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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

The need to seek institutional approval to survey staff – was this a misunderstanding of the purpose of Guideline 2.2.13 in the National Statement on Ethical Conduct in Human Research?0

 

Katherine (Kate) Christian, Carolyn Johnstone, Jo-ann Larkins and Wendy Wright
Federation University

 

We have conducted a research project investigating the factors contributing to the satisfaction – or dissatisfaction – of early-career researchers (ECRs) from across Australia working in the sciences. A requirement of our ethics approval was a need to provide evidence from every university and research institute of permission to approach their staff to invite their participation in our research.

This requirement was a consequence of answering ‘yes’ to the following question:

If your research involves participants from other organisations (e.g. educational institutions, companies, agencies, collectives), you may need to obtain authorised approval before approaching participants, eg: Department of Education and Training, School Principals, School Councils (for research involving Government schools); Catholic Education Office (Catholic schools); School Boards (Independent schools); Senior Officers (Commercial or Government entities); Elders (Aboriginal communities); or Representative bodies (Collectives). Copies of approval letters must be attached to this application or, if pending at the time of submission, forwarded to HREC when available. Some authorities may decline to provide permission letters until ethics approval has been granted. In such cases, you should submit your application to the HREC for provisional approval pending receipt of the documentation.

Does research involve or impact on participants from external agencies or organisations? Yes No

 

 

Our project entailed collection of data from researchers, typically from other institutions, no more than ten years past the award of their PhD who could be participants in a focus group, one-on-one in-depth interviews or in a national on-line survey. The precise method for extending invitations to participants for each of these activities (which included email invitations, social media posts, and advertising by relevant bodies) was specified in the ethics application and approved by our Human Research Ethics Committee (HREC). In most cases email approaches were to be made by third parties, for example distribution of a forwarded email; otherwise email contact was limited to those people whose contact details were known or publicly available.

The eligible population was adult, clearly defined and without special risks; individuals were able to offer informed consent as defined in the overarching principle for consent in the National Statement defined in Section 2.2.1:

The guiding principle for researchers is that a person’s decision to participate in research is to be voluntary, and based on sufficient information and adequate understanding of both the proposed research and the implications of participation in it.

An attempt to meet the requirement to seek approval for people to be invited to take part in the survey from the prospective 37 universities and many independent research institutes was extremely arduous and a significant barrier to recruitment. We question whether seeking this approval added ethical value, and indeed, whether it may have been required because of a misunderstanding of the purpose of the National Statement, in particular of Section 2.2.13:

Within some communities, decisions about participation in research may involve not only individuals but also properly interested parties such as formally constituted bodies, institutions, families or community elders. Researchers need to engage with all properly interested parties in planning the research.

Section 2.2.13 of the National Statement is placed in the section ‘Where others need to be involved in participation decisions’ and appears directly after a section relating to potential participants who lack the capacity to consent. This requirement appears on the documentation of some other Australian HRECs, (including Australian Catholic University, University of Melbourne,  Menzies Research Institute). However, we believe this section of the National Statement is intended to apply to research conducted within organisations and communities that have a duty of care towards people – or groups of people – who are at risk, such as Aboriginal and Torres Strait Islander peoples, school students or adults with special needs.

Alternatively, it could be construed the request to obtain approval is a misunderstanding of the first part of 3.1.16 and that HRECs take the view that the institutions, in their capacity as employers, have a duty of care as ‘gatekeepers’ for their employees.

Researchers and reviewers should consider the degree to which potential participant populations might be over‑researched or may require special consideration or protection and the degree to which the flow of benefits to that population (or to individual participants) justify the burdens.

The latter part of this section suggests that individuals within the ECR population that we were attempting to sample could have been permitted to make up their own minds about participation, as they do not fall into the type of special category suggested.

Equally, people should not be denied the opportunity to exercise self-determination or obtain the potential benefits of research solely because they are a member of a population that might be over-researched or may require special consideration or protection, such as Aboriginal and Torres Strait Islander peoples.

