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Participant protectionAustralasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)
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, through 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 consent form 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. However, 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 If that survey is anonymous, consent and the submitted data cannot be withdrawn after submission, because the researchers won’t be able to tell which data was from which individual.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 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:
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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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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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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
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
Kate Young, Research Fellow, School of Public Health and Preventive Medicine, Monash University
Profile | Kate.Young@monash.edu.au
This post originally appeared on Monash Lens
Endometriosis is finally a hot topic.
We’re hearing more and more women’s stories of having their pain dismissed by loved ones and doctors. Stories of lives being derailed by debilitating symptoms. And stories of strength and determination to make the next woman’s experience a little better.
About 1.5 per cent of the female population worldwide has endometriosis. It’s a chronic disease formed by tissue such as the lining of the uterus (the endometrium). This tissue forms lesions that stick on, and sometimes invade, organs such as the ovaries and bowel.
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Symptoms of endometriosis include painful and heavy periods, diarrhoea and painful sexual intercourse, to name a few. The most accurate form of diagnosis is through surgery. The disease can be removed by surgery and managed with hormonal therapies (such as the contraceptive pill), though about half of all women will redevelop symptoms after treatment.
As a public health researcher, I’m interested in how healthcare for endometriosis can improve women’s experiences of the disease and lives overall.
My research addresses the social, cultural and historical factors that shape what goes on between women and their doctors. Are these interactions meeting women’s diverse needs? And does their healthcare foster their full participation in society?
Room for improvement
My research with doctors suggests there’s room for improvement.
I interviewed eight gynaecologists and four GPs about their views on providing care to women with endometriosis.
The doctors expressed empathy and concern for women with endometriosis. However, they were challenged by those they didn’t know how to help. (This is a lot of patients, considering there’s no effective long-term treatment for at least half of all women.) In response to this challenge, clinicians often turned to the ‘hysteria myth’.
The hysteria myth attributes the cause of women’s illnesses – usually ones that have no clear medical explanation at the time – to their psyche (mind) and failure to uphold their ‘biologically destined’ role of mother. An example of this is Plato’s wandering womb – disease in women was attributed to their uterus wandering around their body, with the ‘cure’ being pregnancy to anchor it. This is echoed in the modern-day trend of doctors recommending pregnancy to women with endometriosis, despite no research evidence for benefit.
There’s little quality research to guide doctors in their care of women with endometriosis. They’re expected to always have an answer for the people who seek their care.
Most doctors began their interview by distinguishing between what we termed ‘good’ and ‘difficult’ patients (labelled by one gynaecologist, the “endometriotic cripple”).
‘Good’ patients were women who accepted their doctor’s interpretation of their disease and symptoms, and didn’t pose a challenge to their doctor.
‘Difficult’ patients were typically women who didn’t find relief from available treatments and who repeatedly returned for help. These women’s symptoms were attributed to their psyche. As one gynaecologist said:
“They [women] make that the focus of a lot of things that go wrong, and perhaps endometriosis has to play a larger part in their lives than it necessarily has … Depending on their … psychological system and ability, I think they make that the focus of their lives, the reason why they can’t go on and do things. They’ve got something to blame.”
Another gynaecologist, however, made a similar distinction but with no value judgement. She said:
“Some people are able to be philosophical about those kinds of things and think, ‘Oh, you know, that’s what nature’s dealt me and I’m just going to have to deal with it and get on with it.’ And for other people it’s a grief response that is much more difficult to deal with and find their way through, and the extent to which that’s influenced by things like people’s sense of self-worth that might relate to their employment or other roles in life … There’s a whole lot of things; I don’t think it’s simple.”
When asked about the potential impact of living with endometriosis on women’s mental health, one gynaecologist stated: “Do mad people get endo or does endo make you mad? It’s probably a bit of both.” Another hypothesised that one of his patient’s symptoms was a “psychosomatic expression” of “matrimonial disharmony”.
Women deserve better
As a woman and feminist, these things were hard to hear. But they weren’t surprising. These findings are consistent with the research into women’s experiences of endometriosis and with the stories shared in the press and social media. There’s no question that women deserve better than this.
But the answer doesn’t lie in condemning individual doctors.
Doctors attributing women’s symptoms to their psyche reflects society-wide beliefs about women and their bodies that have persisted for much of documented human history. (Remembering that it’s largely men who have been doing the documenting.) Beliefs that the sole purpose of women is to reproduce, that they are volatile and controlled only by their raging hormones, and that they’re not to be trusted or believed. These are beliefs that we all, including myself, participate in perpetuating to varying extents.
There’s little quality research to guide doctors in their care of women with endometriosis. They’re expected to always have an answer for the people who seek their care. Our medical system and culture make it difficult for a doctor to say, “I’m sorry, but I don’t know how to help you.” (Though the women in my research valued doctors who did do this.)
We must give clinicians the training and support they need to provide comprehensive healthcare for women with endometriosis. This care should foster women’s full social and economic participation; clinicians need the skills to recognise when their practice may be impeding it.
We must do better.
This post may be cited as:
Young, K. (13 March 2020) Endometriosis, women’s health and the ‘hysteria myth’. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/endometriosis-womens-health-and-the-hysteria-myth
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