Governance you can verify
The principles and procedures BioVault is held to, in plain language.
How we operate
These principles apply to every sample, every project and every partner.
Ethics oversight
No collection before approval of our biobank protocol and consent form by a validly registered ethics committee. We check the committee's registration ourselves and keep the approval on file for every site and every version.
Informed consent
Plain-language consent in the participant's language that names IntenCiv BioVault, states what is collected, how long it is kept, who may use it, whether commercial use is allowed, and how to withdraw. Re-consent where a change affects participants.
Privacy and data protection
Coded samples and data, identities held separately with logged access, data minimisation, and compliance with the Digital Personal Data Protection Act, 2023. Patient information is never entered into public AI tools.
Quality and accreditation
Systems built to ISO 20387:2018 and the NABL specific criteria for biobanks, with SOPs, internal audit and management review. We will state accreditation only once granted.
Biosafety
Approved biosafety and biomedical waste procedures before any handling of samples.
Storage and traceability
Cold storage at -80°C and -20°C with backed-up power, a sample tracking system, and continuous temperature monitoring with alarms.
Access and release
Release only to approved projects, through an access committee and material and data transfer agreements, with chain of custody.
Impartiality and confidentiality
Conflict-of-interest declarations, confidentiality agreements for all staff, and equal treatment of every research partner.
One set of controlled documents
Protocols, consent forms, titles, cohorts and prescribed formats change over a project's life. Every change must carry a version number, the ethics committee's approval and an effective date, with a notice period, a transition plan for participants already enrolled, and a shared change log.
Questions about our governance?
We are glad to walk you through it, and to share documents as they are issued.