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

Resource Library

Research Ethics MonthlyAbout Us

Ethical review

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

“Reminder about service options and an easy way to pay AHRECS,” we say… aware of how corporate sleazy that sounds0

 

Dr Gary Allen, Senior Consultants AHRECS
Prof. Mark Israel
Prof. Colin Thomson AM
  
   .

Just in time for the end of the financial year (though we know many research institutions budget around calendar year), AHRECS has the capacity to receive payments by credit card. We thought this a good time to remind you of those of our services that lend themselves nicely to credit card payment.

In-meeting 30-minute professional development for HREC members ($900) – Workshops/briefings/guided discussion about your selected topic.  An easy way to tick the HREC member training box with minimum interruption to the work of a busy committee.  An experienced AHRECS team member will provide a PowerPoint with pre-recorded audio that could be played in a meeting (and retained for five years for viewing by absent and new members); the team member will ‘phone or Zoom into the meeting for Q&A/discussion. If so AHRECS can also record that component for your later use.

Access the new subscription area ($360) – Thank you to everyone who expressed interest and support for the new in-house subscribers’ area.  This is scheduled to go live in July/August.  By subscribing, you will get access to an impressive (and growing) set of HRE and RI resources that are Creative Commons so you can use them within your organisations as much as you want.

Bespoke webinar for your research community ($1500) – A one-hour webinar on a human research ethics or research integrity topic of your choice, tailored to your institution. The price allows for up to 200 attendees and provision of a recording for your later use.

3-hour orientation workshop for new RIAs ($2300) – Provide your new Research Integrity Advisers with a practical, topical and engaging orientation through this four-hour workshop.

Ten hours of on-call advice ($3400) – On-call advice can be used for both human research ethics and research integrity advice.  We can offer advice on everything from review feedback on a difficult application to commenting on a draft policy and providing advice on a tricky question with which the committee has been struggling.  In the research integrity space, we can suggest an appropriate investigation approach for an alleged breach, comment on a RI resource, or suggest references on a key topic.  The purchased time can be used in 15min, 30min, 1h, 4h and 8h blocks

Send an email to gary.allen@ahrecs.comif you have any questions.

The prices above exclude GST and a 2% credit card processing fee

Is it something I said (or the way I said it)?0

Posted by Admin in Human Research Ethics on May 29, 2019 / Keywords: ,
 

Dr Gary Allen, Senior Consultants AHRECS
Prof. Mark Israel
Prof. Colin Thomson AM
  
   .

Reflecting on review feedback

Feedback from the research ethics review of a project is often one of the first interactions between a researcher and a research ethics committee. It helps define, and can permanently tarnish, the relationship between an institution’s committee and research community – for good, or for bad. So, it’s centrally important to an effective ethics research culture.

Unfortunately, typically, it only receives cursory attention in national human research ethics arrangements and institutional policy. It does not feature highly in review body member training, standard operating procedures or the orientation of secretaries and chairpersons.

Having worked with many review bodies during the last few decades, we thought it might be helpful to share some ideas and experiences.

1 NATIONAL ARRANGEMENTS– review feedback should be based clearly upon the relevant national arrangements: these provide the justification for the feedback and establish a neutral ground on which to resolve differences. For example, in Australia it should be located in and cite a provision of the National Statement (see Common Missteps 6).

Feedback on revision should make its ethical consideration explicit if it is not based on national or institutional policies. (Dr Gan Zhen-Rong, Human Research Ethics Committee, National Cheng Kung University, Taiwan)

2 INSTUTIONAL ARRANGEMENTS– when the host institution’s policy or procedures discuss a matter relevant to the project being reviewed, the review feedback should be located in and cite those arrangements.

3 GUIDANCE MATERIAL– A valuable role can be played by guidance material, such as suggesting ways a national/institutional policy can be applied in a situation, or how a researcher might justify an alternative. The Griffith University Research Ethics Manual (GUREM) is one such document, which Griffith University has licensed[1] so other institutions can copy and modify its booklets to create its own resource manual.

