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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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

A users perspective on the ethics application process in Australia-room for improvement0

 

  1. Suat Chin Ng. MBBS, BMedSc, FRACS. Department of Surgery, Eastern Health, Melbourne, Australia.
  2. Wei Ming Ong MBBS Department of Surgery, Eastern Health, Melbourne, Australia.
  3. Shane Belvedere MBBS Department of Surgery, Melbourne Health, Melbourne, Australia
  4. Creski Gilong. MBBS Department of Surgery, Austin Health, Melbourne, Australia.
  5. Dr Nikolajs Zeps. BSc, PhD Research and Development, Epworth HealthCare, Melbourne, Australia. Eastern Clinical School, Monash University, Melbourne, Australia
  6. Philip Smart MBBS, D.Med.Sci, FRACS. Gastrointestinal Clinical Institute, Epworth HealthCare, Australia  Department of Surgery, Austin Health, Melbourne, Australia.

Compliance with ethical standards is fundamental to conducting human research. While there is a need for a thorough review process to prevent unethical research, the administrative workload required can often be significant. Indeed, researchers largely regard the ethics process as an obstacle that needs to be overcome, rather than a key part of the research process itself. In a recent blog on the AHRECS website entitled “Research Ethics Review as a Box-Ticking Exercise”, A/prof Angela Romano identified a significant problem with our current approach to ethical review as being one that promotes a compliance mentality rather than one that actively encourages appropriate and useful ethical reflection throughout the lifecycle of a research project.

Health and Medical Research is aimed at providing new knowledge to improve the health and wellbeing of the community and the fruits of this work will hopefully translate into tangible benefits for everyone. Significant concerns have been expressed by others that the current processes employed to regulate this work in fulfilment of ethical and legal requirements can itself be unethical. For instance, in a recent Blog by Prof Julian Savulescu he comments that whilst no-one is suggesting that research should not be subject to appropriate regulation and ethical review, given the potential to unnecessarily delay important research, all review processes should be as efficient and proportionate to the risk as is possible. Whilst we cannot immediately fix the lamentable lack of investment in undergraduate and post-graduate training in and practical application of ethics, the processes for review of projects could, in our view, be vastly improved with some fairly low-cost interventions.

What are researchers supposed to do to obtain ethical approval?

We reviewed the webpages of 78 Human Research Ethics Committees (HREC) associated with both public and private health services that we identified from the NHMRC list of registered HRECs. This list is only current to 1st March 2018 and we noted that several of the listed HRECs have in fact closed leaving just 71 that could be assessed. We also excluded from our review websites of small clinics which appear to serve only their own needs, eg IVF clinics.

Our review aimed to assess the ease with which researchers could find the webpages of the HREC, or the office of research and/or governance responsible for research oversight, and the level of information provided in terms of 1) instructions relating to how to make a submission itself, and 2) instructions about ethical considerations that may assist researchers to make a sound submission along the lines of A/Prof Romano’s wishes. We scored these objectively using a binary score of 1 if they had a readily accessible website and 0 if they did not. We scored the information related to the submission process in the same way, that is it was either present or not. We decided to include whether or not there was a clear process for considering low risk research in an expedited way consistent with the National Statement as this provided an insight into whether or not the institution regarded such research in a proportionate manner. We further checked on some of the linked documents and policies provided by the HREC, such as guidance on reporting of Serious Adverse Events (SAEs), to check for consistency and whether they were up to date with current guidelines.

We were surprised to find that 8 of 71 hospital based HRECs did not have a website that we could find. In some instances, the information about the HREC was provided via a central state-based portal where elements of the submission process and key local contact details were provided for each of the HRECs. We checked all of the links present in these websites and found that many were broken and in over half of all cases the links to the relevant policies, procedures, and key guidance documents were significantly out of date.

In contrast, we did find several websites that provided excellent resources such as those provided by the St Vincent’s HREC based in Melbourne and the Bellberry private HREC, which are exemplary in the level of useful information and easily accessible guidance they provide to researchers. We observed that of all of the HREC websites reviewed, 30 of the top 37 HRECs which all had accessible websites with useful information about submission were certified HRECs. Only 6 of the bottom 31, with what we considered to be inadequate levels of guidance information, were certified. This raises an interesting question as to whether the need to become certified led them to invest significantly in all aspects of the administrative process, including the development of useful websites.

