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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

Kua hinga te tōtara i Te Waonui-a-Tāne, the tōtara tree has fallen in Tāne’s great forest1

 

It is with great sorrow that we note the passing of one of our consultants, Barry Smith.

Of Te Rarawa and Ngāti Kahu descent, Barry was an extraordinary man. A true kaumatua, his wit and wisdom on matters of indigenous health and indigenous research ethics is irreplaceable.

Showcasing the best of the leadership through humility, Barry was relied upon by committees to bring an appreciation of Maori – and research ethics more generally – to their work. More than that, because of his diplomacy and humanity he became the kamatua of the process that bought Māori ideas and ways of knowing to the research ethics sector in New Zealand. Just a small list of his appointments is indicative of the status accorded to him senior scientists, ethicists, and government officials and ministers; he was or had been a member (and often a chair) on all the national bodies that set ethical standards and/or reviewed the ethics of research in New Zealand.

– Chair, Royal Society of New Zealand Maori Reference Group on indigenous matters to the Society’s project on gene editing
– Chair, Ministry of Social Development Ethics Committee
– Chair, the Lakes DHB Research and Ethics Committee
– Former Chair, Ethics Committee of the Health Research Council
– Former Chair, multiregional health and disability ethics committee
– Member, Advisory Committee on Assisted Reproductive Technology (ACART)
– Member, Auckland Regional Tissue Bank Governance Advisory Board
– Member, Health and Quality Safety Commission’s (HQSC) Perioperative Mortality Review Committee (POMRC)
– Member, committee re-writing New Zealand’s National Ethics Guidelines.
– Member, Marsden Fund project led by Tim Dare examining the ethics of predictive analytics.

Tena koe Barry Greetings Barry
kua wheturangitia Koe You who have been adorned as stars
ki te korowai o Ranginuia in the heavens
kua wehe atu Koe ki te po You who have departed to the night
Ki  tua o Te Arai To beyond
Ki te okioking To the resting place 
o o tatou tupuna Of our ancestors
Haere, haere, haere. Farewell, farewell, farewell

 

How do we ‘do’ consent?0

 

This blog post expands on ideas from our recent publication: McWhirter, R. E., & Eckstein, L. (2018). Moving Forward on Consent Practices in Australia. Journal of Bioethical Inquiry, 1-15.

Recently I participated in a research study. With the research nurse sitting opposite me expectantly, I moved quickly to sign in the appropriate place.

Hang on a minute. I’m a researcher, and an HREC member. I’ve published papers on informed consent, for goodness’ sake. I know better than this. Dutifully, I went back to the information sheet to read it properly.

After a couple of lines, I got bored and started scanning for key phrases. What will they do with my data? Which HREC approved this? Am I signing myself into eternal servitude?

Oh, who am I kidding, I thought. I’ve already made my decision. So, I just signed it, the research nurse smiled, and we got on with it.

Research suggests that I am not alone in my reaction to consent forms. They are boring, sometimes bordering on impenetrable. HRECs blame researchers for not writing in plain English. Researchers blame HRECs for being too inflexible and demanding a ridiculously long list of things to be included in a rigid format. There’s probably some truth on both sides, as well as some misunderstanding. And so, we end up with long, boring and ultimately unhelpful consent documents.

This is not to suggest that everyone is doing consent badly. There are lots of examples of research groups working with communities – whose members are usually potentially vulnerable in some way – to develop consent materials or processes that actually meet the needs of participants. Sometimes the solutions are technological– involving multimedia tools to overcome literacy or language barriers – and sometimes structural – such as by undertaking consent over several visits, so that individuals can decline to participate either by saying no or by avoiding the researchers, which can be an important option in communities where this is considered a more culturally acceptable method for refusal.

So, consent doesn’t have to be boring.

But what of the other problem indicated by my experience above? I had already made up my mind to participate before I’d been given the information sheet. Those with experience in study recruitment will know that I’m not unusual in this respect either. Depending on how the recruitment is undertaken, first contact might be a phone call, an email or letter, or a face to face conversation. In most cases, there will be some kind of blurb that precedes a participant’s reading of the consent documents and this is largely what people are basing their decision on.

These initial contacts are difficult to standardize (and it’s not necessarily desirable to do so) and difficult for HRECs to review, especially if they are verbal. A lot depends upon the character of the person doing the recruiting (usually a research nurse or research assistant rather than a principal investigator).

For one study in remote Aboriginal communities that I was involved in, I undertook several months of community consultation prior to commencing recruitment. I worked with community members to develop the study design and consent materials, employed local research assistants, and was helped enormously by senior women from each community. The relationships we developed meant that the study better met the needs of the communities, was more ethically sound (complying with both the National Statement and Values and Ethics) and resulted in a wider range of benefits than would otherwise have arisen.

