Reminder: NIH Will Continue to Accept Preliminary Data as Post-Submission Material Through January 2023 Councils
NIH will continue to accept a one-page update with preliminary data as post-submission materials for applications submitted for summer 2022 due dates, ONLY if the Funding Opportunity Announcement (FOA) used for submission allowed preliminary data in the application. The deadline for submitting all post-submission materials, including preliminary data, will be 30 days before the study section meeting or as stipulated in the FOA. Because applications for emergency competitive revisions and urgent competitive revisions undergo expedited review, post-submission materials will not be accepted for those applications. For a visua...
Source: NIH Extramural Nexus - April 28, 2022 Category: Research Authors: NIH Staff Tags: Top Stories COVID-19 Source Type: funding

Same Systems, New Look to eRA Website
A refreshed eRA website was launched on Monday, April 25. The redesign updates the home page, as well as the About eRA page with extensive new information about eRA and the services it offers to existing and potential agency partners.  Don’t worry – the information sections you rely on every day for applicants, recipients and reviewers remain unchanged. The changes reflect the modern, trusted trans-agency program that eRA has become. eRA is recognized as an experienced service provider to NIH and an ever-growing number of HHS operating divisions and federal agencies, including AHRQ, CDC, FDA, SAMHSA, VA, DoD, and Unif...
Source: NIH Extramural Nexus - April 26, 2022 Category: Research Authors: NIH Staff Tags: New Resources eRA eRA Commons Source Type: funding

May 30 (Monday), 2022: NIH Closed for the Federal Holiday
NIH (including help desks) will be closed on Monday, May 30, 2022 for the federal holiday (Memorial Day). If a grant application due date falls on a federal holiday, the application deadline is automatically extended to the next business day. (Source: NIH Extramural Nexus)
Source: NIH Extramural Nexus - April 22, 2022 Category: Research Authors: NIH Staff Tags: Calendar federal holiday General Source Type: funding

When Instructions Conflict – Which One Wins?
NIH grant application instructions can be found in several places: How to Apply – Application Guide (often simply referred to as Application Guide) Funding Opportunity Announcements (FOAs), and Notices posted in the NIH Guide for Grants and Contracts. It is important to read and follow all provided guidance. What happens when guidance between these sources conflicts? Which one wins? In summary, NIH Guide Notices win over application guide and funding opportunity announcements when instructions conflict. Stay up to date and subscribe to the NIH Guide for Grants and Contracts! (Source: NIH Extramural Nexus)
Source: NIH Extramural Nexus - April 21, 2022 Category: Research Authors: NIH Staff Tags: Tips Before You Submit application policy Source Type: funding

Reducing Administrative Burden in Laboratory Animal Research: What Have We Done Recently and What ’s Coming…
Pat Brown, Director, NIH Office of Laboratory Animal Welfare The 21st Century Cures Act called for NIH to collaborate with the U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA) to reduce administrative burdens associated with laboratory animal research programs, while maintaining high standards of animal welfare as well as the integrity and credibility of the research. We jointly released a final report in 2019 outlining steps to accomplish this goal, and have since worked together to implement many of the recommendations. We wanted to take this opportunity today to share some of NIH’s progress...
Source: NIH Extramural Nexus - April 20, 2022 Category: Research Authors: Mike Lauer Tags: blog Open Mike Administrative Burden Animal Welfare RFI Source Type: funding

I Am Conducting a Basic Experimental Study Involving Humans (BESH). Do I Have Flexibilities for Registration and Results Reporting in ClinicalTrials.gov?
It depends. Only BESH studies that were awarded through a BESH-specific funding opportunity are eligible for registration and reporting flexibilities (as noted in NOT-OD-21-088). BESH studies that came in through funding opportunities designated as ‘Clinical Trial Required’ or ‘Clinical Trial Optional’ must register and report results in ClinicalTrials.gov according to the Clinical Trial Dissemination Policy. Not sure if your FOA is designated as BESH? All FOAs have a clinical trial designation listed in the Title and in the body of the announcement in Section II, as illustrated below. See our webpage on Basic Exp...
Source: NIH Extramural Nexus - April 19, 2022 Category: Research Authors: NIH Staff Tags: You Ask, We Answer BESH human subjects Source Type: funding

FY 2022 Fiscal Policies for Grant Awards: Funding Levels, Salary Limits, and Stipend Levels
NIH issued guidance for NIH Fiscal Operations for FY 2022 including the following policies: FY 2022 Funding Levels: Non-competing continuation awards made in FY 2022 will generally be issued at the commitment level indicated on the Notice of Award. Ruth L. Kirschstein National Research Service Awards (NRSA): NIH will increase NRSA stipends by approximately two percent for predocs and two percent for postdocs. The full range of stipend adjustments for FY 2022 is described in NIH Guide Notice NOT-OD-22-108. Salary Limits: The salary limitation for Executive Level II is $203,700. For additional guidance and details, see N...
Source: NIH Extramural Nexus - April 15, 2022 Category: Research Authors: NIH Staff Tags: Top Stories fiscal policies fy 2022 Source Type: funding

NIH All About Grants Podcast Mini-Series: Inclusion Plans – From Application to Post-Award
Dawn Corbett, M.P.H., NIH’s Inclusion Policy Officer Inclusion plans. You have questions. We have answers. What exactly are they? How do they relate to NIH’s policies requiring specific populations be included in NIH-supported clinical research? What do they mean for your application? And, what is an inclusion table anyway? In Part 1 of this NIH All About Grants podcast miniseries, NIH’s Inclusion Policy Officer Dawn Corbett tells us how to consider inclusion plans when putting together your application (MP3 / Transcript). “The good news is there’s no page limit. So you can take the space that you nee...
Source: NIH Extramural Nexus - April 15, 2022 Category: Research Authors: NIH Staff Tags: New Resources application Compliance Inclusion inclusion across the lifespan inclusion of women and minorities Peer review podcast Source Type: funding

