The NHS Ethics Process

October 11, 2018

 

When you mention to fellow academics you wish to do research in the NHS, often one of the first things you’ll hear will be an exclamation of horror at the prospect of an NHS Ethics application. In fact, this was a big concern of mine when I started my PhD. Luckily, I managed to get through my NHS Ethics application. My experience of this was a good one and unlike some researchers, has converted me towards NHS research.

 

As health psychologists we have an arsenal of skills at our disposal, yet the barrier of the ethical approval process prevents some from using these skills in an NHS setting. On discussing this with the wonderful committee and attendees at the Midlands Health Psychology Network career event, I was inspired to help alleviate some of these concerns, fears and barriers towards NHS research. A brief disclaimer though before I start, not all ethics applications run as smoothly as mine did. However, hopefully this blog will go some way to encouraging fellow health psychologists to do research in the NHS.

 

Who am I and how did I come to do research in the NHS?

First things first, my name is Catrin Jones. I am a second year PhD student at the University of Bedfordshire. My PhD is examining the feasibility of an organ donation intervention in primary care. I came to do my PhD after completing my Masters in Health Psychology also at the University of Bedfordshire.

 

What is the NHS Ethics process?

I won’t lie to you, the NHS Ethics process is longer and more complex than an application to a University ethics committee. Going into it prepared for this, will make your experience much easier. The process consists of several steps which I will outline and I will also discuss some tips for applications in this blog.

 

The Steps

 

Step 1: Determine if you need NHS Ethics approval & which other approval you need

  • You might be surprised to hear that not all NHS based research needs NHS ethical approval. For example, research only involving staff often does not. The best way to check is to visit www.hra-decisiontools.org.uk/ethics/.

  • If you are wishing to access any NHS patient data without overt informed consent, you will need to apply to the Confidentiality Advisory Group.

 

Step 2: Preparing for your application

  • The second thing to do is to make sure you are well prepared. Before you start your application make sure you have finalised your protocol, materials (e.g. consent forms, surveys, topic guides) and have explored in-depth any potential ethical issues with your research project.

 

Step 3: Find and contact a Research & Development (R&D) department

  • A mandatory step of the application is to provide the contact of the R&D department which will oversee your research. A directory of contacts can be found here.

  • If your research is being conducted in a hospital, the R&D contacts will be situated in that hospital. However, if your research is being conducted in primary care or another part of the NHS it can be a bit more complicated to find your R&D contact. Again, don’t be afraid to call the departments in your area for advice.

  • The R&D contact will be an invaluable help to you, they will review your application and help iron out any issues.

 

Step 4: Complete the Integrated Research Application System form (IRAS)

  • The most time intensive step in my application was completing the IRAS form. Apparently it is much improved than previous versions, however it is still not the most user friendly form you will ever encounter (!). Take your time and use the online help websites provided, such as this guide.

  • It’s important to know that this form is built for quantitative clinical trials. The whole process is biased towards this type of research, so some sections may not be relevant to you. If you are unsure don’t be afraid to ask for help.

 

Step 5: Upload your additional documents into IRAS and complete the Checklist

  • Once you’ve completed the form, you will need to upload several additional documents. The list of these forms is found in the ‘Checklist’ tab on the IRAS form and include the following:

    • Protocol

    • CV of Lead Investigator, and if a student CV of supervisor

    • Participant Information Sheets

    • Consent Forms

    • Data Collection Materials

    • Recruitment Materials (e.g. posters, email content)

    • Indemnity Insurance from your institution

 

Step 6: Seek authorisations

  • A key step in submitting your application is to seek ‘Authorisation’ from the study Sponsor (usually your faculty or institution representative) and other key investigators via email.

  • This is done through the ‘Authorisations’ tab, it’s important however to only seek authorisation when your application is complete. Any editing to your application will void any authorisation and they will need to be sought again.

 

Step 7: Book your NHS Research Ethics Committee meeting (REC)

  • You’re finally ready to submit, hooray! The next step is to call the Central Booking Service who will book your application in for review with a committee.

  • Have a look at committees in your area before you call. Some specialise in certain applications, for example research including children or qualitative methods.

  • The CBS will ask you several questions to determine whether you need a full review or proportionate review. Proportionate review is for studies that provide no ‘material ethical issues’ and will be fast tracked through the process. Check if your research can go to proportionate review here.

 

Step 8: Submit your IRAS Form

  • Once your application has been booked for review, you can then enter this information into the IRAS form and submit using the ‘E-Submission’ tab.

