Preparing applications and study documents for review

This page describes the documents and other items you might need for a research project involving the NHS, MOD or health and social care. It also describes the Sponsor’s review.

All study documents should have an identifier, version number and date.

It can take months to obtain NHS ethics approval:

  • Study paperwork is often extensive and detailed, so preparing, proofing, and cross-checking is time-consuming.
  • If you require sponsor’s review this may also take several weeks, particularly if study documents require a lot of input or amendments.
  • REC review can take several weeks and often revisions or additional information are requested before a favourable opinion will be given.

You should take this into consideration when planning your project and if you have limited time available consider options which do not require NHS REC review.

The HRA website is a good source of information on the NHS review process, though the NHS Scotland website also holds more Scotland-specific information including REC meeting dates and key contacts.

The information for REC members page, which give details on how RECs operate, how applications progress through the review system and what reviewers should look for, may help applicants understand the process and anticipate any issues. The following are particularly useful:

  • Standard Operating Procedures for RECs – detailed information on how RECs operate, timescales, responsibilities and how opinions are reached.
  • Lead Reviewer Form – this may help you understand what the REC are looking for in an application.

These can be found on the HRA's 'Guidance and policy for REC members' webpage.

Checklist

Sponsor review and approval

As the Sponsor takes on overall responsibility for the project, a thorough review of your application will be completed before Sponsors approval is provided (this is required to submit an IRAS application, see the section on submitting your application). 

If the University is acting as sponsor, Research Governance will require at least two weeks to review your documents. However, this will take longer if documents are missing, incorrect or inconsistent.

To minimise delay, ensure:

  • all required documents are included
  • all documents have titles or version numbers
  • all details are correct
  • all documents have been checked for spelling and grammatical issues
  • information and details are consistent across all documents.

As multiple documents accompany an NHS ethics application it can take several iterative rounds of review to obtain Sponsor’s approval. The total time to approval can therefore depend on the extent to which revisions are required and how quickly an applicant can address these.

For example, if a revision needs to be made to one document, that change must then be implemented across all documents and version numbers updated accordingly. The sponsor then has to check this has been completed. Tracking or highlighting changes will help the sponsor quickly identify where changes have been made.

The Sponsorship review proforma (Word) used by the University’s Research Governance team shows what the sponsor will consider as part of the review.

You can find more information on the role of a Sponsor and the responsibilities that are involved in the UK Policy Framework for Health and Social Care Research.

Why so rigorous?

Careful preparation and review of documents are critical to maximise the chances of receiving a favourable opinion from a REC and obtaining other approvals.

Poor quality applications not only reduce these chances but also impact others’ opinions of the University, potentially impacting trust and the level of scrutiny applied in future reviews or approvals.

Tips for preparing your application

Remember – the RECs priorities are the rights, dignity, safety and wellbeing of participants. They need to be reassured that your study has been carefully planned, that the researcher and study staff have the right skills and experience to ensure the safe conduct of the research and that any risks will be carefully thought through and managed.

  • Select the correct study type in IRAS – this impacts which form fields are available and so is critical to ensure you provide the information required and avoid delays.

  • Write with care and make sure spelling and grammar are correct to avoid the REC perceiving the application as rushed or poorly thought out.

  • Ensure details are consistent between the application, protocol, and study documents. Discrepancies can raise questions and lead to the perception that the applicant does not pay attention to detail.

  • Clearly describe the roles and responsibilities of the research team and give job titles and accreditations – this reassures reviewers that individuals are appropriately qualified and so may pre-empt questions.

  • Clearly distinguish between routine clinical care (managed by the NHS) and any additions, interventions, or changes that are a result of the study.

  • Clearly distinguish between members of the clinical care team and the research team - this helps the REC know that individuals have the right experience and training for the tasks they will perform.

  • Acknowledge if a study is a high risk or novel – do not downplay or minimise risks or ethical issues.

  • Do not suggest that there are “no ethical considerations”. This is extremely unlikely and may be viewed as a lack of insight or consideration for participants.

  • Make clear the justification for, and benefits of, the research, to help reviewers understand the favourable risk-benefit balance.

  • Carefully describe how any risks will be mitigated and include details of how, if a risk occurs, it be managed. For example, if a participant was to become distressed, what steps would the researcher take. These details can be provided in the Protocol itself or attached as appendices such as ‘Standard Operating Procedure’ (SOP) documents (either the researcher’s, University’s, or those already in place at the NHS Board in question) or response protocols. 

  • Do not assume inappropriate responsibility for risk – any risks that result from routine clinical care, i.e. not enhanced or induced by the research or study procedures, fall under NHS protocols and procedures.

  • In the case of research projects with separate protocols governing one or more sub-studies in addition to the main study, a full application should be submitted for each protocol. It is recommended that the parent study and any sub-studies are reviewed by the same REC wherever possible.