FY 2021 Data on Age at Enrollment in Clinical Research Now Available by RCDC Category
We are pleased to announce that for the first time, data are now available on the age of participants in NIH-supported clinical research. The newly available information on age adds to already reported data on participant sex or gender, race, and ethnicity. The NIH Inclusion Across the Lifespan (IAL) policy, implemented in response to the 21st Century Cures Act, requires individuals of all ages (including children and older adults) be included in our supported clinical research absent compelling scientific or ethical reasons. Recipients whose projects fall under the policy have been submitting anonymized individual-level d...
Source: NIH Extramural Nexus - April 11, 2022 Category: Research Authors: Mike Lauer Tags: blog Open Mike Inclusion inclusion across the lifespan RCDC Source Type: funding

Another Look at Applications Submitted During the Pandemic: Part 4
In posts from October 2021, June 2021,and July 2020, we looked at the distributions of gender, race, and ethnicity of designated principal investigators (PI’s) of R01 and RPG applications submitted before and after the onset of the COVID-19 pandemic. Since that time, we have paid close attention to the well-being of the extramural biomedical research workforce, in part through our survey of institutional leaders and scientists. Others have followed preprint postings, manuscript submissions, and publications, finding evidence of disproportionate effects. Here we add to these earlier analyses and look at NIH R01 and RPG ap...
Source: NIH Extramural Nexus - April 8, 2022 Category: Research Authors: Mike Lauer Tags: blog Open Mike applications COVID R01 RPG Source Type: funding

Introducing NIH ’s New Scientific Data Sharing Website
I am very pleased to announce the availability of a new website on Scientific Data Sharing. Whether you are involved in an NIH-funded project and want to understand which sharing policies apply to your research and how to comply, or you are a researcher looking to access scientific data from NIH-affiliated repositories, this site is for you. NIH has a long-standing commitment to making the research it funds available to the public. This commitment is demonstrated through a variety of sharing policies that function to increase the transparency and availability of scientific data and resources.  NIH policies expect: The ap...
Source: NIH Extramural Nexus - April 5, 2022 Category: Research Authors: Mike Lauer Tags: blog Open Mike Data sharing genomic data sharing Resources Source Type: funding

Changes to the Federal Financial Report (FFR) Beginning April 1, 2022 Reduce Recipient Reporting Burden
Effective April 1, 2022, NIH and AHRQ grant recipients will no longer complete the cash transaction section (lines 10a through 10c) of the SF-425 Federal Financial Report (FFR) in the HHS Payment Management System (PMS). Instead, PMS will pre-populate the cash transaction section (lines 10a through 10c) of the FFR using recipient real-time cash expenses information from PMS, and adjust recipient-reported disbursements to equal cash advance drawdowns on all non-closed sub-accounts (PMS type P). This change simplifies the FFR reconciliation process, reduces recipient reporting burden, and supports efficient grants closeout....
Source: NIH Extramural Nexus - April 5, 2022 Category: Research Authors: NIH Staff Tags: Top Stories FFR Source Type: funding

Top 10 Problems Reviewers Cite in Applications
As you prepare your grant application, avoid these common pitfalls! Here is a list of the most frequent problems reviewers in the NIH Center for Scientific Review (CSR) cite when they critique grant applications: Lack of new or original ideas Absence of an acceptable scientific rationale Lack of experience in the essential methodology Questionable reasoning in experimental approach Uncritical approach Diffuse, superficial, or unfocused research plan Lack of sufficient experimental detail Lack of knowledge of published relevant work Unrealistically large amount of work proposed Uncertainty concerning future directions Fin...
Source: NIH Extramural Nexus - April 1, 2022 Category: Research Authors: NIH Staff Tags: Tips Before You Submit application submission peer reviewer Source Type: funding

All About Grants Podcast: Safety Plans for Conference Applications
Paula Goodwin, Ph.D., Program Administration Officer, NIH Liza Q. Bundesen, Ph.D. Senior Advisor to the NIH Deputy Director for Extramural ResearchOffice of Extramural Research As of April 12, 2022, applicants seeking support for their scientific conference are required to submit a plan that promotes a Safe and respectful Environment as part of Just-In-Time materials should the application be recommended for funding (NOT-OD-22-074). The safety plans build on our efforts promoting culture change in biomedical research, with a focus on supporting inclusive and diverse conferences that are free from harassment and discrimina...
Source: NIH Extramural Nexus - March 31, 2022 Category: Research Authors: NIH Staff Tags: New Resources anti-sexual harassment conference podcast R13 U13 Source Type: funding

iEdison, the Invention Reporting System, Transitioning to NIST This Summer
The management of iEdison, the system used to report inventions, patents and utilization data resulting from federally funded research grants and contracts, is moving from NIH eRA to the National Institute of Standards & Technology (NIST) (see NIH Guide Notice OD-NOT-22-100). iEdison has been developed and managed by NIH eRA since 1995. NIST expects to launch the new system in summer 2022. The new iEdison system at NIST will be a modern, user-friendly platform that aligns with all regulatory requirements and will have many new features, including the ability to initiate discussions with the agency staff within an inven...
Source: NIH Extramural Nexus - March 30, 2022 Category: Research Authors: NIH Staff Tags: Top Stories eRA Source Type: funding