Research Approval Process
Gaining NHSBT/ ODT Research ApprovalIntroduction
All research proposals submitted to NHSBT for Organ Donation and Transplant (ODT) directorate support are subject to a formal approval process by RINTAG (Research, Innovation and Novel Technologies Advisory Group.
The approval process is underpinned by the principles of research governance which are outlined in Policy161 Research Governance. The approval process does not provide an ethical or scientific review but takes into consideration impact on the donation process, possible impact on the Specialist Nurses in Organ Donation (SN-ODs) workload, benefit to ODT’s strategic objectives and reputational risk to the organisation.
All projects approved by ODT are recorded in a Research Register and evidence of ethical and local R&D/ Management approval has to be provided by the prospective researcher.
Research Approval is required for all research projects involving ODT activities including:
- NHS staff working for NHSBT
- Patients ( including donors and potential donors)
- The actual or potential organ or tissue donor, and their family, carers or friends
- Blood or blood products
- NHS facilities within ODT
- NHS equipment owned by ODT
Undertaking research with ODT
The Research Manager – ODT, Maria McGee, provides assistance and advice to researchers wanting to undertake research that involves any aspect of ODT's activities or requires support from ODT. Operational advice and support is provided by Maggie Stevens, Specialist Nurse for Research, for those projects that impact on organ donation processes and the SNOD role. By working closely with researchers we aim to provide a streamlined service to support the stimulation, development and set-up of clinical research.
Registering your study with ODT
Registration of a study will enable the Research Manager – ODT to coordinate the study's approval and provide a range of advice and support to researchers. Click here for the project registration pack and for further advice about registering your study contact the Research Manager – ODT.
The Research Governance Framework requires that all research must be registered and authorised by the appropriate R&D Department.
Registration with and approval from ODT is required in addition to local R&D approvals when the research involves or requires support from ODT staff or any aspect of ODT’s activities.
All research proposals submitted to ODT for approval will be given a unique study number and entered onto the ODT Research Register.
The NHSBT/ ODT Research Approval Process
How to Proceed with a Proposal
All research proposals/projects must meet the criteria set out in this document must adhere to the Research Governance Framework for Health and Social Care (2005), and where appropriate the Human Tissue Act (2004) and the Human Tissue (Scotland) Act (2006).
The Principal Investigator (or an authorised delegate, who may be a co-investigator or Research Nurse), should complete and return FRM4624 application form along with any other required documentation to the Research Manager - ODT.
In order to minimise delaying the start of a project, submission for approval by ODT may be undertaken alongside other external approval processes (HRA , local R&D HTA licence etc…).
RINTAG may give provisional approval pending the outcomes of other approvals or may refer onto other NHSBT groups for further input if deemed appropriate.
RINTAG may, when appropriate, seek reimbursement of costs for supporting research. This should be included in any funding or grant applications. Advice on potential financial implications should be sought from the Research Manager – ODT. All transport must be organised by the researcher in advance of the study commencing. All costs for the transport will be absorbed by the researcher. All transport must meet HTA regulations.
On receipt of all appropriate documentation the Research Manager - ODT will notify the appropriate Directors at ODT of the research proposal for their initial approval to proceed the application:
- Research studies involving the use of organs or tissues, medical equipment will be directed to the Associate Medical Director (AMD) or Deputy.
- Research studies involving the donor, donor families, carers or friends, ODT employees or ODT facilities will be directed to the Assistant Director (AD) or Deputy.
- Overview of the project: whether the aims are consistent with the strategic aims of ODT and NHSBT
- Implications for staff, patients, families and carers
- Operational and logistic issues
- Compliance with current legislation and Quality Assurance policies
- Training issues
- Competing projects
- Informing and/or consultation with other clinicians involved in the donation/transplantation process
- Previous delivery
Documentation Required - Always:
- CV of CI
- Application Form with contact details
- A copy of the research proposal or protocol
- Confirmation of the project Sponsor, if this is not NHSBT.
- Research Ethics Committee approval (or evidence that it is being sought)or a letter confirming REC approval is not required
- Local R&D approval, if this is not through NHSBT.
- The protocol should also include:
- A Standard Operating Procedure describing the surgical procedure involved in removing the organ or tissue if this is not covered by existing SOPs.
- Names and qualifications of those of personnel who will retrieve the organ or tissue or name of the appropriate NORS team.
- Confirmation of Human Tissue Authority Post Mortem Removal Licence and ability to adhere to local governance requirements as agreed with the local Designated Individual.
