August 18, 2021
We recently released a Guide Notice discussing various flexibilities for conducting semiannual animal facility inspections. This Notice highlights an optional checklist based on the Guide for the Care and Use of Laboratory Animals (Guide), designed to help Institutional Animal Care and Use Committees (IACUCs) conduct thorough animal facility inspections. Both the Notice and the checklist strive to reduce the administrative burden on IACUCs while also ensuring that all the requirements for the Guide are met.
March 17, 2021
The NIH’s Office of Laboratory Animal Welfare (OLAW), along with their colleagues from the U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA), recently presented a webinar discussing progress towards implementing the 21st Century Cures Act. The new webinar focuses on how the three agencies recommend reducing administrative burden on investigators while maintaining the integrity and credibility of research findings and the protection of research animals. The actions discussed follow the release of their final report in 2019.
July 31, 2020
Opportunity knocks for NIH researchers, who will be able to leverage clinical data from electronic health record (EHR) systems with increased frequency and consistency. The recently published final rule, which went into effect on June 30, 2020, and requires electronic health record (EHR) systems to provide the clinical data necessary for nationwide, interoperable health information exchange through the adoption of the U.S. Core Data for Interoperability (USCDI) standard.
April 28, 2017
Earlier this year I wrote a post about the 21st Century Cures Act and its changes that directly affect the NIH. One part of this new legislation contains provisions to improve clinical research and privacy through certificates of confidentiality.
Currently, certificates of confidentiality (or “CoCs”) are provided upon request to researchers collecting sensitive information about research participants. Soon, CoCs will be automatically provided for NIH-supported research, as set forth in the 21st Century Cures Act. ….
December 14, 2016
You may have been following news of the 21st Century Cures Act, a landmark piece of legislation with provisions for healthcare, medicine, and research. Republican and Democratic lawmakers supported this bill through its development and eventual passage, and yesterday, President Obama signed the bill into law. The Act establishes a multitude of important changes to our nation’s approach to supporting and funding health care, medical interventions, and research. Readers of this blog may be particularly interested in the many changes directly relevant to NIH’s mission. A New England Journal of Medicine Perspective essay ….
0 Comments