ACN - 101321555 Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)
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Ethical review

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

COVID 19, human research and human research ethics review1

 

Prof. Colin Thomson AM
AHRECS Senior Consultant

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.
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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.
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Human research

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:

  1. 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?
  2. 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?
  3. 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.
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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.
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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.”
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An invitation

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.

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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

Can I use your answers anyway?0

 

Dr Gary Allen
AHRECS Senior Consultant

Many national frameworks for human research ethics, such as the National Statement (2007 updated 2018) in Australia have respect as a core principle.  An essential component of respect is obtaining the prior consent of potential participants.

The role of consent in ethical research can be traced back through the Belmont Report and the Declaration of Helsinki, back to the Nuremberg Code and earlier to philosophical, bioethics and clinical texts.

Recent egregious ethical breaches such as the Cambridge Analytica, OKCupid and Emotional Contagion cases highlight that consent problems in research are not just an issue for biomedical research and not just a 20th Century concern.

Where national and/or institutional policies discuss consent and questionnaire-based research, they will generally indicate that completion and return of a completed survey is a valid expression of consent.

Which is indeed reasonable, especially when it is important to conceal from the researcher who has participated in their research (e.g. where an academic is surveying their own students).

Most frameworks and guidance documents for the ethical conduct of human research will indicate participants should be able to freely withdraw from research without comment of penalty.

Indeed, this is again quite a reasonable position, given that genuine respect for our participants should include acknowledging that they must ordinarily be able to withdraw their consent without comment or penalty.

Solid ground thus far?  Good, because now we’re approaching the conundrum that prompted us writing this post dear readers.  For on-line questionnaires, does this mean stopping the completion of a survey whenever they want and not clicking the “submit” button?   Will this mean that the data already entered is not collected?  What if a participant changes her mind after submitting the data and wants to then withdraw her answers? If that survey is anonymous, consent and the submitted data cannot be withdrawn after submission, because the researchers won’t be able to tell which data was from which individual.

The advent of online questionnaires enabled the resolution of some problems that were largely only an online issue anyway and presented another practical ethics challenge.

A1        Using cookies to reduce the likelihood that an individual completes a survey more than once.

A2        Enabling an individual to save their progress through the survey and complete it over more than one session.

For A1 researchers should ensure the cookie does not enable them to identify respondents and ensure it will not compile any previous or future web activity.  This must be explained in the consent material and assurances provided with regard to these two matters.

For A2 the consent material should explain how password information is saved and the degree to which it can be used to identify respondents.

However, as our scenario indicates, the interesting question comes up if a respondent doesn’t finish the survey.

What happens to the information already entered into the incomplete survey?

What are the wishes of the respondents as to what should happen with these data?

The answers to these questions also depend on why the survey wasn’t completed.

Was it a combination of the participant forgetting, not having time, losing interest or struggling to log in?

Alternatively, was there a reason the individual no longer wished to participate?

Regardless of the reason, what does the individual want to happen with the use of their data?

Simple answers here are not necessarily helpful.  Assuming they forgot, etc may not be accurate and the use of their answers may be absolutely contrary to their wishes.  By the same token, losing potentially useful data merely because participants forgot might be a significant loss – especially if the number of participants is already low.

One approach in the National Statement could be used:

The relevant HREC could be asked to approve a waiver of the consent requirement, so as to enable the use of the partially completed surveys (as per NS Chapter 2.3) if they were accessible and this would need to be made clear in the survey instructions.

While the opt-out approach (also discussed in NS 2.3) might seem a promising strategy, the fact the researchers cannot correspond a set of answers with an individual means that an individual’s decision to opt-out could not be honoured.

Depending on why the individual didn’t complete the survey, the waiver of the consent requirement approach is not especially ideal.  It involves time and other resources that might be in short supply.

Proposals about the use of partially completed surveys should be discussed in the research ethics review application, the recruitment materials and consent materials.

This raises a related point: the reasons someone withdraws from a project might be of interest/importance to the researcher, their research centre, the research ethics review body or other researchers.

