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Research ethics review during a time of pandemic0

 

Gary Allen, Mark Israel and Colin Thomson

COVID-19 is prompting changes to academic delivery, essentially intended to contain the spread of the virus and protect the most vulnerable from its effects. As more countries introduce travel restrictions and mandate self-isolation, it will no doubt change the way we conduct research.

Research ethics review needs to adapt to meet the needs of these trying times.

We have written previously about the use of proportional review and proportional processes to progress matters outside of a research ethics committee meeting.

But there will always be matters that need to be considered by a human research ethics committee.

One of the strengths of committee review and one of the reasons flying minutes are not favoured is that a committee’s membership brings together different perspectives, lived experience and knowledge.

It remains important that committees exercise their responsibilities in paragraph 5.2.31 of the National Statement.

5.2.31 Decisions by an HREC about whether a research proposal meets the requirements of this National Statement must be informed by an exchange of opinions from each of those who constitute the minimum membership (see paragraph 5.1.30). This exchange should, ideally, take place at a meeting with all those members present.

But, that does not mean committee members need to sit together in a room.  The same valuable results might be achieved with video conferencing packages like Zoom and MS Teams, Blackboard Collaborate, perhaps even aided by asynchronous online collaborations on feedback. AHRECS has worked with many institutions that already run their meetings successfully online.

Of course, institutions may need to assess their on-line or virtual meeting systems to ensure they enable chairs to be satisfied that there has been an exchange of opinion and not merely individual expressions that are unseen by other members.

In addition, AHRECS can help you take advantage of an online meeting by conducting a short professional development activity on a topic of your choice.  This would involve a further reading and reflection booklet, 15-minute pre-recorded presentation (e.g. Social Media and human research ethics) and 15 minutes of Q&A/discussion.  The cost of such an activity is A$900.

Email enquiry@ahrecs.com to discuss further.

 

Lost time may never be found again but is it time to talk about the duration of ethics approvals?0

 

“To everything there is a season, and a time to every purpose” a time to report on ethical conduct, a time to renew an approval, or a time to face misconduct proceedings.

Dr Gary Allen

What is the length of ethics approvals that your HREC grants?  In this article, I will discuss this question and some of the reasons for choosing approval periods.

A related question is, under what circumstances should an ethics approval be withdrawn?  Can/should research ethics review bodies withdraw approval because of extended/repeated failure by a researcher to provide an ethical conduct report?

Australia is unlike the US where the conventional interpretation of the Common Rule is that ethics approvals are of one year.  Accordingly, US researchers must provide annual ethical conduct reports to maintain ethics approval and avoid needing to make a fresh application.

In Australia, the duration of approval is not specified by the National Statement and the only clear Australia-wide external requirement to provide reports in a certain time is paragraph 5.5.5 of the National Statement which provides that researchers should report to ethics review bodies at least annually.  As a result, approval duration is likely to be dictated by institutional policy and some have adopted maximum duration periods.  A short (e.g. 12 months) approval period and renewal requirement is one lever committees can use to compel researcher compliance to provide evidence that the needs for approval periods are being met.

There are, I suggest, four such needs that are served by a choice of duration of an ethics approval, namely:

  • Compelling a report from a researcher and allowing a review body to confirm that –
    1. a project is being conducted as per the approval, and
    2. the welfare and interests of participants are still being adequately provided for.
  • Providing an opportunity to reflect on any changes to national standards or institutional policies or pertinent cases that warrant a rethink of approvals.

Researchers can typically seek a long duration ethics approval because:

  • The design calls for repeated data collection across an extended period, such as a longitudinal ethnographic study;
  • The work is a component of a program of work focussed on a cure for a chronic condition; or
  • The work intends to compile an archive of biospecimens, data, document samples, audio-visual material or other items of historical/cultural significance.

The maximum duration of a research ethics approval would also appear to be connected to how long an HREC has operated and the amount of work the committee is undertaking. In Australia, institutional decisions on the matter can also be associated with changes in national ethics review requirements that occurred in 1999, 2007 and 2018 (and beyond).

Like other aspects of human research ethics practice in Australia, the approach to duration has reflected practice in the United States.  While Australia does not have the same kind of regulatory framework as the US where failing to maintain ethics approval can have consequences for institutions, the use of single year approvals is probably used as a way to promote adherence to the institution’s ethical conduct reporting requirement.

