News

How do you define a “study” for the purposes of providing information on the PHS Human Subject and Clinical Trial form and registering in ClinicalTrials.gov?

February 5, 2018
Our application instructions provide guidance to submit a study record for each protocol. When in doubt, NIH supports lumping several aims or hypotheses into a single study record, to the extent that makes sense for your research.
Have other questions related to the new PHS Human Subject and Clinical Trial form or NIH clinical trial policies?...
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Where Can I Find the New PHS Human Subjects and Clinical Trials Information Form?

February 5, 2018

Like all NIH application forms, the new PHS Human Subjects and Clinical trials Information form is accessed through the submission method you are using. ASSIST, Workspace and all system-to-system solutions provide a way to access and complete the forms.

ASSIST allows you to complete the forms online within ASSIST or to download a study record form for offline completion and later upload the completed form into your ASSIST application.

Workspace provides the ability to download...

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Having Challenges Tracking Down Students and Postdocs at the Time of the RPPR? Here is a Tip to Make It Easier…

January 30, 2018

Having challenges tracking down students and postdocs at the time of reporting? Establishing a process where you have students and postdocs establish an eRA Commons account at the time they start working on an NIH grant award can save you a lot of time and energy trying to track down people who may no longer be at your institution at the time of your Research Performance Progress Report (RPPR) submission. You may even want to have them create an...

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New to eRA Commons?

January 30, 2018

Sometimes when you are trying something for the first time, it can appear to be somewhat confusing, intimidating, and possibly overwhelming.  eRA is continuously developing new resources for our applicants and grantees to eliminate that perception. Recently eRA has focused on ways to help people new to navigating eRA Commons for the NIH grant application, award, and reporting processes. Because these processes require attention to detail and patience, it can often be overwhelming for those who have never done it before.

With that in mind, a new link has been added to the...

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Change of Grantee Organization

January 26, 2018

Funding Opportunity PA-18-590 from the NIH Guide for Grants and Contracts. The National Institutes of Health (NIH) hereby notify grantee organizations holding specific types of NIH grants, listed in the full Funding Opportunity Announcement (FOA), that applications for change of grantee organization may be submitted in response to this FOA. This assumes such a change is programmatically permitted for the particular grant. Applications for change of grantee organization are considered prior approval requests (as described in Section 8.1.2.7 of the NIH Grants Policy Statement) and will be...

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Successor-in-Interest

January 26, 2018

Funding Opportunity PA-18-589 from the NIH Guide for Grants and Contracts. The National Institutes of Health (NIH) hereby notify grantee organizations holding specific types of NIH grants, listed in the full Funding Opportunity Announcement (FOA), that applications for change of grantee organization status, often referred to in this announcement as Successor-In-Interest, may be submitted in response to this FOA. Applications for change of grantee organization status are considered prior approval requests (as described in Section 8.1.2.8 of the NIH Grants Policy Statement) and will be...

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NIH Announces Inclusion Across the Lifespan Policy

January 24, 2018

Last month, NIH announced a revision (NOT-OD-18-116) to a decades-old policy originally conceived in response to concerns that children were not appropriately included in clinical research. These changes broaden the policy to address inclusion of research participants of all ages, and as discussed at the last Advisory Committee to the NIH Director meeting, will apply beginning in 2019 to all NIH-supported research involving human subjects. Our goal is to...

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Continuing to Strengthen Inclusion Reporting on NIH-funded Phase III Trials

January 8, 2018

Much has been learned about how sex and race may contribute to differences in health outcomes and physiologic conditions (Clayton, 2014). We know that, for example, a specific drug used to treat insomnia requires different dosing for women and men.  African Americans with hypertension are more susceptible to stroke than whites with the same blood pressure levels (...

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