Should I apply for an ethics review for my study?

Ethics committees commonly review research but can also add value to wider evidence gathering processes such as service evaluations, audits, and quality improvement activities. The Public Health Research Ethics Committee is open to reviewing evidence gathering processes based on the criteria described in the following document.

If researchers are new to seeking an ethics review, the Public Health Research Ethics Committee has been designed to support and guide researchers through this process. One-to-one support from the committee is available for discussions regarding the process or potential applications, along with help navigating new ways of working outside of ‘business as usual’ activity. The process aims to empower staff in non-NHS and non-academic settings to carry out evidence gathering as part of their roles and to feel confident in dealing with ethical issues in their work. 

When making an application to the Public Health Research Ethics Committee, it is important that the researcher clearly defines what question they are trying to answer. The question can then be answered by using an appropriate study design. Support with the design of evidence gathering activity can be sought from the NIHR Research Support Service, Specialist Centre for Public Health, delivered by the University of Southampton and Partners. Engagement with this support is encouraged at an early stage, ideally six-months before the work is due to start. A well-designed study will lead to better outcomes and will improve the quality of an application submitted for an ethics review. Engaging with the design support that is available and/or the Public Health Research Ethics Committee, will help to upskill researchers and support their future evidence gathering activity.

It is important to note that evidence gathering activity can be developed into research, due to it undergoing an independent ethics review. It is therefore helpful if the researcher can advise if they aspire to develop the activity into a research study, so the committee can support them in achieving this.

It may be that ‘business as usual’ evidence gathering processes are appropriate for the purpose of the work however, an independent ethics review would help to improve rigor and acceptability. 

A flowchart to determine if an ethics review by the Public Health Research Ethics Committee is appropriate, according to the evidence gathering activity being undertaken, can be viewed in appendix one. Further context on the criteria is provided below.

• An ethics review would be recommended for the following:

• Evidence gathering activity defined as ‘research’ or aspiring to develop into ‘research’. 

• Evidence gathering activity which is taking place outside of ‘business as usual’ activity for the staff involved, i.e. different to their usual role or working with a different population. 

• Where there is no established research governance process for the activity with no clear accountability, e.g. no quality control process exists. 

• Where ethical issues are identified within the activity e.g., working with a vulnerable population, the potential for additional distress to be caused to participants, or lack of informed consent for participation. 

• When this is requested to improve quality or demonstrate due diligence from an ethical risk perspective e.g., requested as part of the governance process by the host organisation or if wanting to publish the results in a research journal. 

Evidence gathering activity should be ethically accountable and this is often through professional roles being accountable to their employer. The actions of these professional roles also need to be justifiable to service users, the public, and regulatory authorities. Where no clear accountability exists for researchers conducting the work, i.e. in the absence of research governance and quality control processes from their employer, an ethics review would be recommended. 

To access support with designing evidence gathering processes, or to make an application for an ethics review by the Public Health Research Ethics Committee, please contact phethics@soton.ac.uk.