RINTAG


Research, Innovation and Novel Technologies Advisory Group (RINTAG)

NHSBT is keen to work with its stakeholders to support innovation and research and, when appropriate, help coordinate implementation of those developments and technologies that will lead to improved rates of organ donation or improved organ function and better outcomes for patients in need of solid organ transplants.

The Research, Innovation and Novel Technologies Advisory Group (RINTAG) has developed from the Novel Technologies in Organ Transplantation Working Party, with the aims of providing NHSBT and other stakeholders with an overview of current innovations 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, in line with the UK Strategy 'Taking Organ Transplantation to 2020'.

Aims of the Group:

1. Horizon Scanning: review and advise NHSBT, Commissioners and other stakeholders of current and future technologies involving organ donation, retrieval and transplantation that may impact on service delivery

2. Current research, innovation and service development: provide an oversight of current innovations, research and service developments affecting the donation and transplant pathway in order to coordinate the smooth implementation of approved studies, reduce duplication and avoid potential conflicts.

3. NHSBT supported projects: RINTAG will review progress reports from such projects.

4. Proposed research, innovation and service development: review new applications and advise ODT SMT on their governance and implementation if appropriate: RINTAG is not constituted to give advice on research ethics.

5. Coordinate research proposals and access to organs and relevant tissues for research purposes

6. RINTAG will review the current NHSBT policies for access to tissue and organs for research and monitor implementation of policies and review cost recovery policies.

7. Develop the business cases for the novel technologies and innovations that are determined as beneficial for increasing the number and quality of the donor organs based on the best clinical evidence.

8. Advise ODT SMT on Research Strategy

1. Terms of Reference

1.1. The roles of the Advisory Group include:

1.1.1. Research Strategy Group: RINTAG will take on the remit of NHSBT's Research Strategy Group in Organ Donation and Transplantation (The generic terms of reference for these groups are shown in the Appendix).

1.1.2. Horizon Scanning: review and advise NHSBT and other stakeholders of current and future technologies involving organ donation, retrieval and transplantation that may impact on service delivery.

1.1.3. Current research, innovation and service development: provide an oversight of current innovations, research and service developments affecting the donation and transplant pathway in order to coordinate the smooth implementation of approved studies, reduce duplication and avoid potential conflicts.

1.1.4. NHSBT supported projects: RINTAG will work with others to ensure timely initiation and implementation of NHSBT projects, review progress reports from such projects, and advise NHSBT’s Research and Development Committee, Advisory Group Chairs Committee or the Senior Management Team of the Organ Donation and Transplantation Directorate (ODT SMT) as appropriate.

1.1.5. Support implementation of proposed research, innovation and service development: RINTAG's executive group will review protocols of proposed research, innovation and service developments to ensure that, prior to commencement, the appropriate approvals and other governance arrangements are in place, that the protocols are clear and comprehensive and that all relevant interested parties have been consulted and given approval and the integrity of the donation and transplantation process is not jeopardized. It should be noted that NHSBT is not constituted to give advice on research ethics and that permission to approve significant changes, such as uterus or face transplants, will be given by the ODT SMT of NHSBT with advice from RINTAG.

1.1.6. Facilitate research proposals and access to organs and tissue for research purposes:

1.1.6.1. NHSBT is keen to facilitate the retrieval of organs and tissue for research. Requests for organs and tissues are received from many sources including UK clinicians and scientists in hospitals and universities as well as pharmaceutical and other companies. NHSBT is also committed to support the QUOD project.

1.1.6.2. RINTAG will review the current NHSBT policies for access to organs and tissue for research (including cost recovery where appropriate) and make recommendations where appropriate to ensure that NHSBT can provide an effective and efficient service that meets the demands of researchers in a fair, transparent, efficient and equitable manner and fulfill the wishes of the donors.

1.1.6.3. RINTAG will monitor implementation of these policies.

1.1.7. Help NHSBT and relevant stakeholders develop the business cases for the novel technologies and innovations that are determined as beneficial for increasing the number and quality of the donor organs based on the best clinical evidence.

1.1.8. Funding: RINTAG will work to identify funding opportunities to support research, innovation and service development.

1.1.9. RINTAG will also provide advice and support to the Department of Statistics and Clinical Studies as requested, with respect to access for data and statistical support.

1.1.10. For the Organ Donation and Transplantation Directorate, RINTAG will assume the role of NHSBTs Research Strategy Group and make recommendations to the ODT Senior Management Team. This includes the terms of reference;

1.1.10.1. To be the forum in which representatives of research, development, operations and marketing/customer relations for a specific business area of NHSBT meet, in order to ensure that:

a. Operational requirements which can be solved by either research or product development are considered for inclusion in the rolling R&D programme.

b. Operational support for R&D projects is considered at the planning stage, costed into research proposals, and reviewed as the project progresses.

c. Operational teams are fully aware of ongoing research and are therefore able to plan for translation of the research through clinical evaluations into routine products and services.

d. Operational facilitation of studies requiring specific research consent and HTA license requirements is adequately managed. For such studies, RINTAG will assume the capacity and capability assessment as part of its approval. In addition to RINTAG approval, such studies will also require sign-off by the NHSBT R&D Office.

1.1.10.2. To consider changes to clinical care, scientific developments, the political landscape, and actions of competitors that impact on NHSBT’s product or service provision.

RINTAG work plan

Short term work plan:

1. Review the principles and policies of allocation of organs for research and ensure that NHSBT can provide an effective and efficient service that meets the demands of the scientists in a fair, transparent, efficient and equitable manner and fulfils the wishes of the donors.

2. Establishing a registry of supported projects (protocol, duration of study, number of organs required, organ traceability mechanisms etc) and a priority system when demand outstrips supply.

3. Work towards developing an electronic offering system to streamline access to organs in a fair manner.

4. Provide support and governance for the NRP/EVLP service evaluation and DCD heart transplant service evaluation

Intermediate term work plan:

1. Explore options to increase consent for research

2. Increase the recovery of organs for research (if not suitable for transplantation) and ensure adequate consent, organ traceability and transport and potential for cost recovery for NHSBT.

3. NHSBT-BTS novel technology and research update day.

4. Develop a policy for utilization of organs beyond current transplant criteria for service development

Gabriel Oniscu, RINTAG Chair, 02.09.15

Reporting Structures

1.2. RINTAG will report formally to ODT SMT

1.3. For items related to the Research Strategy Group, RINTAG will maintain links with the NHSBT R&D Committee.

Next section: Transplant Policy Review Committee

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