CaHRU are pleased to announce the first publication from the Wellcome Trust funded project, NEAT: Network exploring Ethics in Ambulance Trials. The article, entitled ‘Assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review‘, sought to understand the main ethical considerations when conducting clinical trials involving ambulance services.
The review found issues with consent were the most significant ethical issue for ambulance trials. The type of consent gained differed depending on the condition or intervention being studied, but the country in which the research took place had less influence on the type of consent. The terminology used to describe consent varied widely with multiple terms used to describe the same processes. This, coupled with the the wide range of consent types used led to the conclusion that standardisation of consent models and terminology used to describe them was warranted.
The systematic review was published in BMC Medical Research Methodology and is available open access at the following link: http://rdcu.be/vUxW
By Stephanie Armstrong.
The latest CaHRU Implementation Science and Research Methods seminar was given on November 22nd 2016 by CaHRU’s very own Dr Stephanie Armstrong. Stephanie, currently a Lecturer in Healthcare Quality Improvement at the University of Lincoln, comes from a diverse background, starting in the fields of Zoology (Trinity College Dublin) and Equine Studies (University of Coventry), moving on to studying Forensic Anthropology (University of Lincoln) and working on ethics and human rights. She is now researching the ethics of ambulance trials through a grant funded by the Wellcome Trust: Network exploring Ethics of Ambulance Trials (NEAT).
Stephanie’s talk focused on research ethics. She started the seminar by asking the participants to think about ethics and what their definition of ethics was. After a quick discussion around the participants’ thoughts, Stephanie gave an overall definition of research ethics and discussed issues around both the philosophical and legal aspects of ethics. The majority of the seminar was around the four basic constructs of research ethics: autonomy, non-maleficence, beneficence, and justice. Stephanie discussed the most relevant and important laws concerning research, such as the Mental Capacity Act (2005) and the Medicines for Human Use (Clinical Trials) Regulations (2004) – for Clinical Trials Involving Medicinal Products (CTIMPs), before reviewing the different types of participant consent used in research studies. At the end of the seminar, Stephanie reminded the attendees of the importance of ethics in animal research and discussed issues around its governance by the Animals (Scientific Procedures) Act 1986.
The seminar was very well presented and raised some very important issues around research ethics. The next Implementation Science and Research Methods seminar will be presented by Professor Chris Bridle, Director of the Institute for Health at the University of Lincoln, on Tuesday December 6th 2016. His topic will be “Accumulative Evidence Synthesis: fast track through the implementation pipeline”.
By Despina Laparidou
On 4th November 2016, CaHRU played host to an eminent group of researchers, ethicists and patient representatives in a meeting to discuss ethics in ambulance based trials. The group was formed as part of the Network Exploring Ethics in Ambulance Trials (NEAT) project, funded by the Wellcome Trust, which is seeking to understand the issues related to ethics in ambulance trials. The meeting had two main objectives, firstly to update the network on the findings of the NEAT project to date and secondly to discuss potential recommendations and future funding opportunities.
In the morning presentations by Dr Adele Langlois and Dr Stephanie Armstrong, outlined the findings of the project to date. These included a systematic review of published randomised controlled trials, a review of global and national regulations and the preliminary results of interview studies with expert informants, paramedics and patients who have been involved in ambulance trials. The morning sessions generated a lot of lively debate centring on both consent models and regulations, and in fact where there was agreement and conflict between these areas.
After a pleasant lunch the discussion continued with possible recommendations of the project being that more work need to be done to clarify the guidance and regulations ultimately leading to a code of practice for ambulance trials and accompanying common ethics framework. Funding opportunities were discussed and the day ended with an agreement that there should be a commitment to continue the work of the network through collaborative research opportunities.
By Dr Stephanie Armstrong