On July 20, the Office for Human Research Protections (OHRP) published three new draft guidance documents related to the three “burden-reducing provisions” institutions can take advantage of during the “delay period” before the general compliance date of the revised Common Rule. [Update] On July 25, OHRP issued a Federal Register Notice and the community and public has until August 24, 2018 to Read more
I have been an IACUC Administrator for fifteen years and a long-time member of PRIM&R. I can remember my first PRIM&R IACUC Conference back in 2005: all the excitement and anticipation of learning new ideas and best practices. From time to time I’m asked why I still go to PRIM&R IACUC if I've already gone before. And my reply is, because it’s always exciting and new! Like regulatory compliance itself, the conferences always offer new knowledge to be gained, new friends to meet, and exciting adventures to be had. 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
The keynote address at PRIM&R's IACUC Conference by Alison Rockett Frase and Dr. Martin (Casey) K. Childers really should have come with a Kleenex alert! Those of us in attendance all know that research with animals can lead to major advances in treatment for a variety of health issues. Hearing Ms. Frase’s firsthand account of her son's battle with a rare neuromuscular disorder and Dr. Childer’s follow-up description of their search for a treatment or cure for centronuclear and myotubular myopathies was truly inspiring. If you’ve not yet seen the video about their journey please stop what you are doing, close your office door, grab a hankie and watch their video. I dare say there were very few dry eyes in the room at the end of their presentation at IACUC18, and there was a communal feeling of wanting to shout: “Yes, Yes, Yes! This is why we do what we do!” Read more
Expanded access, which is treatment access to experimental drugs (also referred to as "compassionate use" or "pre-approval access"), has generated increasing interest and debate over the last several years. Currently, US federal regulations allow manufacturers to provide Investigational New Drugs (INDs) to patients with serious diseases or conditions who have exhausted approved therapeutic options, and cannot participate in a clinical trial. As key players in the pre-approval access process, IRBs must review and approve expanded access protocols in accordance with FDA guidelines. Moreover, the new “Right to Try” laws currently taking effect on both the federal and state levels make it especially crucial that IRB members stay informed about ongoing developments and potentially thorny ethical issues. Read more
On April 19, HHS and 16 other federal agencies released a new Notice of Proposed Rulemaking (NPRM) that would delay the general compliance date for the revised Common Rule an addition six months, to January 21, 2019. The NPRM also proposes to allow institutions to implement three “burden-reducing provisions” during the delay period. Comments on the NPRM are due May 21, and as you consider developing and submitting your comments, I wanted to share the letter PRIM&R has submitted. Read more
Do you think of customer service when you think of IACUC Administration? No? Well, maybe you should! I recently attended a fabulous session at PRIM&R’s 2018 IACUC Conference entitled “Incorporating Quality Customer Service into IACUC Administration”. We don’t often think of customer service as applying to regulatory compliance. But if instead of viewing regulatory compliance as enforcement, we view it as a service, we may begin to see compliance increase. Read more