While understandable, such short-term approvals can punish conscientious researchers because of an institutional response to recalcitrant researchers.

However, early in a research ethics committee’s operation, it is not uncommon for it to grant approvals with durations of between one and three years.

This can reflect the committee’s confidence:

  1. in its role and decisions;
  2. and trust that researchers understand their responsibilities and will abide within the scope of the ethics approval; and
  3. that projects will progress as per applications or researchers will contact the institution’s research office if the unexpected occurs.

A low workload of a committee can serve as an incentive for short duration approvals and longer duration/longitudinal work is chunked out into two or more applications. Increasing the number of approvals may not allow the committee and research team to develop expertise before the committee commits to an extended period of research. Alternatively, a committee might be tempted to inflate its number of approvals artificially to attract either resources or credibility.

Conversely, when a research ethics committee is very busy, there may be more incentive to grant longer approvals to minimise the number of times the committee needs to review renewals of long duration projects.

Given, the National Statement (2007 updated 2018) is currently silent on the issue of the duration of ethics approvals, it might appear the Australian national framework should not impact on approvals. However, there is both a predictable impact and a real reason to rethink our current approach to the duration of approvals.

At this stage an update to Section 4 of the National Statement might be released in the next six months and an update to Section 5 will move out of the planning stage shortly.

Some institutions and committees tie the duration of ethics approvals and forced renewal around the timeframe during which the national arrangements might change (and perhaps inter alia institutional policy).  In Australia this might equate to around a five year approval duration.

The changed approach to updates to the National Statement means that such a cycle might not be especially helpful.

Suggested change to duration and monitoring procedures

We recommend institutions and HRECs do the following:

  1. Adopt a policy setting that the conduct of human research without prior ethics approval may be considered a breach of the Australian Code for the Responsible Conduct of Research (2018) and of the institution’s research integrity arrangements. This would be consistent with the Investigation good practice guide.
  2. Adopt a policy setting that any proposed change to a project must be submitted for prior review, otherwise the conduct of a project in a manner not in adherence to its ethics approval may be considered in breach of the Australian Code for the Responsible Conduct of Research (2018) and the institution’s research integrity arrangements.
  3. Adopt the practice of reminding researchers of their responsibility –
    1. to consider and safeguard the welfare of research participants
    2. to remain reflective of whether the risks of a project are justified by its benefits
    3. to remain reflective of the degree to which the project addresses the core ethical principles of the National Statement
    4. notify the HREC of any changes with regard to 3a-c.
    5. Notify the HREC if any participant raises a concern about the ethical design or conduct of a project. Including notifying the HREC if any participants withdraw consent because of a concern about ethical matters.
  4. Adopt a policy that a researcher who fails to meet the responsibilities described at 3 may be considered in breach of the Australian Code for the Responsible Conduct of Research (2018) and the institution’s research integrity arrangements.
  5. Adopt a policy that an ethics approval can be approved for the planned duration of a project.
  6. Adopt a policy that researchers must submit an ethical conduct report every 12 months during the currency of an ethics approval. Extended/repeated failure to do so may be considered a breach of the Australian Code for the Responsible Conduct of Research (2018) and the institution’s research integrity arrangements.
  7. Adopt a practice of timed reminders to researchers to provide overdue ethical conduct reports, culminating in breach proceedings[1].
  8. Adopt a policy and practice that every five years a clearance is active the research office/HREC assess whether there are circumstances that require a new ethics review of a project.

In most cases, a new review should not be required, but a standardised, clear checklist should be used to determine whether a new review is required. Subscribers to https://www.ahrecs.vip or https://www.patreon.com/ahrecs will find a suggested checklist for conducting such a check.

On this basis, I suggest research ethics review bodies/research offices can and should withdraw approval because of extended/repeated failure by a researcher to provide an ethical conduct report.  This however must be based upon documented policy and procedure.  It must also be foreshadowed in ethics approval notifications, report reminders and resource material.

[1] The approach here might be constrained by the research management system the institution is using.  This includes usefully tracking correspondence between the researchers and the research office.

This post may be cited as:
Allen, G. (3 March 2020) Lost time may never be found again but is it time to talk about the duration of ethics approvals?. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/lost-time-may-never-be-found-again-but-is-it-time-to-talk-about-the-duration-of-ethics-approvals

The Ethics and Politics of Qualitative Data Sharing0

 

Mark Israel (AHRECS and Murdoch University) and Farida Fozdar (The University of Western Australia).

