HELIOS CLINICAL RESEARCH

PRIVACY POLICY & RESEARCH PARTICIPANT PRIVACY NOTICE

Last Updated: June 16, 2026

Introduction

Helios Clinical Research (“Helios,” “we,” “us,” or “our”) is committed to protecting the privacy, confidentiality, and security of personal information and health-related information entrusted to us.

Helios conducts and supports clinical research activities across a network of research sites and partners. We maintain privacy and security practices designed to meet applicable HIPAA privacy and security standards, FDA regulations, Good Clinical Practice (GCP) requirements, Institutional Review Board (IRB) requirements, sponsor obligations, and applicable federal and state privacy laws.

This Privacy Policy & Research Participant Privacy Notice explains how we collect, use, disclose, store, and protect information when you:

Visit our websites;
Submit information to learn about clinical research opportunities;
Participate in clinical research studies;
Communicate with Helios personnel; or
Otherwise interact with our services.
Complete study pre-screening questionnaires
Express interest in research opportunities
Participate in a clinical trial
Contact Helios by phone, email, website forms, or other communication channels
Register for educational programs, events, or newsletters
Name
Date of birth
Mailing address
Email address
Telephone number
Emergency contact information
Medical history
Diagnoses and conditions
Current and previous medications
Treatment history
Laboratory and diagnostic information
Study eligibility responses
Insurance information when applicable
Gender
Race and ethnicity (when voluntarily provided)
Language preferences
Preferred methods of communication
Participation and outreach preferences
IP address
Device identifiers
Browser information
Operating system
Website activity and usage information
Pages visited
Referral sources
Session information
Healthcare providers
Physicians and referral sources
Electronic Medical Record (EMR) systems
Healthcare organizations participating in approved research activities
Research sponsors
Contract Research Organizations (CROs)
Institutional Review Boards (IRBs)
Recruitment partners
Referral networks and physician partners
Publicly available sources
Determining study eligibility
Conducting participant outreach
Managing study participation
Scheduling study visits
Coordinating research activities
Maintaining study records
Supporting participant engagement
Quality assurance and quality improvement
Compliance monitoring
Workforce training
Internal auditing
Operational management
Compliance with FDA requirements
Compliance with GCP standards
Compliance with sponsor obligations
Compliance with IRB requirements
Compliance with federal and state laws
Responding to inquiries
Providing study-related updates
Sharing educational materials
Supporting participant engagement activities
Website security
Analytics and performance monitoring
User experience improvements
Study sponsors
Principal investigators
Research coordinators
Contract Research Organizations (CROs)
Institutional Review Boards (IRBs)
Regulatory agencies, including the FDA
Healthcare providers involved in your care or research participation
Cloud hosting providers
Website service providers
Data storage providers
Research technology platforms
Electronic data capture systems
Customer relationship management systems
SOC 2 Type II attestation
SOC 3 reporting
GDPR compliance programs
Data Processing Agreements
Encryption of data in transit and at rest
Role-based access controls
Audit logging capabilities
Secure cloud infrastructure hosted through ISO 27001-certified service providers
Ongoing vulnerability management and security monitoring
Comply with applicable law
Respond to lawful requests
Comply with court orders or subpoenas
Report safety information or adverse events
Protect research participants
Protect public health and safety
Prevent fraud or unauthorized activity
Sharing information beyond research activities
Certain disclosures to third parties
Uses not otherwise described in this Notice
Sell health-related information
Sell personal information
Use health information for unauthorized commercial purposes
Share health information for non-research purposes without appropriate authorization
Access personal information maintained by Helios
Request correction of inaccurate information
Request deletion of information where legally permitted
Request restrictions on certain uses
Obtain a portable copy of information where applicable
Withdraw consent when permitted
Update communication preferences
California (CCPA/CPRA)
Virginia (VCDPA)
Colorado (CPA)
Connecticut (CTDPA)
Utah (UCPA)
Texas (TDPSA)
Oregon (OCPA)
Montana (MCDPA)
Delaware (DPDPA)
Iowa (ICDPA)
Nebraska (NDPA)
New Hampshire (NHPA)
New Jersey (NJDPA)
Tennessee (TIPA)
Minnesota (MCDPA)
Access information
Correct information
Delete information
Obtain portable copies
Opt out of certain processing activities
Appeal privacy-rights determinations
Comply with FDA requirements
Meet sponsor obligations
Satisfy IRB requirements
Preserve scientific integrity
Maintain adverse event reporting records
Fulfill legal retention obligations
Protect participant safety
Encryption of sensitive information in transit and at rest
Role-based access controls
Multi-factor authentication where appropriate
Workforce privacy and security training
Vendor security assessments
Ongoing monitoring and compliance reviews
Incident response procedures
Breach notification procedures as required by law
Conduct research activities
Meet regulatory requirements
Fulfill contractual obligations
Resolve disputes
Enforce agreements
Improve functionality
Analyze website performance
Enhance security
Remember preferences

By using our websites, submitting information, or participating in research activities, you acknowledge the practices described in this Notice.

1. INFORMATION WE COLLECT

We may collect information directly from you, automatically through your device, from healthcare providers, research partners, and other authorized third parties.

Information You Provide Directly

You may provide information when you:

Information collected may include:

Personal Information

Health-Related Information

Demographic Information

Communication Preferences

Information Collected Automatically

When visiting our websites, we may automatically collect:

We may use cookies and similar technologies to improve functionality, website performance, analytics, and security.

