Frequently Asked Questions (Scientific Access)

You can apply to perform almost any scientific research, as long as it is not:

• Research which requires a clinical intervention or data not normally collected by the NHS
• Human Application (putting samples or subcellular derivatives into humans)
• Therapeutic cloning and derivation of stem cells for use in treatment (making new cells for putting into humans)
• Reproductive research, including reproductive cloning and abortion research (use of sperm/ova in a manner which require a licence from the Human Fertilisation and Embryology Authority, or for which there is significant opposition)
• Research that is not related to healthcare such as the testing of cosmetics/other consumer products, or market research

Unfortunately, this is not possible using the HBRC protocol, because it is a "generic" and intended to capture clinical waste/surplus for discovery and translational science. The protocol forbids the creation of samples/derivatives for therapeutic use, and it forbids clinical interventions.

As a generic protocol, it is also required to be run under a Human Tissue Authority “research” licence, so anything requiring “human application” (i.e. placement into humans) would be illegal.

You should first discuss feasibility with the appropriate service coordinators in order to establish whether HBRC can meet your needs from a logistical perspective.

If feasible, you should apply using the appropriate application form, which should be emailed to the addresses shown in the forms themselves.

Assuming that you have already discussed feasibility with the appropriate service coordinators, the HBRC works to a “clock” of 2 months from application to decision. In practice, it aims for 3-4 weeks – about the same amount of time as an HRA REC.

If you have a substantive/honorary contract with the University of Birmingham (UoB), you will need to sign an internal Terms of Approval agreement; otherwise, the organisation which employs you (and any non-UoB organisations with which you wish to collaborate) will need to sign an MTA.

There will be one agreement per organisation per application – “super-agreements” do not sit well with the terms of HBRC's own REC approval or the HTA licence governing it.

You will be issued with all the necessary approval documents as part of the application, amendment, extension, and approval processes. Should you mislay these, you can contact the HBRC for copies.

A selection of HBRC's own approval documents is available from this website.

No. Generally-speaking, the HTA licence requires the HBRC to enter into a special type of agreement with NHS Trusts and other hospitals before it can receive identifiable data/collect samples.

In order to release samples/data, the HBRC protocol must also have been approved to do so by the HBRC's REC.

When it comes to private hospitals, the rules are the same. Patients who are receiving a diagnosis/treatment, simply as a service provided by the NHS to the private hospital, are regarded as patients of the private hospital, not the NHS. Only if their treatment is also as an NHS patient might their samples/data be accessible – for example, when concurrent treatment or treatment is being provided by the NHS because it is not available privately.

The HTA licence requires the HBRC to enter into an agreement with any study or organisation supplying samples/data to HBRC before transfer begins.

The operation of the protocol requires that an application declare its desire to collaborate with other studies or organisations, and that approval be given before agreements are signed.

Convention is that the provider initiates the agreement. When the HBRC protocol is involved, such agreements must be sent to the HBRC for checking and upload to Worktribe, since there are specific requirements that must be included (such as material coming to HBRC before release to the researcher).

Any researcher who circumvents HBRC during such transfers will be deemed to have refused to comply with the conditions of HBRC ethical approval, and the approval will be deemed null and void for the samples/data concerned.

The HTA licence requires the HBRC to enter into an agreement with any study or organisation receiving samples/data from the HBRC before transfer begins.

The operation of the protocol requires that an application declare its desire to collaborate with other studies or organisations, and that approval be given before agreements are signed.

The HBRC has template agreements, and the HBRC will issue an appropriate template as part of the approval process. It is important that HBRC checks and upload any returned agreements to Worktribe, since there are specific requirements that must be included (such as no onward transfer without HBRC approval).

Any researcher who circumvents HBRC during such transfers will be deemed to have refused to comply with the conditions of HBRC ethical approval, and the approval will be deemed null and void for the samples/data concerned.

No. HBRC agreements are templated and tailored towards HBRC's needs. They are written to meet HBRC's legal and ethical needs, whilst complementing other collaborative agreements that you may already have in place, or wish to put in place.

The University contracts team will need a significant amount of time to merge HBRC conditions into other agreements, so it is often far quicker simply to ensure that other agreements permit the addition of specific sub-agreements like the HBRC's.

No. The REC's approval of HBRC does not require that site-specific approval be given by NHS R&D units. This is because the HTA licence requires the HBRC to enter into a special type of agreement with NHS Trusts before it can receive identifiable data and collect samples.

The HBRC will ensure that relevant NHS Trusts are kept informed of approved projects and collected samples via monthly updates and copies of its annual report to the REC.

No. If you are both a clinician and a researcher, you must only "wear one hat” at any one moment – you are either the clinician legally permitted to process your patient's identity, or you are the researcher who has no legal or ethical permission to process the donor's identity.

The first stop in any sample or data-item's journey from the clinical context into the research context must be HBRC. Once that stop has been made, you must not attempt to reverse the direction of information flow yourself.

HBRC will always be able to identify patients from its regular hospital sources, and researchers will never be given identifiable data – this is a promise made to donors during the consent process.

NB – the demarcation of data context like this is a well-established point of data law and ethical approval of generic biobanks.

Yes. For the HBRC's approvals, please see Human Biomaterials Resource Centre Approvals - University of Birmingham. For the adult patient consent model, please see Information sheets for potential donors - University of Birmingham.”