How long will the process take?
A Research Ethics Committee (REC) is required to give an ethical opinion within 60 calendar days of the receipt of a valid application. Where the REC considers that further information is required in order to give an opinion, the REC may make one request in writing for further information. The period of 60 days will be suspended pending receipt of this information.
For more information about the process and timelines, see Before you apply to a REC.
[Top]
What is a non-NHS REC? When should I apply to them rather than to an NHS REC?
There are ethics committees in universities and other research centres, and also some private ethics committees. For any research not within the remit laid out in Governance Arrangements for NHS Research Ethics Committees (GAfREC) you should follow the governance arrangements of your host institution.
All research falling under the remit of GAfREC must be reviewed by an NHS REC, unless it is a phase 1 clinical trial of an investigational medicinal product (CTIMP) in healthy volunteers only. If this is the case, it must be reviewed by a Type 1 REC recognised by the United Kingdom Ethics Committee Authority (UKECA) to do so. Some of these committees are independent sector RECs which are managed by the Appointing Authority for Phase 1 Ethics Committees (AAPEC).
[Top]
Do I need to apply to R&D for approval?
Researchers wishing to conduct research in the NHS must obtain NHS permission for each NHS site.
From 1 April 2009 all NHS R&D applications for studies that are potentially eligible for the NIHR portfolio in England must be processed through the National Institute for Health Research (NIHR) Coordinated System for gaining NHS Permission. The Portfolio Adoption Form must be submitted before you submit the R&D Form. You will need to submit a Portfolio Adoption Form in IRAS to assess whether your study is eligible for the NIHR portfolio.
There are different arrangements in place across the UK for handling R&D applications. In IRAS, the text in the submission tab for the R&D Form will provide the relevant guidance (or refer to the R&D Forum).
For more information see NHS R&D approval.
[Top]
What documents do I need to submit with my application?
The following documents are mandatory for submitting for ethical review:
-
IRAS checklist;
-
REC application (IRAS Parts A-D) (signed copy);
-
research protocol;
-
summary CV for chief investigator (CI - see below for downloadable form);
-
research participant information sheet (PIS);
- research participant consent form; and
- evidence of insurance or indemnity (non-NHS sponsors only).
Other types of documents may include:
-
covering letter on headed paper;
- summary, synopsis or diagram (flowchart) of protocol in non-technical language;
-
Site-Specific Information Form (if main REC is also the SSA REC for a non-NHS trial site);
- investigator's brochure (CTIMP applications only);
- letter of invitation to participant;
-
GP/consultant information sheet or letter;
-
advertisement(s), questionnaire(s), interview schedule;
- letters from sponsor, statistician, referees; and
-
scientific critique.
ALL documents must bear version numbers and dates (unless indicated otherwise on the IRAS checklist).
What is a protocol?
Every application for ethical review must be accompanied by a protocol. This is a mandatory requirement and an application would not be valid without it.
The research protocol forms an essential part of a research project. It is a full description of the research study and will act as a ‘manual’ for members of the research team to ensure adherence to the methods outlined. As the study gets underway, it can then be used to monitor the study’s progress and evaluate its outcomes.
No two research protocols will be the same, but they will have a similar structure:
The protocol should go into as much detail about the research project as possible, to enable the REC members to understand your study, because they will only have limited information in the application form. The application form should not be a ‘cut and paste’ from the protocol: it should be written in non-technical language. The protocol does not need to be signed by the chief investigator (CI) as this is not a requirement under our Standard Operating Procedures for NHS RECs (SOPs).
For general advice on your research project, see RDInfo. RDInfo can also direct you to appropriate local sources of advice and expertise.
For information on clinical trials of medicinal products see Clinical Trials Tool Kit. For guidance on research involving human tissue and data see Data and Tissues Tool Kit. For experimental medicine see Experimental Medicine Tool Kit.
[Top]
What is a scientific critique?
A scientific critique asks if there is a clear question to be answered and if the protocol provides the methodology to answer it. It should also determine whether the proposal duplicates other work unnecessarily and if it is of sufficient quality to contribute something useful to existing knowledge.
The review of the protocol should be carried out by experts in the relevant fields able to offer independent advice on its quality. You may want to check with colleagues who have already been through the process.
A scientific critique is often included in the review process for obtaining funding. Where this does not apply, your R&D Department can help you to obtain this.
[Top]
Can I have more than one Participant Information Sheet and Consent Form for a particular study?
In general, there would be one Participant Information Sheet and Consent Form for a research project. However, it may be necessary to have different versions for different groups of participants, for example patients and healthy controls, or children of different ages, etc. The level of detail should be appropriate to the nature and detail of the study and the target audience.
More information is available in our guidance:
[Top]
Do research participants have to be provided with an 'independent' contact on the Participant Information Sheet and Consent Form?
The further information to participants could be subdivided, for example:
-
General information about research (this may cite documents or websites).
