Ethical Statement


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 and thereby making a difference in medical and translational research. Central BioHub strives to offer high-quality human biospecimen 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, an 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 committees (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, 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 anonymised or highly pseudonymised, so that the possibility of inference from specimen data to an identifiable donor is being minimised.

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 the 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 operations, all of which comply with DIN EN ISO 9001, are fully traceable for a long period of time. 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.

Buyers of human biospecimens are required to demonstrate their qualification for acquiring and handling the raw materials. The validation is carried out via a qualification form which needs to be completed by the client and checked by the legal department of Central BioHub. The form can be downloaded on the cumstomer dashboard after logging in to centralbiohub.com.
Depending on specimen origin and collection purpose, the following documents are required: • Informed consent of the donor
• Approval document of the IRB/IEC
• Compliance with the legislation at the place of origin and place of draw.
• Commitment to and compliance with the Declaration of Helsinki and the Declaration of Taipei
• Extensive supplier assessment to verify the ethical integrity of the specimen sourcing.
• Full compliance with the German law and applicable international law.
• Compliance with General Data Protection Regulation (GDPR) and German Federal Data Protection Act (Bundesdatenschutzgesetz).
• Anonymisation of donor-related information that would allow identification of individuals.
• The legal department is your point of contact for ethical and legal questions. Our experts are glad to help you with if any uncertainties occur and provide additional documents. Reach out to us via email (info@centralbiohub.com) or LiveChat on our website.