Aviva Kipen, Union for Progressive Judaism and Progressive Judaism Victoria.
In 2015, I earned a Doctor of Ministry Studies degree from the University of Divinity in Melbourne. The thesis, investigating how 13 Christian and Jewish clergy experienced HREC service in their pastoral care roles, arose from my own human research ethics committee and Victorian Biotechnologies Ethics Advisory Committee service and extensive interfaith work. I had been mentored into my service to the Monash University HREC by the Rev’d Dr Judy Redman, the then Victorian Uniting Church Outreach Ministries Coordinator. I found myself in the company of Anglican clergy and had succeeded Catholics – nuns and priests – Buddhist monks and also male rabbis who had served before me. Joining Judy, the serving female minister, made the gender issue less remarkable than it might otherwise have been, even in the late 1990s. The faith interchanges on succession raised my immediate curiosity that would later lead to the research question and the project on which this piece draws.
The then National Guidelines were clear: we clergy appointees were not there to push our own denominational barrows. Still, I became curious about what was really going on in the minds of others who served HRECs interchangeably from a range of faiths and traditions regardless of often-irreconcilable theologies in the ‘pastoral chairs’. My interfaith work meant I was confident that, in the event of content matters being beyond my own repertoire, I would have an extensive network from which to seek expert guidance if asked to do so. But HREC appointment provides an opportunity to serve far beyond the specifics of faith content occasionally referenced in research applications.
I became aware that the recruitment of ‘the pastor’ in other committees was not always simple. I had been spotted at a meeting about chaplaincy in women’s prisons! How had others been identified and invited to join committees? What constituted their self-understanding of the ministry service being gifted to the committees they served? Would my interviews disclose any kind of ‘evangelism by stealth’? Did faiths or denominations target access to committees assessing large amounts politically/theologically/ethically sensitive, kinds of research?
I discovered no documents showing the means by which the Catholic Church became an early adopter of the opportunity to be represented, but clearly there were Catholic clergy leading the discussion in the early years. My research showed great diversity within the voices of the Christian ministers. Even within denominations, including between current serving Catholics, there was diversity of expression on ground-breaking issues. It became clear that the one participant who asserted his role as being to represent the Catholic position, was the exceptional Catholic voice. Other Catholics applied the provisions of the current National Statement informed by their own faith understanding, but with broad appreciation for other communities’ concerns.
Many clergy enjoyed the intellectual effort of meeting preparation and assessing applications, perhaps indicating a somewhat obsessive character trait. The rigor of disciplined meetings, the collegiality with co-assessors and committee colleagues was experienced by many as a valued counterweight to congregational demands. When appointed, some experienced a bit of resistance and some took a gentle ribbing. But as they became known and trusted on their merits and performance, tenures were frequently extended. There was some inference that if individuals had theologies unable to embrace the content or methodologies required in assessing projects, it would be unlikely that they would find their way onto committees. A few references to short tenures alluded to non-renewal of clergy who were not a good fit.
The diversity of appointments reflects the neighbourhoods/communities served by HRECs and is appropriately representative of our national diversity. One participant was from a highly conservative evangelical denomination. The interview triggered deeply thoughtful reaction about personal identity relative to the HREC work. I would later find out that the reflection resulted in some major theological grappling as a consequence of the conversation. Regardless of denomination, interviewees found themselves intrigued by the attention my investigation was bringing to HREC clergy/pastoral work, which had almost invariably been out of the faiths’ hierarchical spotlights. Most remained entirely grateful for the freedom to do the HREC work without such attention.
One pastor described choosing not to participate in a committee discussion because he was aware his personal knowledge was not sufficient. It was a frank admission. The example begs the question of how applications need to enable comprehension and how lay and other non-disciplinary experts are enabled in their roles. Others found solutions to specific matters of dogma by offering wordings that would provide enough cues to the faith’s adherents to ensure they were going to be able to make informed choices without imperilling projects. What emerged was that clergy were clear about their denominational obligations and the tension between them and the needs of others in the general community.
