The HBRC Application Process

From an ethical perspective, the HBRC protocol is generic, so it can obtain almost any human tissue waste/surplus or body fluid. However, certain NHS procedures do not yield waste/surplus, or they require steps which are incompatible with the scientific needs, or sometimes, the procedure required by the science simply does not happen in the NHS.

For this reason, we recommend that you discuss your needs with one of our “fresh material” team (about fresh or frozen material) or one of our histology team (about histology/NHS diagnostic archive) before you apply. Discussion will also give you an idea of the possible costs for HBRC services, as well as reinforcing what the HBRC Policy permits.

Once feasibility has been established, you should make an application to the HBRC using the special form.

Signed forms should be emailed to the addressees indicated in the form. Signatures must be a scan of a wet signature, or a tablet-stylus signature, or a formal DocuSign stamp – simply typing your name in the signature box is not sufficient.

The HBRC aims to validate applications within 1-2 weeks of receipt, before submitting them to its Access Review Panel. Validation will be delayed where forms need further clarification.

The HBRC Access Review Panel (ARP) meets via a secure, online, asynchronous platform. This means that your application will usually be reviewed for 2 weeks, with the clock starting on the day of submission by the HBRC.

You will receive a formal email of acceptance and submission for review, along with the anticipated deadline for decision. From this moment onwards, your application will be known by a reference number comprising the two-figure year of receipt and a sequential number .

It is important that you refer to the correct reference number in your communications with the HBRC, even if your funding or single line of research covers multiple applications. From an ethical perspective, mixing application numbers is analogous to mixing distinct clinical trials.

Upon favourable decision by the ARP, you will receive a formal email containing an official letter of your application's approval, a copy of the HBRC's own overarching approval, and an agreement.

HBRC agreements require special conditions not usually present in conventional academic collaborative MTAs, so it may be that you need to use yours in addition to other agreements.

All HBRC agreements are usually specific to a single application. This is because an agreement acts as a legal “wrapper” binding the researcher to the details in the application and to the requirements of the HBRC protocol. (Doing it this way means that agreements do not need to be varied when an amendment or extension is approved.)

The agreement will take the form of an internal Terms of Approval (ToA) [PDF, 220kb], and breach of this agreement will be a matter for disciplinary processes.

The agreement will take the form of a formal Material Transfer Agreement (MTA) [PDF, 285kb]. In the MTA, “Material” should be understood to mean not just human tissue and body fluids, but derivatives of them, and any associated clinical data passed to you.

Researchers who are not in the lead researcher's own research group must have been declared in the application form, or else added by amendment. If external to the University of Birmingham, or external to the lead researcher's organisation, a formal MTA [285kb] will also be needed between the HBRC and the legal entity employing them.

Signed MTAs, or those requiring further negotiation, must be sent directly to the HBRC, never submitted to the University contracts portal (Worktribe) by the researcher.

A “contractor” is a group or service where there is no expectation that Material or IP will be retained or used by the contractor, beyond what is required for the performance of the contracted service. Any deviation from this concept needs to be discussed with the HBRC in advance, and written acceptance from the HBRC will be required – otherwise the “contractor” should be regarded as a “collaborator”.

Contractors should be declared in the original application form, or added later by amendment. HBRC will usually accept that a zero- or positive-value purchase order is sufficient to protect the conditions of ethical approval, as long as there is a line in the purchase order which:

• Either states that residual samples must be disposed of safely through an approved waste stream at the service provider’s cost,
• Or which refers to a signed service level agreement requiring the same.