for more information contact: communications@frabsa.org
April 25, 2019, the National Institutes of Health (NIH) finalized a proposal to amend the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to streamline the oversight of gene therapy research. This proposal, which was developed in conjunction with the Food and Drug Administration, included amending the NIH Guidelines to eliminate duplicative review and reporting requirements for human gene transfer protocols and refocuses the role of the NIH Recombinant DNA Advisory Committee (RAC) as a transparent forum for science, safety, and ethics of emerging biotechnologies. After a 60-day public comment period, the NIH Guidelines have been updated to reflect these changes and the RAC has been renamed the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC).
Please note that the roles and responsibilities of Institutional Biosafety Committees (IBCs) to review gene therapy protocols have been modified so that they are consistent with the review of other research covered under the NIH Guidelines. Gene therapy protocols remain subject to Food and Drug Administration (FDA) and other clinical trial regulations, and only after FDA, Institutional Biosafety Committee, Institutional Review Boards, and other relevant approvals are in place can these protocols proceed.
Please also note the HGTprotocols@od.nih.gov mailbox previously listed in the NIH Guidelines is no longer operational. All questions should instead be sent to NIHGuidelines@od.nih.gov
For more information about these important changes, please see the following NIH resources & Liteblue.
Risk Group Database App
FREE for iTunes and Android!
ABSA International created an app for the ABSA Risk Group Database, which is available for Apple and Android devices. The app will allow users to access the ABSA Risk Group Database on their mobile devices.
The ABSA Risk Group Database consists of international risk group classifications for Bacteria, Viruses, Fungi, and Parasites. In many countries, including the United States, infectious agents are categorized in risk groups based on their relative risk. Depending on the country and/or organization, this classification system might take the following factors into consideration: pathogenicity of the organism; mode of transmission and host range; availability of effective preventive measures (e.g., vaccines); availability of effective treatment (e.g., antibiotics); and other factors.
iPhone and iPad Instructions:
You can download the Risk Group Database app in the Apple iTunes store by searching for “Risk Group Database app.”
Android Instructions:
You can download the Risk Group Database app in the Google Play Store by searching for “Risk Group Database.”
The app only works when your device is connected to the internet.
Please send any comments or suggestions about the app to info@absa.org. An update is being planned for early October.
ABSA International would like to express our sincere gratitude to the fellows at the National Biosafety and Biocontainment Program (NBBTP) for updating the ABSA Risk Group Database.
Biosafety director earns acclaim for securing research pathogens | SOURCE
http://www.hhs.gov/news/press/2015pres/06/20150612b.html
HHS selects nine regional Ebola and other special pathogen treatment centers
• Colorado Department of Public Health and Environment in partnership with Denver Health Medical Center in Denver, Colorado