Given that the task of assessing applications and contributing to meetings is identical for all HREC members, how do clergy understand themselves alongside their colleagues (who may be harbouring strong religious views but are not required to disclose them and which need not be presumed) as contributors to the wellbeing of the research landscape? Several clergy described pastoral care for committee colleagues and secretariat staff, by virtue of regular contact with them. This was implicit and automatic pastoral work. Care for researchers and participants whom the HREC members will never meet, is also natural pastoral work and a clear driver for clergy in their appointments.
Serving HRECs also provides clergy with a window to unfolding knowledge, a forward-looking perspective, regular use of critical faculties not always appreciated in congregational work, intelligent company, confidential settings in which they can be full participants without any oversight from their hierarchies resulting in contributions that don’t need to follow predictable, dogmatic lines, and a chance to serve beyond the faith or denomination. Australia has encoded high standards for itself in the research domain. Participants in my research were clear that high ethical research standards fit congruently into their understanding of their ministry work and several specialise in HREC work as their ministry interest. Many of these have high-level academic qualifications and years of expertise, which are offered repeatedly to the Australian community through HREC service.
Rabbi Dr Aviva Kipen has held Monash University HREC appointments and served on the Victorian Bio-Ethics Advisory Committee. She returned to serve a second term on the Australian Health Ethics Committee of NHMRC in 2019 and has begun the current triennium for the Victorian DHHS HREC. All comments reflect material in the thesis Kipen, A. (2015) Serving God and The Commonwealth of Australia: The Ministry Experiences of Clergy in Victorian Human Research Ethics Committees. Melbourne: University of Divinity.
Dr Nathan Emmerich Research Fellow in Bioethics at ANUMS
Despite the fact that one of the urtexts of bioethics—Beauchamp and Childress’ principles of biomedical ethics—offers a set of concepts that purport to apply to both research and medical practice it is nevertheless the case that we standardly contrast research ethics with professional ethics. The operating presumption seems to be that a proper grasp of professional ethics requires an understanding of the unique role professional’s play, whereas the same cannot be said of research ethics. Here the presumption is that researchers are not unique but interchangeable. Furthermore, their individuality is inimical to good, and therefore ethical, research.
Whilst both healthcare professionals and researchers should be objective, the professional enters into a singular relationship with their patients. The position of the researcher can, however, be occupied by any relevantly qualified individual and their function is to report their scientific observations. Thus, underlying this contrast is an epistemological point. The perceived importance of the relationship between doctors and patients means that whilst the ethics of the preeminent profession, medicine, are predicated on professionalism they are equally predicated on something that is distinctively (inter)personal. In contrast, the notion that there might be an (inter)personal dimension to the relationship between researchers and research participants is inimical to the requirement for objectivity, at least for a certain value of objectivity.
. In this thought-provoking blog, Nathan Emmerich challenges the notion that there is any distinction between research ethics and professional ethics when it comes to social science research. That is, the very nature of the enterprise requires that the researcher be deeply engaged in ethical discourse throughout the conduct of the study and not simply at a point in time to satisfy the regulatory requirements of ethics committees to obtain their approval. Whilst the argument is reserved for the social sciences, and there is some hesitancy to extend it beyond this, it is clear that the arguments made are true for all research, including biomedical. There is a reluctance to challenge notions about the divide between research and clinical practice that have been with us for over 50 years, but perhaps it is time to have a proper discussion about whether this is or is not applicable any longer. Patient centered research with an emphasis on co-design with consumers upends the notion that this type of research maintains a separation between researchers and research participants. Social science research provides an immediate opportunity for rethinking how we behave ethically, but biomedical research should follow hot on the heels.
Therein, of course, lies the rub. According to Stark, the differentiation between research ethics and professional ethics can be traced to the National Institute of Health, Bethesda, Maryland, USA, circa 1950. Given the existing competition between the codes of professional ethics promulgated by medicine’s sub-specialties, the nascent idea of a research ethics was conceived pragmatically and in aprofessional terms. When it came to biomedical research, and the epistemology of the natural sciences, this was not an issue. However, consistent with Schrag’s critique of the subsequent development of research ethics as neglecting concerns expressed by social scientists, this is more problematic when it comes to the social sciences, particularly at the more interpretive end of the spectrum. .
