Tag Archives: NIH

October is Biosafety Month

2018 is the 5th anniversary of Biosafety Month. The National Institutes of Health’s (NIH) Office of Science Policy (OSP) initially created National Biosafety Month to encourage institutions to highlight the importance of biosafety and undertake activities to strengthen their biosafety programs. The 2018 Biosafety Month theme is “Promoting a Culture of Biosafety and Responsibility” with […]

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What is the Purpose of Personal Protective Equipment (PPE) in a Biological Research Facility?

It’s really not a simple answer and requires an understanding of general biosafety. The World Health Organization (WHO) defines biosafety as principles, practices, and strategies aimed at minimizing the unintentional release of a biological agent. Biosafety is achieved by utilizing the four primary controls – engineering, PPE, standard operating procedures (SOPs), and administration. These controls […]

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Common Rule Delay and Single IRB Requirement for Federally Supported Studies

On January 17, 2018, changes to the common rule that were scheduled to be effective on January 19, 2018, were delayed 6 months.  The new effective and compliance date is July 19, 2018.  This will allow time for the regulatory agencies to develop more guidance around the 2018 Common Rule, and they will also work […]

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Is it an Unliquidated or Unobligated Training Grant?

Unliquidated vs. Unobligated, Training Grants A NIH Training grant is awarded to eligible institutions “to develop or enhance research training opportunities for individuals, selected by the institution, who are training for careers in specified areas of biomedical, behavioral and clinical research” (NIH Grants Policy Statement).  Training grants are commonly referenced by the acronym NRSA = […]

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Biological, Chemical and Chemicals in Animals Registrations/Forms Review in 2018

          The use of biological materials and chemicals in the laboratory or in animals require the review and approval of the Biosafety Office. Biological and Chemical Registrations, as well as, Chemicals in Animals Forms are maintained in BioRAFT. We are making efforts to synchronize the review of all modules to occur […]

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NIH ALERT: New NIH Submission Requirements Effective January 25, 2018

To all Investigators proposing human subjects research to the NIH, For NIH submissions with due dates on or after January 25, 2018, it is imperative to make an accurate determination of whether your study meets the NIH definition of a clinical trial.  The NIH has broadly defined a “clinical trial” resulting in stringent requirements—some are […]

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October is National Biosafety Month

October is National Biosafety Month (NBM). The Office of Science Policy (OSP) at the National Institutes of Health (NIH) encourages institutions to: Highlight the importance of biosafety. Undertake activities to strengthen their biosafety programs. The 2017 theme for NBM is “promoting biosafety through good governance.” What is Emory University doing? The biosafety office team: Encourages […]

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New Requirements for ClinicalTrials.gov

  Click here to learn about the new requirements for ClinicalTrials.gov.  

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New Requirements for Clinical Trials

March 29 Memo Regarding New Requirements for ClinicalTrials.gov

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Upcoming Human Research Community Event & Guidance on Data Sharing Certifications

Emory Co-Sponsoring a Human Research Community Forum – Augusta GA, July 18-19, 2017: Convenient human subjects research education! Emory joins Augusta University and DHHS’ Office for Human Research Protection, to host a Research Community Forum called “Navigating a River of Change: Bringing Research Up to Par.” The event takes place in Augusta, GA, July 18-19, […]

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