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Clergy service to HRECs: the useful paradox within secular governance of research involving human participants0

 

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.

This post may be cited as:
Kipen, A. (3 November 2019) Clergy service to HRECs: the useful paradox within secular governance of research involving human participants. Retrieved from: https://ahrecs.com/human-research-ethics/clergy-service-to-hrecs-the-useful-paradox-within-secular-governance-of-research-involving-human-participants

Keywords
Clergy, religion, denomination, ministry, faith

Should we Reframe Research Ethics as a Professional Ethics?0

 

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.

COMMENTARY
Nik Zeps, AHRECS

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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.
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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.
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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.
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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.
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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.
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Dr Nathan Emmerich is a Research Fellow in Bioethics at ANUMS. The ideas presented in this post stem from a book chapter entitled ‘A Professional Ethics for Researchers?’ (online first) recently published in Iphofen (Ed) Handbook of Research Ethics and Scientific Integrity (Springer) as well as an earlier publication ‘Reframing Research Ethics.

References:

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

Iphofen, R. (Ed) Forthcoming 2020. Handbook of Research Ethics and Scientific Integrity. Springer, https://link.springer.com/referencework/10.1007/978-3-319-76040-7

Stark, L. 2011. Behind Closed Doors: IRBs and the Making of Ethical Research. University of Chicago Press. https://www.press.uchicago.edu/ucp/books/book/chicago/B/bo12182576.html

Schrag, Z.M. 2010. Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965–2009. The Johns Hopkins University Press. https://jhupbooks.press.jhu.edu/title/ethical-imperialism

This post may be cited as:
Emmerich, N. (1 October 2019) Should we Reframe Research Ethics as a Professional Ethics? Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/should-we-reframe-research-ethics-as-a-professional-ethics

Smarter proportional research ethics review0

 

Rushing toward a faster review decision should not mean relaxing standards or playing chicken with stricter central control

Gary Allen, Mark Israel and Colin Thomson

Too often, there is a danger that ‘expedited ethical review’ (a term not used in the National Statement since 1999) might equate to an approach that abridges the review process to the point where it’s little more than a friendly exchange between peers or a nod to seniority. We won’t call out the well-reported cases where it is hard to fathom how they were granted ethics approval. Such cases should make us uncomfortable, because they are invitations to replace institutional self-regulation with something hasher and unsympathetic.

Don’t get us wrong, we’ve spoken often and enthusiastically about the value of well-designed proportional review arrangements. We have assisted many clients, large and small, to design and implement such arrangements and believe that they form part of a well-conceived review system.

A proportional review arrangement can deliver a review outcome much faster than consideration by a human research ethics committee, but instead of a ‘Claytons’ or mock-review, it should have the following features:

  1. While there can, and should, be a mechanism to do an automated quick self-assessment of whether a proposed project qualifies for ethics review other than by a research ethics committee, the process should:
    1. not rely on questions along the lines of “Is this a low risk research project?”
    2. draw on, reference and link to guidance material.
    3. when using trigger questions, ensure they are nuanced, with probing sub-questions.
    4. include confirmation of a quick assessment by an experienced ethics officer or chairperson.
    5. retain an applicant’s responses, both as a record of what they said about the project, and for future evaluation of whether the arrangement is correctly assessing new projects and guiding applications along the correct review pathway.
  2. The process should preferably be online, easily (re)configurable, easily auditable, with information entered by applicants and ‘triaged’ by an ethics officer.
  3. A quality online system will populate committee papers and reports, will issue reminders and will populate with known information.
  4. While many projects may be reviewed outside of the human research ethics committee, the reviews should be conducted by experienced persons, who participate in annual professional development and who can draw upon internal and external policy and resource material.

In Australia, an institution’s proportional review arrangements might include the following pathways:

  1. Prior review– Research that has already been reviewed by another HREC, appropriately delegated review body, or an international body equivalent to an Australian research ethics review body.
  2. Scope checker– A test to confirm whether a proposed project is in fact human research.
  3. Exemption test– A test to determine whether the proposed research is a type an institution could exempt from ethics review as per the National Statement.
  4. HREC review required test– A test to confirm whether the research project is of a type the National Statement specifies must be reviewed by a HREC.
  5. Institutional exemption test– Many institutionsexempt some categories of human research from research ethics review (e.g. universities often exempt course evaluations and practical activities for a teaching-learning purpose).
  6. Negligible risk research– Subject to qualifying criteria an institution might establish a negligible risk review pathway in which applications are considered administratively.
  7. Low-risk, and minimal ethical issue research– Subject to qualifying criteria, proposed projects that are low risk and have minimal ethical sensitivity could be reviewed by the chair of the research ethics committee.
  8. Low-risk, some ethical issue research– Again subject to qualifying criteria, proposed projects that are low risk but have some ethical sensitivity could be reviewed by a small panel of the research ethics committee (including external member of the committee).
  9. HREC review – Only human research (see 2), that has not previously been reviewed (see 1) that is not exempt (see 3 and 4) and has not been classified as negligible risk (see 6) or low risk (see 7 and 8) needs to be reviewed by HREC.

