Research Ethics Committees are convened to provide independent advice to participants, researchers, funders, sponsors, employers, care organisations and professionals on the extent to which proposals for research studies comply with recognised ethical standards. Please read all this guidance before starting to complete your ethics application form.
The purpose of a research ethics committee in reviewing the proposed study is to protect the dignity, rights, safety and well-being of all actual or potential research participants.
To gain ethical approval you need to complete the online ethics application form at the IRAS website. The online system allows you to fill in and submit your applications electronically.
The online system is compatible with all different types of computers and systems that have web browsers. You do not need to fill in a form in one go, as the system saves your progress every time you finish a page and you can return to it as many times as you like.
If you are typing large quantities of text into the form press the Save Now button regularly to avoid losing data should your internet connection time out. Alternatively, type up the answers in a word processor and cut and paste them in.
If you have not already registered with the ethics online application system you need to do this before you can complete the form.
How to register on the ethics website
To register on the ethics website you need to follow the instructions below:
- go to the IRAS ethics website
- click on enter
- follow the instructions on the screen
If you have not got an account you will need to create one by clicking on create account at the top of the page and follow the instructions.
Process for research studies that are only being carried out at Homerton
You need to complete all the sections of the online ethics form (parts A, B & SSI). The SSI form is also the R&D registration form.
To help with the process here are some definations to help you get the correct person to sign the forms.
Sponsor's signature. If the sponsor is Homerton Hospital then you need to arrange for the director of Research and Innovation to sign the form.
Authorisations required prior to R&D approval - section 39 of the SSI form. This needs to sign by either the clinical director or general manager of the department where the researcher works. By signing this section of the form they indicate that they are aware of the research and authorise that it can be conducted in their unit/clinical area.
Submitting your application form
Once the form is completed and you are happy with the form you can then book your slot with the ethics committee. For reserch studies that are only being carried out at Homerton please contact East London and the City ethics committee for your project to be reviewed at the next available ethics committee meeting.
Please note that depending on your preference there are two different approaches to locking the form, obtaining signatures and booking it in for ethical review.
Booking the application and obtaining a reference number prior to locking and then signing the form
- you need to enter the project reference number you will have been given during booking into the application form. Lock the application form (see about the NRES application form) and print it off. You then need to obtain all the necessary signatures in ink. (An application not signed by all parties concerned will be returned to you as invalid)
- once you have obtained signatures on the hard copies of all the necessary documentation (ie. the locked NRES application form and other supporting documentation as outlined on the checklist) you need to send them to the reviewing REC before the deadline expires.
Locking the form before obtaining a reference number in order to obtain signatures
If you need to obtain the signatures before booking the application in order to meet the submission deadline then please note the following:
- once the content is finalised you can lock the form, then print it off and get all the necessary signatures. You can then book your application (see how to book your application above), write the project reference number and REC name on the paper copy by hand where indicated. The part of the electronic form where the project reference number and REC name need to be inserted will still be accessible even though the form is locked. You can enter these details into the electronic form and separately lock this section for submission once booked using the 'Lock REC Info' button on the NRES application form
- whichever of the above two approaches you use, you need to send a signed paper copy and all accompanying documents to the REC, as listed in the relevant checklist
- the REC co-ordinator will then be able to retrieve the electronic copy of your application form from our electronic system by using the lock code located at the bottom right-hand corner of your locked application form.
You must submit your application by the deadline you will have been given to the REC that will review it. The exact date will be confirmed when you telephone to book the application for ethical review.
Submitting a SSI application for a multicentre study
If you are involved in a multicentre study and you are completing your SSI form for ethics approval. You need to complete the SSI form on line at the ethics website in the normal way.
Once you are happy with the form, then lock it, print a copy off, get the Clinical Director or General Manager of your directorate to sign section 39 of the form and the PI to sign the Principal Investigator declaration.
Take a photocopy of the signed form and then send the orginal with a copy of the PI's CV with a covering letter explaining that you are submitting an ethics application for SSI approval.
Please remember ...
We know that submitting ethics applications on time can have very tight deadlines, but please remember to take a photocopy of the signed ethics application, this will mean that you will have a signed copy if the orginal happens to get lost in the post and the R&D office requires a copy of the signed application as part of the documents required for R&D approval.
The research governance framework outlines the principles of good governance that apply to all research within the remit of the secretary of state for health.
Research governance is one of the core standards for health care organisations. The research governance framework is grounded on the principles that apply generally to research in health and social care.
It can be defined as:
- a broad range of regulations, principles and standards of good practice that exist to achieve and continuously improve, research quality across all aspects of healthcare in the UK and worldwide.
Research goverance improves research quality and safeguards the public by
enhancing ethical and scientific quality, promoting good practice, reducing adverse incidents and ensuring lessons are learned preventing poor performance and misconduct.
Who and what does the research governance framework apply to?
It is for all those who:
- participate in research
- host research in their organisations
- fund research proposals or infrastructure
It is for managers and staff in all professional groups who are involved in research no matter how senior or junior. It applies to the full range of research types, contexts and methods.
What does research governance mean to researchers?
Unfortunately you can not decide that you want to carry out research and then start doing it.
Research must now be approved by the ethics committee and the R&D Office of where the research is happening before the research can start.
If your project is not properly approved by ethics and R&D and you start your research project the Trust is unable to support you if something goes wrong with your research project.
If the study you are involved in at Homerton Hospital is recruiting patients into the study or the study is using Homerton resources you need to register the study with the R&I department.
Documents required where Homerton is recruitment site only
If the study you are involved in at Homerton is only recruiting patients in to the study, then you need to register the study with the R&I office.
To do this you will need to submit the following documents:
- CV of principal researcher/s
- copy of the ethics form parts A&B with signatures
- copy of the protocol
- patient information sheet (on headed paper)
- patient consent form (on headed paper)
- sponsor letter or ethics form part B signed by sponsor
- ethics approval letter/s.
Research where Homerton resources are being used
If you are involved in a study not based at Homerton Hospital or resources from Homerton are being used in a study such as computers, rooms, staff times, drugs, consumables for research studies carried out elsewhere, you will need to register the study with us.
To do this you will need to submit the following documents:
- copy of the protocol
- copies of ethics committee's approval letters
- completed R&I registration form with the relevant signatures.
Once the R&I office has recieved all the relevant documents and are satisfied with them then a registration letter will be issued, until you have this letter you will not be able to participate in the research or recruit patients in studies not carried out at Homerton.