Research Ethics Roundup: New Clinical Trial Transparency Tool, Returning Genetic Data, Genetically Modified Animals in Research, and Placebos as Treatment

This week’s Research Ethics Roundup examines the new online transparency tool from AllTrials, returning data to participants in genetic research, concerns about overuse of genetically modified animals, and the potential for placebos as treatments for non-urgent pain.

What Clinical Trial Results? Now You Can See Who Isn’t Sharing Their Findings: In this STAT Pharmalot article, Ed Silverman discusses a new online tool by AllTrials that shows how many clinical trial sponsors have failed to report results to Both universities and pharmaceutical companies have not been complying with a federal reporting law. In response to drug safety concerns, AllTrials is using this new tool to push pharmaceutical companies and others to publish the results of their clinical trials and increase transparency.

Prototype of women

Geneticists Should Offer Data to Participants: In an editorial published in the World View column of Nature, Sarah Nelson, a human-genetics researcher, describes her frustration after her request for access to her raw data was denied by a genetics group she donated to. Researchers are hesitant to provide data because it can be misinterpreted as medical care, but this hesitancy hurts volunteer recruitment. Nelson proposes that an “anticipatory infrastructure” needs to be developed to return raw data to donors. She argues the mechanisms researchers use to return genetic data need to be reviewed by IRBs, and research groups should create informed consent procedures on the return of raw data.

Man or Mouse? Why Drug Research has taken the Wrong Turning: A New Scientist article discusses how the ability to have genetically modified lab animals has shifted researchers focus away from human disease. Joseph Garner of Stanford University, a keynote speaker at PRIM&R’s 2016 Advancing Ethical Research Conference, points out that only a small number of drugs that are in clinical trials make it to the market. Garner believes one reason for this trend is that current animal models are increasingly poor models for human disease.

Is A Placebo A Sham If You Know It’s A Fake And It Still Works?: In this NPR article, Katherine Hobson examines recent studies involving the effectiveness of placebos for treating pain. Ted Kaptchuck, of Beth Israel Deaconess Medical Center in Boston, has been studying the benefit of placebos when the participants know and understand they are taking a placebo. Earlier studies show a positive effect with irritable bowel syndrome symptoms, and, with Kaptchuck, lower back pain. Kaptchuck believes that “open-label placebos” could be helpful for non-urgent medical situations.