The literature about the work-life of ECRs in STEMM disciplines in Australia does not show evidence of an over-researched ECR population or a group which merits special consideration. We are aware of only two national surveys of Australian ECRs in STEMM in recent years (Hardy, Carter, & Bowden, 2016, Meacham, 2016).

If any university staff member received an invitation to participate from an external researcher, whether directly or forwarded from an internal address, it is unlikely they would have wondered if either the researcher, or they, needed permission from the organization. Instead, they would make an individual decision on participation or otherwise, and act accordingly.

We used several recruitment strategies. Since all the potential participants worked at universities and research institutes, a direct approach to these entities provided the logical and, indeed, preferred avenue. Organisations and associations whose members were likely to represent the target audience were also approached; these ‘umbrella’ groups were very supportive ofrequests for assistance with recruitment of participants and, more generally of the research. They extended an invitation to their members on behalf of the project team via broadcast email and social media. Another HREC-approved method of recruitment was via social media. Social media, which has no boundaries, proved itself to be a successful avenue for recruitment and due to its very nature and culture of sharing brought in responses from prospective participants based at many universities from which we had received no response to our initial request for approval to recruit their staff. Such responses did not violate ethics requirements, again bringing into question the merits of seeking institutional approval.

We did not interpret the requirement to obtain approval as being necessary for the ‘umbrella’ organisations as they do not have the same responsibility for, or duty of care to, the ECRs. This highlights another anomaly in the interpretation of the guidelines: what constitutes ‘an organisation’ from which approval might be required? So saying, we interpreted the ready agreement of these organisations to share the invitation, whether by distributing the link by email or by promoting it on social media, as implicit approval.

We recommend that HRECs amend their forms to permit researchers to offer further explanation about the nature of the people being recruited and their capacity to freely make a consent decision so that the Committee members can make appropriate decisions about the need for institutional approvals. We argue that these approvals should only be required when the research participants need a particular level of protection.

References

Hardy, M. C., Carter, A., & Bowden, N. (2016). What do postdocs need to succeed? A survey of current standing and future directions for Australian researchers.2, 16093. https://doi.org/10.1057/palcomms.2016.93

Meacham, S. (2016). The 2016 ASMR Health and Medical Research Workforce Survey. Australian Society of Medical Research.

Contributors

Katherine Christian, Federation University Australia School of Arts, Mt Helen Campus, Ballarat, Victoria

Carolyn Johnstone, Federation University Australia School of Arts, Mt Helen Campus, Ballarat, Victoria

Jo-ann Larkins, Federation University Australia School of Science, Engineering and Information Technology, Gippsland Campus, Churchill, Victoria

Wendy Wright, Federation University Australia School of Health and Life Sciences, Gippsland Campus, Churchill, Victoria[MI3]

Sources

Menzies Research Institute
https://www.menzies.edu.au › Research › Forms › HREC_Application_Form

Australian Catholic University
https://www.acu.edu.au/research/research-ethics-integrity-and-compliance/research-ethics
https://www.acu.edu.au › assets › Ethics_Guidelines_revised_March_2012

University of Melbourne
https://staff.unimelb.edu.au/__data/assets/pdf_file/0009/1977543/HRE-Application-Guidance-V-1.1.pdf

This post may be cited as:
Christian, K., Johnstone, C. Jo-ann Larkins, J. and Wright, W. (17 September 2019) The need to seek institutional approval to survey staff –was this a misunderstanding of the purpose of Guideline 2.2.13 in the National Statement on Ethical Conduct in Human Research?. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/the-need-to-seek-institutional-approval-to-survey-staff-was-this-a-misunderstanding-of-the-purpose-of-guideline-2-2-13-in-the-national-statement-on-ethical-conduct-in-human-research

Tracing the Patterns of Research Ethics Regulation in Taiwan0

 

台灣的研究倫理規範之發展

甘偵蓉 Gan Zhen-Rong1 and 馬克·伊瑟利 Mark Israel2

Many commentators on research ethics have been based in the Global North and, when we find research ethics regulations that look very much like our own, we tend to make assumptions about the ways in which these patterns of regulation have unfolded. Apart from being disrespectful to local histories, insensitive to difference and intellectually lazy, failure to engage with the rich history of regulatory practices in different jurisdictions makes it hard for research ethicists to learn from others. That is hardly a position with which most people working in the field of research ethics would want to be associated.

