Research Ethics Roundup: New recommendations on incidental findings, considering personhood, and more

by Maeve Luthin, JD, Professional Development Manager

Oh, the weather outside is frightful, but Research Ethics Roundup is so delightful! So, we hope you’ll bundle up, hunker down, and enjoy some of the research ethics stories that are making headlines this week. We, here at PRIM&R, wish you a joyous holiday season and good health in the New Year and always.


GM Maize, Health and the Séralini Affair: Smelling a Rat: The Food and Chemical Toxicology journal retracted a September 2012 study that suggested genetically modified maize causes cancer. Critics of the article complained that the rats used already had a pre-disposition to cancer, that too few animals were included in the study, and that researchers did not distinguish between spontaneous tumors and those that may have been caused by the maize. The publisher said there was no evidence of intentional misrepresentation of the data or fraud. Some members of the scientific community have been concerned that the backlash against genetically modified food has undermined efforts to use genetically modified food, such as Golden Rice, to feed children in resource-scarce nations.

Harvard Fined for Violating Animal Welfare Law in Care of Monkeys: The United States Department of Agriculture fined Harvard Medical School $24,000 for eleven violations of the Animal Welfare Act in its care of nonhuman primates used in research. These infractions, which occurred in 2011 and 2012, led to the deaths of four monkeys. Earlier this year, Harvard announced it would shut down its New England Primate Research Center by 2015.

Medics Should Plan Ahead for Incidental Findings: Earlier this month, the Presidential Commission for the Study of Bioethical Issues (PCSBI) released a report outlining how researchers, physicians, and companies should handle incidental findings discovered in the course of genetic analyses, imaging scans, and other tests. PCSBI contends that researchers have a duty to plan for how they will handle incidental findings.

Rare Cancer Treatments, Cleared by Food and Drug Administration (FDA) but Not Subject to Scrutiny: The New York Times explores the challenges of the FDA’s humanitarian device exemption policy, which was implemented in 1997 and grants companies permission to sell products that are safe and have a “probable benefit” for the treatment of conditions that affect less than 4,000 patients annually—a subject pool generally not large enough to warrant clinical trials. Under the policy, companies are not required to collect safety and efficacy data.

What is Personhood?: The Nonhuman Rights Project (NhRP) filed a series of lawsuits in New York courts demanding writs of habeas corpus, which challenge a person’s alleged imprisonment or unlawful detention, on behalf of four chimpanzees. NhRP contended that the chimps qualified as persons with a fundamental right to freedom because of their autonomy, self-determination, and self-awareness. In response to the lawsuit, James Carroll, a columnist for The Boston Globe, considers the issue of personhood in this thought-provoking piece.