  • On submission of your IRAS form and additional documents, you will receive an email from the NHS REC committee confirming receipt of your application and validating it.

 

Step 9: Receive Health Research Authority feedback (HRA)

  • The first set of feedback you will receive will be from the HRA. They will review your application and send you a list of issues for review or amendment.

  • These you can submit after you receive your REC feedback.

 

Step 9: Attend a REC meeting (optional)

  • If your application requires full rather than proportionate review, you will be required to attend a meeting. This meeting will allow the REC to ask you questions for approximately 15-30 minutes.

  • Importantly however, this meeting is your opportunity to give the REC confidence in you and your application. If this is your first meeting or if your research is complex, it is advisable to take colleagues or supervisors with you. They will be able to assist you in answering questions.

 

Step 10: Receive REC feedback

  • After your REC meeting you will receive a feedback letter within 60 calendar days of the receipt of your application. There are four responses the REC can give:

    1. Favourable opinion

    2. Favourable opinion with additional condition

    3. Provisional opinion

    4. Unfavourable opinion

  • Responses 1 and 2 mean you have approval from the REC. Response 2 as stated will mean approval is dependent on you adhering to certain specified conditions.

  • It is very common for the REC to provide response 3 of ‘Provisional Opinion’. This means the REC cannot make a decision until issues have been resolved. These may be concerning your additional documentation or study procedures. You will be required to resubmit documentation based on these issues.

  • Response 4 unfortunately means your application has been unsuccessful.

 

Step 11: Provide additional information to the REC & HRA

  • Once you’ve received REC and HRA responses, you will be required to address these concerns and resubmit documentation.

 

Step 12: REC & HRA final decision

  • Finally, once you have resubmitted you will receive a final response from the REC and HRA. This response will be in the form of an official letter, detailing approval for the study.

 

This process may seem daunting and overwhelming at first glance, however I believe it is well worth it to conduct important and impactful research in the NHS. There are a few ways to increase the likelihood of an application being successful and most importantly to make the process as stress free as possible. Here are my top tips for your NHS Ethics application.

 

Ask for help!

Don’t be afraid of inexperience. There are fantastic people a phone call away who can guide you through the process. The HRA advisors and REC Committee administrator in particular were wonderful at helping me through.

 

Come up with several different solutions or contingency plans for ethical issues

Ethics committees are there primarily to protect patients and staff. Some elements of your research may cause distress or harm by their nature. It’s really important to think of contingency plans or alternative solutions you can offer the REC, particularly if they have a problem with an aspect of your research. This is to be expected, it is their job to find the ethical holes in your project and it’s your job to find solutions.

 

Remember committees may not be used to psychological/behavioural research

As I said previously, the system is built primarily for quantitative clinical trial research. This also may apply to the committee who are reviewing your application too. Don’t be afraid to explain or justify your methods based on your expertise and the literature. You are invited to attend a REC meeting to do just that and help them understand your research.

 

Budget 6 months from submission of your application to receiving your approvals

The biggest challenge for my submission was the difficulty in planning how long the process would take. This issue is echoed by fellow PhD students and researchers I have spoken to about my frustration at this aspect. It may seem like a long time to give for a process which should give you a response within 60 days. However, these 60 days do not include any time you spend amending elements that the REC request. It also doesn’t account for potential errors in your IRAS form or additional documents which you need to resolve before your application can be reviewed by the REC. Finally, you may find yourself waiting for HRA approval or having to submit additional applications to other groups or bodies (e.g. Confidentiality Advisory Group). My application was submitted in July and my final approval received in December of that same year. I wish at the start of the process I had anticipated this and planned accordingly.

 

Contact any sites you wish to work with informally before you submit your application. Include letters of agreement to participate in your application

A key issue in doing primary care research is the difficulty in recruiting practices. The REC were reassured in my application that I already had an agreement to participate in the research from a primary care practice before I submitted my application. Although you cannot start recruitment of patients or staff specifically for study activities, you are able to approach decision makers in NHS organisations to ask if they would be interested in your research. Include letters from these decision makers which outline their interest in participating and you will have a stronger ethics application.

 

In conclusion, health psychologists have a lot to offer by doing research in the NHS. It’s important for our field that we don’t shy away from this because of the ethics process involved. Yes, it is complex and can be frustrating.  Once you have been through it however, it will only get easier. I hope this blog has helped outline and reassure researchers that it is possible to get NHS Ethical approval for behavioural studies and more importantly come out of it relatively unscathed.

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