Learning More About NIH Research Directions and How You Can Provide Input: Highlighting Autoimmune Disease Research
Regular readers of this blog know that we often seek feedback on various grant policies and initiatives broadly effecting the extramural research community. As just a few examples from last year, we sought input on research misconduct regulations, care and use of laboratory cephalopods, foreign subaward agreements, postdoctoral training, and review of fellowship applications. There are also opportunities to weigh in on future directions for the many different disease-specific research areas NIH supports, which we typically do not discuss on this blog. Here, we wanted to briefly share some resources about these comment oppo...
Source: NIH Extramural Nexus - January 16, 2024 Category: Research Authors: Mike Lauer Tags: blog Open Mike RePORT Request For Information (RFI) strategic plan Source Type: funding

2023: A Year in Review  
2023, what a year! We started it off with implementing the NIH Data Management and Sharing policy, a policy that reflected many thoughtful discussions with researchers, professional societies, and NIH staff over the last several years. The year was capped off with Dr. Monica Bertagnolli beginning her tenure as the next NIH Director. We look forward to supporting her vision for NIH. Between those milestones, we announced that a simplified review framework for research project grants will take effect next January. We continued our focus on the future workforce, including those that support early-stage investigators, launc...
Source: NIH Extramural Nexus - January 16, 2024 Category: Research Authors: Mike Lauer Tags: blog Open Mike Administrative Burden Research integrity workforce Source Type: funding

You are Invited to Participate in a Pilot of Data Management and Sharing Plan Templates
The Federal Demonstration Partnership (FDP) is an association of federal agencies, research policy organizations and academic research institutions with the mission of streamlining the administration of federally sponsored research and create resources that are available to the research enterprise. We have work closely with them over the years on various activities, including efforts to implement our Data Management and Sharing (DMS) Policy that went into effect in January. Since March, we have engaged with FDP to pilot test two DMS plan templates. These templates were developed in close collaboration with staff and leader...
Source: NIH Extramural Nexus - November 30, 2023 Category: Research Authors: Mike Lauer Tags: blog Open Mike Administrative Burden applications data management Data sharing FDP Source Type: funding

Case Study in Research Integrity: This Application Feels Familiar
Imagine you are reviewing an application for an NIH study section meeting, and you come across an application that seems just a bit too familiar. The scientific question falls within your wheelhouse. The methods and strategies seem spot on. And isn’t that how you format your text? In this case study, we will discuss how plagiarism in the grant application process is handled at NIH and remind the research community about the importance of maintaining confidentiality of the peer review process. The scenario presented is based on real-world events, with all names and identifiers removed or changed. Dr. ABC found themselv...
Source: NIH Extramural Nexus - November 21, 2023 Category: Research Authors: Mike Lauer Tags: blog Open Mike case study Confidentiality Peer review research misconduct Source Type: funding

Reviewers, Some Handy Resources to Help With Required Training
Most reviewers participating in review meetings in early 2024 are required to complete 2 training modules before they can access their assigned applications in the Internet Assisted Review (IAR) module. The training, to be taken once every 3 years, is designed to raise awareness of bias in review and actions that breach the integrity of peer review (See NIH Guide Notice NOT-OD-23-156 and Open Mike blog). Two resources are available to help reviewers: An eRA webpage: Take Required Review Integrity & Bias Awareness Training An updated eRA video tutorial: For Reviewers: You Received an IAR Invitation. Now What? ...
Source: NIH Extramural Nexus - November 3, 2023 Category: Research Authors: NIH Staff Tags: New Resources eRA Peer review Source Type: funding

Opportunity for Outstanding DEIA Mentors to Apply for Supplemental Funding
Guest blog by Dr. Marie Bernard, Chief Officer for Scientific Workforce Diversity, NIH. Originally posted on the Chief Officer for Scientific Workforce Diversity blog. Marie A. Bernard, M.D. NIH Office of the Director/Chief Officer for Scientific Workforce Diversity I am pleased to announce the availability of administrative supplements that recognize the essential role of effective mentorship in developing future researchers and building a diverse scientific workforce. Through the reissue of a Notice of Special Interest (NOSI) led by the Chief Officer for Scientific Workforce Diversity (COSWD) office, NIH ...
Source: NIH Extramural Nexus - November 1, 2023 Category: Research Authors: NIH Staff Tags: blog Open Mike Biomedical Workforce Source Type: funding

Trends in NIH-Supported Basic, Translational, and Clinical Research: FYs 2009-2022
I often hear concerns raised that NIH does not fund enough basic research, or enough applied research for that matter. Basically, the concerns center around what is the correct balance. It is an important point to consider, as a better understanding of these wider research areas can shed light on NIH’s approach to higher-level priority setting and funding decisions. To get at this question, we leveraged the Research, Condition, and Disease Classification (RCDC) system and looked at trends in NIH funding of these areas between fiscal years (FYs) 2009 and 2022. For the purpose of this analysis, we used projects reported...
Source: NIH Extramural Nexus - October 31, 2023 Category: Research Authors: Mike Lauer Tags: blog Open Mike basic research clinical research Funding data RCDC Source Type: funding

Your Feedback Sought on Proposed Updates to Research Misconduct Regulations
For the first time in nearly two decades, the regulations and policies governing how we address research misconduct associated with NIH (and other Public Health Service) funding are being updated. We are sharing this announcement on behalf of our colleagues with the HHS Office of Research Integrity (ORI) to ensure we continue maintaining and promoting research integrity of NIH-supported research. The notable changes center around clarifying definitions, explaining procedures for handling allegations, imposing administrative compliance actions, and the appeals process. These steps build upon the existing regulations whil...
Source: NIH Extramural Nexus - October 24, 2023 Category: Research Authors: Mike Lauer Tags: blog Open Mike Request For Information (RFI) Research integrity research misconduct Source Type: funding