In qualitative social science the unique perspective, position or standpoint of the researcher is essential to understanding socio-cultural reality and, therefore, to the process of conducting research. Furthermore, it is not something that can be eliminated by the use of (replicable) quantitative measures. This does not mean qualitative research cannot be objective. Rather, it means that the notion of objectivity differs between the natural and social sciences. Doing qualitative social science does not mean embracing subjectivity. Rather, it requires qualitative researchers to embrace epistemological reflexivity and to aim at objectivity as a value, virtue, or standpoint of social research. .
When this is coupled with the fact that such research often seeks to give expression to the ‘lived experience’ of research participants, one can see how a concern for the (inter)personal must return to center stage in discussions of social scientific research ethics. One way of doing so would be to rethink the ethics of social scientific research as a form of professional ethics. Thus, rather than simply ‘frontloading’ ethical decision-making as a part of the design of proposed research, which can then be subject to peer review or evaluation by committee, we can more clearly acknowledge that engaging with the ethical dimension of research requires ongoing attention. The range of ethical issues researchers might encounter, both in the field and as a function of their role, are such that we cannot hope to fully address them preemptively. In this context, and consistent with the contemporary concern for the integrity of both research and researchers, we might draw on the idea of researchers as professionals and, in so doing, embrace the view that they ought to be guided by a set of internal professional norms or ethics. .
Of course, this is not exactly a solution to the ethical issues social scientists might encounter in the course of research. It does, however, invite further engagement with such questions. Indeed, one can say more than this. Rather than thinking of the ethics of research as something to be addressed and codified by external commentators, such as bioethicists, the idea that research might benefit from a professional ethics invites researchers themselves to lead the discussion. No doubt questions remain, not least on what might constitute a profession or professional group in this context. Nevertheless, this proposal suggests that both professional groups and professional researchers should play a privileged role in creating, interpreting and putting into practice the substantive commitments of their own professional ethics. Furthermore, it is for them to set forth, justify and communicate the stance they adopt to other stakeholders. .
This suggestion stands in relatively stark contrast to conceptions of research ethics, where external standards and evaluations are seen as having priority. To me, the difference is akin to the one we find when comparing research ethics committees and clinical ethics committees. The former tends to be rather one-sided; it assesses and offers judgment on research proposals or documents. The latter engages with professional actors and, through a process of mutual dialogue and discussion, facilitates and contributes to the individual’s own ethical formations. Which approach is more likely to promote the ethics and integrity of research, particularly social scientific research, seems self-evident. .
Beauchamp, T.L., and J.F. Childress. 2009 [1979]. Principles of Biomedical Ethics. 6th Edition. Oxford, UK: Oxford University Press.
Emmerich, N. 2016 ‘Reframing Research Ethics: Towards a Professional Ethics for the Social Sciences’. Sociological Research Online 21(4):7 http://www.socresonline.org.uk/21/4/7.html
Emmerich, N. 2019. ‘A Professional Ethics for Researchers?’ In Iphofen, R. (Ed) Handbook of Research Ethics and Scientific Integrity. Springer. Online First: https://doi.org/10.1007/978-3-319-76040-7_34-1
According to the Belmont Report (1979), respect for persons incorporates two ethical convictions: individuals are to be treated as autonomous agents, and those with diminished autonomy are entitled to protection.
