If you are interested in finding out more about how you can get involved in research, you might find the information on this page useful.
Don’t forget we are always available to answer any questions you may have. You can email the team at: cuh.ppi@nhs.net.
Before you begin your research, make sure you have checked the following:
Application Process
Application Process
Getting started
The application forms for submissions to all review bodies can all be completed through the Integrated Research Application System (IRAS). This national on-line system captures all the necessary information for the relevant approvals. It replaced previous forms such as the National Research Ethics Service (NRES) form and Central Office for Research Ethics Committees (COREC) form.
When completed, the forms can be signed electronically and submitted to the applicable review bodies.
Sponsorship and insurance
A sponsor is an individual, organisation or group taking legal responsibility for the arrangements to initiate, manage, monitor and report on a study. The sponsor could be Cambridge University Hospitals (CUH), the University of Cambridge, a charity, another Trust or university, or a commercial organisation. A sponsor may also finance a study; this is often the case with pharmaceutical research. However, a sponsor is not synonymous with a funder.
Cambridge University Hospitals usually sponsors studies alone or jointly with the University of Cambridge, e.g. when the protocol has been designed by a University employee, or when the University manages the funding.
Insurance
When the sponsor is CUH, usually the study will be covered by NHS indemnity schemes. If the sponsor is a university, a charity or commercial organisation, indemnity needs to be provided under their insurance policies.
Note: protocol indemnity lies in general with the employer of the author. If you are a University employee and want to set up a study you need to contact the University Research Operations Office to apply for an insurance letter.
Agreements
When third parties are involved, e.g. other research sites, the sponsor may need to put contracts in place to set out the roles and responsibilities regarding indemnity, intellectual property, finance and confidentiality. When tissue samples are being collected for a study the sponsor may need to set up tissue transfer agreements.
Protocol and peer review
Protocol
All studies need a protocol. This is the full description of the research. The protocol describes the hypothesis, objectives, methodology and statistical analysis. The protocol can also be used as a research manual, e.g. when other sites are involved in the study. It is a mandatory requirement of the submission to the Research Ethics Committee, the R&D department, and other relevant agencies.
Peer review
All research, except non-doctoral student research needs to be externally peer reviewed. The critique report needs to be submitted to the research ethics committee. Scientific review is often provided during the grant application process. When a fellowship grant or departmental funds are being used, the R&D department can arrange independent review of your proposal and provide you with a critique report.
Research projects involving NHS patients, identifiable data or tissue require a favourable opinion from a Research Ethics Committee (REC) before they can proceed. Studies involving anonymous data or tissue, or research involving NHS staff or NHS facilities may not always need ethical review. Please contact the R&D department when in doubt.
RECs safeguard the rights, safety, dignity and well-being of people participating in research in the NHS. There are about 80 NHS RECs in the UK, including 66 in England. REC members are volunteers.
There are currently five RECs in the East of England, three of which meet in Cambridgeshire. You can ask for your study to be reviewed by a local committee, but certain types of studies may need to be reviewed by a specific REC.
RECs are required to give an ethical opinion within 60 calendar days of receipt of a valid application.
Please see the links below for REC contact details and meeting dates.
HRA Approval is the only route for approval of research within the NHS
The Health Research Authority (HRA) Approval brings together the assessment of governance and legal compliance for the NHS in England, with independent research ethics REC opinion provided through the UK Health Department’s Research Ethics Service.
HRA Approval applies only to the NHS in England. Any studies led from Northern Ireland, Scotland or Wales should apply using the existing systems in each nation.
If English sites are involved, the national R&D coordinating function of the lead nation will share information with the HRA Assessment team, who can issue HRA Approval for English sites and thereby retain existing compatibility arrangements.
HRA Approval does not apply to Research Tissue Banks, Research Databases and studies taking place only in non-NHS sites.
Please see the HRA website for more details on:
Planning & improving research (including training resources)
Approvals & amendments
Governance arrangements for Research Ethics Committees.
