All studies which will involve people as participants need a research ethics committee (REC) review. The principal investigator (or lead researcher on the study) is responsible for seeking this review.
RECs are there to protect the rights, safety, dignity and wellbeing of research participants. So they will consider things such as fairness of the study population, burden to participants and duty of confidence.
In the UK, ethical review is usually sought from the lead researcher’s university or from one of the Health Research Authority’s (HRA) NHS RECs. NHS REC review is a requirement for certain types of research.
In addition to ethical approval, you may need other approvals or permissions in place before your research can begin. Exactly what you will need will depend on your research and what will be involved in your investigation.
You may also need a sponsor. Learn more about ‘sponsorship’ in your local research office.
Any relevant approvals or permissions must be in place before your research starts. They do not need to be in place before you apply for funding.
Resources to help you apply for ethics review
We’ve brought together the following resources to help you understand what research ethics committees will look for in applications for ethics review. Many of the resources below support the HRA’s REC review process. However, the ethical considerations outlined in these resources could equally apply to applications to other RECs.
Check if you need an NHS REC review
If you do not need NHS REC review, you may still need review by another REC. For example, if you work in a university, you may need university REC review (in line with local policy).
Additionally, you may need other research approvals. Your local research office can provide further advice on any approvals that you may need.
The remit and membership of NHS RECs
Standard operating procedures for RECs provides a useful insight into the remit of NHS RECs. Whilst much of the content focuses on the processes and procedures underpinning NHS REC review, there are sections which aim to provide NHS REC members with an understanding of specific types of research. For example ‘Background – what are stem cells’.
In terms of membership, at least one third of an NHS REC committee is made up of lay members. In addition to this, there is no guarantee that any professional members will specialise in your scientific area of expertise. All of which means that writing your application for ethics review in lay language is important.
Find out more about applying to a REC on the HRA website.
Documents needed for NHS REC review
In addition to completing the questions in the Integrated Research Application System (IRAS), you will also need to submit a number of documents to support your application. The following documents are most commonly required for NHS REC review:
- research protocol
- participant information sheets and consent forms
- summary CV for the Chief Investigator
- evidence of insurance or indemnity (for non-NHS sponsors only).
Additional documents may be required, depending on the specific study. IRAS provides a list of documents which may be relevant for your study. Make sure you upload all of the ‘mandatory’ documents.
Writing your application in lay language
As noted above, at least one third of NHS REC members are lay. Therefore, writing your application in plain English (in language that can be understood by members of the public not working in your field) should help facilitate your ethics review.
The HRA’s resources for helping you to write plain language research summaries and plain language summaries e-learning module are designed to help you write a research summary. The e-learning module is on Centric Cortex linked to below in the ‘HRA eLearning for NHS REC members is useful for applicants’ section).
However, the ‘general principles’ can be applied more widely to help you write for a lay audience.
Consent and preparing participant information sheets
Outlining how you will obtain informed consent from participants and the documents which will support this are key pillars in your application. The HRA and MRC consent and participant information guidance contains examples and templates that support the consent process.
As part of their Think Ethics programme, the HRA have introduced a new policy for participant information (13 June 2022). The policy means all participant information will have to meet a measurable standard to be reviewed by an NHS REC.
Additionally, researchers will have to work with people with relevant lived experience when writing the participant information.
Health-related (or clinically significant) findings
Researchers must decide what their strategy will be regarding the feedback of any health-related findings to individual donors. Guidance on what to consider when developing such a strategy is available in the Wellcome Trust and MRC framework on the feedback of health-related findings in research.
Equality, diversity and inclusivity
Considering diversity and inclusion when designing your clinical studies is extremely important.
Research has shown that clinical trial populations do not always reflect the diverse population in which a treatment will be used. This can lead to benefits or problems seen in trials not translating well to real world application.
There is a 15 minute e-learning module around this (INCLUDE E&D – eLearning). This e-learning module is on Centric Cortex linked to below in the ‘HRA eLearning for NHS REC members is useful for applicants’ section.
CTIMPs, medical device and diagnostic studies
You should now apply for NHS REC review of a clinical trial of an investigational medical product (CTIMP) (or a combined trial of an IMP and an investigational medical device) using IRAS for combined review.
When filling in your application, make sure you read the guidance in the grey fields as these fields tell you what information you need to provide.
If you are applying for NHS REC review of a medical device (including software), you will find useful links on HRA’s medical devices and software applications.
If you want to apply for NHS REC review of a clinical investigation for a medical device, you will need to fill in standard IRAS. Make sure you use the green ‘i’ buttons beside each question so you know what information is expected.
In addition to question specific guidance, you can also read guidance on preparing and submitting applications for ethical review in IRAS.
HRA eLearning for NHS REC members is useful for applicants
The HRA Learning Management System (Centric Cortex) has a wide variety of e-learning modules. Some of these are tailored for REC members, so they can help you see research through their eyes, and consider the ethical implications of your own research.
The links below take you directly to the course, once logged into Centric Cortex. You need to use the ‘enrol’ and ‘launch’ buttons to start any of these modules (or ‘retake’ and ‘launch’ if you’ve done the module before).
If your research involves gene editing, and the CRISPR-Cas9 technology in particular, then two videos aimed at REC members may be of interest. Dr Annie Etuk’s first video provides an overview in lay language. CRISPR-Cas9 genome editing: clinical applications includes useful food for thought on what to say in your application about risk and risk mitigation when applying CRISPR-Cas9 in a clinical setting. The relevant section starts at 7:45.
If you are applying for ethical review of a research tissue bank, then the module How to ethically review a Research Tissue Bank may be of interest, particularly the section on ‘Ethical issues’ (pages six to 15).
Research involving Human Tissue – eLearning may also be of interest. You can choose to view the course by audience, such as ‘REC’. We also provide guidance on using human samples in research and Research and human tissue e-learning.
If your research will include participants younger than 18 years of age, there are specific ethical considerations. Consent Assent Dissent offers a seven minute overview of this terminology. You may also find the MRC and ESRC guidance for involving children in research useful.
There will be different considerations for different kinds of stem cells. This review article touches on some of the ethical concerns on different type of stem cells.
UK Research and Innovation has published a booklet which is intended for use by young people but covers the ethical concerns surrounding stem cell research very well and gives insight into concerns of the general public.
There is also guidance on applying for ethical review of stem cell therapies in ‘Annex H’ of the standard operating procedures for RECs.
Data driven technology and artificial intelligence (AI)
When developing data driven technology for the healthcare sector, you will have to address any ethical issues which may arise from its use.
A guide to good practice for digital and data-driven health technologies is designed to help innovators and researchers understand what the NHS expects from the technology it procures for its services. Section 1 is ‘How to operate ethically’ which signposts the Data Ethics Framework.
The World Health Organization document: Ethics and governance of artificial intelligence for health is a good source of help when considering ethics and AI.