We propose the following strategy for a survey in which participants can be linked to their answers:

  • The consent material should discuss what will be done with the answers if the survey is only partially completed;
  • The revocation of consent process and form should be explained; and
  • The resource material for researchers and research ethics reviewers should provide a matrix that explains the treatment of survey responses.

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You will find suggested wording for the consent material and revocation form in the subscribers’ area for institutions and individuals.
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This mechanism uses an optional revocation of consent form.  It is essential that participants are told this form is optional, they can stop participating at any time, without explanation, but then using the form would be very informative to researchers.  In the subscribers’ area is both a suggestion for the questions in the revocation form and the associated text for the consent material.
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We suggest the revocation form would provide some further clarity about the matters above.  In the case of situations where a revocation form is not provided it is perhaps prudent to conclude those individuals don’t want their partially completed survey to be used.
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The same approach could be used for other kinds of research designs where data is collected at more than one sitting/point/session.
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For surveys in which participants cannot be linked to their answers, we propose the following strategy:
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  • The consent material should discuss what will be done with the answers if the survey is only partially completed;
  • The consent material could include an optional incomplete submission advice that provides researchers with information about why the survey was not completed, e.g. chosen from a dot-point list; and
  • The consent material should also clearly state that once submitted, data in completed surveys cannot be withdrawn.

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This post may be cited as:
Allen, G. (30 March 2020) Can I use your answers anyway? Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/can-i-use-your-answers-anyway

Towards a code of conduct for ethical post-disaster research0

 

JC Gaillard
School of Environment, The University of Auckland, New Zealand
Unit for Environmental Sciences and Management, North-West University, South Africa
Profile | jc.gaillard@auckland.ac.nz

Lori Peek
Department of Sociology and Natural Hazards Center, University of Colorado Boulder, USA
Profile | Lori.Peek@colorado.edu

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We recently called for a code of conduct in disaster research. This call is rooted in our respect for the research process itself and our care for affected people and the researchers who do this work. To be clear, we are calling for a cross-disciplinary conversation to advance a shared set of moral and ethical principles to help guide what we study, who we study, how we conduct studies, and who is involved in the research process itself. We are not arguing for another layer of bureaucratic or regulatory oversight such as those required in some countries by internal review boards and ethics committees. Our hope is that such a discussion will launch first within focused academic and policy meetings, before it can be scaled up to the regional and eventually international levels.

Our intent is to prompt further reflection and conversation around the following three possibilities for ensuring that disaster scholarship is relevant, fair, and ethically sound.

First, it is essential that research has a clear purpose that is rooted in present knowledge gaps and emergent context-specific research priorities in the disaster aftermath. The collaborative work that happens before disaster and in the immediate aftermath can help clarify the focus of research studies and ensure that the knowledge generated is locally-relevant and hence more likely to effectively inform response, recovery and future disaster risk reduction efforts.

Second, ensuring that research is filling relevant knowledge gaps requires that local voices be put at the forefront of the research effort. Local voices may include a range of perspectives, including those of local researchers and those who hail from elsewhere but hold deep knowledge of the places and people affected by disasters. They also comprise those voices of the survivors whose ability to deal with the event and contribute to the recovery effort is central to rebuilding damaged physical infrastructure as well as people’s lives and livelihoods. Ensuring that local researchers and survivors are in the driving seat does not exclude outside researchers when prompted by local colleagues. In many instances, outside scholars have access to a wide range of resources (e.g., equipment, funding, time) that may be unavailable locally in times of collective hardship. Crucial, though, is that local researchers have the opportunity to lead efforts associated with research design, data collection and analysis, and ultimately the sharing of findings.

Third, it is crucial that research agendas and projects launched in the disaster aftermath be ethically coordinated and involve locals and outsiders. This means that local researchers need to be identified quickly after disaster—the National Science Foundation-supported Extreme Events Research and Reconnaissance networks have already jump-started these efforts. There are many other organizations and networks globally that have advanced new methods for identifying researchers and communicating creatively in the disaster aftermath through virtual forums and virtual reconnaissance efforts that allow for a wider range of researchers to connect, communicate, and ultimately collaborate.

