Ethical compliance for Biospecimen procurement

Patient consent

To uphold the principles of transparency and autonomy, empowering individuals to make informed decisions about their participation in research studies, all samples collected and used by Labtoo are obtained exclusively from sources that have collected either explicit informed consent or explicit non-opposition

• The informed consent process is carried out diligently, ensuring that participants are fully informed about the purpose of the research, the scope of data collection, and any potential risks involved.

• The non-opposition process is carried out only in cases allowed by French law, typically usage of remnant samples, and must be registered in the medical file of the patient.

Review Board Approval

Prior to engaging in any research project involving human biological samples, Labtoo ensures that the study has undergone rigorous evaluation and approval.

• In France, all human biological sample collections must be validated by the Ministry of Research. All human biological samples transferred from the clinical site to a third party must be validated by the Ministry of Research. All exportations of human biological samples must be validated by the Ministry of Research. The documentation and/or the registration number of the authorizations are always provided by Labtoo to the end user.

• Outside of France, typically, all human biological sample collections must be validated by an Internal Review Board (IRB). The IRB is responsible for evaluating the scientific merit of the research, its compliance with local ethical guidelines, and the protection of participants' rights and well-being.

No Financial Compensation

In accordance with French law, Labtoo abides by the prohibition of providing financial compensation to patients or individuals in exchange for providing samples. Our commitment to non-financial compensation reinforces the ethical handling of human biological samples and mitigates any potential conflicts of interest.

Transparency and traceability

Under French law, any patient who has given consent for the use of their collected samples is permitted to request the cessation of their usage at any given time. To comply with the law, Labtoo ensures:

• Transparency: The end-user is given the full visibility of the clinical site

• Traceability: The end-user is informed about the possibility that the patient may request a cessation of usage of the biological sample.

Anonymization and Pseudonymization

In accordance with French law, all our clinical sites have put in place measures to ensure either full anonymization or, at least when full anonymization is not possible, a pseudonymization of the data transmitted either to Labtoo or directly to the end-user.

Data protection

In accordance with the General Data Protection Regulation (GDPR), and because of the intrinsic data component of the human biological samples and associated clinical data, we have integrated GDPR-compliant processes and tools, and require our clinical sites to achieve compliance as well. Data transfers are done securely.

Contracting

All human biological sample transfers done under the supervision of Labtoo must be done within the scope of a Material Transfer Agreement (MTA) or equivalent. The MTA must include the different aspects described in this document.

Additional requirements from our customers

At Labtoo, we understand that our policies are not universal and that additional requirements from our customers need to be complied with. Since the very initial phases of our service, during the redaction of the specifications of the request (scope of work), our customers can express specific requirements. Labtoo’s team will review the request for ethical and legal compliance and, if it is the case, integrate it into the identification of a solution.