Research Governance Approval – Secondary Care

From Lindsay:

This was quite a lengthy process and took a little while to complete.  As Gemma has already said organisation is key, when I knew that the study had been granted the funding I contacted the Research and Innovation team for some information to see what we needed to do and to ask for some advice as I had no idea and had never done anything like this before.  I found out that they would need copies of all the patient information when they had been developed and that I would need to make a link within the pharmacy department to help identify potential participants (which I did).

The identification of patients was an area I was concerned about, although I hold an honorary contract for the Trust, I was not deemed to be part of the direct care team when I was acting as ‘the researcher’, I was not allowed to identify participants or access any information held about them – the research and innovation team were really helpful in helping to clarify this.  I would advise that when you embark on any research, if you hold an honorary contract to find out what this enables you to do and not to do in terms of your research.

When we received our favourable opinion from NHS ethics I got back in touch with the Research and Innovation team to inform them of this and was asked to submit the relevant documents.  They sent me a list of all the documents required, the list was very comprehensive and involved more information than I had anticipated or realised!  Prior to gaining approval from the Trust, I had to submit:

  • Feasibility form 1 and 2
  • Complete IRAS form
  • SSI application form (via IRAS)
  • HRA approval letters
  • Patient information sheets, written consent form, etc. all dated and version controlled
  • Full protocol (dated and version controlled)
  • Amendments (dated and version controlled)
  • Version control document
  • Copy of current CV
  • Certificate of current GCP training
  • PI agreement for research
  • Sponsorship letter
  • Caldicott Approval
  • PR risk assessment form
  • Copies of honorary contracts/letters of access
  • Legal indemnity/University Insurance Certificate
  • NHS ethics approval
  • University ethics approval
  • Letter of support from the pharmacy department within the hospital

An area where I found difficulty was that we were doing a qualitative research study as opposed to a clinical trial, therefore, some of the documents detailed did not apply and I had to seek further guidance about this – again the research team were great.

In terms of the time line, the SSI when submitted had to be signed off by the Trust research team within a short time frame (15 days) if your project is on the NIHR portfolio (as ours was), therefore, you must make sure that all your documentation has been submitted and is in place prior to submitting the SSI otherwise the request will be invalidated and then resubmission is required.  We had quite a few issues with the SSI as I had signed it and as the lead investigator Gemma was submitting it – however, this was resulting in my signature being corrupted on submission.  Therefore, the SSI had to be transferred to myself for submission before it presented in the correct format – we are still not sure why this happened, so give yourself plenty of time for this process as it isn’t always straight forward!!  However, this has all changed now!!  Since the 31st March 2016 SSIs are no longer required and HRA approval is the new process for the NHS in England.

Another thought when you are carrying out qualitative research is where will you be holding the interviews?  As a consequence of this I had to provide information about where the interviews were likely to take place and state whether I had permission to use clinical spaces to hold interviews.

Remember you need to be GCP trained and have proof of this!  I was unlucky, my training had expired 2 months before we got approval and I had to do this again – the training can be completed via the NIHR CRN website provided you have a login and password.  It does take a while to complete but it is very informative and it reminds you why we go through all of these processes when conducting research.  Ultimately, we need to ensure we understand our responsibilities and duty of care to participants to protect them.

Eventually, we got the go ahead from the Trust – my advice to anyone in secondary care is to get in touch with your Research and Innovation team, they are extremely helpful, friendly, knowledgeable and patient.  Involve them from the very beginning of the process, when you have your concept and are developing the study design – they will be able to provide advice and support and will be aware of what you are hoping to do and achieve.  The research team were brilliant in the support they offered – so get to know your research team!  Each Trust may have slightly different requirements and processes in terms of governance approval so make sure you take the time to familiarise yourself with them so that all the additional documents can be completed alongside your IRAS application and documentation development.

Another tip I would offer in terms of the protocol design is to involve the relevant people within the pharmacy or clinical department you will be working in.  They will have concerns and thoughts about traps they will want to avoid, relationships that they want to maintain etc. and their input and experience is very valuable.

Remember, that once the approval has been given you will need to provide monthly updates on recruitment and complete an end of study declaration, REC sign off and produce an end of year report for Trust records all of which are required to be in place as they could all be requested during an MHRA inspection.

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