-
Specific information about the research project (this may cite someone in the research team).
-
Advice as to whether they should participate (this may cite members of the research team, or a potential participant’s health care professional; for example, the chief investigator or another doctor/nurse involved in the study).
-
Who they should approach if unhappy with the study (for example, the chief investigator in the first instance).
A contact number should also be provided if a subject has any concerns during the study, if this is a different number to call. For some studies an emergency contact number (which will be manned out-of-hours), should be given and be clearly displayed.
[Top]
Do I need to send translations of the Participant Information Sheet and Consent Form to the main REC along with the English version?
The main REC will only require confirmation at A33-1 of the IRAS form whether this will be done and if so, how. They will not need to see a translated copy. NHS R&D Offices can advise on the need for translations in their local area.
[Top]
What signatures will I require?
Signatures will be required for the chief investigator (CI) and sponsor of the study (see (D1 and D2, IRAS, respectively).
-
The CI takes responsibility for ensuring that the information in Parts A-C of IRAS is complete and accurate. By signing the declaration, the CI is legally agreeing to its contents and will be personally liable for any deviation from this agreement.
-
The sponsor's declaration confirms an agreement in principle by the organisation(s) named in the application to act as sponsor(s) for the study.
-
Final confirmation of sponsorship arrangements must be in place before the study starts.
-
If the project involves radiation, authorisations from reviewers of the radiation information will also be required.
-
For all student applications, the academic supervisor’s declaration will be required. (Tasks under the responsibility of the academic supervisor may be delegated to the clinical supervisor at the site where research activity is undertaken. Such an arrangement with a clinical supervisor should be agreed with the research site.)
[Top]
Electronic authorisations
IRAS has made it possible for the facility for electronic authorisations to be offered (except where ink signature is a legal requirement, for example the CI's signature on the REC application for medicinal trials). Electronic authorisation is an option that may be used where convenient thus avoiding the need to take or post paper copies of forms to the various individuals. There is no need to obtain both ink signatures and electronic authorisation. (Please note: if the applicant makes changes to the data after authorisation, the authorisation is invalidated).
[Top]
o I need a sponsor / who is a sponsor?
The study sponsor is the person who takes on ultimate responsibility for the initiation, management and financing (or arranging the financing) of the research. The sponsor satisfies itself that appropriate checks have been undertaken to ensure that the study meets the relevant standards, and makes sure arrangements are put and kept in place for authorisation, management, monitoring and reporting.
All research falling under the remit of the Secretary of State for Health must have a formal sponsor. This includes all research in health and social care that involve NHS patients, their tissue or information, etc. There are similar requirements for research involving social care practitioners, clients and resources, where this falls under the Secretary of State for Health’s remit.
Any organisation that is a legal entity may declare itself as a sponsor. While the Clinical Trials Regulations allow for individuals to become sponsors, many institutions do not permit their staff to take personal responsibility in such areas because of the risks and legal liabilities involved.
A sponsor can delegate specific responsibilities to any other individual or organisation that is willing and able to accept them. However, the sponsor should ensure that the delegation of responsibilities to another party is formally agreed and documented.
In some cases, a co-sponsorship agreement may be reached. If so, you should nominate one body as the lead sponsor for the purposes of the ethics application and a sponsor letter should be provided describing the responsibilities of each sponsor. In particular, this should clarify the agreement about compensation and indemnity in the event of harm to research participants
It should be noted that co-sponsorship is an arrangement that is not recognised in EU states other than the UK and is therefore not applicable to multi-national studies within the EU.
[Top]
Student research
As set out in the Research Governance Framework for Health and Social Care, it is expected that the university will normally act as sponsor for student studies. Therefore, you will need to confirm who the sponsor will be with your academic institution or the NHS care organisation hosting the research.
[Top]
How do I ‘lock’ the IRAS form?
Unlike the old NRES research application form, in IRAS forms are not ‘locked’. When your application is complete and you are ready to submit, you need to book the application for review by telephone, either through the NRES Central Allocation System (CAS) or direct with the Local Allocation System or REC office.
For guidance on booking arrangements, including types of application for which CAS booking is mandatory, see Where to book.
Having booked in your application you will be provided with the name of the main REC and the REC reference number. This information should be entered on the first page of the REC application form. To submit your application, follow the guidance under the Submission tab for the relevant type of form.
Please note that in selecting ‘Proceed to Submission’, it does not actually submit your application to the reviewing organisation, but will store the application in your Submission History in IRAS. A submission code will be generated, which will appear at the foot of each page of the form for reference. You will then be able to save and/or print the completed form for submission.
[Top]
Do I have to attend the REC meeting?
It is not compulsory to attend the REC meeting.
However, the Committee often finds it helpful to be able to ask questions about any ethical issues arising from an application, and your attendance should help you gain approval within a shorter timeframe.
For more information about what to expect at REC meeting, see Attending a REC meeting.
[Top]
