Ethics Policy

Ethics Policy 2024

Introduction

Our Ethics Policy is designed with the intent to provide clarity, transparency, and assurance, incorporating international standards and reflecting the most respected benchmarks in the sector.

Donor Consent and Privacy

1.1. Informed Consent: Consistent with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) principles, we ensure every donor receives extensive and transparent information, spanning the intent behind every collection, methodologies employed, potential benefits to medical science, and any associated risks. Participation is wholly voluntary and informed.

1.2. Confidentiality and Data Protection: Safeguarding donor privacy is paramount. Embracing provisions of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, the GDPR, and the UK's Data Protection Act 2018, we've instituted stringent measures to preserve donor data's confidentiality and security.

1.3. Withdrawal of Consent: We uphold each donor's autonomy, facilitating a seamless process for consent retraction. Donors can request cessation of their sample's use and its subsequent destruction at any juncture.

Biosample Collection and Storage

2.1. Ethical Collection: Abiding by Good Clinical Practice (GCP) standards, we ensure ethical and compassionate treatment of donors. Samples are procured under Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved protocols, consistent with local regulations, ICH guidelines, HIPAA mandates, guidelines of the World Health Organization (WHO) and International Society for Biological and Environmental Repositories (ISBER). 

2.2. Direct Shipping: To maximize sample integrity, we employ direct shipping, dispatching biosamples from the clinical site straight to the recipient's laboratory.

Biosample Distribution and Usage

3.1. Responsible Distribution: With GCP principles guiding us, we meticulously assess each biosample request, ensuring they cater to genuine, ethically grounded research endeavours.

3.2. Usage Monitoring: We sustain oversight systems to affirm that biosamples realize their ethical and scientific potential.

Transparency & Communication

4.1. Open Lines: Open dialogue is intrinsic to our operations. We actively foster clear communication with all stakeholders.

4.2. Continuous Improvement: Embracing the dynamic nature of medical research, feedback is actively weaved into our procedures in alignment with ICH's quality management tenets.

Social Responsibility & Sustainability

5.1. Community Involvement: Beyond operations, we champion the importance and ethical intricacies of clinical research, nurturing an informed, supportive community.

5.2. Environmental Stewardship: Environmental well-being is also in our purview. We relentlessly strive to minimize our environmental footprint and promote sustainability.

Compliance

6.1. Compliance is not just a legal formality for us but a moral compass. While we align our practices with local, national, and international standards such as ICH, WHO, ISBER guidelines, GCP principles, and HIPAA provisions, these standards are rigorously applied and maintained throughout our clinical partner network. Our collective commitment to these standards underscores our dedication to excellence.