Tracking Facilitated IRB Reviews
Alternative models of IRB review have been a hot topic for well over a decade. Although local review remains the norm for most institutions, other mechanisms such as facilitated review…
Author: Matthew Tanner
Webinar Summary – Compliance
Two webinars were held in August 2012 to provide an overview and demonstration of various features that are available for board and program management in the Human Subjects, Lab Animals…
Departures from the Guide: OLAW Webinar, September 13
A webinar entitled “Departures from the Guide” will be presented on September 13, 2012 from 1:00 to 2:00 pm ET by OLAW. The 8th Edition of the Guide emphasizes performance standards…
Tips for handling problem PIs
Do you recognize any of these PIs? Dr. Studies, AKA Dr. “We Can Do That” Dr. Enrollment, AKA Dr. “I Want to Enroll an Incarcerated Schizophrenic Patient with Dual Primaries” Dr. Yes, AKA…
FDA issues draft guidance on prospective assessment of suicidal ideation and behavior in clinical trial participants
FDA recently issued a draft guidance addressing the issue of suicidal ideation and behavior that emerges during clinical trials of investigational drugs and biologics. The guidance includes recommendations for assessment and…
Public workshop on FDA clinical trial requirements
FDA and the Society of Clinical Research Associates (SoCRA) will co-sponsor a public workshop to be held November 14-15, 2012 in Baltimore, MD. The target audience includes clinical research professionals…
Federal appeals court upholds 2011 ruling on federal funding of hESC research
A panel of the US Circuit Court of Appeals for the District of Columbia determined late last week that federal funding of research involving human embryonic stem cells (hESCs) is…
Reproducibility Initiative to Increase the Value of Biomedical Research
Science Exchange, in partnership with the open-access publisher PLOS and open data repository figshare, announced today the launch of the Reproducibility Initiative (www.reproducibilityinitiative.org) – a new program to help scientists,…
Notes from the Field: Lymphocytic Choriomeningitis Virus Infections in Employees of a Rodent Breeding Facility — Indiana, May–June 2012
The current Morbidity and Mortality Weekly Report (MMWR) describes the infestation of an animal facility with Lymphocytic choriomeningitis virus (LCMV), and the subsequent clean-up efforts. Almost 25% of current and…
So what do you do?
When someone asks, “What do you do?”; how do you reply, if you happen to work in an IACUC office, are a member, or work in an animal research facility? …