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The life of a research project in the NHS
Research projects which are carried out within the NHS generally are of two different types.
• The first is where the project is the idea of a member of staff, is developed locally and recruits from the NWTCB (and from other Boards if required). The first step in this project type is generally step number one.
• The second is where the project is developed externally, often includes a number of Boards/Trusts within the UK and recruits participants according to a protocol which has already been developed. The first step in this project type ranges from step four to six.
1. Develop protocol/ research proposal
This is the responsibility of Chief Investigator but can be developed in collaboration with colleagues (internal or external) and/or MSc/ PhD supervisor. All projects must be appropriately peer reviewed. Peer review is the process of subjecting an author's scholarly work (i.e. research proposal), research or ideas to the scrutiny of others who are experts in the same field. The NWTCB Peer Review Standard Operating Procedure has been reviewed and approved by the NWTCB Research and Development Steering Group.
All research projects hosted by this Board must have been appropriately peer reviewed.
Related Document
The NWTCB Peer Review SOP
2. Establish and confirm sponsor
A research project sponsor is defined as the individual, organisation or group taking on responsibility for securing the arrangements to initiate, manage and finance a study. The sponsor and funder can be different organisations, but the sponsor must ensure that the project is adequately funded. Sponsorship will not be confirmed unless the sponsor organisation is satisfied that an appropriate peer review has been carried out.
The NWTCB will sponsor all research except projects within the remit of the European Union (EU) Clinical Trials Directive. For these projects, a partner NHS/ University will be asked to sponsor.
No research project will be approved by this Board unless/until a sponsor has been established.
3. Establish funding
Although a ‘core activity’ of the NHS in Scotland, research is funded separately – clinical funds should not be used to fund research. For this reason, non-commercially sponsored research (e.g. NHS, Universities, and Research Councils etc) should be funded in such a way as to be cost neutral to this organisation. More information on available funding can be found at the following website: rdfunding.org.uk . Commercially sponsored research (e.g. Pfizer, SME’s etc) should be at least cost neutral, and can significantly income generate.
Ensuring that funding will cover costs is part of the project set up process facilitated by the Research and Development Office.
4. Research Ethics application and approval
The National Research Ethics Service (NRES) was launched on 1 April 2007 (replaced COREC). The function of NRES is to protect the rights, safety, dignity and well-being of research participants whilst facilitating and promoting ethical research. NRES does this by providing ethical guidance and management support to Research Ethics Committees, delivering a quality assurance framework for the Research Ethics Service, working with colleagues in the UK to maintain a UK-wide framework and working with colleagues in the wider regulatory environment to streamline the processes.
Further information about NRES can be found at the NRES website , and the Research Ethics application form and associated guidance can be found at the Integrated Research Application Service (IRAS) website .
5. Establish and deal with employment status of researchers.
In order to ensure that all staff involved in research are covered by the NHS indemnity scheme, and because many such staff do not hold an appropriate employment contract with the Boards/ Trusts from which they recruit research participants, a system for managing Honorary Research Contracts – the Research Passport Scheme - has been developed in the UK. The NWTCB has used this guidance to develop a Standard Operating Procedure which is used by the Research and Development Office and Human Resources department.
Research staff tend to fall into the following categories:
• Employment is with NWTCB – this Board pays salary (regardless of funding source) – no issue, indemnity already covered by the Board.
• Option 2: Employment is with another NHS Board – including Honorary Clinical Contracts – HR will review pre-employment checks and issue a Letter of Access.
• Option 3: non – NHS employees will always require an Honorary Research Contract.
Further details can be found in the Board’s Honorary Research Passport Standard Operating Procedure (SOP).
Related Document
The Research Passport Standard Operating Procedure
6. Board Management approval
This is the process of checking that each project has the following in place.
• Sponsor (if already confirmed, peer review is normally assumed).
• Research Ethics (relevant approvals must be in place).
• Documents (protocol, PIS and consent form etc) version numbers must correspond to approved document list in REC approval letter.
• Funding (costs to Board must be at least equivalent to income). This is done with the NWTCB Finance Department.
• Support services.
• Researcher contract status. This is done with the NWTCB HR Department.
• Management approval letter issued
Indemnity may not apply to research projects which start without Management Approval, regardless of the employment status of the researchers.
7. Recruitment of participants and data analysis
Research Governance continues to apply to research projects after they have been approved. As detailed in the Management Approval letter, projects approved by this Board are subject to audit and monitoring. In practice, this means that:
o one tenth of projects hosted by this Board will be audited. This includes (consent forms, the researcher’s project file and possibly Source Data Verification.
o all projects are monitored – annual project monitoring form sent to Chief Investigator.
This process assures the Board and the public that research projects are carried out in accordance with procedures approved by the relevant Research Ethics Committee and that any deviations from the protocol or research ethics application are detected and dealt with. This Board has a Standard Operating Procedure in place to enable it to deal with cases of Fraud and Misconduct in research.
Relevant Document
The NWTCB Research Fraud and Misconduct Standard Operating Procedure
8. Project ends: dissemination
The principle behind this is that the results of all publicly funded research should be made available to the public. This is done in a number of ways:
• Via the UK Clinical Research Network portfolio website – this applies to a subset of research hosted by this Board.
• Via www.nhsgoldenjubilee.co.uk. When developed, this will contain a lay summary for each project and the details of a contract point for further information. It will apply to non-commercially sponsored research only.
• All research publications should be forwarded to the NWTCB R&D Office. Links will be in place to relate research projects to publications.