4 FACILITATION AS A CORE OBJECTIVE– A central objective of research ethics review is facilitating the ethical conduct of research. This can be promoted by constructive feedback with clear explanations and prompts (for what is needed to satisfy the committee) and how the matter can be resolved.

Research regulators in general, including HRECs, have not only a responsibility to uphold the principles of the regulatory ‘ecosystem’, but must ensure and enable a ‘growth mindset’ that fundamentally has the research participant at its core… fostering and nurturing novice researchers as well as redirecting and upskilling seasoned researchers is vital. To this end, removing a punitive viewpoint and replacing it with an opportunity to educate and highlight the principles of the framework is required.  Not only will it foster a strong collaborative research culture, after all we are all on it for the participants’ benefit, but such an approach will assist in removing the ‘us’ versus ‘them’ mindset that currently pits researchers against research administrators. (Sonia Hancock, Manager, Research Integrity and Compliance, Metro South Health Research, Queensland)

We do this at CQU (Chair chats [with researchers about specific items in their proposal]), it promotes a collegial interaction between HREC and researchers and actually reduces workload for the committee as applications don’t bounce around. (Prof. Tania Signal, Chair, Central Queensland University Human Research Ethics Committee)

It’s really important to have a review process that models the respect that the committee would want the applicants to show to participants in the research. (Lindsey Te Ata o Tu MacDonald, University of Canterbury Human Ethics Committee, New Zealand).

— COMMON MISSTEPS —

5 ‘BECAUSE WE ALWAYS INSIST ON THIS’ – When crafting review feedback, a  review body should be wary of matters that do not adhere to one of the above, but are consistently included in the review body’s feedback to applicants, primarily because the committee always insists upon it. Ignoring the circular logic, if there is no other basis for the feedback item (see above), it is almost certainly time to change that habit.

Too often committees can lose sight of the differences in context, participant populations and the myriad other variables that make it difficult to apply precedents. The principles and values of committee members (within the context of applicable regulations and legislation) should drive review. (Lindsey Te Ata o Tu MacDonald, University of Canterbury Human Ethics Committee, New Zealand

Some review bodies still insist on participants signing a consent form (see Wynn and Israel, 2018). Fetishising such standards is dismissive of the agency of potential participants, is excessively paternalistic and may also create a barrier to participation for some demographic groups. There may be circumstances where such practices are warranted, but it should not be an automatic requirement. And don’t get us started on insisting on witness signatures on consent forms.

Discussion of what the National Statement actually requires can also be used to show how familiarity with, rather than prescriptive use of, the National Statement can avoid unnecessarily constraining ethical research.  References to such passages as paragraph 2.2.4 and this paragraph on p.11 of the National Statement speaks to this idea:

These ethical guidelines are not simply a set of rules. Their application should not be mechanical. It always requires, from each individual, deliberation on the values and principles, exercise of judgement, and an appreciation of context.

6 FIXATING ON ONE PROVISION RATHER THAN THE WIDER MESSAGE– In circumstances when a review body is working from a detailed set of arrangements (such as the National Statement (2007 updated 2018) in Australia) there is a danger the review body will focus on one provision, while missing the wider intention of a section. This bad habit can easily become a standard requirement of the review body (see 5). For example, some well-meaning review bodies can insist recruitment material and consent material are depersonalised, written in the passive so that friendly courtesy is removed even from interaction involving peers.  Review bodies may believe in so doing they are faithfully applying NS item 2.2.1 (consent needs to be voluntary) and avoiding language that might be seen as persuasive and therefore in some way manipulative. In doing so they are ignoring NS 2.2.3 and 5.2.17 (be relevant to the participants’ circumstances). Some review bodies still insist on participants signing a consent form (see Wynn and Israel, 2018). Fetishising such standards is dismissive of the agency of potential participants, is excessively paternalistic and may also create a barrier to participation for some demographic groups. There may be circumstances where such practices are warranted, but it should not be an automatic requirement.

