Study stages and process
Application and study process
Any researcher wishing to access tissue can apply by completing the application form. If you are unsure whether samples would be available or require specific information, you may wish to make an informal enquiry first. Once you have completed and submitted the application form, this will be reviewed by the BRAIN UK team. If further information is required, we will contact you. Once this initial check is completed, your application is then sent to the BRAIN UK Committee for review. Once the review process is complete, we will provide a decision and/or feedback. Study approval can be as quick as 2-3 weeks.
Once approved, we will identify suitable tissue for your study and contact the Participating Centre(s). Once agreement has been reached, you will be put in contact directly to arrange the tissue transfers and invoicing.
As part of your agreement with BRAIN UK, you are required to complete an annual review whilst your study is active.
Once the project is finished, you are required to inform BRAIN UK and complete a closing report. Samples supplied for your study are then managed as per your tissue agreement with the Participating Centre(s) and they are informed of the study closure.
Study stages
Enquiry (optional)
If you are unsure whether samples would be available or require specific information to help you shape your study you may wish to make an informal enquiry first. We can search the BRAIN UK databases to gauge if enough information is available for you to decide whether to submit an application. Where there is not enough information available or your request is very specific, your enquiry may be forwarded to one (or more) Participating Centres for further support. Once the information is received, it is given to you with a copy of the application form.
Application
When we receive your application, we check it to ensure that all sections have been completed and that an appropriate level of detail has been given before submitting it for initial review. We also check that the lay summary is fit for purpose, i.e. not too technical or too much jargon etc. and may suggest some appropriate amendments. Read “How to write a good lay summary” under Document Library for guidance.
Applications are sent to the BRAIN UK Director and Co-Directors for informal review. If further information is required, we will email you before submitting it to the committee for review.
Once this initial check is completed we send your application to the BRAIN UK Committee for review. This process usually lasts a week; if we know that there will be a significant delay beyond this, we will inform you. Once the review is complete, we will email you to let you know the outcome or ask for further information if requested by the Committee.
After approval
We email the identified Participating Centre(s) asking if they are able to support the approved study. Please note, each centre has the right to refuse access to its archives irrespective of BRAIN UK approval if, for example, the samples have been allocated.
Once agreement has been reached with the Participating Centre, you will be put in contact with centres directly to arrange for material transfers and invoicing. It is the responsibility of each centre and researcher to ensure that arrangements are in place to ensure the storage, use and disposal of the samples in accordance with the Human Tissue Authority Codes of Practice, the terms of the ethical approval and any other conditions required by the centre supplying relevant material. In addition, it is your sole responsibility to ensure that local R&D approvals have also been attained prior to undertaking any work. Please note that costs incurred due to the retrieval, processing and transportation of tissue will be met by the researcher.
Amendment request (optional)
If at any point you need to change the study, please feel free to contact us to discuss this as you may be able to submit an amendment request for the original study. To do this, please email brainuk@soton.ac.uk, attaching an amended application highlighting the changes you would like to make to the study and a covering explanation describing what you would like to do, whether you require additional samples, or if the methodology has changed. Once we have received this, it will be reviewed by the BRAIN UK Director/Co-directors. If the request is within the scope of the original application and is accepted, an amendment approval letter will be issued. This process usually takes less than a week but is dependent on the type of request.
During the project
Sample information
Once you have received your tissues, we require the name of the supplying centre and the laboratory numbers. This is to facilitate sample tracking and to improve opportunities for collaboration amongst researchers using similar samples.
Cost of sample retrieval
We would like to know the costs incurred for the samples (please include all costs such as any admin charges, preparation, transportation etc.). We are surveying information about the cost of samples (including processing, transporting etc.) to help support future researchers’ grant applications.
Research outputs
Please make sure that you let us know of any research outputs for the project. It is important that you keep us informed of all research outputs as the impact of BRAIN UK is, in part, measured by research outputs for projects we have supported and as such has an effect on future funding of BRAIN UK. You can email your research outputs to brainuk@soton.ac.uk at any time and we will include these in your annual report for you.
Annual review
As part of your agreement with BRAIN UK, you are required to complete an annual review. You will be emailed when your annual review is due, the first will be due once your project has been approved for approximately 12 months. The report should be returned within two weeks of receiving the email. It is a condition of our ethical approval that these are supplied when due. If any of the above requested information was supplied before the review was due we will complete these sections for you. An example annual report form can be found under Document Library.
Project completion
Please let us know once your project is completed, as you are then required to complete a closing report. This is very similar to the details required for your annual report. We will send you a letter confirming the agreement you made with BRAIN UK and any future responsibilities, the withdrawal of your ethical approval with BRAIN UK and as well as your obligation to appropriately manage the samples after the project is closed (such as returning tissue or ensuring suitable storage). An example closing report can be found under Document Library.
For tumour based studies: Once your project has finished, you may want to consider the Brain Tumour Research Novel Therapeutics Accelerator (BTR-NTA) programme.