Streamlining IRB Review of Multi-Site Clinical Research Studies

December 3, 2014

For many decades now the Department of Health and Human Services (HHS), and consequently NIH, has required institutional review board (IRB) review of research involving human subjects. …. as the clinical research landscape evolves, so should our policies to assure that NIH-funded research can more quickly generate research results without compromising protections for those who volunteer to participate in clinical studies. …. Today, NIH released a draft policy proposing that all NIH-funded multi-site clinical studies carried out in the US should use a single IRB’s review, rather than working through the IRB approval process of each participating institution. ….

How Can I Find Out Which Grants at My Institution Are About to End and Require Administrative Actions?

November 30, 2014

For an individual grant, the grantee can conduct a general search in eRA Commons using the grant number and see the project end date in the information displayed for that grant. (See the eRA Commons User Guide for more information.) Officials from a grantee organization who want to search for all grants that will end in the next three months for their entire organization can use this search tool ….

What is NIH’s Time Frame for Closing Out Grants After the Project End Date?

November 30, 2014

HHS policy stipulates that if the agency (NIH) cannot undertake a “bilateral closeout”—i.e., closeout with the cooperation between the grantee and the agency —within 180 days of the project end date, it must initiate “unilateral closeout”—i.e., closeout without receipt of acceptable final reports—for those grantees that are not in compliance with the policy. ….

Learn More About Collaborating with NIH’s Clinical Center

November 28, 2014

In 2012, NIH created a unique opportunity for extramural researchers to collaborate with our intramural scientists and use the exceptional resources of the NIH Clinical Center. I want to remind you of the third round of this program, called “Opportunities for Collaborative Research at the NIH Clinical Center”, in time for the upcoming pre-application date on December 10. ….

Implementing the Modified NIH Biosketch Format

November 26, 2014

Many people have been asking about the new NIH biosketch. As you may recall, in May 2014, NIH announced that we were piloting changes to the biosketch section of grant application forms. This modified format allows researchers to describe how their background and expertise relates to their proposed project. We will require this new format for most grant applications submitted for fiscal year 2016 funding, as described in a guide notice published today. This sounds like a long way off but remember that the first applications for FY 2016 funding begin with due dates of January 25, 2015. The new format is now available in the “additional format pages” section of the SF424 applications page. ….

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