7 PROOFREADING– A review body should not spend more than a few moments of meeting time/words in the review feedback proofreading recruitment/consent material or a data collection instrument. Instead the review body should indicate proofreading is required, provide some examples and indicate there are more requiring attention. Consideration of the revised material should be delegated and handled outside a later meeting.

8 MANY WAYS TO SOLVE A PROBLEM– There is rarely only one solution to an ethical challenge (so there can be difference of view between researchers and reviewers). In addition to project-specific matters such as conventions of the (sub)discipline, methodology, potential participant pool and contextual considerations, there can be more than one ethically acceptable solution. Consequently, a feedback item should not imply there is only one way to tackle a problem.

Committees need to be genuinely open to rebuttal or alternate approaches from researchers if that argument is couched within the framework of the National Statement. (Prof. Tania Signal, Chair, Central Queensland University Human Research Ethics Committee)

Too often committees can lose sight of the differences in context, participant populations and the myriad other variables that make it difficult to apply precedents. The principles and values of committee members (within the context of applicable regulations and legislation) should drive review. (Lindsey MacDonald, University of Canterbury Human Ethics Committee)

9 RISK-AVERSE– The review body should take care to ensure (and reflect on over time) its decisions to ensure they aren’t overly risk-averse or conservative.

— TIPS —

10 POSITIVE FEEDBACK– Learn from the broader literature on effective feedback and identify a component of the proposed project to compliment, such as the importance of the research question, the care and thought demonstrated by the approach to a problem, the described respectful approach to a participant cohort, or perhaps thoroughly addressing a matter that was missed by the applicants in earlier proposals.

Common courtesies go a long way within ethics processes. Thank applicants for applying for review committee, start most requests with ‘please… (comment/consider/explain)’, and rephrase demands as questions. In my experience adding those phrases help to soften even harsh criticism of applications, so that productive – not defensive – relationships thrive between the committee and researchers. Encouraging researchers to ring the Chair as soon as they have a problem with a committee’s feedback was the single most important time-saving device for my time as chair  – a minute or two on the phone is so much more constructive than emails. (Lindsey Te Ata o Tu MacDonald, University of Canterbury Human Ethics Committee, New Zealand)

11 NOT A CONDITION OF APPROVAL– If a review body is aware a matter is beyond its remit but could impact upon the project’s chances of success, its quality or impact, it could be framed in the following way, ‘The following is not a condition of ethics approval, but the reviewers noted… Have the applicants considered this?’.

12 LIMITS OF ETHICS APPROVAL– In some cases, a review body might only feel able to grant approval because of the involvement of a specific individual team member or support service. The implication is that if her/his involvement ends, or the service is no longer available, the project must be paused until alternative arrangements can be made. Similarly, the review body might not want the ethics approval of the project to be seen as a precedent where similar projects without the involvement of that experienced person, or service, will also be approved. In such circumstances, the reasons/limits of the approval should be specified in the review feedback.

13 INVITE REFLECTION– Assuming an applicant has missed a matter or is indifferent to a problem might not only be incorrect, it might make the review process more adversarial. A more positive approach could be: ‘Given the experience of the applicants, <review body> would be interested to hear how you have previously handled… and the degree to which you feel that would be useful in this case.’

14 REAs– If your institution has established a network of collegiate Research Ethics Advisers and the review body is concerned applicants have not understood their responsibilities and/or the review feedback will require considerable explanatory text, the review body could direct the applicants to consult their REA before resubmitting. The Chair (or nominee) could speak with the REA to explain the situation.  If your institution does not have such a network, face to face conversations with researchers, the Chair and/or some committee members can usually achieve agreed resolutions.

15 PILOT TESTING– In circumstances where a review body is uncertain about the described risks/proposed risk mitigation strategy, the review body might suggest a limited pilot test. Such a test might involve a smaller number of participants for a specified period of time, with a view to the researchers reporting back on the actual experience of those matters. The ethics approval could either be converted a full approval or the project modified on the basis of the experienced.

