Research Ethics Committee (REC) members recently debated the issue of inclusion of under-served groups in health and social care research.
Shared ethical debate is a quality assurance exercise designed to support consistency of reviews between different RECs, as well as to give a detailed understanding of the views of RECs on emerging issues relating to research ethics. It also helps develop a consensus on different research ethics related topics.
The topic was chosen in liaison with the devolved administrations and supports our joint work with the Medicine and Healthcare Products Regulatory Agency (MHRA) in improving diversity in research participants.
21 out of 84 RECs in the UK took part in the debate, which discussed the following questions:
- How do RECs examine whether exclusion criteria in research disproportionately excludes those in under-served group?
- What evidence can researchers provide to show they have considered under-served groups as part of their research planning, design and publication?
- What assurances could be sought to demonstrate the proposed study population has been considered in the research application and how can the HRA support RECs in doing this?
Debate themes
Key themes emerged during the debate, which included:
- There is a considerable overlap of research exclusion criteria with under-served groups. Whilst it may be necessary to exclude certain demographics e.g. pregnant people or those over a certain age, this is highly dependent on the research question. The exclusion criteria should be scrutinised against the population which the outcome of the research is intended to serve, to minimise the unnecessary exclusion of certain demographics
- How language and translation of research documentation disproportionately affects under-served groups. Issues ranged from studies excluding those who cannot speak or read English, to complexity of documentation for those with limited literacy. Lack of funding is often cited as a reason for lack of translated documents, which RECs challenge. The NIHR provide funding for the cost of translated participant documents, which some RECs signpost to
- Access to technology disproportionately affects certain groups and presents a barrier to research participation. This linked to study recruitment as well as participation, with many studies advertised online
- The authority of RECs to challenge researchers and the role of the HRA in educating and supporting researchers to be more inclusive in their research design. Supporting an evidence-based value of the inclusivity of research could be a strong driver for change
- RECs also discussed how they assess the consideration of under-served groups, with many RECs looking out for patient and public involvement
Naho Yamazaki, Deputy Director of Policy and PartnershipsThe debate has given rich insights into how RECs manage issues of representation of under-served groups in research, and the barriers they encounter. Their views are vital in realising our strategic commitment to include, by ensuring research is done with and for everyone.
The RECs shared some great ideas, such as adding a question to IRAS as a prompt for research applicants.
Some discussions also indicated that RECs were unsure on the level of authority they have to ask for inclusion of under-served groups when reviewing research.
The outcomes of this debate will be used to help inform the guidance we are developing with the MHRA, to help researchers to improve the diversity of participants in their research. The debate also gave us a good reminder about how we need to develop guidance and offer support for RECs as well as researchers, and we plan to follow this up.