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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.

REAlising a collegiate Research Ethics Adviser network0

 

By
Dr Gary Allen| Senior Consultant AHRECS| gary.allen@ahrecs.com
Dr Mark Israel| Senior Consultant AHRECS| mark.israel@ahrecs.com

Our research ethics consultancy activity in recent years has involved us working with a broad range of research institutions. Despite diversity in size, budget, age, geographical reach and mission, in some respects institutions face similar challenges, frustrations and risks. In relation to research ethics, the recurrent themes that we have noticed include:

  1. There being insufficient time and capacity to conduct professional development activities, especially activities focussed on the needs and experiences of schools, departments, research centres and research offices.
  2. A legacy of an adversarial climate, and distrust, between researchers, research ethics reviewers and the research office (Israel et al., 2016).
  3. Serious budgetary constraints.
  4. Difficulty in recruiting new members of the research ethics committee, especially from areas that do not have a long-standing connection to human research ethics or have had difficult experiences with research ethics review. This may be compounded by university initiatives to reshape their workforce in a way that prioritises research income and outputs.
  5. Review feedback needing to be detailed and long, but often receiving poor and aggressive responses.
  6. Difficulty in eliciting constructive, or sometimes any, response to internal or external consultations from some parts of the institution.

We have developed a strategy (Allen and Israel, 2018) that can form part of the response to these matters as part of a commitment to resourcing reflective practice. It draws on existing resources, fosters a better relationship between reviewers and researchers, helps target constructive feedback, builds the capacity of researchers to engage in ethical research, and prepares a new cohort of researchers to join the human research ethics committee.

SHORT BRIEFING PAPER ON REA NETWORKS

https://www.patreon.com/posts/24928731

Available to USD3/month patrons

A network of collegiate Research Ethics Advisers (REAs) enables a group of experienced researchers to act as a source of collegiate advice to other researchers in their area. Among the roles of a REA should be:
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  1. Involvement in facilitating professional development workshops and other activities in their area. This might initially involve them introducing sessions run by the university on particular aspects of research ethics pertinent to specific disciplines, commenting on the issues raised and engaging in discussion. Eventually, the entire activity might be facilitated by the REA. This strategy distributes leadership of human research ethics, and reinforces its important to quality research in their area, not ‘just’ a matter of complying with externally imposed rules.
  2. When applicants are sent complicated feedback, they might usefully be directed to consult their local REA before responding. This allows the review body to leave long written explanations to be complemented and explained by a more personal verbal explanation, and it should improve confidence that the applicant’s response will resolve the matter, rather than requiring another round of feedback.
  3. The REA network can serve as a conduit for information between researchers and reviewers, providing early warning to an institution when clashes might arise over methodology or changes in regulation.

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Having assisted a number of institutions to establish, appoint, provide professional development and support to REA networks, we have found the optimal appointment level to be at the school/team/department level with the number of REAs recruited from an area reflecting the number of researchers in that area who conduct human research.
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In our Patreon area, we have included:
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A briefing note about a standard operating procedure for a REA network with the heading Basic Structure, which provides a plan for the establishment and operation of a collegiate network.

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A subscription of USD 5/month will provide access to this material. A subscription of USD 15/month will provide access to all our Patreon materials. Contact us at Patreon@ahrecs.com to discuss.
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AHRECS would of course be delighted to help you turn those shells into documents tailored to your institution’s needs. We are also able to assist in the establishment and professional development of a collegiate REA network. Contact us at REA@ahrecs.comto discuss.

Figure 1 – A version of this image, which is not watermarked, is available from https://www.patreon.com/ahrecs with a USD3/month subscription.

References:

Allen, G and Israel, M (2018) Moving beyond Regulatory Compliance: Building Institutional Support for Ethical Reflection in Research. In Iphofen, R and Tolich, M (eds) The SAGE Handbook of Qualitative Research Ethics. London: Sage. pp.276-288.

Israel, M, Allen, G and Thomson, C (2016) Australian Research Ethics Governance: Plotting the Demise of the Adversarial Culture. In van den Hoonaard, W and Hamilton, A (eds) The Ethics Rupture: Exploring Alternatives to Formal Research-Ethics Review. Toronto: University of Toronto Press. pp 285-316. http://www.utppublishing.com/The-Ethics-Rupture-Exploring-Alternatives-to-Formal-Research-Ethics-Review.html
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This post may be cited as:
Allen, G. &.Israel, M. (25 February 2019) REAlising a collegiate Research Ethics Adviser network. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/realising-a-collegiate-research-ethics-adviser-network

Griffith University’s implementation of the Australian Code (2018)0

 

Dr Amanda Fernie, Manager Research Ethics & Integrity, Griffith University Dr Gary Allen, Senior Policy Officer, Griffith University

AUSTRALIAN CODE (2007)

At Griffith University, the implementation, operation, investigations and related professional development of/for the 2007 edition of the Australian Code for the Responsible Conduct of Research is the responsibility of the Research Ethics & Integrity team in the Office for Research.