16 CONTINUE TO BUILD YOUR EXPERTISE – No research ethics committee can be experts in everything. Once a committee accepts this, there are various strategies that it can adopt. First, it can engage in collective professional development making sure it receives regular briefings on new methods, disciplines, groups of participants or regulations. In some cases, these can be provided by researchers (either individuals or groups); in others, the committee may need to bring in external expertise. Second, it might increase the size of the committee to add expertise but look for more flexible ways of deploying that membership.

…if a research team is about to begin utilising a new technique/procedure/machine that beeps etc. consider inviting them to provide a short briefing presentation to the HREC ahead of any submissions. This allows a two-way conversation, HREC can highlight issues that will need further consideration and researchers can address misconceptions. (Prof. Tania Signal, Chair, Central Queensland University Human Research Ethics Committee)

17 PROPORTIONAL CONSIDERATION– If the practice of your review committee is that all researcher responses are considered at the next meeting of the review body, consider delegating this task to administrative review, executive review or to a small panel of the review body depending on the level of the review that might be required for any particular case. Perhaps the response should only go back to the review body in the most sensitive of circumstances. Nevertheless, those delegated bodies should be able to escalate the consideration to a higher pathway.

Distinguish between the problems of submitted proposals to see if they reflect substantial ethical issues or just raise minor matters such as failure to provide sufficient information, demonstrate a lack of submission experience or careless editing. If the latter, consider delegating this task to administrative or executive review.(Dr Gan Zhen-Rong, Human Research Ethics Committee, National Cheng Kung University, Taiwan)

Acknowledgements

We want REM to start conversations among its readers. In this issue, we are grateful to Dr Gan Zhen-Rong (National Cheng Kung University, Taiwan), Prof. Tania Signal (Chair of HREC, Central Queensland University), Dr Lindsey Te Ata o Tu MacDonald (University of Canterbury) and Sonia Hancock (Metro South Health, Queensland) for providing comments (at short notice) on this article.

Bibliography

Wynn, LL and Israel, M (2018) The Fetishes of Consent: Signatures, Paper and Writing in Research Ethics Review. American Anthropologist120(4) pp795–806.

[1]Dr Gary Allen is the principal author of the GUREM and receives a proportion of all sales, so AHRECS acknowledges the conflicts of interest in mentioning the manual.

This post may be cited as:
Allen, G., Israel, M. & Thomson, C. (29  May 2019) Is it something I said (or the way I said it)? Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/is-it-something-i-said-or-the-way-i-said-it

Research Ethics and the New Gene-editing Technology0

 

Nik Zeps, Consultant, AHRECS

Keywords: Ethical Review, International Guidelines, Gene editing technologies,

It has now been over six months since He Jiankuiand his team used the CRISPR/CAS9 gene editing technique to introduce a gene alteration in twin girls (STAT). The revelation that he had performed this audacious experiment shocked the world and left people asking how he had been permitted to do it. Dr He Jiankui is not a medical doctor but is qualified in biophysics and was one of the pioneers of the new gene editing technology in China having worked in the United States for five years where he undertook post-doctoral studies.

The report that accompanied the announcement of the birth of the twin girls outlined how He and his colleagues had sought out couples where the father was HIV-positive but the mother was not. The purpose of their work was to alter a gene known to confer resistance to HIV infection, CCR5, so that the children would be naturally resistant to possible infection. The public response worldwide was one of outrage and fierce opposition from all quarters. His fellow scientists and doctors denounced his actions as immoral and unethical and he was fired by the Southern University of Science and Technology in Shenzhen, China.

Chinese authorities immediately placed a prohibition on any such activities and research (human embryonic gene editing that leads to the birth of babies) and claims were made that he and his team had acted against the law. The People’s Republic of China does have guidelines that forbid any research that involves human reproductive cloning; however, they do permit therapeutic cloning using embryonic stem cells where the aim is to cure or prevent illness. This is similar to the United Kingdom and several other European countries, but this is not legal in Australia. The key question here is whether such research is restricted to generating embryo stem cell lines or whether it permits the creation of embryos that can be implanted and grown to a full-term delivery.

