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How do I get my study started?

There are a number of authorisations required before a research study can start. This section of the website will provide a step by step guide to the necessary approvals required. If your study is a Clinical Trial of an Investigational Medicinal Product (CTIMP), you will need to follow the process outlined in Planning a Clinical Trial


The Research Governance Process

research governance process

 


Identify a Sponsor

All health related research that is covered by the Research Governance Framework for Health and Social Care must have a formal Sponsor. In the first instance establish whether an external partner (e.g. funding body, NHS Trust, external organisation) is willing to take on the role of Sponsor. In the majority of cases the Sponsor will be the Chief/Principal Investigator’s employer or the lead health or social care organisation.

Formal confirmation that Cardiff University will act as Sponsor can only be given by Research, Innovation & Enterprise Services on the University’s behalf.  Please see our Applying for Sponsorship page for more information on the procedure for obtaining Sponsorship.


Set up Master File

Set up a Study Master File which will hold all key documentation (study protocol, participant information sheet, participant consent form, grant application form).


Develop Protocol

A comprehensive study protocol will be required by all review bodies including R&D offices and the Research Ethics Committee.


Develop Study Documentation

  • Ensure that the Patient Information Leaflet and Consent Form are in the correct format.  Guidance on preparing the Patient Information Leaflet and Consent Form is available from the NRES Website.
  • Design data collection tools (for example questionnaires, interview schedules)
  • Write any study specific Standard Operating Procedures if applicable
  • Ensure study responsibilities are clear.

Cost Study

If you are applying for an external grant, you must cost your study using the University's CAP form. Please contact the Pre-Awards Team in RACD for further information.


Contracts

Formal written agreements are usually required at the initiation of a working relationship. They formalise the University's relationship with funders, industry and other academic and research institutions. We can assist you in agreeing appropriate terms and negotiate on your behalf. Contact the Contracts Team for more information.


Approvals

All research involving NHS resources will require approval from the NHS Host organisation and an NHS Research Ethics Committee (REC). The relevant approvals can be obtained via the Integrated Research Application System (IRAS).

IRAS

The Integrated Research Application System (IRAS) is an online system used to apply for R&D approval, NHS Research Ethics Committee (REC) review and a number of additional bodies which may be relevant for some types of project. IRAS allows you to complete multiple application forms (e.g. R&D and ethics forms) simultaneously, without duplication.

IRAS can be accessed via: www.myresearchproject.org.uk. If you don’t have an account you can create one by clicking the ‘Create Account’ link at the top of the page.

When starting to register a new project, you will be presented with a list of filter questions to complete. IRAS will then generate the integrated dataset of all questions needed for your application. You should work through all of the questions in the integrated dataset, and then select each separate application form as you need it to apply to different review bodies.

Further detailed guidance on using IRAS for obtaining approvals is available from the IRAS website

You can use IRAS to obtain approvals from the following review bodies:

  • NHS / HSC R&D Offices
  • NRES / NHS / HSC Research Ethics Committees
  • Medicines and Healthcare products Regulatory Agency (MHRA)
  • Social Care Research Ethics Committee
  • Administration of Radioactive Substances Advisory Committee (ARSAC)
  • Gene Therapy Advisory Committee (GTAC)
  • Ministry of Justice
  • National Information Governance Board (NIGB)

Ethics Approval

All research taking place within a healthcare setting must be reviewed independently to ensure that it meets ethical standards to protect participants and the organisations where the study will be conducted. The National Research Ethics Service (NRES) works to maintain a UK-wide system of ethical review that protects the safety, dignity and well being of research participants, whilst facilitating and promoting ethical research within the NHS. Detailed information on the types of study that require ethical approval are available on the NRES Website.

How do I apply for ethical approval?

1. Complete REC form in IRAS

All applications to Research Ethics Committees (RECs) in the UK are made using the NHS REC form in the Integrated Research Application System (IRAS). All applications must be accompanied by the research protocol and relevant documents as per the applicant’s checklist (which must also be submitted). Detailed guidance on using the IRAS system is available on the IRAS website

2. Book the application for ethical review

Once your application is ready for submission you should telephone either:

  • The local REC
  • The Local Allocation System
  • The Central Allocation System

To check where you should telephone to book your application please visit the NRES Website. It is advisable to select a meeting date which allows someone from the research team, who knows about the study in detail, to attend the ethical review meeting.

