Ethical oversight during COVID-19: rewriting the norms of research ethics review?

By Anna Chiumento and Lucy Frith

One consequence of physical distancing in response to the COVID-19 pandemic has been the rapid suspension or adaptation of ongoing research activity.  This presents an opportunity for the research ethics community and researchers to promote ethical oversight that integrates the situated and informed judgement of researchers, rebalancing away from bureaucratic forms and procedures.  In this post we focus on research granted ethical approval by UK University Research Ethics Committees (RECs) or the NHS Research Ethics Service that had begun participant recruitment and data collection prior to the COVID-19 outbreak.

Physical distancing imposed in March 2020 led to research suspension or the alteration of research design.  In response to an expected influx of requests for approval of study amendments, University RECs and the NHS Health Research Authority developed guidelines for how these would be managed.  Broadly, for research suspension participants must be fully informed about the decisions taken, and continue safety monitoring where required.  These decisions and interactions with participants are wholly entrusted to researcher judgement and do not generally require informing RECs.  For ‘high risk‘ studies (i.e. with populations considered vulnerable or that investigate sensitive or potentially distressing topics), full REC review and approval of research amendments are required.

For research considered ‘low risk’ – i.e. with adults not considered vulnerable, and researching topics not considered sensitive, offensive, or that may cause distress – researchers are asked to self-assess the ethical implications of adjusting research methods, where this is possible within the research design.  Typically, alterations involve changing from a face-to-face to remote formats such as from in-person to online surveys, or in-person to telephone or online interviewing.  These research methods amendments raise ethical issues including equity of access to participate in research, privacy and confidentiality for both researchers and participants, and the training and skills of researchers in the revised methods.

While changes to low-risk studies require the submission of amendments to REC’s, the depth of ethical oversight is categorised by the level of risk to research participants.  This means lower risk studies receive administrative REC approval, whilst amendments that increase potential risks for participants are reviewed by one or more REC members.  This aims to ensure that higher risk research has input from REC members trained to scrutinise research for its ethical implications, and to balance ethical principles to reach judgments about the ethical acceptability of proposed amendments.

What is interesting in these shifts is how the depth of REC review has been scaled-back from procedures that generally required review of all study amendments, regardless of their impact upon level of risk to participants.  The system brought about in recent weeks has entrusted researchers of low-risk studies with the moral authority to assess and reach informed judgments about the ethical acceptability of continuing their research, subject to REC agreement.  As such, the norms governing ethical review of low-risk research are being quietly re-written, and the ethical implications of this need to be examined and discussed.

These tentative steps towards an updated model of research ethics oversight embrace proportionality, ensuring that studies receive ethical scrutiny commensurate with their level of risk, recognising an important role for the informed and situated ethical expertise of researchers.  To become embedded these changes may require researchers to have access to additional support, guidance or training on how to balance ethical principles to reach informed judgments, and to consider the potential ethical implications for participant engagement, researcher skills and training to implement methods well, and ultimately the research findings.

The current shift to embrace researcher-driven balancing of ethical principles to reach ethical assessments of low-risk research may stimulate ethical engagement throughout everyday decision-making in research.  By placing ethics as central to everything we, as researchers, do we have the opportunity to enhance everyday research encounters, to the benefit of researchers and participants alike.

Many have expressed the view that research ethics review has become overly bloated, bureaucratic, and a “hurdle” to overcome.  The subtle changes brought about as a result of COVID-19 offer a window of opportunity to demonstrate that alternative models of research ethics oversight are possible.  Developing and scrutinising these could show how the previous ethical review procedures act to abdicate researchers’ sense of moral responsibility to RECs, whilst the new procedures instituted as a result of the pandemic demonstrate that there is no substitute for researchers making engaged, thoughtful, and situated ethical judgments.

Authors: Anna Chiumento1, Lucy Frith2

Affiliations:

1 Department of Primary Care and Mental Health, University of Liverpool

2 Department of Health Services Research, University of Liverpool

Competing interests: The authors declare they have no competing interests.

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