There remain many unanswered questions from this case. He claims that he had ethics approval but the responsible committee denies they had any involvement. Clearly the clinic that recruited the potential parents (several signed up) also knew of the work and endorsed it. All of those working on the project presumably knew what the aim of their work was and yet still conducted it willingly. It is also important to note here that in this highly controversial case the world does not have any independent confirmation that any gene editing actually happened or that the twin girls have the CCR5 alteration. However, prominent scientists who were present at the announcement appear to believe the claims and some of the details in the report itself appear to reflect the reality of his claim.

In response to international outrage, a group of prominent scientists have called for an international moratorium. This would be similar to the 1975 Asilomar conference on recombinant gene technology. In 2015 UNESCO called for a moratorium on genome editing of the human germline at least until the ‘safety and effectiveness of procedures remain unproven’. Both calls envision the possibility that prohibitions may be lifted if the evidence for safety and effectiveness can be met in contrast to those that wish for a permanent outright ban. The general prohibition on research involving human embryos, such as is the case in Australia, prevents anyone doing research that might demonstrate that such work is safe and effective though, effectively shutting the door. In the United States there is only a prohibition for federal funding of such research so private enterprise could easily step in. Moratoria are notoriously difficult to monitor or enforce and the lure of making money or gaining fame from the research may prove to be too powerful. He might reflect that he has achieved notoriety rather than fame as a hero but reports generally paint him as ambitious and naïve, conveniently ignoring the guidelines or ethical issues rather than being actually evil in intent. After all, the intention was to augment human capacity, even though that has led to claims of ‘taking a step down the road’ of human eugenics by prominent bioethicists such as Arthur Caplan.

One of the key messages coming out of the debate is that self-regulation by scientists remains open to abuse. On the other hand, scientists argue that attempts to limit their work with increased scrutiny may be disproportionate and have a negative effect on research that may ultimately lead to improvements in human health. This is the ‘rotten apple’ argument and to some extent it is fair to be sympathetic toward it as there are good examples of how increased regulation does not necessarily improve patient or community safety. However, there is more to this debate than just regulation of laboratory activities and the issues related to what it is to be human and the consequences of manipulation that extends into augmentation or spurious characteristic selection such as eye colour or enhanced sport performance are real.

The World Health Organisation (WHO) has called for international guidelines https://www.who.int/ethics/topics/human-genome-editing/en/to be developed and deployed by members states, forming a working party to develop these in December 2018. However, these would only be guidelines that would then have to be adopted by member countries. Importantly, the WHO panel does not envisage a permanent prohibition of embryo gene editing but stated in a media release that ‘The Committee will explore how best to promote transparent and trustworthy practices and how to ensure appropriate assessments are performed prior to any relevant work being undertaken.’ This clearly indicates that the intention is to regulate rather than prohibit future work in this area.

In many respects this is not a new ethical issue as the technology to alter the human genome has been around for many years, just not so cheap and potentially efficient. In addition, there are other applications of CRISPR that do not involve use in embryos or require a hereditary component. Somatic cell treatments for diseases such as muscular dystrophy and Beta Thalassemia have the potential to alleviate human suffering and are distinct from embryonic gene editing. It is probable that restrictions on these activities could also occur unless legislation and guidelines are careful to avoid capturing areas that are unintended. One could argue that these treatments which are aimed at people after birth should be treated in the same way as other biological therapies.

It is likely that a general prohibition of embryo manipulation for reproductive cloning will remain in most countries and some may now move to more specifically outlaw therapeutic cloning using gene editing. Many jurisdictions have looked at guidelines that prohibit this but there is little harmonization of these thus far. There is a great deal of work underway in many countries now to examine the issues and to establish appropriate pathways for regulation. AHRECS will monitor these activities and report on them as they arise.

