How to write an ethics application
Projects can’t begin until ethical approval is secured. The ethical approval process is similar in principle regardless of the complexity of the underlying project (from small tissue-only projects to multi-centre RCTs). Useful information can be found here https://www.hra.nhs.uk/approvals-amendments/what-approvals-do-i-need/research-ethics-committee-review/applying-research-ethics-committee/
Start early as the process usually takes several months.
Funding applications will ask whether ethical approval is:
- already granted (this reassures the funders and shows that you are proactive)
- not yet applied for (ideally start the approval application before the ‘second round’ or provide some reassurance that you think ethical approval will be granted e.g. ethics have been granted for a similar project or you’re applying as an amendment to an existing project)
- not applicable (you need to justify this)
Ethical approval for studies involving NHS patients or services is submitted via the IRAS system https://www.myresearchproject.org.uk and reviewed by a REC committee. Ethical approval for studies limited to University staff/student/premises may be granted by your University’s ethical committee.
Preparing an IRAS application
The key to ethics is thinking through how the project will run in detail from start to finish. Get input from:
- collaborators & co-applicants
- research nurses
- laboratory staff
- PPI group
- colleagues who have submitted similar ethical approval applications
- experts e.g. statistician/bioinformatician
- NHS R&D department and/or University R&D department
- colleagues working in your department: are there ‘set phrases’ which you can use e.g. describing your building’s security or your department’s data management policy?
You can subsequently change the ethical approval (as an amendment) but re-submission introduces delays; it’s therefore worth getting it right first time.
Create an account within IRAS https://www.myresearchproject.org.uk
Familiarise yourself with the IRAS website. It has a lot of useful features e.g. the option to print out your IRAS form so that others can review it or duplicate forms (which saves time if submitting applications for similar projects).
Complete the project filter questions. These are important as the answers which you give will determine the questions which are subsequently generated on the IRAS form.
Answer the questions using lay language. Avoid repetition. Keep descriptions broad so that the ethical approval can encompass subsequent minor changes to the protocol without the need for an amendment (e.g. ‘molecular tests’ is a broad descriptor and covers many techniques including techniques you might use in the future).
Create study documents. Include:
- date and version number in the header/footer
- page numbers
- institutional logo
- information about GDPR: https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/data-protection-and-information-governance/gdpr-guidance/templates/transparency-wording-public-sector/
Ask the PPI group which advised on the design of the study if they will review the study documents.
Contact your University and hospital R&D departments – they may need to check your IRAS form prior to submission and issue sponsor agreement and a copy of their indemnity certificate (upload these to the checklist section of the IRAS form). They are likely to ask you to download and complete a HRA Schedule of Events form and Statement of Activities form (an e-learning module about these forms can be found here: https://www.hra.nhs.uk/planning-and-improving-research/research-planning/prepare-study-documentation/ ) They may have other internal paperwork which you will need to additionally complete.
You will need to upload these forms and the study documents to the checklist section of the IRAS form. Don’t forget to upload a CV for yourself and your supervisors if you are undertaking the project as a student (a link to a template CV can be found on the IRAS form or https://www.hra.nhs.uk/planning-and-improving-research/research-planning/prepare-study-documentation/ )
Request the appropriate authorisation signatures on the IRAS system.
Book a REC appointment using the telephone booking system then submit the IRAS application (this must be done the same day). To book a REC appointment, you will need to answer brief questions about the project and know the dates when you and your supervisor would be available to attend a REC meeting (it is preferable if your supervisor accompanies you).
Some types of study are eligible for ‘proportionate review’ (i.e. you do not need to attend a REC meeting) https://www.hra.nhs.uk/approvals-amendments/what-approvals-do-i-need/research-ethics-committee-review/applying-research-ethics-committee/
Tissue may be eligible to be used without consent if it was collected before 1st September 2006 https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/use-tissue-research/
Attending a REC meeting
Ideally attend the meeting with your supervisor (if they are unable to attend, explain why and apologise). The PPI representatives which you have worked with may be willing to attend the REC meeting with you – check with the REC if this would be permitted.
Consider whether it would be helpful to take any study material to the meeting e.g. medical devices which will be used in the study.
Ensure you know the project thoroughly – re-read the IRAS form and study documents to remind yourself of the details.
Most REC committees will comprise many members, but questions may be asked by only one or two. Try to address your answers to the entire committee.
The committee will explore areas which they are unclear about. Sometimes you will be able to defend your decision on an aspect of study design and other times you should accept the suggestions of the REC as an improvement. Do not be aggressive.
After the meeting the REC will issue a decision. If they request changes, make sure you track these and update the dates and version numbers of the study documents.
For an insight into how RECs make decisions visit http://www.reviewingresearch.com
Once REC approval is secured
You will need HRA and hospital R&D approval before the study can commence.
Check the REC approval letter for details of:
- how to report any breaches
- the requirement to submit annual progress reports: put this in your diary so that you don’t forget https://www.hra.nhs.uk/approvals-amendments/managing-your-approval/progress-reports/
- what to do when the study ends
If at a later date you need to change details of the study/add things into the study, contact the REC coordinator to find out whether these changes should be submitted as an amendment and how to do this https://www.hra.nhs.uk/approvals-amendments/amending-approval/ . Substantial amendments are submitted via the IRAS system.