On April 30, 2018, the EPA published in the Federal Register a proposed rule titled, Strengthening Transparency in Regulatory Science. The rule would prohibit the EPA from basing regulatory action on scientific studies for which the underlying raw data and models are not publicly available “in a manner sufficient for validation and analysis.” According to the notice, the proposed rule is “designed to increase transparency in the preparation, identification, and use of science in policymaking.” On its face, this sounds good; however, many in the scientific community are expressing deep concern that this proposed rule is actually a way for EPA to limit the types of science it can and will use in regulatory decision-making, to the detriment of environmental policy and the public’s health. Comments on the proposed rule are due May 30. Read more
TAG ARCHIVES FOR reproducibility
This week’s Research Ethics Roundup looks at why researchers are not enrolling pregnant women in the early phases of Zika vaccine research, a new LGBTQ study that seeks to address participants’ health concerns, a new study that shows the sex of a mouse affects certain traits, and Dr. Susan Reverby’s case for making changes to a monument that fails to note how a prominent gynecologist used slaves in his experiments. Read more
This week’s Research Ethics Roundup reviews the ways research with biospecimens has changed since Henrietta Lacks' story made news, how the National Institutes of Health (NIH)'s grant application changes focus on transparency in preclinical research, how ethicists can avoid stereotyping prisoners who choose to participate in research, and how one of the top research search engines is improving transparency efforts. Read more
The first of three distinguished speakers at PRIM&R's 2017 IACUC Conference is Craig L. Franklin, DVM, PhD, DACLAM, professor of veterinary pathobiology at the University of Missouri. In addition to his professorship, Dr. Franklin directs the Mutant Mouse Resource and Research Center, a National Institutes of Health-funded repository of genetically engineered mutant mice; the Comparative Medicine Program, a post-DVM laboratory animal medicine residency and advanced degree program; and the Veterinary Research Scholars Program, a summer research program for veterinary students. He is also an associate director of the University of Missouri Metagenomics Laboratory and is a co-investigator for the Rat Resource and Research Center. Read more
This week’s Research Ethics Roundup examines what the new 21st Century Cures law means for harmonization efforts, why cancer trials struggle with minority enrollment, a new study on reporting of bias-reducing methodologies in animal research, and the argument for open access publishing.
Cures Law Requires FDA, HHS to Harmonize Regs
Jeannie Baumann reports for Bloomberg BNA about a provision in the new 21st Century Cures law that requires the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) to address any differences between their corresponding [...] Read more