How to Access Clinical Trial & Research Study Records
How to Access Clinical Trial & Research Study Records?
Learn your rights to access medical research records, clinical trial data, and study results. Understand IRB protections, Common Rule requirements, and biobank tissue records.
Understanding your rights to medical research data, clinical trial results, biobank samples, and how federal regulations protect research participants.
Understanding Research vs. Medical Records
When you participate in a clinical trial or research study, multiple types of records are created. Understanding the distinction between research records and standard medical records is essential for knowing your access rights.
Medical Records (HIPAA-Covered)
- •Physical exams and vital signs
- •Laboratory test results
- •Imaging studies (X-rays, MRIs)
- •Medications administered
- •Adverse event documentation
You have full HIPAA access rights to these records
Research-Specific Records
- •Study questionnaires and surveys
- •Experimental measurements
- •Genetic/genomic analysis
- •Blinded treatment assignments
- •Research-specific biomarkers
Access governed by consent form and study protocol
Federal Protections for Research Participants
The Common Rule (45 CFR 46)
The federal policy that governs human subjects research funded by most federal agencies. Revised in 2018, it establishes key protections:
Informed Consent Requirements
Must explain data collection, storage, sharing, and your right to receive research results if clinically significant.
IRB Oversight
Institutional Review Boards must approve all research and monitor participant protections throughout the study.
Right to Withdraw
You can withdraw from research at any time without penalty, though data already collected may continue to be used.
Privacy Protections
Requires adequate provisions to protect privacy and maintain confidentiality of data.
HIPAA Research Provisions
HIPAA applies to research conducted by covered entities (hospitals, clinics, health plans). Key provisions include:
- 1Authorization requirement: Covered entities must obtain written HIPAA authorization to use or disclose PHI for research
- 2Access rights preserved: Research participation doesn't waive your right to access your own health information
- 3Limited data sets: Some research uses data with direct identifiers removed but dates and geographic data retained
- 4Accounting of disclosures: You can request a list of when your PHI was disclosed for research
21st Century Cures Act Requirements
The Cures Act improved transparency in clinical research:
- ✓Clinical trial sponsors must post results on ClinicalTrials.gov within 12 months
- ✓Penalties for failing to report required results information
- ✓Expanded requirements for registering studies and reporting adverse events
- ✓Strengthened patient access to electronic health information
Types of Research Records You Can Access
Clinical Trial Records
Generally Accessible
- • Your individual test results
- • Medical exams performed during trial
- • Adverse events you experienced
- • Treatments administered to you
- • Your signed consent forms
- • Overall study results (after completion)
May Be Restricted
- • Blinded treatment assignment (during study)
- • Comparisons with other participants
- • Proprietary study protocols
- • Unpublished interim analyses
- • Other participants' data
- • Investigator notes about you
Genetic and Genomic Research
Genetic research records have special considerations under GINA and state genetic privacy laws:
Your Genetic Data Rights
- •Access to your individual genetic results (if the study offers this)
- •Notification of clinically actionable findings
- •Choice about whether to receive incidental findings
- •Protection from discrimination based on genetic information
Note: Many genetic studies de-identify data, making it impossible to return individual results. Review your consent form for result-sharing policies.
Biobank and Tissue Sample Records
If you donated blood, tissue, or other biological samples to a biobank, your rights depend on the consent you provided:
Broad Consent Model
You agreed to unspecified future research. You can typically withdraw from future use but not retrieve samples already used or distributed.
Specific Consent Model
You agreed to specific studies. You should receive results from those particular studies if specified in consent.
De-identified Samples
If samples were stripped of all identifiers, re-linking results to you may not be possible even if you want them.
Observational Studies and Registries
Non-interventional research that follows participants over time:
- •Disease registries: Track specific conditions over time. You can usually access your own data entries.
- •Cohort studies: Follow groups of people. Your individual data should be accessible upon request.
- •Survey research: Your responses may be stored with or without identifiers depending on study design.
- •Medical device registries: Track implants and devices. You have rights to your participation records.
