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
Learn About NIH ’s Diversity, Equity, Inclusion, and Accessibility Strategic Plan for FY 2023 to 2027
We are pleased to announce that NIH recently released its Fiscal Years 2023-2027 NIH-Wide Strategic Plan for Diversity, Equity, Inclusion, and Accessibility (DEIA). We invite the research community to learn more about our efforts. You are encouraged to apply any of them to advance your organization’s DEIA goals too.
The plan articulates NIH’s overarching vision for embracing, strengthening, and integrating DEIA into our various activities. It aligns with the current NIH-Wide Strategic Plan and White House Executive Orders. The framework is organized around NIH’s accomplishments, needs, opportunities, and challenges i...
Source: NIH Extramural Nexus - March 20, 2023 Category: Research Authors: Mike Lauer Tags: blog Open Mike Diversity diversity equity inclusion and accessibility scientific workforce diversity strategic plan Source Type: funding
Revamped xTrain Module in eRA Commons Coming March 30
Good news for trainees and principal investigators who work on training grants! eRA is readying a redesigned xTrain module, scheduled to be rolled out on March 30. xTrain is used by program directors/principal investigators (PD/PIs), university administrators, and trainees to electronically prepare and submit PHS 2271 Statement of Appointment Forms and PHS 416-7 Termination Notices for institutional research training grants, institutional career development awards, individual fellowships, and research education awards.
eRA collaborated closely with an external user group on the xTrain redesign. The new xTrain is more task-...
Source: NIH Extramural Nexus - March 20, 2023 Category: Research Authors: NIH Staff Tags: New Resources eRA eRA Commons xTrain Source Type: funding
Learn About NIH ’s Diversity, Equity, Inclusion, and Accessibility Strategic Plan for FY 2023 to 2027
We are pleased to announce that NIH recently released its Fiscal Years 2023-2027 NIH-Wide Strategic Plan for Diversity, Equity, Inclusion, and Accessibility (DEIA). We invite the research community to learn more about our efforts. You are encouraged to apply any of them to advance your organization’s DEIA goals too.
The plan articulates NIH’s overarching vision for embracing, strengthening, and integrating DEIA into our various activities. It aligns with the current NIH-Wide Strategic Plan and White House Executive Orders. The framework is organized around NIH’s accomplishments, needs, opportunities, and challenges i...
Source: NIH Extramural Nexus - March 17, 2023 Category: Research Authors: Mike Lauer Tags: blog Open Mike Diversity diversity equity inclusion and accessibility scientific workforce diversity strategic plan Source Type: funding
Preparing a Small Business Application Involving Vertebrate Animals
Are you an NIH small business (SBIR/STTR) applicant whose research involves the use of live vertebrate animals? If so, access these resources from the recent Preparing a Small Business Application Involving Vertebrate Animals webinar to learn how to complete your grant application or contract proposal.
This presentation from the Office of Laboratory Animal Welfare assists small business applicants with understanding requirements and applicable regulations and how to avoid potential pitfalls during the application and award process.
Watch the webinar recording.
Access the transcript.
Access the slide deck.
Access the he...
Source: NIH Extramural Nexus - March 16, 2023 Category: Research Authors: NIH Staff Tags: New Resources small business Source Type: funding
The ABCs of Authentication Plans
Are you proposing to use key biological and/or chemical resources like cell lines, specialty chemicals, antibodies, or other biologics in your application? The quality of resources used to conduct research is critical to the ability to reproduce the results, so to address scientific rigor in your NIH application, we ask you to include an authentication plan.
Not sure where to begin? Learn more about authentication plans:
What are “key biological and/or chemical resources”?
How should authentication of key biological and/or chemical resources be addressed in grant applications?
Example Authentication Plans (Sou...
Source: NIH Extramural Nexus - March 16, 2023 Category: Research Authors: NIH Staff Tags: Tips Before You Submit authentication rigor Source Type: funding
Mentored Career Development Application (K) Funding Rates by Race-Ethnicity FY 2010-FY 2022
Marie A. Bernard, M.D., Chief Officer forScientific Workforce Diversity
In this post, we analyze funding rates for Fiscal Year (FY) 2010 to FY 2022 mentored career development award (K) applicants according to the race-ethnicity of designated Principal Investigators (PIs). Receipt of a career development award often presages R01 receipt. We used data from frozen, official, NIH success rate files. We focus on applicants for K01, K08, K23, K25,and K99 direct budget authority awards.
We obtained data on the race and ethnicity of PIs from their entries into the eRA Commons Personal Profile. As noted by NIH, PIs provide these d...
Source: NIH Extramural Nexus - March 16, 2023 Category: Research Authors: Mike Lauer Tags: blog Open Mike Diversity Funding data scientific workforce diversity Source Type: funding
Analyses of Demographic-Specific Funding Rates for Type 1 Research Project Grant and R01-Equivalent Applications
Marie A. Bernard, M.D., Chief Officer forScientific Workforce Diversity
In this post, we analyze funding rates for Fiscal Year (FY) 2010 to FY 2022 Type 1 Research Project Grant (RPG) and Type 1 R01-Equivalent applicants according to the race-ethnicity of designated Principal Investigators (PIs). We used data from frozen, official, NIH success rate files.
We obtained data on the race and ethnicity of PIs from their entries into the eRA Commons Personal Profile. As noted by NIH, PIs provide these data on a strictly voluntary basis, and these data are not used for making funding decisions. If individuals described themselves...
Source: NIH Extramural Nexus - March 16, 2023 Category: Research Authors: Mike Lauer Tags: blog Open Mike Diversity Funding data scientific workforce diversity Source Type: funding
New Resources Available on Protecting Participant Privacy When Sharing Scientific Data
An important part of sharing scientific data is protecting the privacy of human participants who contributed to the data.
NIH’s scientific data sharing site now offers information and resources on the following topics:
Principles and Best Practices for Protecting Participant Privacy
Designating Scientific Data for Controlled Access
Considerations for Obtaining Informed Consent
Considerations for Researchers Working with American Indian/Alaska Native (AI/AN) Communities
For further information on working with human participants in research, please visit NIH’s Human Subjects Research page. (Source: NIH Extramural Nexus)
Source: NIH Extramural Nexus - March 13, 2023 Category: Research Authors: NIH Staff Tags: New Resources Data sharing human subjects Source Type: funding
Referring Study Sections Is a Work of “ART” (Assisted Referral Tool)
Did you know there’s a tool to help you find relevant study sections for your grant application? The Assisted Referral Tool (ART) was developed by the NIH Center for Scientific Review (CSR) to recommend potentially appropriate study sections using text from your application. Using these recommendations, you then have the opportunity to suggest the study section for the first level of scientific review of your application in the PHS Assignment Request form. In his blog post titled “Encouraging Use of the PHS Assignment Request Form in Applications,” the NIH Office of Extramural Research Director Dr. Mike Lauer discus...
Source: NIH Extramural Nexus - March 3, 2023 Category: Research Authors: NIH Staff Tags: Tips Before You Submit application forms Peer review Source Type: funding
