How to apply for research ethics committee approval
This article explores when and where ethical approval is required and how this should be undertaken.
This article explores when and where ethical approval is required and how this should be undertaken
Research ethics normally refers to the moral principles that guide research (Economic and Social Research Council [ESRC] 2015). Research ethical approval is a requirement when undertaking health research. Securing ethical approval usually involves the chief investigator applying to a relevant ethics committee where the study is considered by a panel of experts and lay members to decide if the research is safe and justified.
Takes responsibility for the conduct of the proposed research.
In the UK, when research involving children and young people and/or families requires recruitment from a healthcare setting, approval will be needed from the NHS Research Ethics Committee (NREC).
Approval will also be needed from the local research and development (R&D) office on the site where the research will take place.
If research is being undertaken as part of a programme of study or by university employees, approval should be sought from the Higher Education Institute’s Ethical Committee (usually before NREC).
Considering ethical issues related to the proposed research should start at the beginning of the development of a research question, proposal and protocol. The researcher should be certain that the research is justified; consider whether the research is insensitive, unachievable or a risk to participants’ safety.
The ethics committee would expect clear rationale, justification and evidence for the research to be undertaken before approving the study.
Patients and/or the public should be involved in the research design to ensure it reflects patient need and results are more likely to benefit patients and the improvement of care (Royal College of Nursing (RCN) 2012).
Research with vulnerable participants is ethically acceptable as long as consideration is given to the particular needs of participants.
NHS Research Ethics Committees
Comprises up to 18 expert researchers/health professionals and lay members. They consider whether proposed research is ethically acceptable to safeguard the rights and safety of potential research participants.
Research exploring children and young people’s care and treatment needs and/or experience, means that participants might be children, young people, parents, carers, guardians or other relatives.
Children under the age of legal consent are considered vulnerable. Researchers in these situations must be familiar with The Children Act (1989). Other vulnerable persons include frail or older people, those lacking mental capacity according to The Mental Capacity Act (2005), people with learning disabilities and pregnant women.
If research is undertaken with vulnerable groups, rationale and protocols will be required to ensure the physical and emotional safety of participants.
Issues to address
Informed consent is crucial for undertaking a study ethically. Children’s nurses are familiar with this concept and in research terms, the principles of informed consent must be applied to all participants.
Researchers wishing to conduct research in the NHS must have management permission from each NHS site, obtained through the trust’s research & development department.
Anonymity of participants should be safeguarded throughout the research process. This can be achieved by allocating a unique number or pseudonym to each participant. Participants have the right to expect that any information they share will be confidential – and should be with the participants’ consent.
Storage, security and retention of data needs to be in line with guidance from the NHS Research Governance Framework (DH 2005).
The safety and psychological wellbeing of researchers is an additional consideration. Data collection as a lone worker, may put researchers in risky situations. Risk assessment and lone-worker policies should guide the researcher’s safety.
Submitting an application for ethical approval
Applying for NREC approval involves a rigorous online application. Once submitted, the chief investigator will be asked to attend a regional meeting of the NREC. The committee will ask any questions arising from documentation and may request revisions. On permission being granted, R&D approval can progress.
Research ethical approval is a process that should start at the initial research conception and design stage. It is an in-depth process that cannot be rushed. There are guidance documents that can assist such as Planning a New Qualitative Study with Children, Young People and Families (RCN 2012).
Research ethics applications should address key factors such as informed consent, confidentiality, anonymity, data protection and storage and researcher safety.
- Department of Health (2005) NHS Research Governance Framework. DH, London
- Economic and Social Research Council (2015) Framework for Research Ethics. esrc.ac.uk/files/funding/guidance-for-applicants/esrc-framework-for-researchethics-2015/ (Last accessed: 30 June 2016.)
- Royal College of Nursing (2012) Planning a New Qualitative Study with Children, Young People and Families. RCN, London
Michaela Barnard is a lecturer in children and young people’s nursing at University of Salford, UK, on behalf of the RCN Research in Child Health (RiCH) network core community