Helen Rogers and Greig Taylor walk would-be researchers through the process of gaining ethical approval.
BDJ Team is publishing a series of articles in 2019 to inspire readers to get involved in research in dentistry. There are several roles within research studies that dental care professionals can undertake, whether helping to plan the project, collecting the data or assisting in writing up the study.
Our first article is by the two members of CONNECT (Child Oral health NortherN rEsearch CollaboraTive), a group of paediatric dental trainees committed to high quality, multi-centre research in the field of child oral health.
Research is a core function of health and social care. It should be innovative, improve the evidence base, reduce uncertainties and lead to improvements in care. Research projects should be scientifically sound and guided by ethical principles in all their aspects.1 Arguably everyone working in healthcare, especially those involved in research, should understand the underpinning principles as well as the processes involved in gaining ethical approval for research.
Ethical guidelines are accepted as imperative in the light of exploitative programmes which have taken place in the past. A notorious example was the Tuskegee Syphilis Study involving 600 African-American men in Alabama which lasted 40 years (1932-1972) and was designed to observe the natural history of untreated syphilis. Shockingly, after penicillin was developed and found to cure syphilis, none of the men in the study were told or treated. Revulsion at the lengths the researchers went to in order to improve their understanding of disease in this and other unacceptable studies led to a rethinking of the law as well as the development of ethical codes.
Social and clinical value
Fair subject selection
Favourable risk-benefit ratio
Respect for potential and enrolled participants.
Ensuring these principles are considered is the responsibility of all involved in the study1: the chief investigator, funder, research sponsor, research site, employers and health and social care regulators involved in each research study. The law may be authoritative regarding boundaries of acceptable practice but it is not exhaustive. Boundaries cannot always be regulated in advance and therefore ethical guidance and approval is needed.
Health Research Authority (HRA) and Health and Care Research Wales (HCRW)
Applications for ethical approval are now made through a single UK-wide Integrated Research Application System (IRAS) provided by the HRA/HCRW. This decision was made in an attempt to streamline the ethical, legal and governance approvals for all project-based research in the NHS. This approval combines an assessment of governance and legal compliance, undertaken by dedicated HRA and HCRW staff, with an independent ethical opinion provided through the UK Research Ethics Service (RES). This process replaces the need for local participating organisations to each carry out their checks. Adopting this approach allows each of these organisations to better utilise resources on assessing, arranging and confirming their capacity and capability to deliver the study.
For new studies led from Scotland or Northern Ireland but with English and/or Welsh NHS sites, the national R&D coordinating function of the lead nation will share information with the HRA and HCRW Assessment teams, who can issue HRA and HCRW Approval for English and Welsh sites. As mentioned, HRA and HCRW Approval apply only to the NHS in England and Wales. Studies led from England or Wales but with Northern Irish or Scottish sites, will be supported through existing UK-wide compatibility systems, by which each country accepts the centralised assurances, as far as they apply, from national coordinating functions without unnecessary duplication.
The approval process
To start the approval process, the researcher must make an account and log on to https://www.myresearchproject.org.uk. A new project should be created. A series of project filter questions will be asked. Two key filter questions need to be selected to ensure the project can be put forward to receive ethical opinion:
Question 4: ‘IRAS Form’ option should be selected (including all other applications that are needed for your research project)
Question 5: Confirm NHS involvement in your project by selecting ‘yes’.
After completing the filter questions, the researcher should go to the Navigation Page, where their application will appear in the Project Forms list labelled as ‘IRAS Form’. Selecting the label ‘IRAS Form’ will allow the researcher to access this form, and start inputting study-related information. Using the Navigate tab, the researcher can select the section of the IRAS form they wish to complete. Once the relevant information for that section has been inputted, they must click on the ‘Mark as complete’ button to complete that section. It is essential that all sections relevant to the research study should be marked as complete prior to electronic submission as if not, they will not form part of the final IRAS form. Any supporting documentation should be uploaded using the Checklist tab for the IRAS Form.
Electronic authorisations must be requested and received, from both the chief investigator and sponsor of the study, before electronic submission. Once these authorisations have been validated, the application can be submitted using the e-submission tab where a designated IRAS study number will be provided. However, this is slightly misleading as this is actually a pre-submission phase. For the application form to be submitted it must be assigned to a Research Ethics Committee (REC) using the central telephone booking system. Once booked in, the researcher will be able to submit the application electronically using the e-submission tab on the IRAS form.
For further information and support, the following link will provide a step-by-step guide on how to complete an IRAS form (https://www.myresearchproject.org.uk/help/contents/StepByStep_v2-0_20180628.pdf).
The Research Ethics Committee meeting
Research Ethics Committees (REC) are responsible for reviewing the application submitted via the IRAS system and ensuring that any ethical concerns raised by your project have been addressed. There are numerous regional committees across the UK and you can choose your preferred REC when you make the aforementioned telephone call to submit your application.. Researchers will usually book their application in to be reviewed by their local REC, so that less travelling is required to attend the meeting. Nonetheless, it is possible to book your application in with another REC that may be able to review it sooner. Each REC is comprised of experts from a wide range of healthcare specialties, alongside lay committee members, each of whom will serve for a set term. Between seven and fifteen members of the REC will meet at least 10 times per year, usually in the same location.
