Your Rights as a Clinical Trial Participant
Every participant in clinical research has fundamental rights and protections. Understanding these rights empowers you to make informed decisions about your health.
Your Fundamental Rights
✓ Right to Information
Complete details about the study, risks, benefits, and alternatives before you decide
✓ Right to Voluntariness
Participation is always voluntary with no pressure or coercion
✓ Right to Withdraw
Leave the study at any time, for any reason, without penalty
✓ Right to Privacy
Your medical information and identity are protected by law
✓ Right to Safety
Continuous monitoring and immediate care for any adverse effects
✓ Right to Respect
Dignified treatment and respect for your decisions and concerns
Understanding Informed Consent
📋 What Must Be Included
- •Purpose of the research and expected duration
- •Description of procedures, including which are experimental
- •Reasonably foreseeable risks and discomforts
- •Expected benefits to you or others
- •Alternative procedures or treatments available
- •How your privacy will be protected
- •Compensation and medical treatment for injuries
- •Who to contact with questions or problems
⚡ Your Consent Rights
Take Your Time
Never sign immediately. Take the form home, discuss with family, consult your doctor
Ask Questions
No question is too small. Ask until you fully understand every aspect
Get Copies
You must receive a signed copy of the consent form to keep
Ongoing Process
Consent continues throughout the study. New information must be shared
Systems Protecting You
FDA Oversight
Federal regulations ensure safety standards, protocol review, and monitoring of all trials
FDA Resources →IRB Protection
Independent review boards evaluate all studies for ethics, safety, and participant welfare
About IRBs →Data Safety Boards
Independent experts monitor trial data and can stop studies if safety concerns arise
Safety Monitoring →Institutional Review Board (IRB) Functions
Before the Study
- • Reviews protocol for scientific merit
- • Ensures risks are minimized
- • Verifies benefits outweigh risks
- • Approves consent forms
During the Study
- • Conducts continuing review
- • Reviews adverse events
- • Can suspend or terminate studies
- • Ensures ongoing compliance
Your Specific Rights Explained
Right to Withdraw at Any Time
What This Means
- • No reason needed to leave
- • No penalty or loss of benefits
- • Continued medical care if needed
- • Your data may be kept (ask about this)
How to Withdraw
- • Inform study coordinator
- • Preferably in writing
- • May need final safety visit
- • Get copies of your records
Right to Medical Care
During the Trial
- • All study-related care is free
- • 24/7 contact for emergencies
- • Regular health monitoring
- • Immediate care for side effects
If Injured
- • Emergency treatment provided
- • Costs covered per protocol
- • May have additional insurance
- • Right to seek compensation
Right to Privacy and Confidentiality
Protected by Law
- • HIPAA protections apply
- • Coded ID instead of name
- • Limited access to records
- • Secure data storage
Who May See Data
- • Research team members
- • FDA inspectors
- • IRB members
- • Study sponsors (de-identified)
Right to Ongoing Information
You Must Be Told About
- • New risks discovered
- • Changes to the protocol
- • Study results (when available)
- • Better alternatives found
You Can Request
- • Your test results
- • Study progress updates
- • Published findings
- • Your medical records
Additional Protections for Vulnerable Groups
Children
- • Parental permission required
- • Child assent when appropriate
- • Child advocate present
- • Minimal risk standard
Pregnant Women
- • Risk to fetus minimized
- • Special consent requirements
- • Additional monitoring
- • Father's consent (sometimes)
Cognitive Impairment
- • Legally authorized representative
- • Capacity assessment
- • Ongoing consent verification
- • Extra safeguards
Prisoners
- • No coercion allowed
- • Prisoner advocate required
- • Special IRB composition
- • Limited study types
How to Report Concerns or Violations
🚨 If You Have Concerns
Never hesitate to speak up if you feel your rights are being violated or you have safety concerns.
1. Study Team
Start with your study coordinator or principal investigator. Most issues can be resolved at this level.
2. IRB Contact
Every consent form must include IRB contact information. They investigate participant concerns independently.
3. FDA Reporting
Report serious violations to FDA's Clinical Trials Hotline: 1-800-FDA-1088 or online at FDA.gov
4. OHRP Complaints
Office for Human Research Protections: Email OHRP@hhs.gov or call 1-866-447-4777
⚠️ Red Flags to Watch For
- • Pressure to join or stay
- • Rushed consent process
- • Hidden costs or fees
- • Unreported side effects
- • Violation of protocol
- • Privacy breaches
✅ Signs of Good Practice
- • Thorough consent discussion
- • Regular safety monitoring
- • Open communication
- • Respect for your decisions
- • Clear contact information
- • Professional conduct
Clinical Trial Participant Bill of Rights
To be told everything about the study before agreeing to participate
To have enough time to decide whether to participate
To ask any questions before, during, and after the study
To refuse to participate or withdraw at any time without penalty
To receive a signed copy of the informed consent
To be told of any new risks or findings during the study
To have your privacy and confidentiality protected
To be treated with respect and dignity
To receive medical care for study-related injuries
To know who to contact with questions or concerns
Participate with Confidence
Understanding your rights empowers you to make informed decisions about clinical trial participation. We're here to help you find trials that respect and protect your rights.