This humorous Don Mayne cartoon depicts why potential participants in medical research should always be careful that their assumptions about a research project match the design of a project. Even though it is unlikely that a planned project will be this ghastly or dangerous, this is why research ethics review bodies should be aware of how researchers will describe their project in recruitment materials. This is to watch against text that might give a false impression about a project.
In the past, we have played a direct role in the design and delivery of HREC member professional development for the NHMRC. We are now not proud of that involvement because it embedded poor practice into the conduct of research ethics review in Australia. Cases like this are shocking and such research practice needs to be blocked from ever happening again. But the use of an egregious case of medical research from US is unlikely to be considered relevant outside of the health sciences in Australia. Rather than using such cases for shock value or as justification for research ethics review and combative review decisions, it should be used as an opportunity to discuss, vulnerability, conflicts of interest, researcher responsibilities and clinical trial monitoring. That approach might seem to be a less shocking or engaging way to go, but it should result in better review decisions.
The accepted wisdom is that careful research to develop new treatments take many years, if not decades. It is the reason why there has been such a delay between the commencement of clinical trials and the availability of the treatment. That is why some worried that the availability of Covid treatments was an indication the research been rushed and so the vaccines where are unsafe. The reasoning being, fast research couldn’t be quality research. However, the response to the pandemic has shown it’s possible to do quality research research quickly.
(US) Clinical trial coordinators sentenced to prison after data falsification scheme – Endpoints News (Paul Schloesser | October 2022)
Falsifying clinical trial data and results is not a victimless crime. At one level, it is potentially fraud of a funding body or institution. On another, it can place future patients and the wider community at risk, because of a faulty understanding of a condition or the effectiveness/safety of an experimental intervention. It seems this US court agrees. An additional factor when someone considers falsification is that, if you believe in the promise of an intervention, if you cheat, you might sully the reputation of the intervention far into the future.
Unless a researcher is careful, they can cause harm before a person consents to participate in a project. As pictured in this Don Mayne cartoon, body-shape shaming Santa would be an example of this. This consideration is why Chapter 3.1 of the National Statement on Ethical Conduct in Human Research prompts researchers and research ethics reviewers to consider whether a project’s recruitment strategy could be a source of risk. Undermining the self-worth of potential participants is a formal of risk. Shaming Santa is also probably a good way to get yourself on the naughty list. Whatever your religious, spiritual or scientific beliefs, the AHRECS team wishes you a safe and happy holiday season. We will continue working over the holiday period. Insert your own reference to Ebenezer Scrooge here.
This very useful London School of Economics Blog story reflects on an important ethical issue for humanities research and research that is participant led designs. This reflection on the relationship between participant and researcher is very different from the typical design of clinical trials and a great proportion of medical research. This is a useful read for researchers (especially early in their career) and research ethics reviewers (especially if they are unfamiliar with the review of such research).
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.
Practical and Ethical Dilemmas in Researching Sensitive Topics with Populations Considered Vulnerable (Books : Ana Patrícia Hilário & Fábio Rafael Augusto | November 2020)
Preface to “Practical and Ethical Dilemmas in Researching Sensitive Topics with Populations Considered Vulnerable” Conducting social science research is a