• The first is where the project is the idea of a member of staff, is developed locally and recruits from the NWTCB (and from other Boards if required). The first step in this project type is generally step number one.
• The second is where the project is developed externally, often includes a number of Boards/Trusts within the UK and recruits participants according to a protocol which has already been developed. The first step in this project type ranges from step four to six.
1. Develop protocol/ research proposal
This is the responsibility of Chief Investigator but can be developed in collaboration with colleagues (internal or external) and/or MSc/ PhD supervisor. All projects must be appropriately peer reviewed. Peer review is the process of subjecting an author's scholarly work (i.e. research proposal), research or ideas to the scrutiny of others who are experts in the same field. The NWTCB Peer Review Standard Operating Procedure has been reviewed and approved by the NWTCB Research and Development Steering Group.
All research projects hosted by this Board must have been appropriately peer reviewed.
Related Document
The NWTCB Peer Review SOP
2. Establish and confirm sponsor
A research project sponsor is defined as the individual, organisation or group taking on responsibility for securing the arrangements to initiate, manage and finance a study. The sponsor and funder can be different organisations, but the sponsor must ensure that the project is adequately funded. Sponsorship will not be confirmed unless the sponsor organisation is satisfied that an appropriate peer review has been carried out.
The NWTCB will sponsor all research except projects within the remit of the European Union (EU) Clinical Trials Directive. For these projects, a partner NHS/ University will be asked to sponsor.
No research project will be approved by this Board unless/until a sponsor has been established.
3. Establish funding
Although a ‘core activity’ of the NHS in Scotland, research is funded separately – clinical funds should not be used to fund research. For this reason, non-commercially sponsored research (e.g. NHS, Universities, and Research Councils etc) should be funded in such a way as to be cost neutral to this organisation. More information on available funding can be found at the following website: rdfunding.org.uk . Commercially sponsored research (e.g. Pfizer, SME’s etc) should be at least cost neutral, and can significantly income generate.
Ensuring that funding will cover costs is part of the project set up process facilitated by the Research and Development Office.
4. Research Ethics application and approval
The National Research Ethics Service (NRES) was launched on 1 April 2007 (replaced COREC). The function of NRES is to protect the rights, safety, dignity and well-being of research participants whilst facilitating and promoting ethical research. NRES does this by providing ethical guidance and management support to Research Ethics Committees, delivering a quality assurance framework for the Research Ethics Service, working with colleagues in the UK to maintain a UK-wide framework and working with colleagues in the wider regulatory environment to streamline the processes.
Further information about NRES can be found at the NRES website , and the Research Ethics application form and associated guidance can be found at the Integrated Research Application Service (IRAS) website .
5. Establish and deal with employment status of researchers.
In order to ensure that all staff involved in research are covered by the NHS indemnity scheme, and because many such staff do not hold an appropriate employment contract with the Boards/ Trusts from which they recruit research participants, a system for managing Honorary Research Contracts – the Research Passport Scheme - has been developed in the UK. The NWTCB has used this guidance to develop a Standard Operating Procedure which is used by the Research and Development Office and Human Resources department.
Research staff tend to fall into the following categories:
• Employment is with NWTCB – this Board pays salary (regardless of funding source) – no issue, indemnity already covered by the Board.
• Option 2: Employment is with another NHS Board – including Honorary Clinical Contracts – HR will review pre-employment checks and issue a Letter of Access.
• Option 3: non – NHS employees will always require an Honorary Research Contract.
Further details can be found in the Board’s Honorary Research Passport Standard Operating Procedure (SOP).
Related Document
The Research Passport Standard Operating Procedure
6. Board Management approval
This is the process of checking that each project has the following in place.
• Sponsor (if already confirmed, peer review is normally assumed).
• Research Ethics (relevant approvals must be in place).
• Documents (protocol, PIS and consent form etc) version numbers must correspond to approved document list in REC approval letter.
• Funding (costs to Board must be at least equivalent to income). This is done with the NWTCB Finance Department.
• Support services.
• Researcher contract status. This is done with the NWTCB HR Department.
• Management approval letter issued
Indemnity may not apply to research projects which start without Management Approval, regardless of the employment status of the researchers.
7. Recruitment of participants and data analysis
Research Governance continues to apply to research projects after they have been approved. As detailed in the Management Approval letter, projects approved by this Board are subject to audit and monitoring. In practice, this means that:
o one tenth of projects hosted by this Board will be audited. This includes (consent forms, the researcher’s project file and possibly Source Data Verification.
o all projects are monitored – annual project monitoring form sent to Chief Investigator.
This process assures the Board and the public that research projects are carried out in accordance with procedures approved by the relevant Research Ethics Committee and that any deviations from the protocol or research ethics application are detected and dealt with. This Board has a Standard Operating Procedure in place to enable it to deal with cases of Fraud and Misconduct in research.
Relevant Document
The NWTCB Research Fraud and Misconduct Standard Operating Procedure
8. Project ends: dissemination
The principle behind this is that the results of all publicly funded research should be made available to the public. This is done in a number of ways:
• Via the UK Clinical Research Network portfolio website – this applies to a subset of research hosted by this Board.
• Via www.nhsgoldenjubilee.co.uk. When developed, this will contain a lay summary for each project and the details of a contract point for further information. It will apply to non-commercially sponsored research only.
• All research publications should be forwarded to the NWTCB R&D Office. Links will be in place to relate research projects to publications.
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