NHS research sites in England are asked to note that applicants from the devolved administrations may not be familiar with HRA Approval arrangements for site set-up and may still transfer SSI (Site Specific Information) Forms to sites.
The R&D department can assist you or you can contact the HRA directly.
Additional Approvals
Additional Approvals
Additional internal approvals are required for projects involving ionising radiation, devices, drugs, or human tissue.
Approval from the Medicines and Healthcare Regulatory Agency (MHRA) is required for studies that are investigating the efficacy or safety of medicines, research involving medical devices that are not CE (Conformité Européene) marked, or when devices are used outside their intended purpose.
In this section you will find the following information:
Projects involving medicines
Projects involving medical devices
What is a medical device?
Projects involving ionising radiation
Projects involving medicines
Projects involving radiology including guidance notes on Ionising Radiation
Projects involving patient data
Projects involving medicines
Does your study involve a medicine? You may need to submit it to the MHRA. It is best to consult the Cambridge Clinical Trials Unit if you are designing a study that involves a drug.
Projects involving medical devices
Research involving devices that are not CE marked or devices that are used outside their intended purpose require review by the MHRA when commercialisation is intended. All studies involving medical devices need review by the Clinical Engineering Department. The Research Governance Coordinators can assist with this.
What is a medical device?
DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 September 2007, which amended the COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices, defines a ‘medical device’ as:
any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
diagnosis, prevention, monitoring, treatment or alleviation of disease,
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
investigation, replacement or modification of the anatomy or of a physiological process,
control of conception
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
Projects involving ionising radiation
Research involving radioactive materials (for example PET CT or MUGA) or radiation (for example X-rays) require approval by the Radiation Protection team. They can be contacted via cuh.radiation.approvals@nhs.net.
Projects involving radiology
Please contact the Radiology department as soon as possible in the project planning process to discuss any specific requirements and to ensure that the department can accommodate the study. Before R&D approval can be granted, any project involving the department will need authorization from the Clinical Director of Radiology; contact Wendy Phillips,Clinical Trials Administrator, to arrange this:
If your project will involve ionising radiation please read the guidance note below.
Guidance note – Ionising Radiation
All radiation exposures carried out as part of research studies must comply with the Ionising Radiation (Medical Exposures) Regulations 2000 (IRMER). This applies to all studies including those where Cambridge University Hospitals is:
the lead site
a participating site in a multi-centre study
the only site (the study is confined to one site).
Researchers are strongly advised to contact the East Anglian Regional Radiation Protection Service at an early stage in planning their study to discuss local compliance with IRMER and avoid unnecessary delays in obtaining signatures on ethics application forms.
If your project will involve the administration of a radioactive substance then you will need an ARSAC (Administration of Radioactive Substances Advisory Committee) licence. In the first instance please contact the Nuclear Medicine Department who can advise on this:
Dr H K Cheow 01223 586671
Projects involving patient data
All studies involving the use of patient data must be reviewed and approved by the Trust’s Information Governance team. This review is usually arranged by the Research Governance Coordinators.
Costing non-academic studies
Costing non-academic studies
What you need to know
To help prepare costing requirements for non-commercial studies, the R&D department ask for a minimum of seven working days from your original request to process a costing quote, and at least four working days prior to a deadline to allow for an authorised sign-off within R&D.
The team are here to help you to fully prepare your costing requirements in a timely manner, and this will assist in reducing bottle-necks caused by last minute applications. It will also help you as investigators to meet your deadlines.
If you have any particular financial or costing questions relating to your study then please email the Finance team.
Failure to adhere to these timelines may result in your application not being duly authorised by the Trust prior to submission.
If you have any further queries please contact the R&D team .
If you are planning a clinical trial which involves administering medicinal products to participants, your study may fall under the EU Clinical Trials Directive.
These trials are referred to as Clinical Trials of Investigational Medicinal Products (CTIMPs) and will need to meet more regulatory requirements than other kinds of clinical research projects.
If you are unsure, or want to verify your decision please check the algorithm from the MHRA, see below.
It is advisable to work through this document at an early stage in planning your study.