It is because of these guiding principles that we, researchers and health practitioners, are extremely careful in planning and designing our research on populations who are more likely to have diminished autonomy. We endeavour to protect vulnerable groups in our studies because their circumstances make them more susceptible to being taken advantage of. To do otherwise, according to Gillet (2008), would simply be selfish and would be acting in bad faith. In fulfilment of their mandate, ethics review boards likewise have clear guidelines in the protection of vulnerable populations. Unlike protocols for the protection of minors, pregnant women, prisoners, terminally ill, intellectually challenged, and militarized to name some of the most common guidelines for vulnerable populations, guidelines for impoverished population may be more difficult to construct. As laid out by the Guidelines for Good Clinical Practice (1996, p.8), impoverished persons may have the propensity to be unduly influenced by the expectations of benefits associated with participation. But how does one judge whether a token for participation is enough to influence the decision of a person? For children, for example, being below a certain age is understandably a reason to protect the child’s interest and warrants the use of assent forms. However, for the economically disadvantaged drawing the line is more difficult to assess.
Some studies have questioned whether incentives impair the ability of participants to make decisions about risk. These claims have cited the studies of Halpern et al. (2004) and Bentley and Thacker (2004), which find participants are not likely to forego the risks of participation when offered greater compensation.However, these findings were based on hypothetical enrolment and were done with small sample sizes. More important for this discourse, however, is that these studies were done in developed countries. In a study by Kass et al.(2005), participants of studies implemented in developing countries (LMICs) were noted not only to be facing challenges in understanding the study protocol thus affecting their autonomous decision making, but were also noted to participate primarily because of the incentives presented.As Benatar (2002) notes great disparities exist in health and wealth between developed and developing countries and therefore ethical standards must take into consideration the differences and adapt to the rising level of research in developing countries.
Recognizing the imbalances of power, resources, and knowledge that exist in the setting of research between high-income and lower-income, the Global Code of Conduct for Research in Resource-Poor Settings (2018) outlines guidelines to avert ethics dumping in lower-income setting. Article 6 of the guidelines tackle specifically the topic of compensation and benefits, ‘Researchers from high-income settings need to be aware of the power and resource differentials in benefit-sharing discussions, with sustained efforts to bring lower-capacity parties into the dialogue’.
Coming from an LMIC, I could not agree more with the guidelines set. In gauging the amount for benefits, one has to be careful with the amount being paid to participants for their involvement so as not to cause undue influence to those who wish to participate in the study; including the local parties into the dialogue is therefore vital to upholding ethical standards. What is acceptable in one country may cause undue influence in another, especially to economically disadvantaged persons in LMICs. Moreover, even within the LMIC itself, interactions between researchers from a high-income region and participants from a low-income area likewise pose some problems and therefore knowing the local factors that could cause undue influence is important.
In the Philippines for example, a number of factors are involved when it comes to deciding the amount of compensation. For example, the daily minimum wage in one area of the Philippines is 265.00 Philippine Pesos (~AUD7), while in other areas this could be as high as 512.00 Philippine Pesos (~AUD13). For this reason, I have been involved in a study that handed out supplies worth 40 Philippine Pesos (~AUD1), yet in another study we thought it was appropriate to hand out 1,000 Philippine Pesos (~AUD25). In making our decision as to how much to pay participants, we conduct our research based on the principles set forth by the Philippine Health Research Ethics Board’s National Ethical Guidelines for Health and Health-Related Research (2017, p.20):
35.4 Research participants shall be reimbursed for lost earnings, travel costs, and other expenses incurred when taking part in a study. Where there is no prospect of direct benefit, participants may be given a reasonable and appropriate incentive for inconvenience. The payments shall not be so large as to induce prospective participants to consent to participate in the research against their better judgment (undue inducement).
With this we make sure that our computation includes all the components set forth by this guideline, thus we try to include lost earnings, reimbursement for travel, incentives, and other expenses incurred by the respondent. In valuing exactly how much each of these costs, we don’t have a memorandum on the exact cost to follow instead we rely heavily on the nature, population, and area of the study.
Upon discussing this topic with two of my colleagues I find that we share similar techniques in estimating the value of each of the cost. Other researchers in the country may have different techniques, but the following are a few of the methods I have compiled from discourse with my colleagues on how to approximate the amount to compensate the participants.