Announcing a Simplified Review Framework for NIH Research Project Grant Applications
This blog has been co-authored with Noni Byrnes, Director, Center for Scientific Review, NIH. Cross-posted on the Review Matters blog. Noni Byrnes, Ph.D., Director of NIH Center for Scientific Review Mike Lauer, M.D., Deputy Director for Extramural Research, NIH As we have discussed in previous blogs, NIH has heard concerns from the extramural community about the complexity of the peer review process for research project grants (RPGs) and the increasing responsibilities of peer reviewers in policy compliance. NIH has also heard concerns about the potential for reputational bias to affect peer review outcomes. A...
Source: NIH Extramural Nexus - October 19, 2023 Category: Research Authors: Mike Lauer Tags: blog Open Mike Peer review RPG Source Type: funding

Update on Improving NRSA Fellowship Review: Analysis of Comments from the Request for Information
Noni Byrnes, Ph.D., Director of NIH Center for Scientific Review Mike Lauer, M.D., Deputy Director for Extramural Research, NIH As outlined in “Update on Improving Fellowship Review: A Request for Information (RFI),” NIH issued an RFI—from April 17 through June 23, 2023—seeking input on the proposed 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 RFI was published as a Guide Notice, in the Feder...
Source: NIH Extramural Nexus - October 12, 2023 Category: Research Authors: Mike Lauer Tags: blog Open Mike Source Type: funding

Webinar Available to Help Improve Animal Experimental Design
The NIH office of Laboratory Animal Welfare (OLAW) released a webinar recording on how the NC3Rs Experimental Design Assistant (EDA) can assist researchers plan for their studies involving animals. This resource builds on our related efforts to strengthen the rigor, reproducibility, and translatability of NIH-supported animal research (see this NIH Open Mike blog for more). This free online tool helps users build a diagram representing an experimental plan, provides customized feedback, and can make suggestions on statistical methods, randomization, blinding, sample sizes, and other critical design aspects. Dr. Esther P...
Source: NIH Extramural Nexus - October 11, 2023 Category: Research Authors: NIH Staff Tags: New Resources Animal Welfare rigor Source Type: funding

Reminders About When to Cite an NIH Grant in a Paper: Overcite Oversight
In 2021, we wrote that appropriately acknowledging NIH grant support allows us to properly assess award outputs and make recommendations for future research directions. This is a term and condition of award under long-standing federal law. Our Grants and Funding site provides guidance: grants should only be cited if they directly supported the work described in the paper and work described in the paper is clearly within scope of the grant award. We still see examples, though, of researchers improperly overciting grants that are unrelated with the research, be it an honest error or intentional. This post revisits the issue ...
Source: NIH Extramural Nexus - October 5, 2023 Category: Research Authors: Mike Lauer Tags: blog Open Mike Compliance Oversight publications Source Type: funding

Rethinking Population Descriptors in Genetics and Genomics Studies
Guest blog by Vence L. Bonham, Jr., J.D., Acting Deputy Director, National Human Genome Research Institute and Sheri Schully, Ph.D., Deputy Chief Medical and Scientific Officer, All of Us Research Program Sheri Schully, Ph.D., Deputy Chief Medical and Scientific Officer, All of Us Research Program Vence L. Bonham, Jr., J.D., Acting Deputy Director, National Human Genome Research Institute For decades, socially constructed population descriptors such as race, ethnicity, and ancestry have been used as a proxy to describe human diversity but do not accurately capture the full scientific scope of diversity, and their de...
Source: NIH Extramural Nexus - September 28, 2023 Category: Research Authors: NIH Staff Tags: blog Open Mike Diversity genomic data sharing Inclusion Research integrity Source Type: funding

All About NIH Subaward Agreements: Webinar on Oct. 17  
Whether you are a principal investigator considering a subaward arrangement with either a domestic or foreign institution, or a research administrator eager to deepen your understanding of the prerequisites and regulations governing compliant subaward agreements, mark your calendar for October 17 and virtually accompany us as we provide invaluable insights during an engaging  event.  NIH Subaward Requirements: Domestic and Foreign  Date:  October 17, 2023  Time: 1:00 – 2:00 PM (Eastern Time Zone)  Join experts from the NIH Office of Policy for Extramural Research Administration (OPERA)...
Source: NIH Extramural Nexus - September 26, 2023 Category: Research Authors: NIH Staff Tags: Calendar Top Stories Grants policy Source Type: funding

Feedback Sought on Cephalopod Care and Use
Cephalopods are aquatic invertebrate animals that include octopuses, squid, cuttlefish, and nautiluses. Earlier this month, we released a Request for Information (NOT-OD-23-176) seeking public input on the humane care and use of laboratory cephalopods at Assured institutions.   The proposed guidance acknowledges the evidence suggesting these animals would benefit from oversight, but also that there are not yet specific care and use standards to allow them to be regulated under the Public Health Service Policy for the Humane Care and Use of Laboratory Animals (PHS Policy). Instead, the U.S. Government Principles p...
Source: NIH Extramural Nexus - September 20, 2023 Category: Research Authors: Mike Lauer Tags: blog Open Mike Animal Welfare Request For Information (RFI) rigor Source Type: funding