If you believe that it is a CTIMP, your study will need approval from the Medicines and Healthcare Products Regulation Agency (MHRA) in addition to the Research Ethics Committee (REC) opinion and NHS permission.
Detailed guidance from the MHRA can be found at the link below.
Another important aspect to consider is to identify an appropriate source for your medicine that you wish to use in your trial. The medicines under investigation in your trial, the so called “Investigational Medicinal Products” (IMPs), have very specific requirements. Therefore it is important to involve pharmacy early on.
The Department of Health and the Medical Research Council provide a clinical trials toolkit which provides information on all aspects of setting up and running a CTIMP.
First of all you need to establish who will sponsor the trial.
Will Cambridge University Hospitals sponsor my trial?
Clinical trials conducted by local investigators (Trust and University) may be sponsored by CUH or by CUH in partnership with the University of Cambridge. Please contact us as soon as possible so that we can establish sponsorship.
My trial will be sponsored by another organisation, can you help?
For those trials sponsored by other hospitals and academic institutions and where our site is just one of many taking part, please contact the R&D office directly.
For CTIMPs where you wish to have CUH as Sponsor (or CUH and the University as joint Sponsor) the Cambridge Clinical Trials Unit (CCTU) will help you with all the necessary steps for setting up a protocol, establishing necessary resources and funds, obtaining all necessary approvals, coordination and management.
Please contact the CCTU for further specific details.
In general, before patients can be recruited into a clinical trial the Sponsor must be satisfied that proper arrangements for all necessary regulatory requirements are in place:
Protocol (a clinical-trial specific template is available)
Peer review
Ethical approval
Clinical Trials Authorisation from the MHRA
Pharmacy review, supply and control of the IMP (investigational medicinal product)
The pharmaceutical company’s Investigators Brochure for the drug or SmPC (Summary of Product Characteristics)
Radiation protection
Sponsorship and liability cover
Tissue supply issues
Contracts
Safety reporting and monitoring
Honorary contracts
These processes all take time and proper advance planning can save you time, trouble and money in the long run. Please contact therefore the CCTU at the very earliest stages, preferably at the planning stages of a grant proposal.
The application forms for submissions to all review bodies can all be completed through the Integrated Research Application System (IRAS). This national on-line system captures all the necessary information for the relevant approvals. It replaced previous forms such as the National Research Ethics Service (NRES) form and Central Office for Research Ethics Committees (COREC) form.
When completed, the forms can be signed electronically and submitted to the applicable review bodies.
Sponsorship and insurance
A sponsor is an individual, organisation or group taking legal responsibility for the arrangements to initiate, manage, monitor and report on a study. The sponsor could be Cambridge University Hospitals (CUH), the University of Cambridge, a charity, another Trust or university, or a commercial organisation. A sponsor may also finance a study; this is often the case with pharmaceutical research. However, a sponsor is not synonymous with a funder.
Cambridge University Hospitals usually sponsors studies alone or jointly with the University of Cambridge, e.g. when the protocol has been designed by a University employee, or when the University manages the funding.
Insurance
When the sponsor is CUH, usually the study will be covered by NHS indemnity schemes. If the sponsor is a university, a charity or commercial organisation, indemnity needs to be provided under their insurance policies.
Note: protocol indemnity lies in general with the employer of the author. If you are a University employee and want to set up a study you need to contact the University Research Operations Office to apply for an insurance letter.
Agreements
When third parties are involved, e.g. other research sites, the sponsor may need to put contracts in place to set out the roles and responsibilities regarding indemnity, intellectual property, finance and confidentiality. When tissue samples are being collected for a study the sponsor may need to set up tissue transfer agreements.
Protocol and peer review
Protocol
All studies need a protocol. This is the full description of the research. The protocol describes the hypothesis, objectives, methodology and statistical analysis. The protocol can also be used as a research manual, e.g. when other sites are involved in the study. It is a mandatory requirement of the submission to the Research Ethics Committee, the R&D department, and other relevant agencies.