First, we get to know the population of interest very well. This includes taking into consideration the cultural, historical, and geographic background of the region, province, city, municipality, and town. Towns inhabited by people of a certain religion for example should not be brought a specific type of food. Another example could be that because of the terrain of a certain town, getting to the interview may mean riding a motorcycle for an hour. Knowing this we will be able to estimate the reimbursement of travel better.
Different areas at different times of the year will have different needs as well. Therefore, we make sure to take this into consideration. For example, if we know that classes are about to start in one area, we might offer school supplies to participants. Similarly, if it is the rainy season, one could probably give out umbrellas to respondents.
Knowing the region, a general rule of thumb one of my colleagues utilizes is to base his computation on the regional minimum wage published and updated by the Department of Labor and Employment. Using the published minimum wage, he then computes the hourly wage and makes this the maximum compensation for every hour of participation.
Another practice done is to discuss the amount with local government units. Talking to the officials in the town, we are able to gauge the average income of their residents as well as the usual occupation in the area.
We also take into consideration the type of study being done and the inconvenience it could cause. For example, a more difficult questionnaire asking very specific points in the timeline of the patient’s disease may warrant higher compensation than a simple demographic survey.
We talk to researchers or local data collectors who have done studies with the same population, or who have undertaken the same method. Knowing how the respondents reacted to a specific amount of bother fee in the past gives us a benchmark for our studies.
During the conduct of pre-testing our tools, we likewise ask our colleagues for an estimate that they believe would be a reasonable compensation for participants who would answer the questionnaire.
After we have the appropriate ‘bother fee’ in mind, we then submit this to the research ethics committees responsible for the study area. We are then given feedback whether the amount is appropriate and reasonable.
This system seems to be working largely because of the safeguards and competency of local research ethics committee and partly because of our familiarity with the system being locals ourselves. However, I cannot help but wonder how the increasing number of research projects in developing countries can affect this process. With more studies being done in LMICs maybe there is now a need to perform research into this area specifically on the exact amount or situations wherein undue influence can unintentionally occur. For example, with the theories of colonial mentality, does research done by non-Filipinos affect the responses or even influence the participation of respondents in studies done in the Philippines? Due to the volatile weather in the Philippines affecting the prices of commodities every month, does the bother fee deemed appropriate in one month still assure that there won’t be undue influence in the other months? Does the status of diplomatic relations between other countries and the Philippines affect the decision of participants when dealing with researchers from another country? Are there undue influences caused by the perception of Filipinos about certain companies funding the studies? Will the reputations of certain institutions or organizations leading the study cause participants to participate even if normally they would not have agreed to do so? Could certain areas in the Philippines be more susceptible to undue influence than other areas due to the large gaps in income and health services between regions? Knowing these may be helpful to local researchers and those who wish to do studies locally by providing us with evidence-based standards that could guide our data collection process away from undue influence.
The author declares that he has no affiliations with or involvement in any organization or entity with either financial or non-financial interest in the subject matter or materials discussed in this manuscript. The author has no conflict of interest.
Bibliography
Benatar SR (2002) ‘Reflections and recommendations on research ethics in developing countries’, Social Science & Medicine,1131–1141.
Bentley JP and Thacker PG (2004) ‘The influence of risk and monetary payment on the research participation decision making process’, Journal of Medical Ethics,200430293–298.
TRUST Project (2018) Global Code of Conduct for Research in Resource-Poor Settings.http://www.globalcodeofconduct.org/ (Accessed September 8, 2018).
Halpern SD, Karlawish JHT, Casarett D, Berlin JA and Asch DA (2004) ‘Empirical assessment of whether moderate payments are undue or unjust inducements for participation in clinical trials’, Journal of the American Medical Association Internal Medicine, 164801–803.
Kass NE, Maman S and Atkinson J (2005) ‘Motivations, Understanding, and Voluntariness in International Randomized Trials’, IRB: Ethics & Human Research, 27(6):1-8.
We invite debate on issues raised by items we publish. However, we will only publish debate about the issues that the items raise and expect that all contributors model ethical and respectful practice.
