AMSBIO’s Ethical and Legal Standards in Human Biospecimen Collection

AMSBIO’s biospecimen collection process is grounded in a comprehensive informed consent procedure, ensuring donors are well-informed and their rights are respected. Before undergoing treatment or participating in a study, a potential donor will be given a consent form. This will vary based on the study on the researchers, but the consent form will cover essential information, including: 

• Purpose and Scope of Use: Donors are briefed on how their surplus surgical tissues or biofluids will contribute to research efforts. The form will outline the potential use of their samples in diagnostics, biomarker development, genomic analysis, drug discovery, and therapeutic development. Their samples cannot be used outside of the agreed scope. 

• Privacy and Data Security: AMSBIO employs a strict coding system to protect donor confidentiality. Personal identifiers are excluded from shared data, with samples assigned a unique code at the collection site and a secondary code before sharing with researchers. Only the original clinical site holds the key to re-link identities, ensuring donor anonymity and GDPR compliance in Europe.  

• Transparency on Data Processing: Donors are informed about what data is collected, how it is handled, and who may have access. The consent form also clarifies the nature of sample storage, potential future uses, and the possibility of samples being shared with non-profit or commercial entities, all under ethically approved protocols. 

In the case of deceased donors, the next of kin will be asked to sign a form with the same provisions of cover.  

This structured consent process not only complies with regulations like the U.S. Common Rule and EU’s GDPR but also reinforces AMSBIO’s commitment to ethical and responsible research practices. 

In all sample collections, there will be oversight by an Institutional Review Board (IRB). This is an independent organisation that reviews and continually reviews the collection process and research proposals, at both the clinical sites and by the vendor to ensure they are ethically sound and follow the relevant laws and rules. An IRB will consist of members with different backgrounds and expertise in scientific, medical, ethical, legal, and social aspects of human tissue collection and research. 

An IRB is responsible for approving, modifying, or rejecting human tissue research proposals based on ethical factors like scientific value, donor risk-benefit balance, informed consent, privacy, and cultural respect. 

 It also oversees research protocols by ensuring consent, reviewing plan changes, conducting audits, addressing issues, and stopping unethical practices. 

For labs with strict regulatory standards, AMSBIO’s data management practices support compliance with data protection laws, including Europe’s GDPR and the U.S.’s HIPAA.  

Our procedures include: 

• Double Coding for Anonymity: Each biospecimen is assigned a unique code at the study site, with an additional code applied before the sample is shared. This dual-code system minimizes the chance of re-identification. 

• Data Control: Direct identifiers like names, addresses, or medical record numbers are excluded from shared data, and only the original clinical sites retain the “key” to reconnect codes to donors. This maintains anonymity and privacy, enabling the use of biospecimens in sensitive research without compromising donor confidentiality. 

In addition, AMSBIO has a GDPR officer, and can always be contacted at [email protected] for any questions.  

AMSBIO ensures that all samples meet local and international compliance requirements. This commitment to regulatory excellence supports labs in fulfilling their own quality and compliance objectives. 

• EU and UK: AMSBIO’s practices are aligned with GDPR requirements and UK Human Tissue Authority (HTA) regulations, guaranteeing that biospecimens are managed according to stringent European standards. 

• United States: Compliance with FDA and Common Rule guidelines means AMSBIO samples are collected in ways that meet U.S. ethical standards, with informed consent and Institutional Review Board (IRB) oversight when applicable. 

• Canada: Our practices adhere to the Tri-Council Policy Statement, which guides biospecimen research in Canada, respecting privacy, informed consent, and ethical standards for human tissue research. 

AMSBIO can also provide a written, signed ethical statement to confirm that all human biospecimens provided are legally procured under the laws and regulations of the country of acquisition and in accordance with privacy laws.  

With certifications like ISO 9001:2015, AMSBIO partners only with suppliers who meet high standards of quality and reproducibility. These measures allow lab managers and quality officers to maintain consistency in sample integrity, enhancing the reliability of research results: 

• Standardized Sample Handling: Ensures that samples are collected, stored, and transported according to globally accepted standards. 

• Sample Traceability: Every step of the process, from collection to delivery, is documented, ensuring traceability and accountability—a key component of compliance in regulated labs. 

AMSBIO’s biospecimen collection methods offer a solution that aligns with global standards and high-quality research. Through stringent consent processes, robust data protections, and adherence to international regulations, AMSBIO is committed to advancing research responsibly. 

 If you have additional question, please contact our Business Unit Manager for Biorepository, Dr Phillip Pridham-Field directly ([email protected]) for more information.