An arrangement with the features listed above would allow for review that is proportional, timely, efficient and justifiable. Reviews that are merely expedited or fast places us all at risk. The increasing examples of “how could that have been approved?” makes it feel as though some institutions are gambling that a desire to meet researchers’ calls for quick, if superficial, review won’t be exposed by unethical practice. Perhaps they are correct, but every new reported review misstep makes us more nervous. Realistically, establishing a nationally administered reliable, robust and agile proportional review process requires substantial investment of time and other resources so is unlikely to happen.  But, what poor review processes could do is invite far more detailed direction on how institutions can design, conduct and monitor processes outside of a HREC. In our experience, there are greater and longer-lasting benefits that can accrue from an institution having a high quality approach to proportional review.

The above is a summary of the discussion we typically include in blueprint documents about establishing a robust proportional review arrangement. We have included some further notes on this topic on our https://www.ahrecs.vip and Patreon pages.

Please contact us at proportional@ahrecs.com if you would like to discuss how we might assist your institution.

This post may be cited as:
Allen, G., Israel, M. & Thomson, C. (26 August 2019) Smarter proportional research ethics review.  Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/smarter-proportional-research-ethics-review

Proportional processes can sometimes be the answer to a few (apparently competing) problems0

 

But they shouldn’t equate to abridged consideration

Dr Gary Allen | AHRECS senior consultant | Profile
Professor Mark Israel 
| AHRECS senior consultant | Profile
Professor Colin Thomson AM
 | AHRECS senior consultant | Profile

 

There are three things that we have consistently found when we have conducted desktop audits of human research ethics arrangements:

  1. Researchers believe the manner in which their interactions with their institution’s human research ethics arrangements are being treated is disproportional to the real risks and ethical sensitivity of their work. Symptoms include delays waiting for the next meeting of the research ethics committee and lengthy forms, which seem excessive for a project that might be following the well-established practice in a discipline. For busy researchers, this seems to confirm their suspicion that the research ethics committee is indifferent to the nature and value of the project and the process is about policing their conduct and catching them in wrongdoing. This perception can be especially acute in disciplines other than those in health sciences and clinical trials and is particularly prevalent for participant-directed designs. We have written about the dangers of this adversarial climate (Israel et al., 2016), and as consultants have advised many research institutions on how to tackle it.
  2. Research ethics committees(and research office staff) talk of being overwhelmed with work (and sometimes paper), struggling to find time to focus properly on the most risky and ethically challenging projects, and being left with insufficient resources to conduct professional development or other constructive activities that could improve ethical practice (design, review, conduct or reporting). One of the common complaints of review bodies who are overwhelmed by their workload is that matters would be improved if more researchers were more familiar with and understood the requirements and submitted better applications.

Reviewers and researchers commonly point to the other as the source of the problem and insist only change to the other party’s attitudes will fix the ‘ethics problem’.

The irony is that a suite of related strategies can fix both these behaviours. Rather than one party changing and the other ‘prevailing’, if both change cooperatively and the functioning of human research ethics arrangements shifts to a more positive approach, the process can facilitate research and achieve the objective of resourcing reflective practice.

This article is not about a proportional research ethics review arrangement (a piece on that will be in the Research Ethics Monthlyincluding discussion about constructive review feedback). Instead, this piece is about proportional processes, which complement research ethics review. And, this is linked with our third finding.

  1. Institutional risk concerns appear to be associated with any delegation of these matters to a process outside of the research ethics committee.

Those processes relate to the consideration of:

  1. applicant responses to review feedback,
  2. ethical conduct reports, and
  3. variation requests.

Figure 1 This image (without the watermark) is available to USD3+ Patrons https://www.patreon.com/posts/27638074

The default position for consideration on those matters should be processing outside the research ethics committee, such as panel review (a small group of committee members via email), executive review (by the Chairperson or Deputy Chairperson) or administrative review. Full research ethics committee review should be reserved for the most risky and ethically sensitive of projects.