Table 1: Key findings overall

CriteriaNo of HRECs scoring 1 (total 71)
Easily accessible information about key functions62 (87%)
Clear instructions about submission process62 (87%)
Additional information to guide applicants about ensuring their project met ethical requirements27 (38%)
Clear and proportionate pathway for low risk research43 (61%)
Up to date policies and guidance documents31 (44%)

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Our findings suggest that many health services that run HRECs could significantly improve the researcher experience by simply upgrading their websites to guide researchers more clearly about what is expected of them. As Angela Romano highlighted, the process should not be a box checking exercise and we suggest that if there was clear guidance about what was substantive ethical considerations that needed to be met rather than simply how to fill in the relevant forms we might achieve this, or at least take a step in the right direction.

Whilst we cannot provide any analytical evidence of a correlation it would not be surprising if the improved guidance provided by some HRECs meant that the time to approval was shorter due to a reduction in non-compliant submissions and perhaps even the quality of submission in terms of covering the substantive ethical concerns likely to arise. It is fair to argue that researchers themselves should take the time and effort to ensure that they find out what is expected of them but we suggest that it would be a highly cost efficient exercise to start by making the websites themselves more useful and geared toward this end.

Would you like to find out the score for your institution’s web site/or have an assessment conducted? If you are a https://www.ahrecs.vip subscriber this can be done for free.  Send an email to enquiry@ahrecs.com to discuss.

We did note in reviewing all of the websites that they were all designed differently and put information in different places and in different formats. We would also like to suggest that there would be some value in establishing a national standard for the presentation of core information regarding ethical submission and that there really is no reason that we can see for such wide variation in the way documents are provided. Efforts to harmonise content are evident in groups of hospitals such as Ramsay Healthcare, and we did note that several institutions now utilise the services of a central HREC, either their own for a group of hospitals or of other (certified) HRECs as part of the National Mutual Acceptance (NMA) scheme. We did not observe a great deal of harmonisation of content though outside of mandatory state-specific forms.
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Australia is committed to fostering health and medical research to improve the lives of patients as demonstrated by the State, Federal and charitable sector financial commitments that run to several billion dollars. Enhancing and harmonising website content would seem one way in which a small amount of effort would go a very long way to boosting our capability of doing ethically sound research.
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References:
National Statement on Ethical Conduct in Human Research 2007 (Updated 2018). The National Health and Medical Research Council, the Australian Research Council and Universities Australia. Commonwealth of Australia, Canberra.

Romano, A. (22 June 2019) Research Ethics Review as a Box-Ticking Exercise Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/research-ethics-review-as-a-box-ticking-exercise

This post may be cited as:
Ng, S. C., Ong, W. M., Belvedere. S., Gilong, C., Zeps, N. & Smart, P. (4 February 2020) A users perspective on the ethics application process in Australia-Room for improvement. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/a-users-perspective-on-the-ethics-application-process-in-australia-room-for-improvement

Question for Research Ethics Monthly readers: Win for your institution a new 12-month subscription to https://www.ahrecs.vip0

Posted by Admin in AHRECS Admin, Human Research Ethics, Research Integrity, Services on December 23, 2019 / Keywords: , ,
 

Prof. Mark Israel and Dr Gary Allen

We would like to encourage institutions to try out the ahrecs.vip set of resources. We also would like to crowdsource additional material and request the help of members of the research ethics community of practice. People like you. So, if you would like an opportunity to win a new 12-month subscription to ahrecs.vip, please send us your answer to one of the following questions:

  1. The best thing our HREC ever did was…
  2. The most important change I’d make to how my institution deals with research ethics is…

Your response to either of these questions should be between 50 and 500 words and can take the form of a short briefing note, a poem or a video recording with emphasis on either entertainment or information or both. Your submission must be received by 5pm Friday 31 March 2020.

Entries will be judged by members of the AHRECS team.  The best entry will win for their institution a new 12-month subscription to https://www.ahrecs.vip (valued at $350).  The April edition of the Research Ethics Monthly will include excerpts from some of our favourite entries and AHRECS reserves the right to draw on material within the entries and reproduce within the ahrecs.vip site while acknowledging the source of the material.

For more information send an email to gary.allen@ahrecs.com.

