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