Once the application is booked in with the REC, they will invite a member of the study team to attend the meeting to discuss the application. Whilst attendance is not essential, it is highly recommended. Being present at the meeting enables you to explain your study further, and clarify any issues that the REC may have identified. If you have not attended a REC meeting before, it may be beneficial to ask a more senior researcher from your study team to attend with you to provide further support.
Studies that raise no material ethical issues may only require a ‘proportionate review’, in which case attendance at the meeting is not normally necessary. Further guidance on whether your study will require ‘full’ or ‘proportionate’ review can be found on the HRA website.
The REC meetings are formal, and the panel will discuss a number of applications during each meeting. You will be invited to enter the room once the panel has discussed your application and highlighted any concerns that require further clarification. Following introductions, the Chairperson may ask you to summarise your research project to ensure the panel fully understand the study in question. Next, the Chairperson will discuss the concerns raised by the panel, giving you the opportunity to justify your study plan. The rest of the panel will then be invited to ask you any further questions, and may make comments or suggestions on how potential ethical issues could be avoided.
As a minimum, anyone involved in collecting data must have completed the NIHR Good Clinical Practice Course (https://learn.nihr.ac.uk/course/index.php?categoryid=38) which is available as a face-to-face course, or an e-learning programme. Usually, the ethics application form and REC meeting would be completed by those leading the project, though it is good experience for other members of the research team to get involved with these stages as they can gain a better appreciation of the process involved.
A useful starting point could be the Clinical Research Network of the National Institute of Health Research https://www.nihr.ac.uk, the research delivery arm of the NHS.
Additionally, the Health Research Authority has quite a range of material on the web some useful links being
If the panel are not satisfied by an answer that you give them, they will explain their concerns and suggest an alternative. They will also ask you whether your project would be negatively affected if you adopted the alternative which they have suggested. Whilst you should give your honest opinion in these matters, ultimately the final decision lies with the REC. The discussion surrounding your project is unlikely to last more than 15 minutes.
The panel will not provide you with an opinion at the time of the meeting, this will be provided via email shortly afterwards. If the REC continues to have concerns about the project, the email will contain a ‘no opinion’ letter, detailing any changes or clarification that would be required before the project can commence. Once these changes have been made, a favourable opinion letter may be issued at the discretion of the Chairperson, often without necessitating another REC meeting.
Top tips for a positive REC meeting:
Read through your application in advance of the meeting and take note of any potential ethical issues that you may have not addressed. Consider the ways in which you could minimise any negative impacts on your study participants and be prepared to explain these to the REC. Remember that the application form is a large document – the panel won’t expect you to have memorised every minute detail about the project, especially if it is a large study. It is useful to bring a copy of your application with you to the meeting, so that you can refer to it if necessary.
Despite the formality, the REC meeting is not meant to be a nerve-wracking experience. The panel aim to be supportive and encouraging of the research, and allows researchers the opportunity to ask their own questions or for further clarification.
Don’t take criticism to heart
Researchers often put a lot of time and effort into planning a research project which can make it hard for them to hear their hard work being criticised. It is important to remember that the REC has a responsibility to ensure that your project meets the ethical standards, and that ultimately, their comments and feedback will make your study stronger. Try not to be disheartened; it is better to address any issues early, rather than risk complications arising later.
The ethical basis of a study is a primary concern for researchers and participants alike. Seeking appropriate ethical approval is a key part of any study, and so it is beneficial for those involved in research at any level to familiarise themselves with the requirements. Whilst applying for ethical approval for NHS-based research may at first seem to be a daunting process, it is important to remember that there is a wealth of information and support available through the HRA. We encourage you to come on board.
Helen is a Doctoral Research Fellow funded by the National Institute of Health Research, and a Post-CCST Specialty Registrar in Paediatric Dentistry based at the University of Sheffield. Helen has successfully completed her specialist examinations in Paediatric Dentistry (MPaedDent) as well as a Masters in Clinical Research. She has been involved in numerous research studies, and her current interests include child-centred research and health economics in dentistry. She is Assistant Editor for the International Journal of Paediatric Dentistry: Clinical Effectiveness Bulletin, Chair Elect for the Teachers Branch of the British Society of Paediatric Dentistry, and both Founder and Chair of the novel CONNECT trainee-led research group.
Greig D Taylor
Greig is an National Institute for Health Research Academic Clinical Fellow/StR in Paediatric Dentistry and is based at the School of Dental Sciences, Newcastle University. Greig is currently a clinical academic trainee developing his research interests whilst undertaking higher specialist training in paediatric dentistry. His research interests include: compromised first permanent molars; dental trauma; health economics in relation to dentistry; child oral health care pathways, including the liaison between primary and secondary care providers. Greig is currently the Secretary of the CONNECT trainee-led research group.
UK policy framework for health and social care research, Health D.o., Editor. 2017: London.
Emanuel, E.J., Wendler D., and Grady C., What makes clinical research ethical? JAMA, 2000. 283(20): p. 2701-2711.
About this article
Cite this article
Rogers, H., Taylor, G. How to get ethical approval for NHS-based research. BDJ Team 6, 19042 (2019). https://doi.org/10.1038/bdjteam.2019.42