Information Received from Third Parties

Where permitted by law and authorized by you, we may receive information from:

Online Forms and Study Interest Submissions

Information submitted through website forms, pre-screening questionnaires, study interest forms, event registrations, referral forms, or similar online tools may be reviewed by authorized Helios personnel to determine potential eligibility for research opportunities and to facilitate communication regarding studies, educational programs, events, or services that may be of interest.

Information submitted through these forms may be entered into authorized research, operational, and participant engagement systems for follow-up, scheduling, study matching, regulatory compliance, and communication purposes.

2. HOW WE USE INFORMATION

We use information for legitimate research, operational, compliance, and communication purposes.

Clinical Research Activities

Research Operations

Regulatory Compliance

Communications

Website Administration

3. HOW WE SHARE INFORMATION

Helios does not sell personal information.

We may share information when necessary to support clinical research activities, research operations, regulatory obligations, or legal requirements.

Clinical Research Partners

Information may be shared with:

Technology Providers & Data Security

Helios works with trusted service providers that support our operations, including:

HubSpot Security & Compliance

Helios utilizes HubSpot as a customer relationship management (CRM) platform to support participant engagement, study inquiries, scheduling workflows, communication management, website functionality, and operational activities.

HubSpot maintains a comprehensive security and compliance program that includes:

Helios configures and manages HubSpot in accordance with applicable privacy, security, and regulatory requirements and limits the use of information to authorized research, operational, and participant engagement activities.

Information maintained within HubSpot is used solely to support clinical research recruitment, participant communications, scheduling workflows, research operations, website interactions, and related business functions.

Legal & Safety Requirements

Information may be disclosed when necessary to:

4. HEALTH INFORMATION PRIVACY

Helios may receive, create, maintain, or process health-related information in connection with research activities.

While Helios may not be a HIPAA Covered Entity in all circumstances, we maintain privacy and security practices designed to meet or exceed applicable HIPAA privacy and security standards.

Helios implements administrative, technical, and physical safeguards designed to protect health information from unauthorized access, use, disclosure, alteration, or destruction and limits access to authorized personnel with a legitimate business or research need.

Where health information is received from healthcare providers, sponsors, or other regulated entities, Helios handles such information in accordance with applicable legal, contractual, and regulatory requirements.

5. USES REQUIRING AUTHORIZATION

Certain uses or disclosures may require your authorization.

Examples may include:

You may revoke an authorization at any time in writing unless action has already been taken in reliance upon that authorization.

Helios will not:

6. YOUR PRIVACY RIGHTS

Subject to applicable law, you may have the right to:

You may submit requests by contacting our Privacy Officer.

7. STATE PRIVACY RIGHTS

Residents of certain states may have additional rights under applicable privacy laws, including:

Depending on applicable law, individuals may have rights to:

Certain rights may be limited by research, legal, scientific, public health, safety, or regulatory requirements.

8. RESEARCH PARTICIPANT DATA & REGULATORY REQUIREMENTS

Clinical research is subject to extensive federal regulations and scientific standards.

As a result, certain participant information and study records may be retained even if a participant requests deletion or modification.

Information may be retained to:

Where permitted by law, Helios will honor privacy requests. However, research-related records may be exempt from deletion or modification when retention is required by law, regulation, contract, or scientific necessity.

9. DATA SECURITY

Helios maintains administrative, technical, and physical safeguards designed to protect personal and health-related information.

Security measures include:

Only authorized personnel with a legitimate business or research need may access sensitive information.

10. DATA RETENTION

Information is retained only as long as necessary to:

Certain research records may be retained for extended periods as required by FDA regulations, sponsor agreements, Institutional Review Board requirements, Good Clinical Practice (GCP) guidelines, applicable laws, or scientific and research integrity obligations.

11. COOKIES & WEBSITE TECHNOLOGIES

Our websites may use cookies and similar technologies to:

Users may manage cookies through browser settings.

12. CHILDREN’S PRIVACY

Our websites are generally not intended for children under the age of 18 unless participation is part of a parentally authorized clinical research study.

If we become aware that personal information has been collected without appropriate authorization, we will take reasonable steps to remove the information.

13. CHANGES TO THIS NOTICE

Helios may update this Privacy Policy & Research Participant Privacy Notice periodically to reflect changes in legal requirements, research practices, technology, or business operations.

The most current version will be posted on our website with an updated effective date.

14. RESEARCH PARTICIPANT PRIVACY NOTICE

This Privacy Policy & Research Participant Privacy Notice describes Helios Clinical Research’s privacy and information-handling practices. It is not intended to constitute a Notice of Privacy Practices under HIPAA unless otherwise required by applicable law.

Helios maintains privacy and security safeguards designed to meet applicable HIPAA privacy and security standards, FDA regulations, Good Clinical Practice (GCP) requirements, Institutional Review Board (IRB) requirements, sponsor obligations, and applicable federal and state privacy laws governing clinical research activities.

15. CONTACT US

Helios Clinical Research
1307 8th Avenue, Suite 201
Fort Worth, Texas 76104

Privacy Officer
Email: info@heliosclinical.com
Phone: 214-550-3029

Questions, privacy requests, concerns, or complaints may be directed to the Privacy Officer using the contact information above.