ResLabQ&C Ltd
Clinical Research Laboratory
Quality and Compliance
Research Biobanks
Over time, research biobanks have grown from simple biological sample repositories to complex and dynamic units. There are now several hundred NHS REC approved Research Tissue Banks in the UK alone, and they have evolved into essential structures for modern clinical research, particularly in the area of personalised medicine.
​
Setting up and maintaining a successful research biobank is not without its challenges. Specimen quality is critical for the accuracy and reliability of the research data produced, and strict ethical standards must be adhered to in order to preserve the human and legal rights of donors. In addition, effective management and governance structures are required to maintain regulatory compliance, to govern access to samples and data, and to ensure financial sustainability.
How can we help?
ResLabQ&C can offer expert consultancy services for all aspects of biobanking whatever the size of your facility, or its stage of development.
Obtaining an HTA research licence
If cellular material is to be stored, then your establishment will require an HTA research licence to remain compliant with the Human Tissue Act 2004.
We can advise on the requirements for licensing, the implications of setting up and maintaining compliance with the licence conditions, as well as assisting with the completion and submission of the application form to the HTA.
Obtaining ethical approval
It is not a legal requirement to have ethical approval to establish a research biobank, but it is certainly good practice to do so. In addition to obtaining approval for the collection and storage of samples it is also possible to request that generic approval is obtained to conduct research using the samples, both within the host institution and elsewhere. This is extremely useful as it removes the need to submit multiple REC applications for similar projects.
​
We can help by crafting the biobank protocol and developing Participant Information Sheets and Consent Forms. We can also oversee the submission and review of your ethics application, right through to approval.
Maintaining quality and compliance
Protecting biospecimens from degradation and deterioration throughout the sample life cycle is an important requirement for a biobank, as is maintaining compliance with the current legislation and regulations. An effective, quality assurance programme that includes a robust Quality Management System, training, and audit programs is vital.
See QMS services
See Training services
See Audit services
Access to samples and data
It is not essential that you make your samples available to other research institutions, but you will be asked to justify this if you are seeking ethical approval for your biobank.
You will be required to develop an access policy. After evaluating how you want to make best use of your bioresource, we can provide a written policy document for you to review.
You will also be required to implement a scientific board to review access requests and project proposals. ResLabQ&C can advise on the organisation of this board and the administrative process of application, including the provision of a fit-for-purpose template application form.
Contracts and agreements
The HTA requires that both the collection and the release of human biomaterials is governed by a contractual agreement between the provider and the recipient.
ResLabQ&C can provide ready-to-review template agreements specifically tailored to biobanking activities.
Like what you see? Get in touch to learn more.