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Guidance on Applying for HRA Approval (formally NHS REC)

If you have determined that your research requires ethical review and you have determined that this is via the HRA approval process, you will need to submit an IRAS online application to the Health Research Authority (HRA) by completing the following steps:

  • You will first need to create an IRAS account (if you do not have one already) by visiting the IRAS website.
  • Complete the application form for HRA Assessment and Review: one form for all types of review has replaced the older versions of the NHS REC and NHS R&D forms.
  • Submit a copy of the completed application form (unlocked) along with all supporting documentation (research protocol, faculty research approval form/PanMan form and Insurance Assessment form) to your University Sponsor's Representative:

Lynne MacRae for those in all Faculties

  • The sponsor will aim to review your application within 10 working days and will liaise with you directly for any suggested clarifications to your documents and will also inform you if UREC approval will be required.
  • The sponsor will then generate your letters of indemnity and insurance that are required attachments to your IRAS application
  • Once all of your documents have been updated and uploaded to the IRAS website, send an electronic authorisation request to your sponsor via the IRAS website.

***NEW INFORMATION REGARDING THE HRA APPROVAL PROCESS***

  • Your sponsor will electronically sign your IRAS form, which can then be submitted via the IRAS portal to request assessment by a HRA Advisor.
  • The HRA Advisor will then be in touch to discuss the progression of your application and any required actions.
  • After assessment, documents are passed directly to the REC for review and approval (if applicable). Additional, if required, the documents must be sent by the CI to the NHS sites for the capacity and capability assessment.
  • Researchers will be given two approval letters: one from the HRA (main approval) and one from the REC. Please ensure sponsors receive a copy of both letters for their records.
  • NHS sites are able to provide confirmation that a study can be undertaken via a capacity and capability assessment, but will not have the authority to provide approval.
  • New required documents include a Statement of Activties and Schedule of Events which will replace the Site Specific Information (to be dissolved in future).
  • For more information about the HRA Approvals Process, see their website.

Useful Documents

The following documents are required when they are being used:

  • Participant information sheet
  • Consent forms
  • Letters to participants/ clinicians/ GPs
  • Adverts/flyers/posters
  • Questionnaires
  • A schedule (i.e. a list of topics) to be discussed at any interview or focus group
  • Ground rules for any meetings or focus groups
  • Distress policy (see here for example)

Reporting the Outcome of an NHS REC Ethical Review

Once you have received final ethical approval from an NHS REC you must submit a copy of the approved documents to FBMHethics@manchester.ac.uk.

NHS Applications - Standard Answers

When completing the IRAS application form, please ensure that you answer the filter questions carefully, as this can result in an incomplete form. 

IRAS e-learning Module

An online module has been added to IRAS to guide new users through IRAS. The module, which is free, explains how IRAS is structured and guides users through how to prepare and make applications using IRAS.  

Questions

A2           Chief Investigator

For student research this should be the supervisor unless it is a PhD student.

A4           Who is the contact on behalf of the Sponsor?

Lynne MacRae

Room 1.21a Simon Building

University of Manchester

M13 9PL

fmhsethics@manchester.ac.uk

Tel 0161 275 5436

A36. Storage and use of personal data?

Once the appropriate box(s) have been selected, please also include the following information:      

 “Study data and material may be looked at by individuals from the University of Manchester, from regulatory authorities or from the NHS Trust, for monitoring and auditing purposes and this may well include access to personal information.”

For advice on encryption please view the University Guidance

A43.       How long will personal data be stored or accessed after the study has ended?

Please select 3+ years, and include the following statement:

“Consent forms will be retained as essential documents, but items such as contact details will be deleted as soon as they are no longer needed.”

 

A44.       Storage of research data?

Data should be stored in a way that permits a complete retrospective audit if necessary. Unless ethical/professional/local or funding body guidance requires otherwise, research results should be archived in a durable form that is immune to subsequent tampering and falsification for a minimum period of 5 years after the date of any publication which is based upon it. It is recommended good practice that evidence for research based on clinical samples or relating to public health should be retained for 15 to 20 years. Further Information please read the University of Manchester Code of Good Research Conduct

 

A56.      How have the statistical aspects of the research been reviewed?

THE REC expects for all applications, except those involving qualitative methods only, has the applicant provided details of who has reviewed the statistical aspects of the research?