The clinical trial workforce's incredible response to the COVID-19 pandemic has generated some of the most positive media coverage and public acclaim the drug and device research and development industry has ever seen. "We need to harness that public awareness," says Elisa Hurley, PhD, executive director of PRIM&R. Read more
Bioethical discussion of sharing research findings with participants has proliferated over the last decade. The University of Rochester and Kennedy Krieger Institute are conducting a study that seeks to ascertain stakeholder perspectives on the return of individual research results through qualitative interviews in order to inform decisions related to the return of individual results. Read more
The last few years have seen a growing call across the research enterprise to increase transparency around animal research—why we do it, why it’s important, and what it has accomplished. I also wonder whether there is another layer of transparency we ought to be promoting—namely, transparency about the ethical dimensions of animal research and its oversight. Specifically, how might being more open about the ethical issues and questions that are part of the day-to-day work of those involved in animal research serve our collective goals of educating and engaging the public; increasing their understanding, trust, and support for the animal research enterprise; and reframing the public conversation? Read more
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
This week’s Research Ethics Roundup looks at the first known US-based attempt of changing the DNA of embryos with CRISPR, the results of a large-scale wellness study, why researchers are challenging the notion that pregnant women are a “vulnerable” research population, and why European researchers are choosing to be transparent about their research with animals. Read more
