When it comes to the research ethics review of multi-site clinical trials, sometimes it can feel like a race to issue an approval in time for your institution to be included as a site for the trial. This can be especially acute for small institutions where being a trial site can be particularly valuable. Committees and institutions should always resist that urge. Good and careful review takes time and is not a sprint to get it done as quickly as possible. Often a speedy review is not a thorough and careful one.
The march of technology has transformed the practicalities of research. Data storage, archiving, analysis and (as pictured in this humorous Don Mayne cartoon) safe storage of bio hazards. They can be a great help, fantastic savers of time and resources, they can also literally be a life saver. But our enthusiastic adoption of such technologies does not mean that we should blithely accept what they tell us when it is at odds with what our senses and commonsense are telling us.
Sometimes the struggle and effort to recruit star or the best researchers can feel something like the professional sports draft in the USA. But as this humorous Don Mayne cartoon depicts, are those researchers being judged on the most important things. One thing that is often overlooked is the question of how ethical they are. Researchers with the highest reputation, are not necessarily the ones with the most ethical practice. Other factors to consider is the degree to which they nurture the development of more junior researchers in their area and whether they make a positive contribution to the research culture of their host institution.
Clinical trial monitors play an essential role, that requires them to be independent and attentive. They are supposed to keep an eye on the integrity of a trial and upon the degree to which the benefits of the trial justifies the risk. A trial monitor must never have a conflict of interest that might be a potential, perceived or actual conflict of interest. A spouse is NEVER an appropriate trial monitor for their partner’s clinical trial. Reading the newspaper is something that a trial monitor can’t do while they are supposed to be monitoring a trial in progress.
The research ethics review of proposed human research, especially high risk clinical trials is not a race. And potential participants aren’t trapped objects held prisoner waiting to be experimented on. But sometimes it can feel that is exactly how researchers and institutional review arrangements approach it. As depicted by this humorous Don Mayne cartoon. Institutions must strive to ensure that the framing of its research ethics review is based upon resourcing reflective practice and that is how it should approached by its research community.
This isn’t an area that we typically discuss, but this humorous Don Mayne cartoon will be excruciatingly familiar for anyone that has tried to provide technology, or process advice over the phone. It is a good reason to have familiar and dedicated support people available, rather than busy staff who try to fit it around their other work and so end up rushing and making a bad job of their explanations.
There can be valid reasons to give participants alcohol. Indeed such research can explore questions of significance to society. But as pictured in this humorous cartoon the circumstances need to be carefully managed and the welfare of individual participants monitored. It is unlikely a wild booze up and underage drinking will ever be ethically justifiable.
Merit and integrity is a core ethical principle in Human Research. The last thing you want potential participants worrying about is that a team’s intentions are nefarious and thinking that the researchers wish them ill. This humorous Don Mayne cartoon illustrates the point with US early settlers conducting research with a turkey. The extension of the same principle to animal research could raise some interesting challenges.