Peer review
All research, except non-doctoral student research needs to be externally peer reviewed. The critique report needs to be submitted to the research ethics committee. Scientific review is often provided during the grant application process. When a fellowship grant or departmental funds are being used, the R&D department can arrange independent review of your proposal and provide you with a critique report.
Research projects involving NHS patients, identifiable data or tissue require a favourable opinion from a Research Ethics Committee (REC) before they can proceed. Studies involving anonymous data or tissue, or research involving NHS staff or NHS facilities may not always need ethical review. Please contact the R&D department when in doubt.
RECs safeguard the rights, safety, dignity and well-being of people participating in research in the NHS. There are about 80 NHS RECs in the UK, including 66 in England. REC members are volunteers.
There are currently five RECs in the East of England, three of which meet in Cambridgeshire. You can ask for your study to be reviewed by a local committee, but certain types of studies may need to be reviewed by a specific REC.
RECs are required to give an ethical opinion within 60 calendar days of receipt of a valid application.
Please see the links below for REC contact details and meeting dates.
HRA Approval is the only route for approval of research within the NHS
The Health Research Authority (HRA) Approval brings together the assessment of governance and legal compliance for the NHS in England, with independent research ethics REC opinion provided through the UK Health Department’s Research Ethics Service.
HRA Approval applies only to the NHS in England. Any studies led from Northern Ireland, Scotland or Wales should apply using the existing systems in each nation.
If English sites are involved, the national R&D coordinating function of the lead nation will share information with the HRA Assessment team, who can issue HRA Approval for English sites and thereby retain existing compatibility arrangements.
HRA Approval does not apply to Research Tissue Banks, Research Databases and studies taking place only in non-NHS sites.
Please see the HRA website for more details on:
Planning & improving research (including training resources)
Approvals & amendments
Governance arrangements for Research Ethics Committees.
NHS research sites in England are asked to note that applicants from the devolved administrations may not be familiar with HRA Approval arrangements for site set-up and may still transfer SSI (Site Specific Information) Forms to sites.
The R&D department can assist you or you can contact the HRA directly.
Additional Approvals
Additional internal approvals are required for projects involving ionising radiation, devices, drugs, or human tissue.
Approval from the Medicines and Healthcare Regulatory Agency (MHRA) is required for studies that are investigating the efficacy or safety of medicines, research involving medical devices that are not CE (Conformité Européene) marked, or when devices are used outside their intended purpose.
In this section you will find the following information:
Projects involving medicines
Projects involving medical devices
What is a medical device?
Projects involving ionising radiation
Projects involving medicines
Projects involving radiology including guidance notes on Ionising Radiation
Projects involving patient data
Projects involving medicines
Does your study involve a medicine? You may need to submit it to the MHRA. It is best to consult the Cambridge Clinical Trials Unit if you are designing a study that involves a drug.
Projects involving medical devices
Research involving devices that are not CE marked or devices that are used outside their intended purpose require review by the MHRA when commercialisation is intended. All studies involving medical devices need review by the Clinical Engineering Department. The Research Governance Coordinators can assist with this.
What is a medical device?
DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 September 2007, which amended the COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices, defines a ‘medical device’ as:
any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
diagnosis, prevention, monitoring, treatment or alleviation of disease,
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
investigation, replacement or modification of the anatomy or of a physiological process,
control of conception
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
Projects involving ionising radiation
Research involving radioactive materials (for example PET CT or MUGA) or radiation (for example X-rays) require approval by the Radiation Protection team. They can be contacted via cuh.radiation.approvals@nhs.net.
Projects involving radiology
Please contact the Radiology department as soon as possible in the project planning process to discuss any specific requirements and to ensure that the department can accommodate the study. Before R&D approval can be granted, any project involving the department will need authorization from the Clinical Director of Radiology; contact Wendy Phillips,Clinical Trials Administrator, to arrange this:
If your project will involve ionising radiation please read the guidance note below.
