Working with Human Subjects? New Human Subjects System Replaces NIH’s Inclusion Management System

On June 9 a new Human Subjects System will replace the Inclusion Management System (IMS) currently used for reporting participant sex/gender, race, and ethnicity information for NIH grants. The new system consolidates human subject information submitted in applications and progress reports and will be used for all human subject-related post-submission updates as of its release. Continue reading

xTRACT Anticipated to be Required in Fiscal Year 2020

In October 2015, eRA introduced xTRACT as an electronic system within eRA Commons for creating research training data tables and tracking trainee outcomes. xTRACT permits users to leverage data already in eRA Commons to pre-populate training tables with trainee names, institution information, award information, etc., which can be used both in new application submissions and for progress reports [the Research Performance Progress Report (RPPR)]. While use of xTRACT is not required currently, it is anticipated to be required as of FY 2020 for certain types of training grant applications. …. Continue reading

Why Attend the Spring 2018 NIH Regional Seminar in Washington, DC

You’ve heard about it and may even know someone who attended, but is it right for you? With the next NIH Regional Seminar on Program Funding and Grants Administration coming to Washington DC May 2-4, let us help you decide. Or check out our YouTube video to get thoughts from previous attendees. If you are an investigator or research administrator new to working with the NIH grants process, don’t let the 2018 NIH Regional Seminar in Washington, D.C. pass you by. Registration is underway now and seminars typically sell out! Learn about the NIH grants process and polices directly from ~ 70 NIH & HHS program, grants management, review and policy staff. …. Continue reading

Due Dates on Holidays/Weekends/NIH Office Closures

With winter weather upon us, remember that when a due date falls on a weekend, Federal holiday, or when Washington, D.C.-area Federal offices close (due to severe weather, for example), the application deadline is automatically extended to the next business day. See NIH Guide Notice NOT-OD-17-041 for additional details. If you suspect Federal offices in D.C. are closed due to severe weather you can …. Continue reading

Reminder: Changes for January 25, 2018 Application Due Dates

Two major changes impact applications submitted for due dates on or after January 25, 2018.

Applicants are required to use FORMS-E. Wondering what this means for late applications or reviewers submitting under the continuous submission policies? See NIH Guide Notice NOT-OD-17-062 to learn more.
Applications that include one or more clinical trials must be submitted in response to funding opportunity announcements that allow for clinical trials. See NIH Guide… Continue reading

New Electronic Submission Requirement for Diversity Supplements

The funds provided in response to Diversity Supplement requests are used to improve the diversity of the biomedical research workforce by recruiting and supporting students, postdoctorates, and eligible investigators from groups that have been shown to be underrepresented in health-related research. Currently, NIH does not require that diversity supplements be submitted electronically, which poses a challenge to NIH staff when trying to identify and track diversity supplement awardees and their subsequent research careers. Effective January 25, 2018, all single and multi-project diversity supplement requests MUST be submitted electronically …. Continue reading

NIH Single IRB Policy Reminder

As we approach the implementation date for NIH’s Policy on the Use of a Single Institutional Review Board (Single IRB) for Multi-Site Research, we would like to remind you of the resources available for understanding this policy. 

The policy affects multi-site studies involving non-exempt human subjects research funded by NIH, and applies to grant applications with due dates on or after January 25, 2018 and R&D contracts in response to solicitations issued on or after January 25, 2018.

We encourage you to familiarize yourself with the single IRB plan, considerations in the selection of the sIRB, costs, exceptions to the policy, and where you should include this information as part of your grant application or contract proposal.

Visit the following resources to learn more: …. Continue reading