Trying to stay toasty and stave off the arctic chills that keep blowing through the United States? Grab a mug of something warm and dig into some of the research ethics news that is making headlines this month.

 

 

A New Paradigm for Animal Research: Let Them Participate: Manatees are routinely sedated or restrained for diagnostic tests and medical examinations in labs across the country. One exception is Hugh, a manatee at the Mote Manatee Laboratory in Sarasota, FL, who willingly holds still as a result of daily training. Using Hugh as a model, researchers are looking for ways to actively involve animals in the conduct of research. 

 

FDA’s ‘Safe and Effective’ Drug Approvals Based on Widely Varied Data, Study Finds: A new study from researchers at Yale University’s School of Medicine has concluded that the ways the Food and Drug Administration (FDA) arrives at approvals for new drugs varies widely. Using publicly available documents that summarize the FDA’s rationale for approval, investigators identified disparities in the quality of information provided to the agency and the subsequent outcomes. 

 

Method of Study Is Criticized in Group’s Health Policy Tests: The Affordable Care Act allotted $10 billion over a ten year period to a research institute named the Innovation Center, which was charged with investigating how to most effectively deliver health care. The Innovation Center is now being criticized by many researchers and economists for almost exclusively using demonstration projects that rely on mathematical modeling, rather than randomized clinical trials, to judge the results. Experts say the center is “squandering a crucial opportunity to develop the evidence needed to retool the nation’s troubled health care system.”

Budget Offers Recovery Hope: On January 17, President Obama signed a $1.1 trillion spending bill into a law that reversed much of the damage wrought by the sequestration of early 2013. However, relief was not equal across all federal agencies; those that fund physical sciences research received larger increases than those that fund biomedical research.

Secrets from Belfast: An interview with a former member of the Irish Republican Army (IRA) that was conducted as part of an oral history project on the conflict in Northern Ireland was published in a book, Voice from the Grave: Two Men’s War in Ireland, and unknowingly served as the impetus for a massive legal firestorm. In this piece, The Chronicle of Higher Education recounts the case, which exemplifies many ethical questions surrounding oral history, including what needs to be disclosed to participants, how to protect those being interviewed, whether IRB review is necessary, and how to assess risks to participants.