Research and Development

NHS REC Approval (Ethical Approval) and R&D Approval

I would like to conduct a research study at ULHT, what do I do?

The first step is to define whether your project is research, service evaluation or audit using the following NRES guide:

Defining Research Leaflet (PDF, 143KB)

If you are unsure where to start, please contact Fiona.Smith@ulh.nhs.uk who will be able to advise accordingly. It may be suitable that you meet with the Research Governance Manager for project clarification prior to contacting the query line.

If you feel that your project falls under the category of ‘Service Evaluation’ or ‘Audit’ you must contact the NRES query line (queries@nres.npsa.nhs.uk) outlining your project title and a summary of your research project.

Upon classification from the query line please send a copy of the e-mail to Julia Farmery (Julia.Farmery@ulh.nhs.uk)

I am sure that my study falls under the category of research, who do I contact for further advice?

If your research might lead to new technology or products, please contact the Trusts’ Intellectual Property (IP) lead Dr T. Ahmed
E-mail: Tanweer.ahmed@ulh.nhs.uk
Tel: 01522 573941

Otherwise, contact the following:

Julia Farmery
Research Governance Manager
E-mail: Julia.Farmery@ulh.nhs.uk

Or Fiona Smith
Research Governance Administrator
E-mail Fiona.Smith@ulh.nhs.uk
Tel: 01522 512512 ext 2915

What are the next steps?

NRES Application Process Flow Chart (PDF, 272KB)

The key steps to developing your research study are as follows:

  1. Establish a research team as necessary including patient and public members, where appropriate.
  2. Write a Research Protocol and supporting research documents. For example:
    • Participant Information Sheet
    • Consent Form
    • Invitation Letter
    • GP Letter
    • Interview Schedule
    • Topic Guidelines
    • Questionnaire
    • Advertisement
    • Poster
    • Other

    Advice on creating supporting research documents and standardised templates are available within the following NRES guide:

    Guidance for Researchers & Reviewers – Information Sheets and Consent Forms (PDF, 989KB)

  3. Obtain Peer Review for your Protocol and make amendments as advised (the R&D Department can advise on suitable peer reviewers for your project)
  4. Establish a Sponsor for your project (all research projects require a sponsor under the Research Governance Framework for Health and Social Care Act 2005) and a funder (if required).
  5. Complete online IRAS forms: NHS REC and R&D Form:

    To complete these you must create an IRAS account at www.myresearchproject.org.uk.

    For guidance please see the IRAS e-learning module available on the above site.

    If you require further advice please contact IRAS staff:
    Tel: 0207 099 2015
    E-mail: helpdesk@infonetica.net

  6. Once you have completed your IRAS forms they must be locked (you will be provided a lock code and it will not be possible to change the forms)
  7. Submit your forms to the REC along with the following documents:
    • Completed protocol and supporting research documents with appropriate versions and dates
    • Statement of sponsorship and signed D2 (of NHS REC) including all relevant costs
    • Completed peer review forms
    • CVs from all research team (Principal Investigator/Chief Investigator/Research Nurse/Academic Supervisor)
    • Confirmation of insurance and indemnity cover arrangements—where appropriate
    • If your project involves Investigational Medicinal Products or Radiation please refer to the following MHRA site for further information: http://www.mhra.gov.uk/

What happens after I submit my documentation to the Ethics Committee?

The Ethics Committee have 60 days to review your application. They will register your documents and send you a confirmation letter.

You may be required to book an agenda slot that the next meeting of the REC which you have applied to. Further details are available on the 'how to book' page of the NRES website.

There are three possible outcomes from your application:

I have Ethical approval, now how do I obtain ULHT R&D approval?

In accordance with the Research Governance Framework for Health and Social Care 2005 all research conducted within or linked to ULHT hospitals MUST obtain R&D approval prior to commencement.

We will require:

  1. Approved IRAS forms and completed SSI Form populated from the NHS REC form.
  2. All copies of documents submitted to REC (with corresponding versions and dates and localised using ULHT logo, relevant hospital address and containing ULHT customer care details)
  3. Evidence of changes made following a conditional ethical approval
  4. CVs of any other staff not included in the ethics application
  5. Completed Research Passport (where appropriate) – please refer to the 'Research Passport' page of the Lincolnshire Clinical Research Facility site.