Research Ethics Roundup: No Voluntary Compliance of New Common Rule Changes, President Proposes Large NIH Cuts, Using Technology Instead of Animals in Research, FDA Commissioner Nominee Announced

This week’s Research Ethics Roundup examines legal experts’ reasons for advising against voluntary compliance of Common Rule changes, President Trump’s plan for the National Institutes of Health (NIH)’s budget, the debate over whether technology can replace animal models in research, and the reaction to President Trump’s pick for Food and Drug Administration (FDA) Commissioner.

Early Adoption Not an Option for Research Rule Changes: Jeannie Baumann reports for Bloomberg BNA that attorneys with expertise on the Common Rule are advising other attorneys not to voluntarily implement changes to the Common Rule at their institutions until they officially take effect in January 2018.

The attorneys believe there may be some confusion because voluntary compliance language that will affect close to 20 federal agencies and the grants they issue was in the proposed rule, though ultimately not included in the final rule.

NIH Would See Huge Budget Cut Under President’s Proposal: In this Washington Post article, reporter Lenny Bernstein analyzes the implications of President Trump’s proposed budget for the NIH which asks Congress to cut approximately 19 percent of the agency’s discretionary budget. The President would also like there to be a “major reorganization” of NIH including the elimination of the Fogarty International Center which works on creating partnerships between American and overseas health research institutes. However, the President’s budget outline does not offer further details on what kind of reorganization efforts the agency is likely to face.

Study Aims to Check if Other Methods Can Replace Animal Testing: In this Baltimore Sun article, Meredith Cohn finds that experts are actively debating whether research with animals can be replaced with new scientific methods, such as computer models. The Evidence-based Toxicology Collaboration at the Johns Hopkins Bloomberg School of Public Health is currently conducting a study and has promised to publish its findings no matter the outcome. Supporters of research with animals argue that animals are still needed because currently we do not have the technology to replicate a full living system.

Trump Chooses Dr. Scott Gottlieb to Head Food And Drug Administration: In this NPR article, Joe Neel reports that President Trump’s nominee for FDA Commissioner, Dr. Scott Gottlieb, is popular with the industry and is familiar with FDA issues, as he previously served as an FDA deputy commissioner during President George W. Bush’s administration. If Dr. Gottlieb is approved by the Senate, he would be in charge of an agency that regulates everything from pharmaceuticals to certain animal health issues.