These relationships also created trust between us. And that no doubt had an effect on our recruitment. The women liked me and wanted to help me. I had the support of influential elders. And by the time we got to use our carefully designed audio books, with information recorded in multiple dialects and with culturally relevant illustrations, most participants had already heard about the study, either from the community meetings during the consultation phase or through word of mouth. Although I stressed that participation was voluntary, and they were welcome to say no, everyone I invited agreed to participate.

So, what was the point of informed consent here? Well, it’s still polite to ask. The process of consultation that preceded it was effectively a form of community consent. And although individual decisions were probably influenced by their relationship with me and other study team members, these participants arguably had a greater understanding of the study than many participants in studies using more traditional methods.

I’m not sure there is a perfect way to ‘do’ consent. But it helps to be aware that the process is wider than just the consent documents. Providing training and ongoing team-based reflection for recruiters would help to address concerns over the quality of the less formal elements of consent. And it would be useful for HRECs to recognize the value of community consultation and consumer engagement in the study design phase, and to be open to non-traditional approaches to undertaking consent, rather than focusing unduly on the precise wording of consent forms.

We can’t ‘protect’ participants from researchers through mandating lists of information to be conveyed through formal documents, but we can encourage a culture of ethical research that better addresses community interests by reflecting on what we’re actually doing when we ‘do’ consent.

Contributor
Rebekah McWhirter
Centre for Law and Genetics, Faculty of Law, University of Tasmania
http://www.utas.edu.au/profiles/staff/law/rebekah-mcwhirter

This post may be cited as:
McWhirter R. (26  August 2018) How do we ‘do’ consent?. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/how-do-we-do-consent

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.

Release of the National Statement on Ethical Conduct in Human Research 2007 (updated 2018) – With interview0

 

The revised National Statement on Ethical Conduct in Human Research 2007 (updated 2018) was released on 9 July 2018.

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Content of the updated National Statement

The National Statement consists of a series of guidelines made in accordance with the National Health and Medical Research Council Act 1992 and is subject to rolling review. This means that parts of the National Statement are updated as needed, in accordance with strategic planning, or in response to user feedback or national or international developments in research or ethics.

Since 2007, Section 3 of the National Statement has addressed ethical considerations specific to research methods or fields. The 2018 revision provides a new structure for Section 3, based on the elements of a research project (from conception to post-completion). The revised Section 3 begins with a chapter that addresses ethical issues in all research, followed by specialised guidance for research involving human biospecimens, genomics and xenotransplantation.

This approach emphasises that researchers, Human Research Ethics Committees (HRECs) and other users of the National Statement must take account of the principles and major themes in research ethics addressed in Sections 1 and 2 of the document as the foundation of the guidance in Section 3 and then, in turn, consider the guidance provided in Chapter 3.1 as a base for the guidance provided in the other chapters included in this section.

While significant changes have been made to all aspects of the guidance provided in Section 3, we note, in particular, the additional guidance that has been provided in relation to collection, use and management of data and information and to management of the findings or results arising from genomic research.

As part of this update, changes have also been made to Chapters 5.1, 5.2 and 5.5 in Section 5, the Glossary and the Index as a consequence of the revisions to Section 3.

Revisions to the National Statement were informed by working committees and through public consultation in accordance with requirements of the National Health and Medical Research Council Act 1992.

Currency and effective date

All users of the National Statement, including HRECs, research offices and researchers are expected to ensure that the current version of the National Statement is being used in developing research proposals, making submissions for ethics review and undertaking ethics review. However, as a consequence of the scope of the revisions to Section 3, we expect that users of the National Statement will gradually integrate these revisions into their proposals, submissions and review over the period from July to December 2018, with full implementation expected by 1 January 2019.

This timeline is intended to give researchers and HRECs an opportunity to familiarise themselves with the new guidance prior to the revocation of the version of the National Statement updated, most recently, in 2015. To facilitate this transition, both the current version of the National Statement and the updated version are available on the NHMRC website at http://nhmrc.gov.au/guidelines/publications/e72.

Use of the National Statement is also linked to the Human Research Ethics Application (HREA), released in December 2016 to replace the National Ethics Application Form.

To coincide with the release of the revised National Statement, questions in the HREA will require revision and users of the HREA will be advised when the revised HREA is online.

Institutions and HRECs are encouraged to allow a transition period for researchers while the revisions to the HREA take effect. The provision of a transition period, how it will be managed and its timeframe are at the discretion of individual Institutions/HRECs.

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Context

Australia’s research integrity framework is underpinned by three national standards developed by NHMRC and its co-authors, the Australian Research Council (ARC) and Universities Australia (UA). Together these three standards provide guidance on responsible and ethical research conduct for both humans and animals.

