We at AHRECS, like all our friends, colleagues and clients, are becoming more and more aware of the immediate and probably long-lasting impact of this pandemic on almost every part of our lives. It has compelled researchers to vary methodologies adopted for both ongoing and planned human research. It has also been forcing institutions to adapt human research ethics review processes to enable responsible social distancing.
In this brief item, we are opening a conversation to offer assistance, ideas, successes and strategies to achieve these changes while maintaining the ethics and quality of human research and ethics review.
Human research ethics review
A number of our clients have long been conducting ethics review meetings online because of geographical necessity. Australia’s regional universities have led these innovations and acquired considerable experience in managing to achieve effective, efficient and quality ethics review. They use different online platforms and have experience of the strengths and weaknesses of several of these in running both synchronous meetings and asynchronous review processes.
They also have experience of assisting those committee members who have been reluctant to review digital applications. The current crisis may compel further limitations on such assistance; for instance, institutions may be unable to print and dispatch agenda papers and members may be less willing to receive them. Experience in enabling less IT-savvy members to adopt online processes with comfort could be a value now to other institutions making these changes.
There may also be substantive issues in addition to these ones of process. For example, how does COVID-19 change our perceptions of merit; what if it shifts the balance in an unfavourable direction after a project has been approved?
We have asked some of our clients who have these experiences to respond to this item and encourage others to either offer or seek assistance, not necessarily through AHRECS, but directly. This may be the time in which the development of broader community of human research ethics review practice will be more needed than ever.
For researchers, particularly those with approved projects that involve interaction with participants, the new restrictions on physical distancing and self-isolation are likely to present significant difficulties in continuing and completing their projects. They will need to change the manner of that interaction and the ways they collect the data they need so as to limit risks to participants and to themselves.
In normal circumstances, such changes would require prior ethics approval to conform to the conditions of approval that the National Statement requires (National Statement 5.5.6 (c)). However, the consequences for researchers of seeking prior approval may have a greater impact on the continuity and completion of their work and, in busy research institutions, lead to a significant workload increase in approval requests for urgent project variations. In addition, those alterations to data collection will involve, in due course, changes in the manner in which data are stored, used and either retained or destroyed, all of which would, in normal circumstances, require consent from participants.
Other issues that researchers may face include:
- Identifying and fulfilling the responsibilities that arise when they have to close down their research, e.g. can they use data already collected? Do they inform participants and, if so, how?
- What obligations they may have to participants who are distressed by the current situation, especially when relevant to the research, as it is entirely foreseeable?
- How do they continue to engage in consultations to which they are committed, whether with communities or with all stakeholders?
In the situation that now presents itself, new strategies will need to be devised and it is likely these will depend more than ever on the ethics reviewers’ trust of researchers. For example, an institution could permit researchers to make urgent changes themselves to data collection methods in order to protect participants and meet COVID-19 limitations on condition that they notify the ethics reviewers as soon as practicable following the implementation of the change. That later application could also include a request for approval of changes to data use, management and retention or destruction.
Guidance for researchers
Australian governments at Commonwealth, State and Territory level have provided combined guidance for researchers, especially those conducting clinical trials and other institutions have combined to offer practical advice for researchers on how to negotiate needed changes and ethics review.
Research about COVID-19
The COVID-19 situation will generate research initiatives, not only in relation to the immediate medical needs such as vaccines, but also about the impact on health professionals, researchers, and families of those victims of infection, serious illness or death, as well as about the social impact of information, social distancing and self-isolation.
In vaccine projects, issues of justice in inclusion of participants are likely to be difficult to resolve: should all be included or only those capable of a voluntary consent. And achieving an ethically sound consent will be complicated by the need to provide sufficient information, counter the possibility of social pressure to participate or the heightened influence of health professionals. As Haaser says, “It is not easy to say no to a hero.”
In this brief note, these are but early suggestions. We invite our readers to respond to these thoughts with ideas and experience of strategies that they, as researchers or ethics reviewers, have adopted to address the new needs.
Further, and more importantly, this invitation is to encourage institutions, ethics review administrators, ethics review committees and researchers to exchange their ideas and their experiences. It may be ironic that one of the effects of the COVID-19 crisis is to promote a wider community of good ethical human research practice – but it would nonetheless be a very good outcome.
This post may be cited as:
Thomson, C. (18 April 2020) COVID 19, human research and human research ethics review Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/covid-19-human-research-and-human-research-ethics-review