Engaging with the three aforementioned areas of possibility is crucial given the rising number of disasters and disaster studies. It is clear that disasters stir the interest of researchers, as evidenced by the growing number of academic publications on the topic. Most of these researchers are driven by a genuine desire to contribute to reducing suffering, but researching disasters can be difficult and there is not a clear ethical playbook for how to proceed.

This becomes especially pressing because researching disasters entails navigating a complex and sensitive environment where survivors may struggle with both the consequences of the event and the task of recovering. Meanwhile, local and outside responders try to support the relief and recovery effort. To fully grasp the complexity of the situation, researchers need to be equipped with an appropriate ethical toolkit that goes beyond the requirements of the research ethics committees of universities and other research institutions. It entails a nuanced understanding of the cultural, social, economic and political context wherein disasters unfold. For scholars who choose to work in new contexts following disasters, this sort of competence is difficult to acquire ad-hoc and in a short span of time.

With these challenges in mind, it remains a dominant pattern after major disasters that outside researchers converge and lead studies conducted in locations beyond their familiar cultural environment. In fact, disaster studies are often driven by scholars located in Northern America, Europe, East Asia, and Australasia. A review of publications on disasters over the past four decades shows that there are fewer researchers publishing studies from Africa, South and Southeast Asia, the Pacific, and Latin America although these regions of the world are those where disasters claim more lives and occur more frequently.

Such unequal power relationships in terms of who leads, conducts, and communicates research on disasters influences how disaster scholarship is framed and approached on the ground. Disaster studies are largely informed by Western ontologies and epistemologies that do not necessarily reflect local worldviews and ways of generating knowledge, which means that implications for policy and practice may be misleading.

Identifying these gaps opens up the possibility for reconsidering some of the fundamental assumptions about how research is conducted and ultimately how knowledge is generated and shared. Our call for a code of conduct is about ensuring that ethical concerns have the same primacy as our research questions. We look forward to continuing the conversation.

This post may be cited as:
Gaillard, JC. & Peek, L.  (21 March 2020) Towards a code of conduct for ethical post-disaster research. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/towards-a-code-of-conduct-for-ethical-post-disaster-research

Research ethics review during a time of pandemic0

 

Gary Allen, Mark Israel and Colin Thomson

COVID-19 is prompting changes to academic delivery, essentially intended to contain the spread of the virus and protect the most vulnerable from its effects. As more countries introduce travel restrictions and mandate self-isolation, it will no doubt change the way we conduct research.

Research ethics review needs to adapt to meet the needs of these trying times.

We have written previously about the use of proportional review and proportional processes to progress matters outside of a research ethics committee meeting.

But there will always be matters that need to be considered by a human research ethics committee.

One of the strengths of committee review and one of the reasons flying minutes are not favoured is that a committee’s membership brings together different perspectives, lived experience and knowledge.

It remains important that committees exercise their responsibilities in paragraph 5.2.31 of the National Statement.

5.2.31 Decisions by an HREC about whether a research proposal meets the requirements of this National Statement must be informed by an exchange of opinions from each of those who constitute the minimum membership (see paragraph 5.1.30). This exchange should, ideally, take place at a meeting with all those members present.

But, that does not mean committee members need to sit together in a room.  The same valuable results might be achieved with video conferencing packages like Zoom and MS Teams, Blackboard Collaborate, perhaps even aided by asynchronous online collaborations on feedback. AHRECS has worked with many institutions that already run their meetings successfully online.

Of course, institutions may need to assess their on-line or virtual meeting systems to ensure they enable chairs to be satisfied that there has been an exchange of opinion and not merely individual expressions that are unseen by other members.

In addition, AHRECS can help you take advantage of an online meeting by conducting a short professional development activity on a topic of your choice.  This would involve a further reading and reflection booklet, 15-minute pre-recorded presentation (e.g. Social Media and human research ethics) and 15 minutes of Q&A/discussion.  The cost of such an activity is A$900.

Email enquiry@ahrecs.com to discuss further.

 

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