In earlier editions of Research Ethics Monthly, guest posts from the Philippines have introduced developments in regulation there (Miguel, 2018). In this article, we briefly trace the growth of regulation in Taiwan. It is based on an article recently published in Developing World Bioethics (Gan and Israel, 2019). The pattern of research ethics in Taiwan reflects three distinct but interacting processes.

 

Transnational Policy Migration
Taiwan transitioned from an authoritarian regime towards democracy through the legalization of opposition parties in 1986 and the end of martial law in 1987. Legislative initiatives to regulate research ethics need to be understood within larger national moves towards good regulatory practice, economic growth and competitiveness and globalization on the one hand, and democratization, Taiwanese nationalism, recognition of multiculturalism and Indigenous rights on the other. Given their country’s political, economic and educational ties to the United States, it is not a surprise that Taiwanese regulators looked to that country for legislative models.

The first legislation governing human trials in Taiwan, the Medical Care Act, was passed in 1986. Subsequent enforcement rules included the Department of Health’s3 Ethical Guidelines for Human Subjects Research in 2007 and its Regulations on Human Trials in 2009 which mandated the application procedure, review criteria and information to be disclosed relating to a human trial, and the 2011 administrative regulations for the Human Biobank Management Act.

Partly in response to a series of biomedical scandals, in 2011 the Taiwan legislature passed the Human Subjects Research Act (HSRA). Before the HSRA came into effect, ethics review was only required by law for clinical trial and human biobank research. The main legislative purpose of the HSRA was to regulate biomedical, healthcare, and behavioural research involving human participants no matter where the work was to be conducted, with whom the principal investigator was affiliated, or which government department funded the research.

Interdisciplinary Policy Transfer
A series of administrative decisions championed by some social scientists, implemented by professionals with experience with health research ethics committees and reinforced by an oversight regime aligned with the biomedical sciences facilitated the extension of a particular form of research ethics regulation from biomedical sciences to other disciplines.

Until the HSRA came into effect in 2011, social scientists were only affected by the regulation of biomedical research ethics if they were funded by particular government departments or conducted research in or were employed by hospitals. Despite the stated purpose of the Act, HSRA changed that. Furthermore, there is evidence that both the legislature and the Department of Health made efforts to avoid extending the ambit of the HSRA. Ultimately, they failed. In time, a range of processes extended the regulation well beyond health sciences.

The first extension came as a result of a change in administrative rules by a government department responsible for funding social research that had already been developing initiatives around research ethics. The National Science Council4 attempted to create research ethics review processes more suitable for social research than those adopted in medical institutions. However, once the HSRA had passed, each time an initiative strayed from the requirements of HSRA the weight of the legislation and its accompanying bureaucracy pulled social science review into line with biomedical standards.
This intensification of scrutiny on social research was not imposed by biomedical organisations but by senior social scientists and legal scholars. These advocates included some who had been socialized into biomedical research ethics practices and had built up professional expertise in that area – either because they had undertaken their postgraduate work in countries like the United States where research ethics review had already been extended to the social sciences or because they had participated in health institutional review boards.

University compliance with the HSRA has been enforced by the Ministry of Education (MOE). MOE took the conservative path of adopting the oversight regulations that had already been operating for ten years at the Department of Health. MOE also invited biomedical researchers with experience of the processes of the Department of Health to support MOE’s inspection role. In turn, most universities had neither the time nor the resources to build up discipline-specific responses. Rather than hiring people with expertise in social research ethics, they appointed as committee chairs or administrative directors those who had already worked on or for biomedical research ethics committees. Application forms, standard operating procedures and resources were often generated quickly by making only minor modifications to existing biomedical resources.