Once the booking is complete you will be given the name of a REC, a REC reference number and a submission date.

3. Submit your application

You should submit your application to the REC within 4 working days of making your booking.

For more information regarding NHS ethical approval please visit the NRES Website.


R&D Approval 

Any study undertaken within the NHS must have R&D approval from the NHS organisation(s) hosting the research. Research studies that involve NHS facilities, NHS patients, their tissue, data or samples require R&D approval from the NHS.

R&D Approval: NHS

All applications for R&D approval from NHS organisations are made using the NHS/HSC R&D form in the Integrated Research Application System (IRAS). You must submit an R&D application pack anywhere you need NHS R&D approval. Application packs should consist of:

  • the study-wide R&D form generated by IRAS
  • the Site-Specific Information Form (one form for each research site)
  • supporting documentation as specified in the R&D submission checklist in IRAS

Contact details for NHS R&D Offices can be found on the NHS R&D Forum website.

Detailed guidance on completing the IRAS form is available from the IRAS website

R&D Approval: Cardiff and Vale UHB

Advice on applying for R&D approval form Cardiff and Vale UHB is available on our Cardiff and Vale UHB Approval page

R&D Approval : Primary Care

In Wales, a central Primary Care R&D Coordinating Office has been established operating a system known as SPARC (Streamlined NHS Permissions Approach to Research – Cymru). All R&D applications relating to primary care should be sent to the co-ordinating office. For further information see the All Wales Primary Care Research Management & Governance Office website.

In England, the National Institute for Health Research (NIHR) Coordinated System for gaining NHS Permission (CSP) is a new system designed to support the application and approvals process for NHS R&D approval for NIHR Clinical Research Network Portfolio studies. For more information see the NIHR website

In all other circumstances applications should be made directly to the participating R&D Office. Contact details for NHS R&D Offices can be found on the NHS R&D Forum website.


Site-Specific Assessment for NHS Sites/ non-NHS Sites

NHS Site-Specific Assessment

Site Specific Assessment (SSA) is a review of the suitability of the Principal Investigator (PI), the research site and the facilities of a research project.  From 1 April 2009, SSA at NHS sites became the responsibility of the relevant NHS R&D Office(s).  SSA should be undertaken for certain types of study and it forms part of the governance review prior to giving approval for a project to commence. The information required for SSA is incorporated within the Site specific Information (SSI) for NHS sites via the Integrated Research Approval System (IRAS).

The favourable opinion from the main (NHS) Research Ethics Committee (REC) is provided on the condition that permission is given by the NHS R&D Office.  The main REC does not conduct a review of site-specific issues.

PIs must submit the SSI form to their local NHS R&D office in accordance with the normal R&D process.

Non-NHS Site-Specific Assessment

When a research study does not involve NHS sites and requires an SSA, the responsibility for undertaking SSA at non-NHS sites still lies with the NHS REC.

SSA by an NHS REC is always required as part of the ethical review where the application relates to:

  • A clinical trial of an investigational medicinal product
  • A clinical investigation of a medical device
  • Research involving adults unable to consent for themselves.

To obtain SSA approval from NHS REC, PIs are required to complete a non-NHS SSI form.

Cardiff University procedure for obtaining signatory for non-NHS SSI form

1. Signing of form

All Cardiff University - Sponsored research projects that require an SSA should approach the Research and Commercial Division (RACD) to sign off the SSI form. RACD will sign the form on behalf of Cardiff University confirming the following four points:

  • the PI and all members of the research team have contracts with the Site Management Organisation (Cardiff University) to conduct this research;
  • all insurance and indemnity arrangements described in the SSI form will be in place before the study starts at the site;
  • the employer’s procedures for compliance with the Ionising Radiation (Medical Exposures) Regulations 2000 will be followed during the conduct of the study;
  • the arrangements described above for management and monitoring of the research will be implemented.

2. Submission of form

SSI forms should be submitted to the Research Governance Team

3. Review and endorsement of form

RACD will undertake a review of the SSI form.  If the information provided is correct RACD will sign/ endorse and return the form to the PI.  If there are any discrepancies relating to the form, RACD will notify the PI accordingly. RACD will endeavour to review and sign the SSI form in an appropriate time period.