Advances in Medicine often require innovation in ethical thinking too0

 

Nik Zeps and Tanya Symons
AHRECS Consultant

Breakthroughs in medicine often highlight the existing limitations of the frameworks established to manage the ethical responsibilities arising in healthcare. The contraceptive pill, organ transplantation, assisted reproductive technology, gene therapy and more recently gene editing are notable examples that have stimulated major debates and, in several instances, prompted changes to not only ethical guidelines but also legislation. However, there are also more subtle ethical issues that arise from doing established activities in a different context or scale. Think of so-called Big Data applied to health care or to uses of machine-based learning which promise to revolutionize practice but are really just larger scale applications of business as usual using more sophisticated technology than before. One result of these two developments is the amassing of personal data online which coupled with improvements in reidentification techniques present challenges to how we manage the privacy of individuals.  These have prompted amendments in regulation that facilitate the use of personal data whilst also strengthening protections for individuals (link to GDPR).

Less well known, are changes in the way we evaluate existing healthcare practices to ensure they are truly safe, effective and economical.  One such example is the increasing focus on Comparative Effectiveness Research (CER). These studies compare two or more existing practices that are in widespread use and have been found safe and efficacious. CER is an extension of audit/QI practices in that it uses clinical trial methodology and the power of randomisation to remove the biases inherent in the observed outcomes in a population of non-randomised patients receiving a particular health service. These studies generally include large numbers of patients (sometimes several thousand) so that they can detect differences between the interventions that, while relatively small, can nonetheless be clinically meaningful at a population level.

There is an over-riding ethical need to do this work constantly within what can be termed a ‘learning healthcare system’ 1.  Conceptually this means that every single instance that a person interacts with the health system should be captured in a manner in which it can be evaluated to make sure that optimal care is provided. Both patients and health system leaders expect this to be happening and yet in truth, the lack of standardisation in data capture, storage and interoperability means that few do this efficiently and effectively as part of routine healthcare activity. Moreover, existing research ethics frameworks impede the integration of healthcare and research by failing to recognise the differences between studies that involve standard care treatments from studies testing novel interventions with unknown safety profiles.  One example is the requirement to apply to comparative effectiveness studies informed consent processes that differ so greatly from routine consent to treatment they are impossible to integrate into routine clinical workflows.

In a recent paper, (Symons et al 2) we have considered whether approaches that utilise modified consent pathways for CER are permissible from an ethical and regulatory perspective. In an accompanying editorial 3Dr Evan Kharasch challenges the readers of the journal to consider how the existing ethical and legal frameworks can be complied with for trials where the risk of harm is small. There is a perception that as soon as a study employs randomisation it becomes more than low risk when this may not, in fact, be true. It is also important to consider the ethical issues that arise when this type of ‘public good’ trial is simply not done because using consent processes suitable for interventional trials of unapproved therapeutics makes them impracticable. If indeed a particular treatment is less effective or causes more harm and we continue to use it because we consider that currently required ethics processes render them impracticable, then those processes have led to potentially unethical outcomes.

To achieve the best healthcare outcomes, greater sophistication of thought is needed at the ethics committee level. It also seems obvious that greater engagement with consumers is a necessary and relevant pathway to designing and conducting trials that deliver on expectations. The Australian Clinical Trials Alliance (ACTA) together with the Trials Clinical Trials: Impact & Quality (CT:IQ) have developed a consumer involvement and engagement toolkit that serves this purpose [1]. By working more closely together and encouraging more flexible and contemporary approaches to research ethics compliance, we can achieve the ideal of encouraging and supporting clinicians and health services to undertake continuous improvements to health services using the best methodologies to achieve this for the benefit of the community they serve.

References

1          Faden, R. R. et al. An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics. Hastings Cent Rep Spec No, S16-27, doi:10.1002/hast.134 (2013).

2          Symons, T. J., Zeps, N., Myles, P. S., Morris, J. M. & Sessler, D. I. International Policy Frameworks for Consent in Minimal-risk Pragmatic Trials. Anesthesiology 132, 44-54, doi:10.1097/ALN.0000000000003020 (2020).

3          Kharasch, E. D. Innovation in Clinical Research Regulation. Anesthesiology 132, 1-4, doi:10.1097/ALN.0000000000003026 (2020).

[1] https://involvementtoolkit.clinicaltrialsalliance.org.au/

This post may be cited as:

Zeps, N. (22 December 2019) Advances in Medicine often require innovation in ethical thinking too. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/advances-in-medicine-often-require-innovation-in-ethical-thinking-too-2

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