Human Rights and Dignity Framework for Cell & Gene Therapy Research and Clinical Trials

Pficell, as a leader in cell & gene therapy R&D, is committed to ensuring the highest standards of human rights and dignity throughout all research and clinical trial activities.

Ethical Principles

• Respect for Persons: Autonomy, privacy, and dignity of all individuals must be protected.
• Beneficence and Non-Maleficence: Maximizing benefits and minimizing risks to participants.
• Justice: Ensuring fairness in selection and treatment of research participants.
• Accountability and Transparency: Full transparency in all aspects of research and clinical trials.

Informed Consent Process

The informed consent process must be clear, voluntary, and continuous:

• Clear Communication: Information must be understandable and accessible to all participants.
• Voluntary Participation: Participants must have the right to withdraw at any time.
• Comprehensive Information: All risks, benefits, and procedures must be explained.
• Ongoing Consent: Continuous consent is maintained throughout the trial.

Privacy, Confidentiality, and Data Protection

We adhere to strict privacy and confidentiality standards:

• Data Security: Protecting all participant data from unauthorized access.
• Anonymity and Pseudonymity: Ensuring privacy through data anonymization.
• Informed Data Usage: Participants are informed about how their data will be used.

Inclusivity and Non-Discrimination

We strive for inclusivity and fairness in all research practices:

• Diverse Participation: Ensuring equal representation across all demographics.
• Equitable Access: No individual or group should be excluded unfairly from participation.
• Protection of Vulnerable Populations: Extra care is given to children, the elderly, and individuals with disabilities.

Ethical Oversight and Review

Independent ethical oversight is essential:

• Institutional Review Boards (IRBs): All studies must be reviewed and approved by an IRB.
• Continuous Monitoring: Ongoing review to ensure ethical compliance.
• Compliance with International Standards: Adherence to the Declaration of Helsinki, GCP, and other guidelines.

Participant Safety and Welfare

Ensuring the safety and well-being of participants:

• Risk Assessment: Evaluating and mitigating risks to participants.
• Emergency Medical Protocols: Immediate medical assistance in case of adverse effects.
• Ongoing Health Monitoring: Continuous health checks during and after trials.

Accountability and Transparency

We commit to being accountable and transparent:

• Public Disclosure of Results: All results, including negative findings, are published.
• Ethical Reporting: Any violations or adverse events are reported immediately.
• Complaint Mechanisms: Accessible systems for participants to report concerns.

Training and Capacity Building

Ongoing training ensures ethical standards are maintained:

• Ethics Education: Regular training for staff on human rights and research ethics.
• Ethical Leadership: Fostering a culture of integrity and respect for human rights.

Community Engagement and Social Responsibility

We engage with the communities impacted by our research:

• Community Consultation: Engaging local and global communities to align research with societal needs.
• Public Engagement: Promoting transparency and understanding of our research.
• Global Health Equity: Ensuring that our research benefits all populations fairly.

Reporting and Addressing Ethical Violations

Clear procedures are in place to address ethical violations:

• Whistleblower Protections: Confidential channels for reporting unethical conduct.
• Investigation and Corrective Action: Addressing violations promptly and thoroughly.