This blog post expands on ideas from our recent publication:McWhirter, R. E., & Eckstein, L. (2018). Moving Forward on Consent Practices in Australia. Journal of Bioethical Inquiry, 1-15.
Recently I participated in a research study. With the research nurse sitting opposite me expectantly, I moved quickly to sign in the appropriate place.
Hang on a minute. I’m a researcher, and an HREC member. I’ve published papers on informed consent, for goodness’ sake. I know better than this. Dutifully, I went back to the information sheet to read it properly.
After a couple of lines, I got bored and started scanning for key phrases. What will they do with my data? Which HREC approved this? Am I signing myself into eternal servitude?
Oh, who am I kidding, I thought. I’ve already made my decision. So, I just signed it, the research nurse smiled, and we got on with it.
Research suggests that I am not alone in my reaction to consent forms. They are boring, sometimes bordering on impenetrable. HRECs blame researchers for not writing in plain English. Researchers blame HRECs for being too inflexible and demanding a ridiculously long list of things to be included in a rigid format. There’s probably some truth on both sides, as well as some misunderstanding. And so, we end up with long, boring and ultimately unhelpful consent documents.
This is not to suggest that everyone is doing consent badly. There are lots of examples of research groups working with communities – whose members are usually potentially vulnerable in some way – to develop consent materials or processes that actually meet the needs of participants. Sometimes the solutions are technological– involving multimedia tools to overcome literacy or language barriers – and sometimes structural – such as by undertaking consent over several visits, so that individuals can decline to participate either by saying no or by avoiding the researchers, which can be an important option in communities where this is considered a more culturally acceptable method for refusal.
So, consent doesn’t have to be boring.
But what of the other problem indicated by my experience above? I had already made up my mind to participate before I’d been given the information sheet. Those with experience in study recruitment will know that I’m not unusual in this respect either. Depending on how the recruitment is undertaken, first contact might be a phone call, an email or letter, or a face to face conversation. In most cases, there will be some kind of blurb that precedes a participant’s reading of the consent documents and this is largely what people are basing their decision on.
These initial contacts are difficult to standardize (and it’s not necessarily desirable to do so) and difficult for HRECs to review, especially if they are verbal. A lot depends upon the character of the person doing the recruiting (usually a research nurse or research assistant rather than a principal investigator).
For one study in remote Aboriginal communities that I was involved in, I undertook several months of community consultation prior to commencing recruitment. I worked with community members to develop the study design and consent materials, employed local research assistants, and was helped enormously by senior women from each community. The relationships we developed meant that the study better met the needs of the communities, was more ethically sound (complying with both the National Statement and Values and Ethics) and resulted in a wider range of benefits than would otherwise have arisen.
These relationships also created trust between us. And that no doubt had an effect on our recruitment. The women liked me and wanted to help me. I had the support of influential elders. And by the time we got to use our carefully designed audio books, with information recorded in multiple dialects and with culturally relevant illustrations, most participants had already heard about the study, either from the community meetings during the consultation phase or through word of mouth. Although I stressed that participation was voluntary, and they were welcome to say no, everyone I invited agreed to participate.
So, what was the point of informed consent here? Well, it’s still polite to ask. The process of consultation that preceded it was effectively a form of community consent. And although individual decisions were probably influenced by their relationship with me and other study team members, these participants arguably had a greater understanding of the study than many participants in studies using more traditional methods.
I’m not sure there is a perfect way to ‘do’ consent. But it helps to be aware that the process is wider than just the consent documents. Providing training and ongoing team-based reflection for recruiters would help to address concerns over the quality of the less formal elements of consent. And it would be useful for HRECs to recognize the value of community consultation and consumer engagement in the study design phase, and to be open to non-traditional approaches to undertaking consent, rather than focusing unduly on the precise wording of consent forms.
We can’t ‘protect’ participants from researchers through mandating lists of information to be conveyed through formal documents, but we can encourage a culture of ethical research that better addresses community interests by reflecting on what we’re actually doing when we ‘do’ consent.
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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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