Research Approvals FAQ, version 1.0, June 2014
Research Approvals FAQs
Research Approvals FAQ, version 1.0, June 2014
Contents
Pre-Application
Is my project research?
My project is research, where do I start?
What study documents do I need?
Peer review
What do I need to do for a multicentre study?
Approvals
Which approvals do I need?
How do I make my applications?
What is the NIHR CRN Portfolio?
Applying for NHS Management Permission
What order should I do my approvals in?
Pre-ethics
Concurrent to ethics
When can I start my research?
Acronyms
Pre-Application
Is my project research?
Projects can generally be classified as research, audit, service evaluation or service development. Only research projects require NHS Management Permission prior to commencement. If you are unsure which category your project falls into please look at the guidance on our website:
If you are still unsure then email a copy of your project proposal/protocol to Trust.R& and one of the RM&G Managers will get back to you with an opinion. Please note that it is important to explain why you are doing the project and what you hope the project will achieve.
My project is research, where do I start?
If your project is research then you need to start thinking about research sponsorship and funding before starting the applications for relevant approvals (REC, MHRAetc).
Research Sponsorship – the Research Governance Framework requires all research within the NHS to have an identified sponsor. The sponsor has a specific set of responsibilities including taking overall responsibility for the research project:
Due to these responsibilities, researchers should not assume that an organisation will take on this role without any discussion or risk assessment of the project therefore potential sponsors should be approached as early as possible.
If your intention is for Newcastle Hospitals to act as research sponsor then you must follow the process identified in JRO SOP 11 for studies which are not Clinical Trials of Investigational Medicinal Products (CTIMPs) or JRO SOP 17 for CTIMPs.
Funding – all projects have associated costs whether these are staff time, cost of interventions, consumables or payment of participant travel costs. These costs must be met either through a research grant, directorate funds or educational award. Costs can be classified as:
- Research Costs – the costs of the R&D itself that end when the research ends. They relate to activities that are being undertaken to answer the research questions
- Treatment Costs – the patient care costs, which would continue to be incurred if the patient care service in question continued to be provided after the R&D study had stopped
- Excess Treatment Costs – the difference between the NHS Treatment Costs and the cost of standard treatment
- NHS Support Costs – the additional patient care costs associated with the research, which would end once the R&D study in question had stopped, even if the patient care involved continued to be provided.
Further information can be obtained from the Attributing the cost of health and social care Research & Development (AcoRD) guidance document. If you require help with your costs assistance can be obtained from our R&D Finance Managers.
What study documents do I need?
Protocol – you should begin drafting your protocol as soon as funding is confirmed for your project. The protocol provides the details of your project and describes how the study should be run. Review bodies rely on the protocol to provide them with the relevant information of a research project so it is important that your protocol is as comprehensive as possible.
The sections of your protocol will depend upon the type of project being conducted but as a minimum it should contain:
- Title
- Abstract/summary
- Background or rationale of the project
- Aims / objectives
- Experimental design and methods (including statistical analysis)
- Ethical considerations
- Details of how data will be recorded and what will be classified as source data
- A definition of the end of study
- Publication/dissemination policy of the results
- References
PIS & ICF – except for those studies that are exempt from obtaining participant consent, your research project will require a PIS and ICF. If your study has multiple treatment arms, sub-studies, involves paediatric participants or those without capacity to consent then several PIS and ICF will be required.
Researchers must follow the guidance provided by the HRA when compiling these documents and can use the template provided by the HRA when drafting the ICF.
GP Letter – you should always inform a participant's GP of their patient’s involvement in an interventional study and this is achieved through a GP Letter. A GP Letter should include:
- The title of the study
- The name of the participant/patient
- Details of the intervention under study and potential side effects
- Contact details for the investigator in case of queries from the GP
The research participant must be informed that their GP will be notified of their participation, through the PIS, and have given consent for their GP to be contacted as part of the ICF.
Please note that for certain types of research (e.g. HIV or sexual health) informing the GP may constitute a breach of confidentiality. If the GP is not being contacted, this must be justified in the protocol and ethics application.
There may be other documents required for your study e.g. Participant Letter of Invitation or Participant Diary Card but these documents can be completed once your study protocol is finalised.
Peer review
Once you have developed your protocol it should be reviewed by experts in the relevant field(s) who are independent of the research team, to offer advice on its quality and suitability. If you have obtained external funding then peer review should have been performed as part of the award process.
For those projects which are funded through departmental funds (i.e. “own account”) or as part of a programme grant where the individual project has not been reviewed, then independent peer review will need to be arranged and this must be in place prior to making an application to the NHS REC.
If Newcastle Hospitals is the research sponsor of your project and your study hasn’t already undergone peer review then the R&D Department will arrange one. Peer review takes a minimum of 20 working days so this must be taken account when making a submission.
What do I need to do for a multicentre study?
Due to increasing national focus on recruitment to research studies, it is important that each site undergoes a feasibility assessment prior to confirming their involvement. The most common way of conducting a feasibility assessment is by getting the potential site to complete a feasibility questionnaire. The three main focuses of the questionnaire are: how many potentially eligible patients are seen by the site and what proportion of these could be recruited to the study; what clinical research experience does the site have and; will they be able to conduct the study according to the protocol and GCP. The completed questionnaire is then reviewed by the CI and the sponsor in order to decide whether the site should be involved in the study.
