Ethics in Collection
Our commitment to ethical biospecimen procurement is foundational to everything we do. Every sample we provide is collected with the highest standards of donor welfare, informed consent, and regulatory compliance.
Ethical Sourcing Is Not Optional — It Is Foundational
At Specibio, we believe that the integrity of biological research begins with how specimens are obtained. Our procurement practices are guided by internationally recognised ethical frameworks and enforced through rigorous internal governance. We do not simply meet the minimum requirements — we set a higher standard.
Informed Donor Consent
Every human biospecimen in our catalogue is collected with the full, freely given, and documented informed consent of the donor. Donors are provided with a clear explanation of how their samples will be used, their right to withdraw without consequence, and the privacy measures protecting their identity. Consent is obtained by trained clinical staff at licensed collection facilities, in compliance with applicable local law and ICH-GCP requirements.
International Ethical Frameworks
Our collection practices align with the foundational documents of biomedical research ethics:
- Nuremberg Code (1947)— foundational principles of voluntary consent in research
- Declaration of Helsinki (2013)— WMA principles for medical research involving human subjects
- The Belmont Report— respect for persons, beneficence, and justice in research
- CIOMS International Ethical Guidelines— for health-related research with human participants
- Nuffield Council on Bioethics— guidance on ethics of human biological collections
- Good Clinical Practice (ICH-GCP E6)— internationally accepted standard for all clinical collection activities
Institutional Review Board (IRB) Oversight
All human biospecimen collections are conducted under IRB-approved protocols, in compliance with the U.S. Code of Federal Regulations (45 CFR Part 46), FDA 21 CFR requirements, and equivalent regulatory standards in all operating jurisdictions. Protocols are reviewed and renewed on schedule. All amendments are submitted for IRB approval before implementation. End users may request IRB protocol numbers and relevant ethical approval documentation.
International Ethical Frameworks
Our collection practices align with the foundational documents of biomedical research ethics:
- Nuremberg Code (1947)— foundational principles of voluntary consent in research
- Declaration of Helsinki (2013)— WMA principles for medical research involving human subjects
- The Belmont Report— respect for persons, beneficence, and justice in research
- CIOMS International Ethical Guidelines— for health-related research with human participants
- Nuffield Council on Bioethics— guidance on ethics of human biological collections
- Good Clinical Practice (ICH-GCP E6)— internationally accepted standard for all clinical collection activities
Donor Privacy & Confidentiality
Donor identity is never disclosed to end users. All specimens are de-identified and tracked solely by barcode. Clinical metadata is provided in anonymised, non-traceable format in compliance with HIPAA and international data protection frameworks including GDPR. To maintain donor confidentiality and prevent sampling bias, no personally identifiable information is ever included in product documentation.
Animal Welfare — The 3Rs Principle
All animal-derived specimens are obtained in strict accordance with the 3Rs framework, endorsed by the NC3Rs and regulatory authorities worldwide:
Replace — We prioritise in-vitro and other non-animal alternative methodologies wherever scientifically valid, actively reducing dependence on animal models
Reduce — Collection procedures are optimised to obtain maximum scientific value from the minimum number of animals, using statistical design to avoid excess
Refine — All collection procedures use the least invasive techniques possible. Animal welfare is continuously monitored by qualified veterinary professionals, with defined endpoints and minimisation of suffering
Traceability & Transparency
We maintain complete documentation of the chain of custody for every specimen from the point of collection to final shipment. Pharmaceutical and diagnostic customers may request proof of ethical collection, IRB protocol numbers, and consent language in redacted form to support regulatory submissions. We believe that transparency in biospecimen provenance is an essential element of research integrity, and that knowing the source of specimens strengthens — rather than undermines — data protection.
Jurisdiction-Specific Standards
United States
FDA-licensed collection facilities • OHRP 45 CFR Part 46 • HIPAA-compliant data handling • FDA 21 CFR Parts 606 and 610 • CLIA-certified laboratory testing
European Union & United Kingdom
EU Human Tissues and Cells Directive (2004/23/EC) • HTA (Human Tissue Act, UK) • GDPR-compliant data handling • Ethics Committee authorisation for all EU collections
International
ISBER Best Practices for Repositories (4th Edition) • ICH-GCP E6(R2) compliance • CITES permits for NHP-derived specimens • WHO standards for biological substances
Animal Collections
USDA Animal Welfare Act compliance • EU Directive 2010/63/EU • UK ASPA (Animals (Scientific Procedures) Act) • NC3Rs 3Rs compliance and ARRIVE guidelines