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Smarter proportional research ethics review0

 

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

Gary Allen, Mark Israel and Colin Thomson

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

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

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

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

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

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

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

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

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

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

Complainant anonymity in misconduct proceedings depends on the forum0

 

Prof. Colin Thomson AM, Senior Consultant, AHRECS

This news item, while identifying the fact that the decision relates to court proceedings and not to university processes, leaves out some informative facts.

Two members of the La Trobe academic staff lodged complaints about bullying by Professor Keyzer, whom the university suspended.  In turn, Professor Keyzer commenced proceedings against the university in the Federal Court to challenge the way it had handled the complaint. The complainants were not parties in these proceedings.  However, they sought to intervene in the case (Keyzer v La Trobe University [2019] FCA 646) to request that the court order that their names not be published.  They were represented at the hearing but both the university and Professor Keyzer were not.

The court needed to decide whether to allow the complainants to intervene in the case and, if they were allowed, whether there was a case to suppress their names in the court hearing and record.  The court allowed them to intervene but did not order suppression of their names.

The question of suppression of the complainants’ names raised, and was ultimately decided on, the fundamental difference between proceedings in institutional investigations and those in superior courts.  That difference is that publicity of court proceedings is seen to be central to the administration of justice in Australia, and characteristic of the English common law tradition that informs Australian court proceedings.

In concluding his comprehensive judgement, that contains a thorough account of the open justice principle at stake and the exceptions that have been permitted, Anastassiou J said:

I echo the sympathy expressed by Mahoney JA for the “great pain” that is often felt by those subjected to publicity surrounding court proceedings. However, the power conferred by s 37AF is constrained by the grounds under s 37AG and by the overlay of priority to be given to the public interest served by open justice pursuant to s 37AE. In my view, s 37AG(1)(a) makes clear that the public interest served by open justice may only be qualified where it is necessary in the strictest sense to prevent prejudice to the proper administration of justice. The legitimate personal interest of the interveners in maintaining their privacy in connection with the complaints process is not sufficient to conclude that the protection of their interests is necessary to prevent prejudice to the administration of justice.

The following is the text of sections referred to:

37AE  Safeguarding public interest in open justice

In deciding whether to make a suppression order or non-publication order, the Court must take into account that a primary objective of the administration of justice is to safeguard the public interest in open justice.

37AF  Power to make orders

(1)  The Court may, by making a suppression order or non-publication order, on grounds permitted by this Part, prohibit or restrict the publication or other disclosure of:

    • information tending to reveal the identity of or otherwise concerning any party to or witness in a proceeding before the Court or any person who is related to or otherwise associated with any party to or witness in a proceeding before the Court; or

(b) information that relates to a proceeding before the Court and is:

(i)   information that comprises evidence or information about evidence; or

(ii)   information obtained by the process of discovery; or

(iii)   information produced under a subpoena; or

(iv)   information lodged with or filed in the Court.

(2)  The Court may make such orders as it thinks appropriate to give effect to an order under subsection (1).

37AG  Grounds for making an order

(1)  The Court may make a suppression order or non-publication order, on one or more of the following grounds:

(a)  the order is necessary to prevent prejudice to the proper administration of justice;

(b)  the order is necessary to prevent prejudice to the interests of the Commonwealth or a State or Territory in relation to national or international security;

(c)  the order is necessary to protect the safety of any person;

(d)  the order is necessary to avoid causing undue distress or embarrassment to  a party  to or witness in a criminal proceeding involving an offence of a sexual nature (including an act of indecency).

(2)  A suppression order or non-publication order must specify the ground or grounds on which the order is made.

Concluding observation

Within the scope of a university’s own investigation or disciplinary procedures, the assurance of confidentiality in internal procedures and policies can be relied upon. However, when proceedings in relation to staff misconduct are brought in an Australian superior court, such as the Federal Court or a State Supreme Court, the priorities among principles changes. In those courts, the principle of preserving the “proper administration of justice” is fundamental and has priority over the principles that governed the conduct of institutional proceedings. In such courts, the grounds on which exceptions can be made to that principle, such as orders that suppress the name of a person, as this case illustrates, are few.

This post may be cited as:
Thomson, C. (24  May 2019) Complainant anonymity in misconduct proceedings depends on the forum. Research Ethics Monthly. Retrieved from: https://ahrecs.com/research-integrity/complainant-anonymity-in-misconduct-proceedings-depends-on-the-forum

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.

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