Category Archives: Regulatory Burden

Is your research a clinical trial? The answer may surprise you!

Background In October 2014, the National Institutes of Health (NIH) announced a change in its definition of a clinical trial, to take effect in January 2015. The new definition, which applies only to NIH-funded clinical trials, reads: “A research study in which one or more human subjects are prospectively assigned to one or more interventions… Read More »

New Report Promotes Regulatory Efficiency in Animal Research

A new report from FASEB and its partners contains proposed changes to federal regulations, policies, and guidelines governing the use of animals in research. Directed to federal agencies involved in the oversight of federally funded animal research – primarily the U.S. National Institutes of Health and the U.S. Department of Agriculture – the recommendations aim… Read More »

National Science Board meets to discuss policy issues

On November 7-8, the National Science Board (NSB) met at National Science Foundation (NSF) headquarters in Arlington, Virginia, to discuss a long slate of science policy issues. Many topics were raised during the open sessions of the meeting, including an update on the NSF strategic plan, discussions of a new pilot program pertaining to NSF… Read More »

National academies workshop on animal models for microbiome research

The National Academy of Sciences Institute for Laboratory Animal Research (ILAR) Roundtable will host a workshop entitled, “Animal Models for Microbiome Research: Advancing Basic and Translational Science” on December 19–20. The workshop agenda includes discussions on the standardization and biological variability in gnotobiotic organisms, the translatability of preclinical studies to humans, alternative models for microbiome research, and… Read More »

HHS advisory committee addresses institutional review board rules

The fall meeting of the Secretary’s Advisory Committee on Human Research Protections (SACHRP) on October 25–26 focused in large part on clarifying new rules affecting institutional review boards (IRB). The committee advises the Secretary of Health and Human Services on human subjects research matters and offers recommendations to researchers and institutions conducting studies with human… Read More »

NIH seeks input on inclusion of preprints in grant applications and reports

On October 6, the National Institutes of Health (NIH) released a Request for Information (RFI) seeking input on the inclusion of interim research products and preprints in grant applications and reports as well as known standards for reporting such products. Specifically, NIH asks the research community to provide insights about existing interim research products and… Read More »

New rules on registering and reporting clinical trials

The Department of Health and Human Services (HHS) issued new rules on announcing clinical trials and reporting their results. On September 16, HHS released the Final Rule on clinical trials registration and summary results information submission on the ClinicalTrials.gov website. The Final Rule mirrors the Notice of Proposed Rulemaking (NPRM) published in November 2014. At… Read More »