This month’s Research Ethics Roundup covers the reportage of the PHS Study of Untreated Syphilis, considering the ethics of research on insects, multiple perspectives on patient engagement in clinical trials, and the challenges of developing drugs for ultrarare diseases.
How an AP reporter broke the Tuskegee syphilis story
AP | Allen Breed
Fifty years ago, Associated Press reporter Jean Heller, with help from colleague Edith Lederer, broke the story of the Tuskegee Study of Untreated Syphilis in the Negro Male. The story paved the way for much of what we’ve come to know as the modern research ethics enterprise, and was a watershed moment in the understanding of systemic racism, particularly within the medical and scientific fields. This “story-behind-the-story” explores the details of how the seminal reporting came to light.
If Insects Feel Pain, Should They Be Protected in Research?
Undark | Katarina Zimmer
Inspired by the surprisingly nuanced behavior of bumblebees, scientist Lars Chittka, who this story profiles, has taken the position that some insects deserve increased protection when it comes to their use and treatment in research. Though some invertebrates, such as octopuses, are receiving increased protection now that their cognitive capacity is becoming more popularly understood, there remains a huge range of other invertebrates who have not received this level of scrutiny in research.
Patient involvement in clinical trials
Nature Communications Medicine | Multiple authors
This open-access article explores the topic of patient engagement in clinical research from a range of different perspectives, including a patient, a parent, a researcher, and others in the clinical trial space. Several authors take the increasingly common position that patient engagement should happen earlier in the trial and take patient quality of life more seriously (as opposed to narrow focus on clinical endpoints). Others focus on the need to diversify trials geographically, in order to reduce travel burdens and expand access to research; toward that same end, several authors advocate for increased payment for patients’ time and expertise.
Research on ultrarare diseases are inherently challenging: the patient pool is small, and so the studies are underpowered, and ethics approval can be thorny or impossible. This puts drug developers and the FDA in a difficult position when it comes to drug approvals for these diseases, when tiny statistical differences carry millions of dollars of weight. Some suggest that FDA adopt the “animal rule” for these situations, which, according to Silverman, “would permit the FDA to approve a drug based on a well-controlled study in animals when effectiveness studies in humans are not feasible or ethically possible.”