ACN - 101321555 Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Resource Library

Research Ethics MonthlyAbout Us

Human Research Ethics

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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
    2. Professional development material
    3. Images
    4. Audio files
    5. Video files
  3. There will be tools to link to related items, profile items and search the library.

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.

Reflections on chairing a human research ethics committee0

 

Prof Colin Thomson AM

Chairing an HREC can be complicated, demanding, stressful and tiring but also stimulating, rewarding, satisfying and hugely enjoyable. In this article, I reflect on my experience of being a chair of four HRECs in universities, public health organisations and public sector agencies. Of course I accept, from watching a number of other committees, the ways chairs guide committees to their decisions vary widely, express different personal experiences and can be affected by an institutional environment. As a result, these reflections are not intended to appear as a set of instructions for other chairs.

 

The invitation

So, where to begin? One point is at the invitation: am I equipped to take on this role and what do I need to know about the committee and the institution it advises? An HREC chair requires some exposure and familiarity with the ideas that are central to the ethics of human research and a sense of what reaching a decision in an ethics review requires. Ethics committees are unlike typical administrative committees in some significant aspects. The central difference is the nature of the subject matter and the decisions that need to be made: of their nature, they are less definitive than administrative decisions but share, with those, the need for adequate reasons and justification. In this tension between ethical judgement and adequate justification lies their challenge.

AHRECS offers a coaching service for Chairs (and for HRECs/RECs).  This involves observations of 3 committee meetings, meetings with specialist  consultants and a written report. Email coaching@ahrecs.com to find out more.

Other personal considerations include not only do I have the time but what is important to me in the role? For me, this has not been one consideration but a blend. The intellectual challenge of sound ethical analysis, appreciation of the creativity and skill of good research design and the refinement of inter-personal skills: all harnessed toward enabling ethically sound human research.

 

Decision-making

HREC decisions are rarely clear approvals or rejections but tend to be conditional: of the ‘not yet approved’ kind. Notification of those decisions should provide clear reasons and  practical advice: committees show respect for researchers by providing reasons for the outcome and advice about responding. At the same time, outcomes should fairly reflect the position that the committee has come to – and this can be difficult.

I have always found it challenging recapping and summarising fairly and accurately what different members of the committee have said and blending those into a reasonably clear outcome that the HREC can agree to at the meeting. Doing so is much easier after the meeting when settling the minutes and providing advice to applicants. But are such clarifications what the committee has agreed to or are they expressing a chair’s preference for the outcomes?

One discussion strategy that I watched with admiration in in one committee and tried, with some success, to emulate was to follow the same order of issue category for each proposal:

  1. does the proposal have value and validity and, if not, what do we need to know to be satisfied that it does?
  2. what risks to participants or others does the project involve; how is it planned they will be mitigated and are we satisfied with the level of mitigated risk?
  3. how are participants being recruited and how is their consent being sought, gained and recorded?
  4. are there issues of fairness in the imposition of burdens of participation on a particular population?

This worked well because members who, for example, would always have questions about consent, knew that they did not need to raise them at the start of the discussion of that proposal because that subject matter would be addressed in due course.

It also made it easier to recap the committee’s discussion. Sometimes it can be useful to do this at the conclusion of the discussion of each category – doing so meant that I did not have to remember all that was said 15 minutes ago or rely on notes taken while I was listening. Further, I found that it could be as inclusive as starting with an open invitation for ‘any comments’ and also avoided disordered and repetitive discussion.

I did find that acceptance of such a structure by a committee used to lack of structure took longer and required constant reinforcement. I came to realise that it was practice, rather than prescription, that generated acceptance of the strategy but maintained a relaxed and comfortable informality.

 

Working with an HREC

Here, a skill that comes with getting to know a committee well is knowing who to refer to, of whom to ask questions, who is likely a waste time with irrelevant matters and how to courteously persuade them to desist. These are generic chairperson skills but the nature of discussion at an ethics committee can make them more sensitive because ethics opens a wide arena for personal yet legitimate and relevant opinions. Dismissing one of these requires tactical use of reasoned ethical analysis lest it be treated as merely personal.

