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Ethics Consult: Skirt U.S. Rules and Conduct Research in Africa?

— You make the call

Last Updated August 27, 2021
MedpageToday
3 blister packs of white pills lie on a map of the African continent.

Welcome to Ethics Consult -- an opportunity to discuss, debate (respectfully), and learn together. We select an ethical dilemma from a true patient care case. You vote on your decision in the case and, next week, we'll reveal how you all made the call. Bioethicist Jacob M. Appel, MD, JD, will also weigh in with an ethical framework to help you learn and prepare.

The following case is adapted from Appel's 2019 book, .

Treatment for a bone infection, or osteomyelitis, usually requires 4 to 6 weeks of intravenous antibiotics. Researchers at a U.S. university would like to test whether a shorter course of antibiotics, lasting only 2 weeks, can prove effective in most cases. However, setting up a study that compares patients receiving 2 weeks and those receiving 4 weeks of antibiotics would never be approved in the U.S., because the 4- to 6-week regimen is known to be highly effective.

Instead, the researchers want to conduct their study in a developing nation in sub-Saharan Africa, where they have a positive relationship with public health authorities. In that nation, patients who contract osteomyelitis often go untreated, and many die.

The researchers plan to offer a group of such patients who would otherwise receive no treatment a 2-week course of antibiotics to see if it is effective. The team will provide other basic medical care as well, but will not offer anyone the longer course of antibiotics that is already known to work.

See the results and what an ethics expert has to say.

Jacob M. Appel, MD, JD, is director of ethics education in psychiatry and a member of the institutional review board at the Icahn School of Medicine at Mount Sinai in New York City. He holds an MD from Columbia University, a JD from Harvard Law School, and a bioethics MA from Albany Medical College.

And check out some of our past Ethics Consult cases:

Force Unvaxxed to Use Telehealth?

Spill Patient's Medical Secrets to SEC?

Help Family Have Child for Marrow Donation?