Another item to consider is a site agreement between the research sponsor and the site. This agreement details the division of roles and responsibilities between the two parties and any funding or supplies being provided to the site. The responsibility for arranging and executing research agreements lies with the research sponsor. Researchers cannot perform this task themselves.
Approvals
Which approvals do I need?
Once the above have been completed you are now in a position to consider which research approvals will be required for your project. The type of approvals required will depend upon the type of project you wish to conduct. Please consult our decision tool to determine which approvals you require.
How do I make my applications?
Most research applications are completed through IRAS. By selecting the appropriate responses to the filter questions, IRAS will create the necessary forms for your project.
IRAS has a very good training module to familiarise first time users with the system. The module takes approximately one hour to complete and all researchers new to IRAS are strongly encouraged to go through the training module. Please bear in mind that R&D staff do not use IRAS for purposes other than providing authorisations so find it difficult to help researchers with IRAS-related questions.
What is the NIHR CRN Portfolio?
The NIHR CRN Portfolio consists of high-quality research studies that are listed on the Portfolio database. There are a number of benefits of having a study adopted to the NIHR CRN Portfolio and we strongly encourage all researchers with potentially eligible projects to apply for adoption.
Where your study can be adopted will depend upon whether it meets the established eligibility criteria. The R&D Team can advise you on whether your project would be potentially eligible but cannot confirm if it will definitely be adopted.
Applying for NHS Management Permission
If your project involves patients of the NHS, their tissue or data, NHS staff as research participants or NHS facilities then you will need to obtain NHS Management Permission (also known as R&D Approval) from each of the Trusts involved. It is recommended that you make all of your applications for NHS REC, NHS Management Permission and MHRA Clinical Trial Authorisation (if applicable) in parallel to minimise delays to your study. However, please note that you must have confirmation of funding before you can apply for NHS Management Permission (you can apply for a NHS REC favourable opinion while the decision on funding is still pending).
Each Trust in the country does things a little differently so if you have a multicentre study please contact the relevant R&D Department to discuss their requirements. Within Newcastle Hospitals we require researchers to complete our R&D Checklist and provide all of the necessary documentation:
- NHS R&D Form (from IRAS)
- NHS SSI Form (from IRAS)
- NUTH FT Costing Template (you should contact the relevant Research Team Lead for advice on how to complete this)
- Confirmation of Funding (grant award letter, written confirmation from relevant Clinical Directorate Manager that they are willing to support the study etc.)
- The CV of the PI at the Trust and a copy of their GCP certificate
- A copy of the PIS, ICF and all other participant documentation
- A signed copy of our PI Letter of Responsibilities
Your application will be processed in accordance with our Working Instruction.
What order should I do my approvals in?
This very much boils down to each individual study and depends upon which approvals you need. Each approval has its own timeline and it is preferable to make your applications in parallel where possible. However, as a rough guide:
Pre-ethics
If your study involves ionising radiation (even as part of standard care) then you will need to obtain an IRMER review from a medical physics expert. This review will be needed for your submission to REC and R&D.
Studies exposing participants to radioactive materials will need to obtain an ARSAC certificate for each and every site. There is currently no timeline for ARSAC approval so applications should be made as early as possible, once the IRMER review has been conducted.
For those projects that require the approval of CAG, this should be in place prior to making an application for an NHS REC favourable opinion (the REC will need to see the approval prior to giving their favourable opinion).
If you would like your study to be adopted to the NIHR CRC Portfolio then you can submit your Portfolio Adoption Form as soon as your funding is confirmed. If your study is potentially eligible then you will be invited to submit your NHS R&D form and associated documents for full review. You will need to have all of these items in place and bear in mind that one of the requirements of portfolio adoption is a favourable ethical opinion so you will not receive confirmation of adoption until this is received.
Concurrent to ethics
NHS REC, NHS Management Permission and approvals required from the MHRA can all be submitted in parallel. Each of these approvals are conditional on the other being in place so bear in mind that you cannot start your research until you have ALL approvals in place. Failure to do this is an ethical breach with serious consequences.
Caldicott approval can be applied for once you have made the above submissions however NHS Management Permission will not be granted until it is in place. Therefore you should make your application for Caldicott approval as soon as your application for NHS Management Permission has been submitted.
If you will be conducting research within the NHS but don’t hold an honorary contract or letter of access then you need to start thinking about access as early as possible. You can make a submission for a honorary contract or letter of access once your project is registered with R&D i.e. you have an R&D reference number. Please review our SOP on the Research Passport system for further information.
When can I start my research?
NHS Management Permission is not granted until all other items are in place so you can begin your research once you have this. It is confirmed in the form of a letter, on Trust letter-headed paper, and will be signed by one of the RMG Managers or the Research Governance Manager. NHS Management Permission is not given in any other form.
Acronyms
ARSAC / Administration for Radioactive Substances Advisory CommitteeCAG / Confidentiality Advisory Group
CRN / Clinical Research Network
CSP / Coordinated System for gaining NHS Permissions
GCP / Good Clinical Practice
HRA / Health Research Authority
ICF / Informed Consent Form
IRAS / Integrated Research Applications System
IRMER / Ionising Radiation Medical Exposure Regulations
LCRN / Local Clinical Research Network
NIHR / National Institute for Health Research
PAF / Portfolio Adoption Form
PI / Principal Investigator
PIS / Participant Information Sheet
REC / Research Ethics Committee
R&D / Research & Development
RM&G / Research Management & Governance
SOP / Standard Operating Procedure
SSI / Site Specific Information
Research Approvals FAQ, version 1.0, June 2014