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The case of Paolo Macchiarini is truly horrific. It is a perfect example why research institutions cannot believe their research superstars are above reproach. The story sounds like that it has been lifted from a movie script. In fact, there is currently a Netflix series and an opera about this horrifying case. Caution should be observed before spending much time referencing this case in guidance material and in professional development. It is titillating and may well engage your audience. In our experience, cases like this are unlikely to engage researchers to reflect on their own practice and motivate them to make a change.
This item from the US initially was promising news for people who are at high risk for stroke. The alerts whistleblowers paint a far more depressing and tragic picture. Scientific enquiry and clinical trials are never certain, so there must be a robust system for monitoring trial results and considering serious adverse events. Even a single death should prompt the reviewing research ethics committee to suspend the ethics approval and request a follow-up safety review. Multiple deaths raise serious concerns and begs the question, did the size of the impact on the monitoring mechanism? This story is a useful case study for the professional of clinical trial research ethics reviewers and safety monitors.
It is perhaps tempting to think eugenics is confined to the Nazis past and fringe science. But as this London School of Economics Blog piece discusses, this flawed and dangerous philosophy persists in plain sight. We ourselves have recently encountered a well-funded research team who are looking to do a major clinical trial to substantiate their decidedly fringe ideas.
Do you remember the days when the most formidable recruitment challenge for human researchers was recruiting enough participants to give you useful and hopefully compelling evidence for your theory? It seems those days are just happy memories, especially if you are offering an incentive to your participants. This item, published in The Transmitter, shares the dismayed reaction of a researcher who realises that her participant pool contains more fraudulent participants than real participants. Such a realisation will undermine your confidence in your data and invalidate the information shared by your real participants. It underlines the importance of researchers having mechanisms to protect the integrity of their data collection.
The rapid adoption of artificial intelligence, such as Large Language Model Systems (such as ChatGPT) in scholarly publications is rapidly changing the field and raising difficult copyright questions. The United States Copyright Office has recently embarked on an inquiry into artificial intelligence and copyright. This Scholarly Kitchen piece takes a look at the contentious and topical issues involved.
Many national human research ethics arrangements implicitly encourage researchers and research ethics committees to exclude vulnerable populations, such as women who may be pregnant, people with disabilities and people highly dependent on medical care. This reflects a concern that they may be highly susceptible to risk/harm, unable to make a discerning decision about their participation, and more easily coerced into participating. This screening of potential participant pools has a couple of predictable consequences; we may not know if a treatment is safe for that population (the COVID-19 pandemic and the consternation safety of vaccines for different populations is a good example of this). The silencing of important voices in data collection is an example of why this is a concern. It should be recognised that participation in research and contribution to a public need can be a source of dignity and social engagement for people who may feel otherwise isolated and powerless. The reporting of clinical trial results needs to start including a statement about people who were excluded from the potential participant pool. This post by Pär Segerdahl takes a look at these important issues.