The Griffith University Code for the Responsible Conduct of Research was the University’s policy implementation of the Australian Code (2007) and it was supplemented by the Research Integrity Resource Sheet (RIRS) series. The Griffith University Code was largely a direct repeat of the Australian Code into Griffith University policy. The RIRS is a series of short (most are four pages) guidance documents that provide practical tips related to the University’s implementation of Part A and Part B of Australian Code (2007).

IMPLEMENTING THE AUSTRALIAN CODE (2018)

This is the first post in the series about institutions implementing the Australian Code (2018). We’d love to hear about your instution’s progress and story. Email us at IntegrityStory@ahrecs.com to discuss logistics.

At the outset, Griffith University decided to give its Research Integrity Adviser (RIA) network a more collegiate advisory role, and while RIAs were made available to advise complainants and respondents, or parties in a dispute, their primary role was providing advice and suggestions.
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Professional development workshops on research integrity for new HDR candidates were conducted a few times a year (as part of the orientation) and were co-facilitated by the Office for Research and the Griffith Graduate Research School. Workshops on research integrity were also conducted for new HDR Supervisors as part of their accreditation. Since 2007, professional development workshops in Schools, Departments, Research Centres, Administrative units and Groups have been co-facilitated by the relevant RIA and a member of the Research Ethics & Integrity team.
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APPROACH TO THE AUSTRALIAN CODE (2018)

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Griffith University aims to have fully implemented the Australian Code (2018) by the end of March 2019. Griffith’s Research Committee has recommended to the Academic Committee that the redundant detail of the Griffith University Code be replaced by the Griffith University Responsible Conduct of Research policy. This policy articulates the University’s implementation of the principles and responsibilities of the Australian Code (2018), the role of the University’s collegiate RIAs, and the existence and role of the resource material that will be produced by the Office for Research.
Our Office for Research is currently liaising with the relevant parts of the University to determine who has control of:

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Level 1 – Documents that refer to or link to the Australian Code, where a simple change to the reference/URL is required. Example: HDR candidate supervision policy.
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Level 2 – Documents that derive authority from the Australian Code, where it will need to be determined if the Australian Code (2018) still directly provides that authority or if any changes are required. Example: Publication ethics standards.
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Level 3 – Documents that copy, refer to or use a component of the Australian Code (2007), where it will need to be determined if the Australian Code (2018) still provides that component or if it needs to be replaced by institutional guidance.
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The above work is underway and progressing well.
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In the event new institutional guidance is required, it will be included in the updated RIRS series.
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UPDATED RESEARCH INTEGRITY RESOURCE SHEETS

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The following resource sheets are being produced:
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  1. Introduction to research integrity at Griffith University
  2. Moving to the 2018 version of the Australian Code
  3. Planning and conducting a project responsibly
  4. Responsible research outputs
  5. Responsible data management
  6. Collaborative research: Hints and tips
  7. The responsible supervisor
  8. The responsible candidate
  9. Conflicts of interest
  10. Tips for peer review
  11. Disputes between researchers
  12. Investigations of alleged breaches of the Australian Code for the Responsible Conduct of Research
  13. Alleged breaches: Tips for complainants
  14. Alleged breaches: Tips for respondents
  15. Research Misconduct

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Initially any ‘new’ guidance material will use text from Part A of the Australian Code for the Responsible Conduct of Research (2007), but the intention is to refine the material based on (sub)discipline and methodological feedback from the University’s research community, drawing from useful ideas from the Committee on Publication Ethics (COPE), International Committee of Medical Journal Editors (ICMJE), US Office of Research Integrity (ORI) and the UK Research Integrity Office.
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As new good practice guides are released the relevant RIRS will be reviewed and updated as required.
Griffith University is taking a ‘learning institution’ approach to this material, where it is refined and improved over time based on user feedback and suggestions, institutional and (inter)national experience/events and changes in needs.
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COMMUNICATION PLAN

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The Office for Research is currently finalising a communication plan, in addition to regular updates to Research Committee, the RIA network and the areas of the University identified for the consultation above. This will include briefings for the Group Research Committees.
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AWARENESS AND PROFESSIONAL DEVELOPMENT PLAN
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Early in 2019, the Office for Research and RIAs will commence professional development activities to raise awareness and understanding of the national and international changes.
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Amanda is happy to be contacted with any questions or suggestions about this work.
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Contributors
Amanda Fernie, Griffith University | a.fernie@griffith.edu.au & Gary Allen, Griffith University

This post may be cited as:
Fernie, A. & Allen, G. (26  November 2018) Griffith University’s implementation of the Australian Code (2018). Research Ethics Monthly. Retrieved from: https://ahrecs.com/research-integrity/griffith-universitys-implementation-of-the-australian-code-2018
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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.

 

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