There is considerable momentum behind the argument that public data is a national asset and should be made more easily available for research purposes. In introducing the Data Sharing and Release Legislative Reforms Discussion Paper in September 2019, the Australian Commonwealth Minister for Government Services argued that proposed changes to data use in the public sector would mean that

Australia’s research sector will be able to use public data to improve the development of solutions to public problems and to test which programs are delivering as intended—and which ones are not.

Data reuse is seen as a cost-efficient use of public funds, reducing the burden on participants and communities. And, the argument is not restricted to government.  Journals, universities and funding agencies are increasingly requiring social scientists to make their data available to other researchers, and even to the public, in the interests of scientific inquiry, accountability, innovation and progress. For example, the Research Councils United Kingdom (RCUK) takes the benefits associated with data sharing for granted

Publicly-funded research data are a public good, produced in the public interest; Publicly-funded research data should be openly available to the maximum extent possible.

In Australia, both the National Health and Medical Research Council (NHMRC) and the Australian Research Council (ARC) have adopted open access policies that apply to research funded by those councils. While the ARC policy only refers to research outputs and excludes research data and research data outputs, the NHMRC strongly encourages open access to research data.

And yet, several social researchers have argued that data sharing requirements, developed in the context of medical research using quantitative data, may be inappropriate for qualitative research. Their arguments rest on a mix of ethical, practical and legal grounds.

In an article entitled ‘Whose Data Are They Anyway?’, Parry and Mauthner (2004) recognised unique issues associated with archiving qualitative data. The main considerations are around confidentiality (is it possible to anonymise the data by changing the details without losing validity) and informed consent (can participants know and consent to all potential future uses of their data at a single point in time?, and alternatively what extra burden do repeated requests for consent place on participants?).

There is also the more philosophical issue of the reconfiguration of the relationship between researchers and participants including moral responsibilities and commitments, potential violations of trust, and the risk of data misrepresentation. There are deeper epistemological issues, including the joint construction of qualitative data, and the reflexivity involved in preparing data for secondary analysis. As a result, Mauthner (2016) critiqued ‘regulation creep’ whereby regulators in the United Kingdom have made data sharing a moral responsibility associated with ethical research, when in fact it may be more ethical not to share data.

In addition, there is a growing movement to recognise the rights of some communities to control their own data. Based on the fundamental principle of self-determination, some Indigenous peoples have claimed sovereignty over their own data: ‘The concept of data sovereignty, … is linked with indigenous peoples’ right to maintain, control, protect and develop their cultural heritage, traditional knowledge and traditional cultural expressions, as well as their right to maintain, control, protect and develop their intellectual property over these.’ (Tauli-Corpuz, in Kukutai and Taylor, 2016:xxii). The goal is that its use should enhance self-determination and development.

To be fair to both the Commonwealth Minister and the RCUK, each recognises that data sharing should only occur prudently and safely and acknowledges that the benefits of sharing need to be balanced against rights to privacy (the balance proposed for earlier Australian legislative proposals have already been subjected to academic critique). The challenge is to ensure that our understanding of how these competing claims should be assessed is informed by an understanding of the nature of qualitative as well as quantitative data, of how data might be co-constructed or owned, of the cultural sensitivity that might be required to interpret and present it, and the damage that might be done as a result of misuse or  misrepresentation.

Acknowledgements
This article draws on material drafted for Fozdar and Israel (under review).
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References:

Fozdar, F. and Israel, M. (under review) Sociological ethics. In Mackay, D. and Iltis, A. (eds) The Oxford Handbook of Research Ethics. Oxford: Oxford University Press.

Kukutai, T. and Taylor, J. (Eds.) (2016) Indigenous data sovereignty: Toward an agenda (Vol. 38). Canberra: ANU Press.

Mauthner, N.S. (2016) Should data sharing be regulated? In van den Hoonard, W. and Hamilton, A. (eds) The Ethics Rupture: Exploring alternatives to formal research-ethics review. University of Toronto Press. pp.206-229.

Parry, O. and Mauthner, N.S. (2004) Whose data are they anyway? Practical, legal and ethical issues in archiving qualitative research data. Sociology, 38(1), 139-152.

