Category Archives: NIH

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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Overruns and Over-the-Limit Transactions

The Payment Management System (PMS) is a secure, online grants payment platform, which provides awarding agency and grant recipient customers with efficient grant and grant-like payments, cash management, and personal grant accounting, support services. PMS is widely used by NIH for most awards administered by NIH. PMS supports the entire financial assistance payment process for […]

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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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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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NIH has Revised the Guidance for Submitting Project Outcomes in F-RPPRS and I-RPPRS (FRAMs and IRAMs)

NOTICE from NIH:  As most investigators will know, NIH Progress Reports, both the F-RPPR and I-RPPR, include a section for Project Outcomes, Section I – Outcomes. It is NIH’s intent that the information provided in the Project Outcomes section will be made publicly available. Therefore, investigators should avoid including overly scientific language or technical terminology […]

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Important News About NIH-Funded Human Subjects Research

NIH Policy for NIH-Funded Human Subjects Research Effective October 1, 2017, all new and ongoing NIH-funded research meeting certain criteria is deemed to be issued a Certificate of Confidentiality (CoC) via a new NIH policy. This policy results from a directive in the 21st Century Cures Act. For more information about the change in policy, please see this notice. Previously, researchers […]

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New Requirements for ClinicalTrials.gov

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

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Application Completeness and Compliance Stressed in NIH Notice

NOTICE from NIH: NIH Applications Must Be Complete and Compliant with NIH Policy and Application Instructions at the Time of Submission NIH has issued a notice (NOT-OD-17-105) reminding all applicants that NIH will consistently apply standards for applications completeness and for compliance with all submission requirements and NIH policies. The notice did not include any […]

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NIH Provides Updated Definition of Clinical Trial

***IMPORTANT: NIH CLINICAL TRIAL FUNDING OPPORTUNITY ANNOUNCEMENT and UPDATED DEFINITION OF CLINICAL TRIAL*** The NIH Clinical Trial Funding Opportunity Announcement policy requires all applications with due dates on/after January 25, 2018 involving clinical trials be submitted through a FOA specific to clinical trials. More information on this will be provided by ORA over the upcoming […]

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NIH Announces new “FORMS-E” Grant Application Forms and Instructions, Effective January 25, 2018

  NIH has announced that there will be changes to its grant application forms and application guide instructions for all proposals with due dates on or after January 25, 2018. The new “FORMS-E” package will include the consolidation of human subjects, inclusion enrollment and clinical trial information, the expansion and use of discrete form fields […]

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