In our experience, it is common for institutions to include these items on the research ethics committee agenda. The purpose of this can be unclear: is it for ratification or notification? And are all committee members expected to consider these? In our view, this is often impractical: these matters typically need to be considered in the context of the whole project, a context that committee members cannot be expected to retain or revisit. Provided adequate records of the panel or executive consideration are kept, committee agendas may need to include these items only when the ethics consideration merits committee consideration.

AHRECS has been able to assist clients to define triggers for the processing pathways, stage transition towards the ultimate delegated review and establish the required record keeping. We have also assisted small/early journey institutions to set thresholds (soft and hard) that would trigger transitioning from the point at which all matters are considered by the research ethics committee to the implementation of delegated processing. In this way, change is proactive and stays ahead of the predictable rise in workload.

In the AHRECS subscribers’ area, USD10+ Patrons can access suggested criteria for the delegated processing of (b) and (c) from the list above.

If implemented correctly, this approach should help:

  1. Researchersperceive the process as far more relevant, reasonable and client focussed. They also should have a clearer appreciation of the triggers for higher review.
  2. Research ethics committees have more time and capacity to concentrate on genuinely risky cases, to be involved in professional development and to formulate policies and resources.
  3. Institutional risk concerns are alleviated by having transparent criteria for escalated consideration and reduced reasons for researchers to avoid the processes.

Reference

Israel, M, Allen, G & Thomson, C (2016) Australian Research Ethics Governance: Plotting the Demise of the Adversarial Culture. In van den Hoonaard, W & Hamilton, A (eds) The Ethics Rupture: Exploring Alternatives to Formal Research-Ethics Review. Toronto: University of Toronto Press. pp285-316.ISBN 9781442626089 http://www.utppublishing.com/The-Ethics-Rupture-Exploring-Alternatives-to-Formal-Research-Ethics-Review.html

Commentary

Dr Mark Bahr, Chair of Bond University Human Research Ethics and Assistant Professor Psychology

Communication is the key to much of what we do in any part of our lives. Much of the time what is said and what is heard are very different things… communication and a shared understanding of our roles in reviewing and conducting research is vital, and as indicated often misunderstood through the lens of our role. There is a clear need to establish trust at the three levels indicated in the article. Where there is a reasonable understanding of the role of each group, institutional risk managers, research ethics committees and researchers there is plenty of scope for alternate models of review for certain types of low-risk review. For example, where research methods are being taught using authentic assessment methods with clearly defined limits there is scope for flexible review especially when a process is in place for escalation to a greater level of scrutiny when called for.

One difficulty with all review is the evaluation of risk, it is clear that we each appreciate risk differently. Appreciation of risk in the study and indeed the benefit of the study varies with the beholder. There is no intrinsic issue with proportional approaches but the setting of thresholds is an important consideration. One of the concerns I would have in perhaps the intermediate-term is that what starts off as a flexible framework with responsive settings, over time tends to drift towards rigidity. We need to be vigilant that we don’t drift in that direction.

Shara Close, Manager, Research Integrity & Ethics, Charles Darwin University

Broadly from my experience over the last five-plus years working in the research integrity and ethics space – both pre- and post-implementation of proportional review – the introduction of expedited review processes and streamlining of the administrative functions associated with HREC review has drastically shifted attitudes and the ‘adversarial climate’ associated with ethics review at the University. Colleagues joining the University post-implementation have commented on how peculiar it is to find such positive attitudes towards ethics review. We now find ourselves focusing on more nuanced issues regarding improving engagement with researchers and improving applications in an effort to increase the number of high-quality applications that are ‘approved first go’ or with only very minor adjustments.

Laura Thorncraft, Research Ethics Coordinator, Charles Darwin University

Our proportional process gives researchers a sense of choice and control over the review of their proposals. The researcher nominates the risk level and justifies the risks, so they make a case for proportional review that is treated seriously by research admin staff. It’s relatively rare that proposals are escalated. I think this feeds into the article’s first point about perceptions and adversarial relationships, and something that we do quite well.

This post may be cited as:
Allen, G., Israel, M. & Thomson,  C. (23 July 2019) Proportional processes can sometimes be the answer to a few (apparently competing) problems. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/proportional-processes-can-sometimes-be-the-answer-to-a-few-apparently-competing-problems

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