Ethical Statement

Central BioHub is dedicated to fostering research and development in life sciences. The goal is to advance medicine and to enable superior, novel diagnostic systems thereby making a difference in medical and translational research. Central BioHub strives to offer high-quality human biospecimens from a huge variety of human properties and conditions for basic and preclinical research and development by scientific institutions and companies in the field of life sciences. At the same time, it is deeply rooted in Central BioHub's origins to maintain all standards of ethical compliance and to go even further.

Requirements for biospecimen buyers:

CBH aims to bring biospecimen buyers and suppliers together at a virtual marketplace to enable supply relations between qualified specialists in the life sciences field. The buyers are therefore required to demonstrate their qualification to handle human biological samples before they can purchase on the platform. The form is available for download in the personal customer’s dashboard and can be uploaded for validation. Every single customer is checked by the compliance department according to our quality standards.

Requirements for biospecimen suppliers:

Biospecimen suppliers undergo a defined and comprehensive audit that includes legal and ethical aspects of providing human raw materials. These essential requirements comprise the fundamental principles of biomedical research, namely:

• For all products obtained from specimen collections for scientific research, informed consent from the Donors is available. The submission of the informed consent form is regularly checked by the Central BioHub compliance department.
• Products offered on centralbiohub.com that originate from dedicated specimen collections for scientific research have been collected and approved by an institutional review board (IRB) / independent ethics committee (IEC) or comparable ethics committee.
• Full compliance with all applicable legislation at the place of origin of the supplied biospecimens and the place of business of the supplier.
• Compliance with the Declaration of Helsinki and the Declaration of Taipei of the World Medical Association (in the version in force at the time of collection of the biospecimens), the Oviedo-Convention of the Council of Europe, the Universal Declaration on Bioethics and Human Rights and the International Declaration on Human Genetic Data of UNESCO, and the International Ethical Guidelines for Biomedical Research Involving Human Subjects of the Council for International Organizations of Medical Sciences (CIOMS).
• Full transparency on limitations and restrictions applicable to the supplied biospecimens.
• Observation of applicable guidelines and standards of practice for handling and storage of biospecimens or clinical research samples, including best practice rules for pre-analytics, cold chain, hygienic standards, classification, and diagnosis of the biospecimens.
• Clinical remnant samples do not require informed consent from the subject regulating the further use of the specimens (see 45 CFR 46, §46.104 Exempt research, exemption d, 4 LINK). Sample-related data is available anonymized or highly pseudonymized so that the possibility of inference from specimen data to an identifiable donor is minimized.

Furthermore, we require the suppliers to communicate the specifications and quality levels of each biospecimen offered on our platform and declare whether any restrictions on the use of the biospecimens apply. Where opinions from ethics committees or institutional review boards (IRB) were necessary for collecting or handling the biospecimens, Central BioHub can provide you with all the necessary information.

Requirements for our services:

We take particular care to conduct our transactions with biospecimens in full compliance with German law, in particular, the personality rights of the sample donors as guaranteed under national and international laws, such as the rights of subjects in  clinical research . We observe any property rights of the sample donors protected by the German Civil Code. Our internal processes are designed to conform to the EU General Data Protection Regulation and the German Federal Data Protection Act
(Bundesdatenschutzgesetz). With respect to donors, the biospecimens only come in an anonymized form with information such as medical diagnoses, sex, and age at collection. Our work processes, which comply with DIN EN ISO 9001, are traceable over the period corresponding to the standard. Both physical and digital documents are stored in locations with the highest security regulations.

Our services have been checked by independent legal experts in the field of life sciences and healthcare law. We periodically ask external legal advisers for an updated legal opinion on our services to reflect the changing legal landscape and keep our processes and services compliant with applicable law. We maintain a constant quality improvement system; therefore, we are open to your feedback and recommendations.

Our Commitment to Ethical Practices: Modern Slavery Act Policy

Our Ethical Stance

At Central BioHub GmbH, we are dedicated to upholding the highest standards of ethics and legality in every aspect of our business. This includes a zero-tolerance approach to modern slavery and human trafficking within our operations and our broader network. Our Modern Slavery Act Policy is a testament to our commitment to human rights and ethical business conduct.

Purpose of Our Policy

The essence of our policy is to set forth clear guidelines that prevent any form of modern slavery or human trafficking in our business endeavors and our supply chain. It is a reflection of our unwavering commitment to conducting our business ethically and with full integrity.

Who This Policy Applies To

This policy is universally applicable across our organization, including every employee, director, customer, supplier, contractor, external consultant, third-party representative, and business partner associated with Central BioHub GmbH.

Key Policy Directives

1. Legal Compliance: Adhering to the Modern Slavery Act and related legislation is foundational to our operations.
2. Risk Management: We proactively identify and manage risks associated with modern slavery through regular assessments.
3. Supply Chain Due Diligence: Our supply chains undergo thorough evaluations to ensure compliance with human rights standards, focusing specifically on eradicating modern slavery.
4. Supplier Standards: We demand high standards of ethical conduct from our suppliers in regard to their workers' rights, safety, and freedom.
5. Education and Empowerment: We are committed to educating our team, especially those in supply chain management, about the risks of modern slavery and ways to combat it.
6. Reporting Mechanism: We encourage the reporting of any unethical behavior or policy violations, ensuring thorough investigation and action on reported issues.
7. Immediate Action and Support: We are committed to taking swift action to address any instances of modern slavery in our operations or supply chain, including providing support for victims.
8. Transparency: Our commitment to ethical practices and combating modern slavery is transparent and public, with our policy accessible on our website.

Governance and Policy Management

• The policy is under the purview of our board of directors, ensuring it meets our ethical obligations and legal requirements.
• Our management teams are instrumental in enforcing this policy among their teams.
• The Compliance Team oversees the policy's efficacy and provides guidance on its enforcement.

Review and Updates

Our Modern Slavery Act Policy is subject to regular reviews to keep our commitment to ethical business practices and human rights protection robust and relevant.

Through the establishment of this policy, Central BioHub GmbH showcases its dedication to ethical business operations and the safeguarding of human rights across all its activities and supply chains.