The revised Common Rule requires that an IRB-approved version of an informed consent form be posted on a public federal website for all NIH-funded clinical trials. This must be done after enrollment ends and within 60 days of the last study visit. See Guide Notice NOT-OD-19-050. Continue reading
Beginning with RPPRs due on or after October 1, 2019 (FY 2020), recipients must use the xTRACT system to create the required training tables for submission with NIH and AHRQ T15, T32, T90/R90, and TL1 progress reports. While it is not mandatory to use xTRACT for new and renewal applications for the specified types of training grants, it may be required in future years. Continue reading
NIH takes the issue of sexual harassment and discrimination very seriously. As such, beginning with applications submitted for due dates on or after January 25, 2019, institutional training grant applications (T15, T32, T34, T35, T36, T37, T90/R90, TL1, TL4) must include a letter that describes the institutional commitment to ensuring that proper policies, procedures, and oversight are in place to prevent discriminatory harassment and other discriminatory practices. Continue reading
NIH has released a revised Grants Policy Statement that applies to all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2018. This revised version does not introduce new policies, but it does incorporate all policy changes or updates made throughout the previous year and includes significant enhancements to improve the user interface, navigation, and search. Continue reading
We recently released a policy notice announcing that as of September 26, 2018, the NIH will no longer be offering the Protecting Human Research Participants (PHRP) course. It is important to note that investigators are still required to comply with all aspects of the NIH policy Required Education in the Protection of Human Research Participants, and can do so through a different training program or course.
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
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
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
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
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