This post may be cited as:

Zeps, N. (26  May 2019) Research Ethics and the New Gene-editing Technology. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/research-ethics-and-the-new-gene-editing-technology

A call for a national inquiry into the burden of research ethics and governance1

 

Adrian Barnett, Queensland University of Technology

.
Do we need a national inquiry into the burden of research ethics and governance in health and medical research Australia? Many Australian researchers would cry “yes!” because they have repeatedly experienced application systems that are time-consuming and illogical.

I have never met a researcher who did not think that ethics and research integrity wasn’t vitally important, but many current application systems have more to do with risk aversion than the safety of patients or the public.

This risk aversion means that millions of dollars worth of Australian researchers’ time is being wasted on submitting the same forms to multiple ethical review committees. For example, getting approvals for our group’s low-risk survey of nurses in 50 hospitals cost an estimated $348,000 in staff time and delayed the study by six months (Barnett et al 2016).

Another Australian study of 60 nationwide hospitals spent an estimated $264,000 on approvals and the researchers’ experienced puzzling variations in submission requirements and decisions about the study’s level of risk (Clay-Williams et al 2018).

Another Australian study found that the time taken to complete the ethics and governance forms for a negligible risk study took eight times longer than the actual research (Rush et al 2018).

These are not isolated experiences and the current processes are driving researchers crazy. In our recent one-day meeting on improving research quality, we asked attendees to vote on the changes most needed to improve research and reduce research waste. The idea of a national inquiry into ethics and governance was voted fourth highest out of 21 policies (the full survey results are available here).

What should a national inquiry consider? The primary question should be: why can’t we have a national system? A national system that has standardised forms and is used by every state and territory health department. A national system that covers all types of research, not just clinical trials.

An inquiry into ethics processes could have been part of the Chubb inquiry (had Labor won the election) that promised a root-and-branch examination of Australia’s overall research framework and to “ensure that Australia maintains its international competitive advantage”. Other countries use simpler approval processes and we hamper our ability to conduct research by tying up researchers in wasteful knots of unnecessary paperwork.

A national inquiry should engage with the people doing the hard work of reviewing applications on ethics committees. These people should also welcome a streamlined system that cuts-out the requirement for them to review already reviewed applications, giving them more time to focus on important ethical considerations.

Researchers should also acknowledge that some delays and duplication are their own fault. A key problem is that ethics applications can be so badly written that committee members cannot judge the ethical implications of the study.

Australian researchers want a system that improves and facilities their research, not one that puts “virtually insurmountable and costly barriers in place” (Clay-Williams et al 2018). We want a “tailored and harmonised” system (Rush et al 2018).

Many researchers have been talking about the need for change for over a decade, but have seen only small improvements and plenty of backwards steps too. A national inquiry would cost time and money, but the potential long-term savings to researchers and the public from this important reform could be enormous.

Declaration of conflicts of interest: Adrian Barnett receives funding from the National Health and Medical Research Council.

References

  • Rush, A., Ling, R., Carpenter, J. E., Carter, C., Searles, A., & Byrne, J. A. (2018). Research governance review of a negligible-risk research project: Too much of a good thing? Research Ethics, 14(3), 1–12. https://doi.org/10.1177/1747016117739937
  • Clay-Williams, R., Taylor, N. & Braithwaite, J. (2018) Potential solutions to improve the governance of multicentre health services research. Med J Aust; 208 (4): doi: 10.5694/mja16.01268
  • Barnett, A. G., Campbell, M. J., Campbell, Shield, C., Farrington, A., Hall, L., Page, K., Gardner, A., Mitchell, B.G. & Graves, N. (2016) The high costs of getting ethical and site-specific approvals for multi-centre research. Research Integrity and Peer Review 1:16 https://doi.org/10.1186/s41073-016-0023-6

This post may be cited as:
Barnett, A. G. (22  May 2019) A call for a national inquiry into the burden of research ethics and governance. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/a-call-for-a-national-inquiry-into-the-burden-of-research-ethics-and-governance

0