Apply for research approval

In the first instance, please take a look at the NHSBT ODT Research Process Handbook - INF1393 (PDF 700KB)

It is provided to guide researchers who wish to:

• Obtain access to organ donors and/or organs, tissues and cells from donors for research purposes
• Set up qualitative studies with members of the wider Organ and Tissue Donation and Transplantation (OTDT) team such as Specialist Nurses or National Organ Retrieval Service (NORS) team members
• Set up service evaluations appraising the OTDT process
• Test and/or implement novel therapies/technologies (such as novel transplants)

Executive summary

• Researchers are encouraged to engage early with the Research Team, by emailing ODTResearch@nhsbt.nhs.uk
• The Research Team will provide advice on governance and the operational considerations of a study.
• The Research Governance Co-ordinator facilitates applications to the Research Operational Feasibility Group (ROFG), for their review.
• ROFG will score and rank studies requiring access to organs via the National Allocation Scheme, according to a prioritisation matrix.
• The approval timeframe varies between different types of study. We are committed to keeping timescales to a minimum. In some cases, final approval will be required from the OTDT Senior Management Team (SMT).
• Before a study can commence, the study’s Chief Investigator and Sponsor will be required to sign an agreement with NHSBT, which outlines their responsibilities.
• Researchers with active studies are expected to complete progress reports. These are used for improvement and monitoring purposes, and to re-rank studies that receive organs through the National Allocation Scheme.
• If a research study’s circumstances change (e.g. the number of organs/tissues required, planned duration or intended use), the researcher should complete a resubmission form which will be submitted to ROFG for their approval.

Handbook and appendices

Associated links are included within the useful links list.

• NHSBT ODT Research Process Handbook - INF1393 (PDF 700KB)
• NHSBT ODT Research Application Form - FRM4624 (Word 77KB)
• ODT Research Application Re -Submission Form  - FRM5893
• Allocation of Research Organs for use in Research and Other or Scheduled Purposes - POL263 (PDF 370KB)

The Research Operational Feasibility Group (ROFG) is the new name for the Research, Innovation and Novel Technologies Advisory Group (RINTAG). RINTAG was developed from the Novel Technologies in Organ Transplantation (NTOT) Working Party.

In line with the UK Strategy Taking Organ Transplantation to 2020, the group aims to provide NHSBT and other stakeholders with:

• an overview of current innovation and supporting the implementation of appropriately approved and funded research
• innovations and service development
• horizon scanning and working with commissioners and others to ensure the introduction of novel approaches to improve the outcomes of patients undergoing solid organ transplantation

Find out more about ROFG

Research proposals are regularly reviewed by ROFG. Upcoming submission deadlines and processes are detailed below.

Step one: External submission deadlines* 2024

• 2nd February
• August, date to be confirmed

Step two: ODT Research team carry out final review of study paperwork and gain operational support for proposals if required

• approximately two weeks 

Step three: Protocol and application form made available to ROFG

• 16th February
• August/September, date to be confirmed

Step four: ROFG read and review proposals

• approximately two weeks

Step five: Responses collated and decision made

• 1st March
• September, date to be confirmed

*It is expected that by this deadline researchers have already submitted an application form, draft IRAS form and their protocol to the ODT Research team and had these reviewed/approved in principle.

The Quality in Organ Donation (QUOD) initiative is a nationwide programme in the UK, funded by NHS Blood and Transplant (NHSBT) which aims to better assess quality and identify pathways of injury and repair in donor organs for transplantation.

The QUOD initiative is led by Prof Rutger J Ploeg, Professor of Transplant Biology and Consultant Transplant Surgeon and his team.

It is part of a national consortium of experts from intensive care and transplant units across the UK.

QUOD aims to reduce uncertainty over which organ is viable or not and facilitates transplant-related research by collecting blood, urine and tissue samples of appropriately consented / authorised organ donors.

These samples are then accessible by researchers across the UK and worldwide to gain better insights of the mechanisms of injury and repair to donated organs.

Through this type of translational research, it may be possible to identify biomarkers which can be used to better predict the outcomes of transplantation.

Applications for access to samples and associated data is open, visit the QUOD website for more information.