“Regulations don’t solve things. Supervision solves things” Wilbur Ross 2015
Dr Gary Allen, Prof. Colin Thomson AM and Prof Mark Israel AHRECS Senior Consultants
HDR supervisors should, and often do, play an important role in the formulation of a candidate’s research ethics review application. If you talk to an experienced busy research ethics committee member, they will tell you they’ve seen too many applications where there wasn’t any indication the supervisor even saw the application prior to its submission.
Many institutions consider the supervisor to be the lead investigator for candidate research. Even those that don’t usually will expect the supervisor to be a key adviser and mentor for the candidate’s passage through the research ethics review process.
A supervisor not taking an active role in a candidate’s review application can reflect a worrying attitude: “I don’t have time to know about research ethics in detail. The candidate should submit what they have, the experts on the committee can tell them what they need to fix and how they want it changed.”
Such thinking is irresponsible and concerning at numerous levels, not least because research ethics is a fundamental component of the quality design of research.
Being able to think and write about ethical challenges is an essential component of the research training of new researchers.
A supervisor or a research school that isn’t systematically engaged in a candidate’s ethical capacity-building and professional development is failing them.
But a not unreasonable question is “What should I be looking for, when I read an HDR candidate’s application?” A reader of the Research Ethics Monthly asked for a tool she could use.
Attached here is the start of such a tool. The Research Ethics Monthly community includes some very experienced research ethics reviewers. It would be deeply appreciated if you could comment on what we have drafted and suggest other elements for the tool.
Elle Loughran Student, Trinity College Dublin Elle Loughran is a Laidlaw scholar studying genetics at Trinity College Dublin in Ireland
This post first appeared in Spectrum, the leading site for autism research news.
I am a student and researcher studying evolutionary genetics, and I am autistic. I often come across papers on autism research, but unfortunately, reading them is rarely a positive experience.
Too much autism research fails to acknowledge autistics as people who can read and make valuable contributions to the field. Instead, it casts them as little more than passive study participants or recipients of treatment. This shortsightedness damages research and scientists’ ability to help autistic people.
Reading autism research as an autistic person can feel like being treated as an alien. For example, consider a 2019 paper that stated: “This finding reinforces other work which shows that autistic people can have, maintain, and value close romantic relationships and friendships.” Imagine how bizarre it would be to read that about yourself.
I do not mean to pick on that paper in particular, but on a research culture in which anyone would think that sort of statement needs to be made.
This sort of culture results in seeing top researchers throw around blatantly wrong and offensive ideas about my community. For an old but powerful example, British researcher Simon Baron-Cohen endorsed a quote that suggested autistic individuals experience people at dinner parties as “noisy skin bags” that are “draped over chairs.” In my view, the appropriate response to that is, “No, that is absolutely not how we experience anything. What the hell?” Of course, that would not be an appropriate academic reply.
I understand that even seemingly obvious things need to be examined and tested in science, but if someone were to suggest that the moon is made of cheese, I doubt researchers would insist on disproving it with a study. Yet somehow autistic people must be so strange and unknowable to researchers that they cannot dismiss equally implausible characterizations of us.
In fact, many autistic people are available to answer questions about how we see things. Many of us speak up and share our stories proactively. It can seem to us as if scientists are not listening.
Then there are papers that suggest society would rather fewer people like me existed — and not because they care about my suffering. Or those that survey the prospects of preventing autism, pointing out that these are “high priorities for researchers, parents, advocates, clinicians, and educators.” Why is there is no mention of autistic people on that list?
Integration barriers:
The opportunities for someone like me to correct the culture in autism research are limited.
Often when I see these things in the course of my work, I just sigh and ignore them. If I’m discussing a paper with my scientific peers, I do not want to bring up issues with the paper’s treatment of autism and be seen as an ideologue, research subject or object of pity rather than as a respected colleague.
Other people’s responses can also thwart meaningful exchange. Last summer, I ‘came out’ as autistic while in conversation with an autism researcher and several of her colleagues. The people in the group responded with something along the lines of, “Oh, well, you’re not like other autistic people, so those points do not apply to them.”
If a person’s ability to converse with you makes you assume she is not like ‘real autistics,’ then your idea of autism is automatically going to be ‘people who can’t talk to me.’ You will have a flawed understanding of autism and may not be able to see autistic people as potential colleagues. This risks researchers perceiving autistic people purely as research subjects who do not talk back, have opinions or contribute to the process.
Autistic people are treasure troves of information on their own lives. By including more autistic voices in research, we as scientists could improve our ability to gather knowledge about the condition.
Given the flaws in prevailing theories of autistic psychology, I believe we should encourage more qualitative, open-ended research that seeks input from autistic people and establishes a firmer basis for future studies. We could also seek their help in prioritizing treatment targets. Likewise, if biomedical researchers are going to get funding for studying autism, they must make more of an effort to engage with the autistic community and their wishes.
Things are getting better, and many researchers are doing good work. But listening to autistic people could help them make faster progress. Autistic people are not aliens with whom scientists cannot communicate. We are right here. We are reading what you have to say, and that communication can go both ways.
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. .
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:
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.” .
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.
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.
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.
. You will find suggested wording for the consent material and revocation form in the subscribers’ area for institutions and individuals. .
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. .
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. .
The same approach could be used for other kinds of research designs where data is collected at more than one sitting/point/session. . .
For surveys in which participants cannot be linked to their answers, we propose the following strategy: .
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.
The senior consultants started AHRECS in 2007. We were looking for a way of responding to requests for advice on research ethics and integrity from the government, health and education sectors read more...
Comments’ rules
We decided to include comment functionality in the Blog because we want to encourage the Research Integrity and Human Research Ethics communities to contribute to public discourse about resourcing and improving practice. read more...
Random image from the AHRECS library. These were all purchased from iStockPhoto. These are images we use in our workshops and Dr Allen used in the GUREM. Less
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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.