Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research

NIH recently published a Guide Notice (NOT-OD-19-128) announcing requirements for research involving human fetal tissue (HFT). These changes will apply to competitive applications for grants and cooperative agreements submitted for due dates on or after September 25, 2019 and R&D contract proposals submitted to solicitations issued after September 25, 2019. Continue reading

Early Stage Investigator (ESI) Extension Request Process Moving to eRA Commons

NIH recognizes that a lot can happen to interrupt the ten-year eligibility window of your Early Stage Investigator (ESI) status, such as family care responsibilities, military service, medical concerns, and more. While you may currently request an extension of that ten-year period by completing an Extension Request Form, the process for requesting an extension of ESI status will soon be moving to the eRA Commons. Continue reading

Noticing More Notices of Special Interest?

You might have noticed an increased use of Guide Notices called Notices of Special Interest (NOSI), rather than full program announcements, to alert the community of specific research topics of interest. This is not a new concept, as some NIH institutes have been using this approach for many years – we are just formalizing it and expanding its use across all institutes. Continue reading

Where to Post Informed Consent Forms for NIH-Funded Clinical Trials

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

Explore xTRACT Before Its Required Use in FY 2020

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

New Application Requirements for Institutional Training Grants: Letter of Institutional Commitment to Harassment and Discrimination Protections

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

Revised NIH Grants Policy Statement for Fiscal Year 2019

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

Protecting Human Research Participants (PHRP) Online Tutorial No Longer Available as of September 26, 2018

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.
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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