The threat of government sanctions and the associated reputational damage encouraged research institutions and their ethics committees to take risk-averse positions. Some universities required all research involving human participants to follow the HSRA irrespective of methodology or discipline. In these ways, biomedical approaches to research ethics were generalized across all disciplines.

Decolonization
The expansion of the universalist model of research ethics has not been inexorable and was disrupted when power relations between the state and Taiwan’s Indigenous peoples changed. This moment reflected larger scale processes of democratization and Taiwanization, processes that were sometimes antagonistic towards decolonization and the struggle for Indigenous self-determination. It was also made possible by a period when Indigenous legislators held the balance of power in the national legislature and used it to formalize communal rights, rights that might be asserted when negotiating with external researchers. As a result, and partly in reaction to three biomedical scandals concerning Indigenous peoples, Article 15 of the HSRA mandated that researchers who conducted biomedical and healthcare research involving Indigenous peoples not only had to seek individual informed consent but also had to seek consent from their communities in relation to their participation, publication of research results, and commercial benefits.

The various regulations relating to group consent aimed at granting greater liberty to Indigenous communities and tribes, ensuring that conversations occurred between equals and that benefits were shared. Given the history of exploitation of Indigenous peoples in Taiwan, the prospect of strengthening the hand of Indigenous communities in negotiating with researchers is to be welcomed and could be aligned with the current government’s ongoing reconciliation efforts.

Comparative Research Ethics
Expansion of research ethics regulation from a biomedical legislative base and the existence of biomedical scandals prompting further regulatory intervention will not surprise readers in North America or Australasia, nor will the failure to attend specifically to the needs of social researchers.
However, some features of the Taiwan experience are unusual. The role of some social scientists in advocating for the regulations concerning research ethics review to be applied to social research through administrative processes is surprising given the resistance to such moves by most social scientists across the globe. Again, the constitutional position and the slowly unfolding political power of Indigenous people in Taiwan might afford them more say in how they are affected by research than might be the case in some other ‘settler nations’.

Acknowledgements
This article appears in Research Ethics Monthly with the agreement of Wiley and Sons, publishers of Developing World Bioethics.

Gan, Z-R. and Israel, M. (2019) Transnational Policy Migration, Interdisciplinary Policy Transfer and Decolonization: Tracing the Patterns of Research Ethics Regulation in Taiwan. Developing World Bioethics. DOI: 10.1111/dewb.12224

Miguel, T.D. (2018) Undue Influence in Research Between High-Income and Lower-Income Countries. Research Ethics Monthly. 27 September. https://ahrecs.com/human-research-ethics/undue-influence-in-research-between-high-income-and-lower-income-countries

1 Member, Human Research Ethics Committee; Assistant Research Fellow, Research Center for Humanities and Social Sciences; Adjunct Assistant Professor, Center for General Education, National Cheng Kung University, Taiwan. ganrrec@mail.ncku.edu.tw

2 Senior Consultant, Australasian Human Research Ethics Consultancy Services. mark.israel@ahrecs.com

3 The Department of Health of the Executive Yuan, the top-level administrative arm of government, was renamed as the Ministry of Health and Welfare in 2013.

4 The Department of Health of the Executive Yuan, the top-level administrative arm of government, was renamed as the Ministry of Health and Welfare in 2013.

This post may be cited as:
Gan, Z-R. and Israel, M. (24  April 2019) Tracing the Patterns of Research Ethics Regulation in Taiwan. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/transnational-policy-migration-interdisciplinary-policy-transfer-and-decolonization-tracing-the-patterns-of-research-ethics-regulation-in-taiwan

Requesting your input0

 

We’re preparing to work on a new version of the subscribers’ area, so we’d appreciate hearing your thoughts and ideas.