This post may be cited as:
Israel, M. & Fozdar, F. (5 February 2020) The Ethics and Politics of Qualitative Data Sharing. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/the-ethics-and-politics-of-qualitative-data-sharing

Conversations with an HREC: A Researcher’s perspective0

 

Dr Ann-Maree Vallence and Dr Hakuei Fujiyama
College of Science, Health, Engineering and Education, Murdoch University, Perth, Australia
http://profiles.murdoch.edu.au/myprofile/ann-maree-vallence/
http://profiles.murdoch.edu.au/myprofile/hakuei-fujiyama/

In our careers to date, we have had many formal conversations with members of HRECs across different institutions regarding human research ethics applications and amendments. We have also had many informal conversations with members of HRECs regarding standard operating procedures in the labs we have worked in. In this article, we share our experience engaging with our HREC in a different context, specifically, formal negotiations with our HREC following an adverse incident that occurred during our data collection for one of our projects.

To provide some context, our research often uses non-invasive brain stimulation techniques including transcranial magnetic stimulation (TMS). TMS has been commonly used in research since the mid-1980s, and is considered safe, non-invasive, and painless. TMS involves a brief, high-current electrical pulse delivered through a handheld coil placed over the scalp, which induces a magnetic field that passes through the scalp and skull with little attenuation. The magnetic field induces current flow in the underlying brain tissue, and if the stimulation is sufficiently intense, it will activate the underlying brain cells providing a measure of brain excitability [1, 2]. There are published international guidelines for the safe use of TMS [3, 4] that are used to design the experiments and screen for contraindications to TMS (for example it is routine to exclude any persons who have a history of epilepsy, metal implants in the skull, or cardiac pacemakers). Nonetheless, research using TMS involves a small but finite risk. Occasionally, research participants experience a mild and temporary headache, nausea, muscular problems, dizziness, or fainting during or after TMS.

In a 12-month period in 2017, we experienced three adverse incidents: three participants in our research projects using TMS fainted#. As mentioned above, TMS studies involve a small but known risk of fainting. There have been some reports of syncope in the literature [5-7]. It is proposed that anxiety and exposure to a novel stimulus are likely responsible for fainting in the context of TMS [3, 5-7], however it is not possible to determine whether fainting or syncope is a secondary effect of an emotional response or a direct effect of the TMS on the nervous system.

It was following the reporting of these adverse events that we found ourselves in formal conversations with our HREC as well as informal interactions with several members of the HREC. There were two key steps involved in these conversations worth outlining. First, we invited the members of the HREC to visit the lab and attend a lab meeting in which we were discussing the adverse events. This engagement with the members of the HREC in our lab environment was a mutually beneficial exercise: it helped researchers to fully understand the concerns of the HREC and helped the members of the HREC to better understand our research procedures and aims, and observe our commitment to minimizing the risks associated with our research.

Second, we scrutinised our standard operating procedures to determine what changes we could make to minimize the risk of another adverse event. As outlined above, fainting during a TMS experiment is highly likely to be related to a psycho-physical response, although we cannot rule out the possibility that it is due to a direct effect of TMS on the nervous system. Following the adverse incidents, we have made several changes to our procedures. First, and perhaps most importantly, we send our potential participants a short video so they can see a typical experiment before they enter the lab. Second, when participants come into the lab we ask them if they have had any substantial change to their routine (for example sleep pattern, medication) feel stressed by factors independent of the research, and if they have had food and water in the preceding few hours (we have snacks and water in the lab if participants haven’t eaten). Third, we made changes to our lab setting such as moving to a modern, clinical testing room which was larger and brighter than the old testing room. Fourth, we take time to explain all of the equipment in the lab, not just the equipment being used in that particular experimental session.

Since the implementation of the changes to our standard operating procedures, we have not experienced an adverse event. The entire process of conversing both formally and informally with the HREC has led to improved written communication of our research to potential participants and HREC in the form of new project applications. Additionally, the process led to the development of resources for members of the lab, such as evolving standard operating procedures and a formal (compulsory) lab induction, and resources for potential participants, such as the communication of study information via a combination of written, video, and photo formats. Importantly, the implemention of revised procedures not only improved the safety profile of our experiments, but also it brought us in a better position to conduct high-quality research by enriching our resources in training lab members, communications with participants, and experience in engaging with HRECs. So, what did we learn from our conversation with an HREC? The processes of conversing with the HREC in the context of an adverse event is beneficial and needn’t wait for an adverse event to occur!