A central feature of an effective chair is to have the ongoing confidence and support of all members of the HREC, even if there are differences of opinion as to proposed outcomes of a review. I have chosen not to introduce each application with my own analysis and my recommended conclusions. My preference has been for discussion and development of a consensus view rather than to aim for an outcome that, in anticipation, I would have preferred. Doing so reduces the risk of closing down discussion and, depending on the relative status or perceived status of the chair vis-vis other members, chilling some members’ input.

I learned very early that I lacked depth in a number of perspectives that are intended to be reflected in the composition of the committee. This is of central importance: the decision is a decision of the whole committee and one that the whole committee can agree to. Frequently, the outcome I foresaw in reviewing an application in preparation for a meeting was not the one that the HREC reached. In preparing for meetings, as a result of these experiences, I would identify issues that, in my view, needed more attention from the researcher but I learned to remain open to other issues that had not occurred to me.

Following a meeting in which such an outcome is reached, the ongoing challenge is to explain to an often disgruntled researcher why the committee reached that view and why further refinement or modification of the application is needed for approval. Here, the burden often falls on the chair and the HREC executive officer. However, where the difference between a researcher and the committee lies in, for example, the traditions of the research discipline involved, I have tried to include the appropriate researcher member of the HREC in order to demonstrate respect to the researcher and to the committee.

There is a tension between the authority that a chair is often seen to have and the humility that a chair needs to bring to the role. The authority of the chair is not the same as the authority of the committee, even if some researchers think that it is or should be. Because it is essential that a committee be seen to be the decision-maker, explaining those decisions often requires more input than just from the chair.

 

The background of a chair

Would these challenges be reduced if, unlike me, chairs were also active researchers? From a committee point of view a researcher-chair is likely to generate considerable respect from the members of the HREC but, because of her very expertise, may also chill contributions from those with far less research awareness. From an institutional point of view, appointment of a researcher does add status to the committee which is, in many people’s eyes, essentially a research activity. However, any researcher chair will have disciplinary boundaries and it can be difficult to represent the committee’s ‘not yet approved’ decisions to researchers from completely different fields. In my experience, this has generated unintended tensions for some chairs.

This raises another more general issue as to whether a chair should be an institutional employee or external to the institution. There are benefits and shortcomings in each. An internal chair will know the institutional landscape and culture and can bring stature to the committee: the appointment itself can testify to the importance that the institution attaches to the HREC. The shortcomings will often be related to research fields, as noted above. For external chairs, the degree of independence can also add to the status of the HREC, particularly where the reputation, professional status or achievements of the chair can signal to committee members and researchers the importance the institution places on the committee’s role. On the other hand, an external chair will usually have limited knowledge of an institution, of its ethos and its culture and this can limit effective communication: particularly in outreach activities.

Beyond the HREC processes, chairs can make significant and valuable contributions to an institution’s research culture by representing the HREC at governing body meetings; participating in outreach activities to promote awareness of (and debunk myths about) a committee and participate in professional development in human research ethics.

 

Enjoying meetings

My final comment echoes the final quality that I suggested at the beginning of this short reflection. HREC meetings should be enjoyable: it is a place where thoughtful, committed and articulate people come together and, so long as they respect and are willing to listen to one another’s points of view, can be an environment in which intelligent and enjoyable, even light-hearted (but not cynical), conversation adds to the fulfilment of an important and worthwhile role.

Contributor
Prof. Colin Thomson AM | Senior Consultant AHRECS | AHRECS profile | colin.thomson@ahrecs.com

This post may be cited as:
Thomson, C. (23 April 2019) Reflections on chairing a human research ethics committee. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/reflections-on-chairing-a-human-research-ethics-committee

Travelling Consultants and Professional Development Roadshows0

 

Prof. Mark Israel plans to be in CANBERRA (2-3 April), SYDNEY (8-10 May), UK and Belgium (27 May-8 June), MELBOURNE (13 June) and Perth (22-26 April, 1-5 July) should any universities, health services or research organisations wish to meet to discuss their research ethics or research integrity needs with an AHRECS Senior Consultant.

Prof. Colin Thomson plans to be in CANBERRA (8-10 April), BRISBANE (30 April – 1 May).

Mark and Colin are also available to run professional development workshops for HRECs, academic or professional staff, in research ethics and research integrity including the changes to the National Statement and the new Australian Code.

AHRECS has other consultants based in those cities or who travel through regularly should these dates not be convenient. Of course, we also remain available by videoconference at other times.

Send an email to enquiries@ahrecs.com if you would like any further information.

0