Some of you have told us you’d like to subscribe, but your institution’s accounting rules don’t allow for open ended online subscriptions.  Some subscribers have told us that it would be helpful if the listed items were better organised.

We agree, but the Patreon platform doesn’t provide the kind of flexibility to make these kinds of sensible changes.

So, we’re exploring the cost and logistics of creating a subscribers’ area we control. While we work out its details, the key changes will be:

  1. Institutions that wish to access the contents in the subscribers’ area will be sent a tax invoice for a 12-month subscription which would be paid by EFT or PayPal.
  2. The area will be structured in two sections (Human Research Ethics and Research Integrity) each with five subsections:
    1. Commentaries
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Subscribers to the existing Patreon service can move to the new service at the same level for the remainder of whatever time they have remaining, at no extra cost.

Because we suspect some users of the Patreon service may prefer to stay there, we plan to continue posting items to both Patreon and the new service.

Is the new service something you’d recommend your institution subscribe to?  Before we spend the money to build it, we’re hoping to hear at least 15 institutions are interested in-principle.  Please send an email to patron@ahrecs.com.

Why do we need Category D appointments on HRECs and how should we find suitable people?0

 

Judith C S Redman

The compulsory presence of the Category D members on Australian Human Research Ethics Committees (HRECs) can be controversial. Category D used to be termed ‘minister of religion’ and most HRECs recruited ordained Christian ministers to fill these roles, although at least one of the Monash University HREC Category D members has been a rabbi (recruited by me). People question the need for a ‘religious perspective’ on HRECs, especially on those that regularly look at research concerning issues like abortion, contraception or euthanasia, or stem-cell research where ‘the Church’ is seen to have negative stances. I am a Uniting Church minister and a long-term university chaplain, which makes me a prime target for recruitment to the Category D position on university HRECs. I am currently in my 18th year as a Category D appointment, serving my fourth university. Clearly, it is something I find interesting and rewarding and I would like to offer some comments on the nature of the position.

First, referring to the category as ‘minister of religion’ is misleading, because the role is not to provide a religious perspective per se. ‘Minister of religion’ was included as a category (along with lay woman, lay man and member external to the institution) in the First Report by the NH&MRC Working Party On Ethics in Medical Research published in 1982 (p 20) and incorporated into the first National Statement published in 1983. In the 1999 version of the National Statement, the position was listed as: ‘at least one member who is a minister of religion, or a person who performs a similar role in a community such as an Aboriginal elder’ (NHMRC, 1999, p 16 – emphasis mine), thus hinting that it was not the minister’s religious perspective that was being sought. In fact, even when Australian society was far less multi-faith than it is today, no one clergy-person could provide a representative religious perspective. The 2007 National Statement made the purpose more overt in describing the category as ‘at least one person who performs a pastoral care role in a community, for example, an Aboriginal elder, a minister of religion’ (NHMRC, 2007 p 81). This wording has carried across to the current revision. (NHMRC, 2018 p 87).

What, then, is it that Category D members of HRECs bring to meetings? What is pastoral care? Finding a simple definition is somewhat challenging but Grove (2004, p. 34) defines it as ‘all measures to assist an individual person or a community reach their full potential, success and happiness in coming to a deeper understanding of their own humanness’. Pastoral carers are not therapists, but they do come into contact with human beings at high and low points of their lives. Often, however, they see more every-day lows than those that typically cause people to make appointments with therapists – and very few people will pay a therapist to share joys. They do, however, come to congregational clergy and Aboriginal elders to share the joy of the birth of a child and to mark other rites of passage within the life of their communities. Pastoral carers thus have insights into how people make meaning in their lives that many other people are not privileged to share. They can therefore offer broader perspectives on how participants might respond to some kinds of research than can many other HREC members.