#In a 12-month period in 2017”, note that these are the only fainting incidents that we experienced since we have started our role at MU in 2015

References:

1.         Barker AT, Jalinous R and Freeston IL, Non-invasive magnetic stimulation of human motor cortex. Lancet, 1985. 1(8437): p. 1106-7.

2.         Hallett M, Transcranial magnetic stimulation: a primer. Neuron, 2007. 55(2): p. 187-99.

3.         Rossi S, Hallett M, Rossini PM and Pascual-Leone A, Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol, 2009. 120(12): p. 2008-39.

4.         Rossi S, Hallett M, Rossini PM and Pascual-Leone A, Screening questionnaire before TMS: An update. Clinical Neurophysiology, 2011. 122(8): p. 1686-1686.

5.         Kirton A, Deveber G, Gunraj C and Chen R, Neurocardiogenic syncope complicating pediatric transcranial magnetic stimulation. Pediatr Neurol, 2008. 39(3): p. 196-7.

6.         Kesar TM, McDonald HS, Eicholtz SP and Borich MR, Case report of syncope during a single pulse transcranial magnetic stimulation experiment in a healthy adult participant. Brain stimulation, 2016. 9(3): p. 471.

7.         Gillick BT, Rich T, Chen M and Meekins GD, Case report of vasovagal syncope associated with single pulse transcranial magnetic stimulation in a healthy adult participant. BMC neurology, 2015. 15(1): p. 248.

Dr Yvonne Haigh
Chair, HREC, Murdoch University. Perth Western Australian

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In 2015, Murdoch University’s HREC received increasing numbers of applications that covered innovative approaches to cognitive neuroscience with a specific focus on TMS (Transcranial Magnetic Stimulation). The topic area covered was very new with significant levels of technical and neuroscience language. While the methods of data collection were relatively unfamiliar for the committee members, several members did undertake some broad reading in order to establish greater familiarity and understanding. However, the applications did refer to different forms of TMS which further exacerbated the committee’s hesitation. In order to establish good rapport between the researchers and the committee, we invited the researchers to present on the topic – TMS. The aim of the presenting was to provide an overview of the variations of the technology, any side effects, international benchmarks and so forth. The committee was certainly reassured with the researchers’ level of experience and expertise. Moreover, it was also apparent the researchers had a sound approach to safety and participants’ wellbeing.
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However, over the ensuing years a range of adverse incidents occurred which involved dizzy spells and fainting in a few cases. The researchers informed the committee and put in place a range of options. The committee was invited to the laboratory to observe and experience the methods. This was particularly helpful and reassuring for the members who attended and enabled a broader discussion with those committee members who could not attend the laboratory. The Manager, Research Ethics & Integrity was also invited to attend a laboratory team meeting where the incidents were discussed, safety procedures revised, and student researchers reminded of their roles and obligations. This meeting enabled a confident report back to the HREC which was aligned with the adverse incident reports and made the committee’s task of reviewing the incidents significantly clearer.
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These conversations and visits resulted in updated procedures (including safety) from the research leaders. This has led to clearer exclusion criteria and additional questions incorporated into the consent process to ensure any known risks are minimised. While adverse incidents are difficult, the outcome in this instance has led to building increased trust between the committee and the research team and a proactive approach from both sides to ensure that new emerging issues are discussed and resolved.
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One of the very clear outcomes of this process has been an increased level of quality in these ethics applications which take less committee time and effort to approve.  While the technology is always evolving, and research in the area is ‘cutting edge’, the possibility that this research may change the lives of participants in these projects is evident in the researchers’ applications. From the committee’s perspective, it has been the open and respectful communication between all parties that has generated both a solid working relationship and enabled high level ethical research. The HREC’s response to a more recent ethics application reviewed since the adverse incidents described begins with the words: “The committee were impressed by the quality of this application and the careful attention to detail. The committee thank the researchers for their ongoing efforts to incorporate suggestions and advice in the collaborative effort to attain ethically strong research and positive outcomes for the community”.

This post may be cited as:
Vallence. A. and Fujiyama, H. (4 February 2020) Conversations with an HREC: A Researcher’s perspective. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/conversations-with-an-hrec-a-researchers-perspective

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