- Process for appropriate storage and disposal of human organ, tissue or samples.
- Process of training SN-ODs where appropriate
- The number of organs required
Proposals/ projects are reviewed and approved by RINTAG on a bi-monthly basis.
Confirmation in writing of the outcome of the approval process should be sent to the researcher within 1 week of the RINTAG decision. If approval has not been given this letter should include an explanation of why the project was unsuccessful to enable re-submission if appropriate.
All proposals/ projects successfully approved or not will be entered onto the ODT Research Register for record and to aid the monitoring and audit of projects.
The PI should submit regular progress reports to RINTAG and a final report once the study is completed
Supporting research proposals may incur costs to ODT which may have to be recovered.
Where appropriate NHSBT may seek reimbursement of these costs.
These costs will need to be factored into any research funding or grant applications and advice on these costs should be sought from the Research Manager – ODT.
Financial arrangements need to be agreed in advance of a project submission to ODT for approval.
Responsibilities for those Involved in Facilitating Retrieval of Tissue or Organs for Research Purposes
This covers the responsibilities of three groups of personnel who may be asked to facilitate retrieval of tissue or organs:
The researchers are responsible for:
Prior to the Research Commencing
- Developing a clear protocol for the retrieval of the tissue/organs. This should include:
- The purpose of the research
- The inclusion and exclusion criteria for the donation
- What specific samples/material is required
- A start date and finish date and/or number of samples required.
- A single phone number for the SNOD to alert the research team that an appropriately consented sample is available
- The packaging instructions although it is the retrieval personnel’s responsibility to pack organs/tissues for research
- The transport arrangements
- The researcher should inform NHSBT when the required number of samples has been obtained
- Ensuring that the SN-ODs have been provided with an adequate understanding of the research protocol.
- The researcher, supported and directed by the Research Manager – ODT, should work with the SN-OD teams supporting the research to supply information and training necessary for the SN-ODs to obtain valid consent.
- Ensuring that the research has all the appropriate consents and approval (including Research Ethics Committee and Trust/Hospital approval).
- Ensuring there are trained personnel who can lawfully retrieve the tissue/organs.
- Ensuring that the legal requirements are fulfilled for handling, storing and disposing of donated material.
- Ensuring, when appropriate that the costs incurred by NHSBT will be refunded.
- Provide periodic feedback/updates on the research and at completion of the study to NHSBT and the SN-OD teams involved.
- Ensuring that the removal of organs/tissues under the local removal licence complies with the local governance arrangements as agreed with the local Designated Individual.
- England, Wales and Northern Ireland - Ensuring the removal of organs or tissues for research is carried out in a premises licensed by the Human Tissue Authority for this purpose if taken from deceased donors and that local governance arrangements are followed ensuring this activity is recorded and reported to the local Designated Individual (DI) responsible for this licence. Note: for Scotland there are no licensing requirements for the removal of material for research.
- Ensuring that any samples are collected in a timely manner from an agreed location, by an approved courier and delivered to an appropriate location to ensure traceability of the donated material.
- Ensuring the tissue/organs are packaged and transported appropriately as clearly outlined in the research proposal/guidance documentation provided to the SN-OD team(s) involved.
The SN-OD is responsible for:
- Obtaining valid consent/authorisation from the appropriate person under the relevant legislation (Human Tissue Act 2004 or Human Tissue Act (Scotland) 2006. whilst working within the NHSBT procedures for Consent/Authorisation.
- Recording the consent/authorisation as detailed in the NHSBT Consent/Authorisation procedures.
- Informing the researcher that consent/authorisation has been given.
- Ensuring any organ retrieved for transplant purposes and subsequently deemed unsuitable, has been offered to the appropriate transplant centres before being considered for research
The retrieval personnel are responsible for ensuring that:
- Any removal of organs/tissue for research does not interfere with the retrieval for transplantation.
- Appropriate consent/authorisation has been obtained.
- The retrieval takes place in licensed premises (not required in Scotland) and in accordance with all current regulations.
- Agreeing with the researcher (if not the researcher or deputy undertaking the retrieval) an appropriate time and location for the collection of the samples.
- The retrieved material is transferred to the custodianship of the research team.
- Recording the retrieval of organs/tissue for research according to current legislation and local governance arrangements.
Confirmation of responsibilities
Before the project starts, the Principle Investigator will be required to confirm in writing that they understand their responsibilities and ensure compliance with all regulations. Next section: Potential Donor Audit