Guidance note – Ionising Radiation
All radiation exposures carried out as part of research studies must comply with the Ionising Radiation (Medical Exposures) Regulations 2000 (IRMER). This applies to all studies including those where Cambridge University Hospitals is:
the lead site
a participating site in a multi-centre study
the only site (the study is confined to one site).
Researchers are strongly advised to contact the East Anglian Regional Radiation Protection Service at an early stage in planning their study to discuss local compliance with IRMER and avoid unnecessary delays in obtaining signatures on ethics application forms.
If your project will involve the administration of a radioactive substance then you will need an ARSAC (Administration of Radioactive Substances Advisory Committee) licence. In the first instance please contact the Nuclear Medicine Department who can advise on this:
Dr H K Cheow 01223 586671
Projects involving patient data
All studies involving the use of patient data must be reviewed and approved by the Trust’s Information Governance team. This review is usually arranged by the Research Governance Coordinators.
Costing non-academic studies
What you need to know
To help prepare costing requirements for non-commercial studies, the R&D department ask for a minimum of seven working days from your original request to process a costing quote, and at least four working days prior to a deadline to allow for an authorised sign-off within R&D.
The team are here to help you to fully prepare your costing requirements in a timely manner, and this will assist in reducing bottle-necks caused by last minute applications. It will also help you as investigators to meet your deadlines.
If you have any particular financial or costing questions relating to your study then please email the Finance team.
Failure to adhere to these timelines may result in your application not being duly authorised by the Trust prior to submission.
If you have any further queries please contact the R&D team .
If you are planning a clinical trial which involves administering medicinal products to participants, your study may fall under the EU Clinical Trials Directive.
These trials are referred to as Clinical Trials of Investigational Medicinal Products (CTIMPs) and will need to meet more regulatory requirements than other kinds of clinical research projects.
If you are unsure, or want to verify your decision please check the algorithm from the MHRA, see below.
It is advisable to work through this document at an early stage in planning your study.
If you believe that it is a CTIMP, your study will need approval from the Medicines and Healthcare Products Regulation Agency (MHRA) in addition to the Research Ethics Committee (REC) opinion and NHS permission.
Detailed guidance from the MHRA can be found at the link below.
Another important aspect to consider is to identify an appropriate source for your medicine that you wish to use in your trial. The medicines under investigation in your trial, the so called “Investigational Medicinal Products” (IMPs), have very specific requirements. Therefore it is important to involve pharmacy early on.
The Department of Health and the Medical Research Council provide a clinical trials toolkit which provides information on all aspects of setting up and running a CTIMP.
First of all you need to establish who will sponsor the trial.
Will Cambridge University Hospitals sponsor my trial?
Clinical trials conducted by local investigators (Trust and University) may be sponsored by CUH or by CUH in partnership with the University of Cambridge. Please contact us as soon as possible so that we can establish sponsorship.
My trial will be sponsored by another organisation, can you help?
For those trials sponsored by other hospitals and academic institutions and where our site is just one of many taking part, please contact the R&D office directly.
For CTIMPs where you wish to have CUH as Sponsor (or CUH and the University as joint Sponsor) the Cambridge Clinical Trials Unit (CCTU) will help you with all the necessary steps for setting up a protocol, establishing necessary resources and funds, obtaining all necessary approvals, coordination and management.
Please contact the CCTU for further specific details.
In general, before patients can be recruited into a clinical trial the Sponsor must be satisfied that proper arrangements for all necessary regulatory requirements are in place:
Protocol (a clinical-trial specific template is available)
Peer review
Ethical approval
Clinical Trials Authorisation from the MHRA
Pharmacy review, supply and control of the IMP (investigational medicinal product)
The pharmaceutical company’s Investigators Brochure for the drug or SmPC (Summary of Product Characteristics)
Radiation protection
Sponsorship and liability cover
Tissue supply issues
Contracts
Safety reporting and monitoring
Honorary contracts
These processes all take time and proper advance planning can save you time, trouble and money in the long run. Please contact therefore the CCTU at the very earliest stages, preferably at the planning stages of a grant proposal.
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