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PIPEDA Authorization and Informed Consent Form

Informed Consent Forms and PIPEDA

Last update: 11/10/2025

Informed Consent

AUTHORIZATION FOR USE AND DISCLOSURE OF PERSONAL HEALTH INFORMATION

By signing this document, I request and authorize Massive Bio Inc. (“Massive Bio”) to provide Services to me and my healthcare provider (as required). My electronic signature creates a legally binding agreement under applicable Canadian law. I confirm that I have reached the age of majority in the province or territory where I receive healthcare services.

Information to Be Released and Used

I authorize my healthcare providers and facilities to release all records necessary for Massive Bio to perform its Services, including information relevant to my diagnosis, treatment, and medical history.
This may include, as applicable:
• Hospital discharge summaries, consultation notes, and treatment history
• Laboratory and pathology results (including genetic or genomic tests)
• Radiology and diagnostic imaging (X-rays, CT or MRI scans)
• Medication and procedure records, operative or surgical reports, and related documentation

Sensitive Information: These records may include information about mental-health treatment, substance-use disorder treatment, HIV/AIDS status, sexually transmitted diseases, or results of genetic testing. I specifically authorize the release of such information to Massive Bio for the purposes described in this authorization.

Purpose of Disclosure

The information described above will be used and disclosed by Massive Bio and its authorized subcontractors to:
• Analyze clinical-trial eligibility and biomarker testing results;
• Provide diagnostic and therapeutic matching services;
• Coordinate trial navigation, appointments, and communications with my health-care providers.

Voluntary Authorization

  • This authorization is voluntary. Refusal to sign will not affect my treatment, payment, or eligibility for health benefits.
  • Massive Bio may communicate with my healthcare providers to collect medical data, verify biomarker testing, and coordinate trial-related activities on my behalf.

Right to Withdraw Consent

I may revoke this authorization at any time by notifying Massive Bio in writing at [email protected]. Revocation becomes effective within 30 days of acknowledgment and stops new processing of identifiable information. Information already used or disclosed may continue to be retained as required by law or for data integrity.

Communication and Safeguards

Massive Bio may use secure communication methods—including encrypted email, patient portals, and secure file-transfer systems—to ensure the confidentiality of your personal health information. Massive Bio complies with the Personal Information Protection and Electronic Documents Act (PIPEDA) and applicable provincial laws governing health information custodians.

Recipients of Information

  • Massive Bio staff and agents performing Services permitted by this form
  • Vendors and sub-contractors (e.g., laboratories, genomic testing facilities, contract research organizations, pharmaceutical or diagnostic companies, and real-world-data partners)
  • Clinical-trial sites and investigators involved in screening or coordination activities

Disclaimer and Limitations of Services

Massive Bio is not a health-care provider and does not practice medicine. Its reports are for educational and informational purposes only. All treatment decisions are made solely by your treating physician. Massive Bio is not liable for clinical outcomes resulting from these decisions.

Trial Enrollment Disclaimer: Clinical-trial participation is determined only by the trial sponsor or investigator. Massive Bio supports eligibility matching and navigation but does not control enrollment or guarantee acceptance.

Proprietary and Confidential Analytics: Massive Bio’s analytics and reports use proprietary algorithms and expert input. Specific data sources and contributors are confidential and not publicly disclosed.

Retention and Use of Information

Massive Bio may retain and use anonymized and aggregated information after Services to support research, real-world-evidence analytics, and product improvement. Anonymized data is not subject to PIPEDA. This authorization remains valid for ten (10) years from the date of signature unless revoked earlier. Data will be stored within Canada where required by law.

Disclosure of Sponsor Support

In some cases, a clinical-trial sponsor (for example, a pharmaceutical company) may provide financial support to Massive Bio to cover concierge, navigation, or last-mile coordination services for you and/or your treating physician once a decision to pursue participation in an eligible trial has been made. This support is paid directly to Massive Bio and does not affect your rights, the cost of your care, or your eligibility for any trial. Massive Bio remains independent, and your physician retains full clinical decision-making authority.

Patient Rights and Contact Information

You have the right to access, correct, and withdraw your personal information in accordance with PIPEDA. For questions or requests, contact:
Data Compliance Officer: Cagatay M. Culcuoglu
Email: [email protected]
Phone: +1-844-627-7246 Fax: +1-844-742-8837

Patient’s Consent (Signature)

I authorize my health-care provider to disclose my personal health information to Massive Bio and its subcontractors for the purposes described above, including clinical-trial eligibility analysis, diagnostic options, and therapeutic optimization.