NIH Natural Disaster Policy Reminder:  Mississippi Severe Storms, Winds, and Tornadoes
NIH is deeply concerned for the health and safety of people and animals, and about the biomedical enterprise in the areas in Mississippi affected by these natural disasters. Due to the exceptional impact of these storms, NIH wants to assure our recipient community that we will be doing our part to help the extramural community continue its research. NIH has issued a notice  identifying policy exceptions for impacted organizations to relieve short-term administrative, financial management, and audit requirements.   Our website on  Extramural Response to Natural Disasters  has a list of available...
Source: NIH Extramural Nexus - April 28, 2023 Category: Research Authors: NIH Staff Tags: Top Stories natural disaster Source Type: funding

Animal Welfare Webinar: Foundations for Evaluating Study Design and Statistical Approaches for the IACUC
Do you want more tools to understand good experimental design when reviewing animal use protocols? Watch this informative webinar hosted by the NIH Office of Laboratory Animal Welfare on approaches for the Institutional Animal Care and Use Committee (IACUC) to effectively evaluate study design, animal numbers, and statistical descriptions in animal protocols. By focusing on concepts rather than mathematical equations, this webinar is for all IACUC members regardless of scientific or statistical background.   (Source: NIH Extramural Nexus)
Source: NIH Extramural Nexus - April 28, 2023 Category: Research Authors: NIH Staff Tags: New Resources Animal Welfare Source Type: funding

Update on Improving Fellowship Review: A Request for Information
This blog has been co-authored with Noni Byrnes, Director, Center for Scientific Review, NIH. Originally posted on the Review Matters blog. Mike Lauer, Deputy Director for Extramural Research, NIH Noni Byrnes, Ph.D., Director of NIH Center for Scientific Review NIH is recommending changes to the peer review of Ruth L. Kirschstein National Research Service Award (NRSA) fellowship applications by restructuring the review criteria and modifying some sections of the PHS Fellowship Supplemental Form that are specific to NRSAs. The goal of this effort is to facilitate the mission of NRSA fellowship peer review – to iden...
Source: NIH Extramural Nexus - April 25, 2023 Category: Research Authors: Mike Lauer Tags: blog Open Mike fellowship NRSA request for information Request For Information (RFI) Review Source Type: funding

Navigating the NIH
Guest post by Chuck Dunn, Associate Director, Office of Communications and Outreach, NIH Center for Scientific Review, and Lamont Williams, Associate Director, Office of Communications and Outreach, NIH Center for Scientific Review. Originally posted on the Review Matters blog. Lamont Williams, Associate Director, Office of Communications and Outreach Chuck Dunn, Associate Director, Office of Communications and Outreach NIH has a vested interest in receiving proposals from a wide range of investigators, from a wide range of applicant institutions. However, data on funding of research project grants (RPGs) and a rece...
Source: NIH Extramural Nexus - April 20, 2023 Category: Research Authors: NIH Staff Tags: blog Open Mike applications Resources submission policy Source Type: funding

How Many Researchers: The FY 2022 Cumulative Investigator Rate  
We are pleased to share our annual snapshot of how many researchers NIH supports. These fiscal year (FY) 2022 data are also available in the NIH Data Book (see report #303) and represent awards made with traditional and supplemental coronavirus appropriations. Please keep in mind that these data are distinct from success rates, however, which are application-based metrics (see this post). Our cumulative investigator rate is an NIH-wide person-based metric. The metric is calculated as the number of unique principal investigators who were designated on an NIH research project grant (RPG), activity or mechanism, divided by...
Source: NIH Extramural Nexus - April 18, 2023 Category: Research Authors: Mike Lauer Tags: blog Open Mike cumulative investigator rate Funding data funding rate Source Type: funding

Spring Into Action: How to Find Help at NIH
Have questions about funding opportunities, developing an application, or managing a grant award? Unsure who to contact for help? Don’t be scared to reach out to NIH staff – it’s literally our job! You may be able to find answers to your questions through your institutional contacts or our online resources (Grants & Funding, Policy & Compliance, How to Apply, FAQs). If you’ve checked these sources and still need help, our Need Help page is a great place to start finding contacts for NIH grants administration questions. If you want a refresher on the ins and outs of what to do when seeking assistance from...
Source: NIH Extramural Nexus - April 11, 2023 Category: Research Authors: NIH Staff Tags: Tips Before You Submit applications General Grants policy Resources Source Type: funding

Revised Post-Submission Material Policy
With the expiration of the Public Health Emergency on May 11 comes the end of the special exception that allowed applicants to submit a one-page update of preliminary data as post-submission materials. However, going forward, NIH is revising our standard post-submission material policy to allow a one-page update with preliminary data to be submitted as post-submission material for Type 1 R01, R21, or R03 applications, including resubmissions, as long as the funding opportunity used for submission allows preliminary data in the application. For applications submitted for the May 25, 2023 receipt date and beyond, the special...
Source: NIH Extramural Nexus - April 5, 2023 Category: Research Authors: NIH Staff Tags: Top Stories COVID-19 post-submission materials Source Type: funding

Revised Post-Submission Materials Policy
With the expiration of the Public Health Emergency on May 11 comes the end of the special exception that allowed applicants to submit a one-page update of preliminary data as post-submission materials. However, going forward, NIH is revising our standard post-submission material policy to allow a one-page update with preliminary data to be submitted as post-submission material for Type 1 R01, R21, or R03 applications, including resubmissions, as long as the funding opportunity used for submission allows preliminary data in the application. For applications submitted for the May 25, 2023 receipt date and beyond, the special...
Source: NIH Extramural Nexus - April 5, 2023 Category: Research Authors: NIH Staff Tags: Top Stories COVID-19 post-submission materials Source Type: funding

