By Chiara De Poli (Care Policy and Evaluation Centre, London School of Economics and Political Science)

In this blog, Chiara De Poli, Research Officer at the Care Policy and Evaluation Centre based at the London School of Economics and Political Science (LSE), outlines key messages from a recent journal article in PLOS ONE on research ethics. She unpacks the origins of research ethics guidance, highlights challenges translating research into practice, and charts out a way forward for collaborative research.

How did research ethics originate

The current research ethics frameworks that oversee how research involving human participants is conducted in the UK and internationally, were developed in response to major scandals and ethical violations in medical research from the 1930s to the 1970s. Regulation and guidance on research ethics were founded on the principles of respect for participant autonomy, justice, beneficence (i.e., to do ‘good’), and non-maleficence (i.e., to do no harm). Initially, they were introduced to regulate biomedical, experimental research only. However, they since have been expanded to cover nonbiomedical, social sciences research, including non-experimental research methods.

The aim of this move was to protect participants in all types of research. Participating in research, even social sciences research, might involve risks (to confidentiality, autonomy) and harm (physical and psychological) that should be avoided. However, applying these standards outside of the original biomedical field has proved difficult.

For example, it is often difficult to fit some social sciences research that is designed to adapt to participants’ demands and changes in context to a standardised research protocol template. Research that uses qualitative or mixed methods, emergent designs (such as participatory research) or collaborative approaches (e.g. co-creation, co-design, co-production), as well as research that involves populations perceived as vulnerable, are examples of this.

Research ethics: policy vs practice

In a recent journal article, we compared how the research ethics system is expected to work according to current research ethics regulation and policies against how it works in practice in the context of collaborative health and social care research.

We analysed the UK research ethics policies which govern research in health and social care to establish how the research ethics system is expected to work. From this analysis, we identified twelve overarching themes, for example, participant protection. We also were able to unpack the related normative principles and operational processes upon which the UK the research ethics system is built. Then, we conducted a scoping review of the literature published between 2010-2020 and complemented it with focus group data collected from active researchers working in this field in England. This helped us establish how the research ethics system operates, in practice, in relation to collaborative health and social care research.

Our review identifies three types of results:

1. Some themes and principles underpinning research ethics policies are sparsely covered in the literature, possibly because they are not considered core aspect of research ethics. This includes themes around compliance with legislation, integrity, quality and transparency of research.
2. The literature discusses two themes, labelled as ‘Training on research ethics’ and ‘Research Ethics Committee (REC) membership’, which are not codified in UK policy documents. The UK Policy Framework focuses solely on the competencies and qualifications of research teams. It assumes that REC members are competent to review any type of study, regardless of their actual research expertise. Policies do not address REC membership and their expertise either, which may result in a mismatch between the expertise of REC members and the type of research studies they review. Focus group participants resonated with this, and shared the idea of establishing RECs with specialist interest in specific research approaches, topics, or populations, as a possible solution to this issue.
3. We found that other themes, such as the working of RECs and the research protocol, have received substantial attention in the literature and fundamentally resonated among focus group participants. Results across themes, principles, and processes, were highly coherent and seem to converge around issues in how the research ethics system deals with collaborative research. This seems to show that the positivist approach to research ethics is not suitable for reviewing research that is not positivist in nature.

Overall, our work does not question the need for regulation and ethics oversight of research, but we believe that the current rule-based and procedural approach to ethics needs to be re-evaluated.

Translating ideas about ethics into practice

Our findings have led us to endorse processes of ‘micro ethics’, ‘situated ethics’, ‘relational ethics’ and practices of ‘ethical mindfulness’ and reflexivity on the part of individual researchers. All of these approaches involve effort by the researchers to listen, attune and align to the participants, and to tend to the relationships with them as the research unfolds. We also offer some suggestions on how to translate these ideas into practice. Some of these include creating RECs with specialist methodological expertise, creating opportunities for research ethics mentoring throughout a research study, and ensuring that research ethics documents are genuinely accessible (i.e., shorter and simpler) to participants. The findings from this work contribute to an agenda for improving research ethics for collaborative research in the health and social care field, and beyond.

Further reading on research ethics for health and social care research

De Poli, C., & Oyebode, J. (2023). Research ethics and collaborative research in health and social care: Analysis of UK research ethics policies, scoping review of the literature, and focus group study. PLOS ONE, 18(12), e0296223. https://doi.org/10.1371/journal.pone.0296223

DEEP. (2020). The DEEP-Ethics Gold Standards for Dementia Research. DEEP. https://www.dementiavoices.org.uk/wp-content/uploads/2020/07/The-DEEP-Ethics-Gold-Standards-for-Dementia-Research.pdf

Fletcher, J. R. (2021). Unethical governance: capacity legislation and the exclusion of people diagnosed with dementias from research. Research Ethics, 17(3), 298–308. https://doi.org/10.1177/1747016120982023

Goodyear-Smith, F., Jackson, C., & Greenhalgh, T. (2015). Co-design and implementation research: challenges and solutions for ethics committees. In BMC Medical Ethics (Vol. 16, Issue 1, p. 78). BioMed Central. https://doi.org/10.1186/s12910-015-0072-2

Opsal, T., Wolgemuth, J., Cross, J., Kaanta, T., Dickmann, E., Colomer, S., & Erdil-Moody, Z. (2016). “There are no known benefits.”: Considering the risk/benefit ratio of qualitative research. Qualitative Health Research, 26(8), 1137–1150. https://doi.org/10.1177/1049732315580109