own merits; recognizing that not every issue is misconduct-but every concern deserves to be heard.
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When an issue is reported, HVA aims to…….
Review the situation objectively and without bias
identify whether the concern relates to policy, procedure, communication, or conduct
Help volunteers understand their rights responsibilities and options
Offer guidance on appropriate and professional next steps
Advocate for clarification or fair review when warranted
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“HVA does not encourage hostility, confrontation, or public escalation”
We promote professional, constructive resolution whenever possible- with the goal of improving understanding, accountability, and fairness within clinical research!
WHAT THIS PAGE IS FOR
The Healthy Volunteers Alliance (HVA) supports healthy volunteers who experience concerns at any stage of a clinical trial -before, during or after.
You may use this page to report issues related to:
Study conduct or protocol deviations
Informed Consent (ICF) concerns or inconsistencies
Compensation disputes or unclear payment terms
Early termination, follow-up requirements, or post-study obligations
Communication breakdowns with clinical staff or sponsors
Retaliation, blacklisting, or unexplained restrictions
Safety, dignity, or respect concerns
Clerical or database errors affecting eligibility
Any situation where you believe fairness or transparency may be lacking
~IMPORTANT~
Not every issue is misconduct-but every concern deserves to be heard and at the very least, be evaluated!
Use the “Repot An Issue” Box at the top of this page, to share your experience!
We can’t promise to resolve every issue — but we can help you understand your rights, offer direction, and push for fair treatment.
Together, let’s raise the standard for respect, fairness, and accountability in clinical research — on both sides.
To better understand your responsibility as a healthy participant in clinical research, click on the “Participant Responsibilities” button below for additional information.