New FY 2022 Categorical Spending Data Are Now Available
NIH recently updated its annual categorical information with fiscal year (FY) 2022 actual spending data and estimates for FY 2023 and 2024. Available on the Research, Condition, and Disease Categorization (RCDC) page, you will find the annual support level for various research, condition, and disease categories. The data are based on grants, contracts, and other funding mechanisms used across NIH. There were 215 public categories when RCDC information began being reported in 2008. Now in our fifteenth year, there are a total of 315 categories. The following new categories were added in FY 2022: Cocaine PASC (Post-Acute Se...
Source: NIH Extramural Nexus - April 4, 2023 Category: Research Authors: NIH Staff Tags: New Resources NIH budget RCDC Source Type: funding

ClinicalTrials.gov is Modernizing to Serve You Better
Anna M. Fine, PharmD, MS, Acting Director, ClinicalTrials.gov Guest post by Anna M. Fine, PharmD, MS, Acting Director of ClinicalTrials.gov at the National Library of Medicine (NLM), National Institutes of Health. Originally posted on the Musings from the Mezzanine blog.  ClinicalTrials.gov is the world’s largest database of privately and publicly funded clinical trials. It provides easy access to clinical trial information for millions of users every month—from patients and their advocates to data submitters, data researchers, and the broader public. NLM is in the midst of a multi-year effort to modernize ClinicalTr...
Source: NIH Extramural Nexus - March 31, 2023 Category: Research Authors: Anna Fine Tags: blog Open Mike Clinical Trials Clinicaltrials.gov human subjects Source Type: funding

NIH All About Grants Podcast – Discussing Not Discussed
Gene Carstea, Ph.D., Respiratory, Cardiac, and Circulatory Sciences Review Branch Chief, Center for Scientific Review, NIH Your application was “not discussed.” What does this actually mean? What should you do next? We are discussing “Not Discussed” in this NIH All About Grants podcast episode (Audio/Transcript). Dr. Gene Carstea, a Review Branch Chief at the Center for Scientific Review, will share insights on the NIH peer review process, how many applications are not discussed, reasons why, who to contact, appealing a not discussed decision, and much more. “…If your application is not discussed, it do...
Source: NIH Extramural Nexus - March 29, 2023 Category: Research Authors: NIH Staff Tags: New Resources applications Peer review podcast Source Type: funding

NIH Clinical Trials Reporting Compliance: A Shared Commitment
As the largest public funder of clinical trials in the United States, NIH is committed to the timely dissemination of clinical trial results information so that the benefits of the trial data can be realized. In support of this goal, in September 2016, NIH issued the NIH Policy on Dissemination of NIH-Funded Clinical Trial Information to establish our expectation that summary results of NIH-supported clinical trials be submitted to ClinicalTrials.gov for posting within 365 days of the actual primary completion date. This policy is complementary to a 2016 updated HHS regulation aimed at further increasing the availability o...
Source: NIH Extramural Nexus - March 24, 2023 Category: Research Authors: Mike Lauer Tags: blog Open Mike Clinical Trials Clinicaltrials.gov human subjects Source Type: funding

Trends in Extramural Research Integrity Allegations Received at NIH
At the start of the year, we briefly touched on our efforts to address research integrity violations in our 2022 Year In Review. Today we are sharing some more information on the overall trends in research integrity allegations associated with the NIH grants process. I want to note that while we are sharing these aggregate data, NIH does not discuss grants compliance reviews on specific funded awards, recipient institutions, or supported investigators, and whether such reviews occurred or are underway. Table 1 shows the total number of new research integrity allegation types that NIH received between calendar years (CYs) 2...
Source: NIH Extramural Nexus - March 22, 2023 Category: Research Authors: Mike Lauer Tags: blog Open Mike Peer review Research integrity Source Type: funding

NIH All About Grants Podcast – Using Review Critiques and Program Input on Applications
Brian Hoshaw, Ph.D., Chief, Scientific Review Branch, NEI Tracy Rankin, Ph.D., M.P.H., Deputy Director for Clinical Sciences, NIDDK In this NIH All About Grants podcast episode, we share advice for investigators to help them understand the critiques of their application, and how program staff input may be helpful when deciding what to do next (Audio/Transcript). Drs. Brian Hoshaw, Review Chief at the National Eye Institute, and Tracy Rankin, a Deputy Director with the National Institute of Diabetes and Digestive and Kidney Diseases, explain what you can expect to see on a summary statement, roles for NIH review and program...
Source: NIH Extramural Nexus - March 21, 2023 Category: Research Authors: NIH Staff Tags: New Resources applications podcast resubmissions Review Summary Statements Source Type: funding

Data Management and Sharing Plan vs. Resource Sharing Plan
The Data Management and Sharing (DMS) Plan and Resource Sharing Plan are separate attachments that may be required for your application. One does not necessarily replace the other. NIH has a number of sharing policies. The Data Management and Sharing and Genomic Data Sharing Policies have been hot topics of late, but there are also Model Organism Sharing, Research Tool, and other policies that may also apply. See Which Policies Apply to My Research? Data Management and Sharing Plan Required for all applications submitted to funding opportunities subject to the NIH Data Management and Sharing Policy Use new “Other Plan(...
Source: NIH Extramural Nexus - March 20, 2023 Category: Research Authors: NIH Staff Tags: Tips Before You Submit application policy data management Data sharing Source Type: funding