The overarching document is the Australian Code for the Responsible Conduct of Research, 2018. The Code is the leading reference for researchers and institutions across all disciplines about the expectations for responsible research conduct and the handling of investigations into research misconduct. After 10 years in operation, the Code has been reviewed and the 2018 edition was released in June 2018. The other two documents are the National Statement and the Australian code for the care and use of animals for scientific purposes (also endorsed by CSIRO).


INTERVIEW

AHRECS (While we know it predated the recent work on s3) What drove the decision to conduct a rolling review, rather than a review of the entire document?

NHMRC During the revision of the National Statement that was completed in 2007, it was determined that a more flexible, more efficient approach to revising the document would be a good innovation. We wanted to be able to both respond to the needs of users for more limited changes – from a word, to a paragraph, to a single chapter – without having to review the whole document and to be able to integrate or modify the content in response to changes nationally or internationally in research, research ethics or government regulation. Review of the 1999 National Statement took three years from start to finish and we thought we could improve on that timeline! We have found that this approach has, in practice, enabled us to make both minor changes and significant changes to single chapters of the document, as well as to review one of the five sections of the document, as we have just done.

AHRECS Are there downsides to that approach?

NHMRC Yes, there are. The major downside is that the document is ‘of a piece’ and changes to any one part of the document invariably require consideration of changes to the other parts, not just in terms of cross-referencing, but in terms of the content itself. This issue of ‘consequential effect’ manifests itself in the need to ensure consistency in our guidance and to consider the impact on the whole document of more philosophical or conceptual changes that have been introduced by the changes. An example in the most recent revision of Section 3 is that our approach to interventional research in Section 3 had a ‘flow on’ effect to Section 5 in terms of where certain guidance belonged, how that guidance should reflect changes in the clinical research sector since 2007 and how it should reflect other guidance documents (e.g. related to safety reporting) that NHMRC has published in the last 12 months.

AHRECS What were you hoping to accomplish with the changes to section 3 (and Section 5 + the Glossary)? Was it achieved?

NHMRC Principally, we were hoping to facilitate a re-thinking on the part of users (researchers and HRECs, primarily) regarding how they conceptualise and address ethical issues in the design, review and conduct of the research. We began with a decision to abandon the idea of ‘categories’ or ‘types’ of research as the main way to package this guidance and to focus on the reality that most ethics guidance applies to ALL research, thereby requiring ALL researchers to consider it, rather than just going to their specialised chapter of the document and, potentially, ignoring the broader issues. We then settled on the ‘life cycle’ of a research project as the best structure – that is, from conception to post-completion stages of a research project. This also enabled us to see more clearly what was not general guidance and encapsulate that extra guidance in separate, specialised chapters that each required consideration of the general guidance as a prerequisite to fully understanding and implementing the specialised guidance content.

The changes that we made to Section 5 and the Glossary were a direct consequence of the revision of Section 3 and we purposefully did not introduce changes to those parts of the document that were independent of the Section 3 revision, even though it was pretty tempting to do so sometimes.

We do think that we achieved our objectives and we are very satisfied with the results of the review process.

AHRECS If you could say just one thing about the work to date what it be?

NHMRC Review of the National Statement, while challenging, involves very stimulating and satisfying dialogue with lots of researchers, reviewers and other users of the document. We are so committed to it that we are almost immediately taking on the review of Section 4 and Section 5 – so, watch this space!

AHRECS When someone says they would have liked examples to better illustrate the new concepts in the update how do you respond?

NHMRC A weaselly response would be: it depends on which new concepts you are talking about; but, to use one example, a good look at Chapter 3.3: Genomic research and the Decision tree for the management of findings in genomic research and health care that we included (on page 52) to address this complex issue provides just such an attempt to illustrate by example. The main impediment to using examples or case studies to illustrate concepts is the difficulty of deciding which concepts to illustrate and with how many examples, as well as potentially expanding the size of the document exponentially in order to do the examples justice.

AHRECS When will a html version be available online?

At present, the 2007 version of the National Statement (updated May 2015) is available in both PDF and HTML format; whereas the version updated 2018 is only available in PDF. We are not 100% sure when the HTML version of the National Statement (updated 2018) will be available, but we anticipate within the next two to three months. Please also note that the current address (https://beta.nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018#block-views-block-file-attachments-content-block-1) is only temporary, which means that you’ll need to update your bookmarks/links again when the final version of the new NHMRC website is released in late August or early September.


 

This post may be cited as:
NHMRC (31 July 2018) Release of the National Statement on Ethical Conduct in Human Research 2007 (updated 2018). Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/release-of-the-national-statement-on-ethical-conduct-in-human-research-2007-updated-2018-with-interview

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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