NIH – Page 4 – Emory Research Administration News

Single IRB Review Reminder

Dec 21, 2018

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If your NIH RFA will involve collaborating sites, and NIH requires the use of a single IRB (“sIRB”), we remind you to consult with the Emory IRB very early on in the grant-writing process, and to not submit your sIRB plan without our prior review. We also remind you that reliance on an independent IRB is…

October is Biosafety Month

Oct 3, 2018

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jruch

in EHSO

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…

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

May 30, 2018

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jruch

in EHSO

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…

Common Rule Delay and Single IRB Requirement for Federally Supported Studies

Feb 13, 2018

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bmoran3

in IRB, NIH, OHRP

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…

Is it an Unliquidated or Unobligated Training Grant?

Feb 13, 2018

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bmoran3

in Announcements, NIH, RGC

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 =…

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

Feb 7, 2018

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jruch

in EHSO

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…

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

Jan 2, 2018

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bmoran3

in Announcements, IRB, NIH, RAS

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…

October is National Biosafety Month

Oct 3, 2017

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by

jruch

in EHSO

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…