Step-by-Step: Requesting Your Research Records
Review Your Informed Consent Document
Your consent form is the key document that outlines your rights. Look for sections covering:
- • Data access and result sharing provisions
- • Contact information for the research team
- • IRB contact information
- • Withdrawal procedures
- • How long records will be retained
Contact the Research Coordinator
The study coordinator is your primary point of contact. Reach out via phone or email to:
- • Confirm what records are available
- • Understand the request process
- • Ask about study completion status and results
- • Request copies of your consent forms if needed
Submit a Written Request
For formal records access, submit your request in writing. Include:
Your written request should include:
- • Full name and any study participant ID
- • Study name and protocol number (if known)
- • Dates of participation
- • Specific records requested
- • Preferred format (electronic or paper)
- • Your signature and date
Contact the IRB if Needed
If the research team is unresponsive or you have concerns about your rights, contact the Institutional Review Board that approved the study. IRBs can:
- • Help resolve disputes about record access
- • Investigate complaints about research conduct
- • Clarify your rights under the study protocol
- • Provide guidance on proper procedures
Search Public Registries
Even if you can't get individual records, you may find study results publicly:
Special Situations
Terminated or Abandoned Studies
If a study ended early or the research institution no longer exists:
- •Check ClinicalTrials.gov for study status and sponsor contact information
- •Contact the IRB that approved the study - they track ongoing obligations
- •Reach out to the study sponsor (pharmaceutical company, NIH institute, etc.)
- •File a HIPAA request with any healthcare facility where study procedures were performed
Incidental Findings
Sometimes research discovers unexpected health information unrelated to the study:
Disclosure Varies by Study
Not all studies have policies to return incidental findings. Your consent form should state whether you'll be notified of unexpected discoveries and under what circumstances.
If findings are clinically significant and actionable, most ethical guidelines recommend disclosure. However, research tests may not be validated for clinical diagnosis and may require confirmation with clinical testing.
Pediatric Research Records
Special rules apply when children participate in research:
- •Parents/guardians typically have access rights during minority
- •Upon turning 18, individuals gain independent access rights
- •Assent (child's agreement) documentation should be available
- •Some states allow mature minors to access their own records
See our guide on minors' medical records access for more details.
Deceased Research Participants
Family members seeking a deceased person's research records should:
- 1.Establish legal authority (executor, administrator, or next of kin)
- 2.Provide death certificate and proof of relationship
- 3.Review whether the original consent allowed family access
- 4.Contact both the research institution and IRB
HIPAA protections continue for 50 years after death. Research records may have different retention requirements specified in the protocol.
Withdrawing from Research
You have the right to withdraw from research at any time without penalty. However, the impact on your data depends on timing and the type of withdrawal:
Full Withdrawal
Stop participation AND request deletion of all identifiable data not yet analyzed or published
Prospective Withdrawal
Stop participation and prevent future use of data, but allow already-collected data to remain in analyses
Participation Only
Stop active participation but allow all data (past and future from samples) to continue being used
Important Limitations
- • De-identified data cannot be withdrawn because it can't be re-linked to you
- • Published results cannot be retracted due to participant withdrawal
- • Aggregated analyses already completed typically cannot be undone
- • Samples distributed to other researchers may be difficult to retrieve
Frequently Asked Questions
Do I have a right to my clinical trial records?
Yes, under HIPAA you have the right to access your protected health information collected during clinical trials, including test results, medical exams, and treatment records. However, you may not access the full research dataset, study design, or other participants' data. The Common Rule also requires researchers to share individual research results when clinically significant.
Can I access my tissue samples stored in a biobank?
Your rights depend on the consent form you signed. Many biobanks allow you to request information about how your samples are being used, withdraw your samples from future research, and access results from studies using your samples if available. Some research uses de-identified samples where re-identification is not possible.
What is the difference between research records and medical records?
Medical records document your healthcare for treatment purposes and are covered by HIPAA. Research records are created for scientific study and may include additional data like questionnaires, genetic analysis, and experimental measurements. While overlapping information exists, research records may have different retention periods and access rules depending on the study protocol.
How do I get results from a completed clinical trial?
Contact the research team or study coordinator listed in your consent form. For federally-funded trials, results are often posted on ClinicalTrials.gov. You can also request a summary of findings through the IRB that approved the study. Under the 21st Century Cures Act, sponsors must post results within 12 months of study completion.
Can I withdraw my data from a research study after it's complete?
You can generally withdraw from ongoing studies and have your identifiable data removed. However, once data has been de-identified, aggregated, or published, withdrawal may not be possible. Some studies allow prospective withdrawal only, preventing use in future analyses but not removing data from completed analyses. Check your consent form for specific withdrawal provisions.
Related Resources
Need Help Accessing Your Research Records?
Our team can help you understand your rights as a research participant and guide you through the records request process.