Second, ‘the Church’ does not have a uniform perspective on biomedical ethical issues. While some denominations have specific stances on abortion, contraception, euthanasia, stem-cell research and so on, others do not. In my own denomination, most forms of contraception are widely accepted although some, such as the ‘morning after pill’ would divide members and clergy alike. Abortion, euthanasia and stem-cell research are all controversial, with Uniting Church members and clergy holding a range of opinions very close to the spread found in the wider community. It is therefore not possible to assume that any given Christian minister of religion will be against this kind of research as a matter of principle. This would also be true for pastoral carers from other world religions. Further, it is my experience as someone who has worked in a multicultural and multifaith university environment for several decades that while the things that divide religions are the things we notice most, we have far more in common than things that divide us. A fundamental part of most religions is an attempt to help people to understand what it means to be human, so someone with pastoral care experience from within a religious context can offer valuable insights into the human condition that are not bound by the teachings of her or his religion. They may well, for instance, have supported people making difficult decisions about biomedical ethical issues and have a better insight into whether the researchers have put appropriate measures in place for support of participants.

In addition, ministers of religion are not the only people on HRECs whose perspectives are shaped by religion. I have certainly known people serving in other roles on HRECs whose faith positions affect how they view some of the applications we are considering. The religious perspectives of Category D members are more likely to be overt, but any member of a HREC should declare a conflict of interest if s/he holds a faith/moral position that would not allow her/him to approve particular research no matter how well it complied with the National Statement. It is also quite likely that ministers of religion have studied ethics at a tertiary level as part of their ministry training.

Thus, I would argue that people with experience in providing pastoral care bring a unique and valuable perspective to the deliberations of HRECs, as long as they are selected with a little care. If you are responsible for recruiting members and biomedical research involving abortion, euthanasia, contraception or stem cell research and/or research around human sexuality and sexual orientation come up regularly in your business, you need to address the issues in your recruitment of Category D members. Although members of some religious groups are more likely to have problems with these issues, you cannot predict how a particular pastoral carer might react based on his or her religious group’s official policy. If you are replacing a Category D appointee or recruiting an extra one, the current one may be able to suggest colleagues that s/he thinks might be suitable. If you are setting up a new committee, the Category D appointees on nearby committees might have some ideas about suitable people. Some pastoral carers might even be willing to belong to more than one committee as long as the agendas are not too long and the meeting dates do not clash. In the end, however, you need to inform potential appointees about the kinds of issues you regularly deal with and ask them if they see any problem about their being able to assess these kinds of applications objectively. You also need to ensure that they understand that they are being recruited for their pastoral care experience not to provide a religious perspective. Taking these two steps should see your committee well served by your Category D appointments as they offer their particular perspectives on the applications before you.

We would like to build upon Judith’s excellent post about the pastoral position in future editions with similar commentaries about other positions.  Please contact us on HREC_members@ahrecs.com to discuss.

References

Grove, M. (2004). The Three R’s of Pastoral Care: Relationships, Respect and Responsibility. Pastoral Care in Education, 22(2), 34-38. doi:10.1111/j.0264-3944.2004.00261.x.

National Health and Medical Research Council (Australia) (1982). First Report By NHMRC Working Party on Ethics In Medical Research: Research in Humans. National Health and Medical Research Council, Canberra, ACT.

National Health and Medical Research Council (Australia) (1999). National Statement on Ethical Conduct in Research involving Humans. National Health and Medical Research Council, Canberra, ACT.

National Health and Medical Research Council (Australia) (2007). National Statement on Ethical Conduct in Human Research. National Health and Medical Research Council, Canberra, ACT.

National Health and Medical Research Council (Australia) (2018). National Statement on Ethical Conduct in Human Research, updated 2018. National Health and Medical Research Council, Canberra, ACT.

Contributor
Rev Dr Judith C S Redman, Chaplaincy Coordinator, Charles Sturt and La Trobe Universities, Albury-Wodonga Campuses | jredman@csu.edu.au

This post may be cited as:
Redman, JCS (27 March 2019) Why do we need Category D appointments on HRECs and how should we find suitable people? Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/why-do-we-need-category-d-appointments-on-hrecs-and-how-should-we-find-suitable-people

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