Prepare a Proposal

NIH has issued the Data Management and Sharing (DMS) policy (effective January 25, 2023) to promote the sharing of scientific data. Under the DMS policy, NIH expects that investigators and institutions:

• Plan and budget for the managing and sharing of data
• Submit a DMS plan for review when applying for funding
• Comply with the approved DMS plan

More information on creating a DMS Plan, budgeting for data management, and resources related to the new policy are available here.

https://nexus.od.nih.gov/all NIH Extramural Nexus Wed, 02 Nov 2022 16:02:42 +0000 en-US hourly 1 https://wordpress.org/?v=6.0.3 112833137 https://nexus.od.nih.gov/all/2022/11/02/if-you-see-something-amiss-say-something/ https://nexus.od.nih.gov/all/2022/11/02/if-you-see-something-amiss-say-something/#respond Wed, 02 Nov 2022 16:02:42 +0000 https://nexus.od.nih.gov/all/?p=23722 If you ever come across misconduct, whether it be harassment, fraud, grant scams, research misconduct, peer review violations, or foreign interference, please report it.

 

You can find the appropriate contacts for various types of concerns on our new Report a Concern page. (Or just click on this button located on various pages of the NIH Grants and Funding website.)

If you’re looking for other contacts at NIH, check out the Need Help page.

https://nexus.od.nih.gov/all/2022/11/02/if-you-see-something-amiss-say-something/feed/ 0 23722 https://nexus.od.nih.gov/all/2022/10/31/forms-h-instructions-forms-and-a-handy-checklist/ https://nexus.od.nih.gov/all/2022/10/31/forms-h-instructions-forms-and-a-handy-checklist/#respond Mon, 31 Oct 2022 18:15:28 +0000 https://nexus.od.nih.gov/all/?p=23718 Hopefully, you’ve seen our notices (NOT-OD-22-195, NOT-OD-23-012), tweets, and previous Nexus posts (FORMS-H Coming for January 2023 Due Dates, Gearing Up for Transition to FORMS-H Application Forms, data sharing posts, genomic data sharing posts) regarding our pending transition to an updated set of grant application forms we refer to as FORMS-H and the implementation of new Data Management and Sharing (DMS) requirements. If so, you already know that you must use FORMS-H forms for grant application due dates on or after January 25, 2023 and that our forms and instructions have been updated to support the new sharing requirements.

The FORMS-H application instructions are posted, FORMS-H application packages are starting to show up on active opportunities, and it’s time to get to work on your applications.

This checklist will help you navigate the changes.

FORMS-H Checklist

• Use an application form package with a Competition ID that includes “FORMS-H”.
  • Not sure how to identify the correct form version? See Do I Have the Right Forms for My Application?
  • If you find you have started your application on the wrong form set, take advantage of copy features available in ASSIST, Grants.gov Workspace, and many institution system-to-system solutions.

• Use the SF424 (R&R) – Version H application form instructions on the How to Apply – Application Guide page.
  • Read the Significant Changes section to become familiar with recent updates.

• Determine if your proposed research is subject to the DMS policy.
  • The policy applies to all research that generates scientific data (e.g., single and multi-project research projects and centers), but not to some other activities (e.g., training, fellowship, construction, conference grants, resources).

• Identify appropriate methods/approaches and repositories for managing and sharing scientific data.

• Develop a Plan for managing and sharing scientific data and submit this Plan within the funding application or proposal.
  • Submit a single Plan per application using the new “Other Plan(s)” item on the PHS 398 Research Plan or PHS 398 Career Development Award Supplemental form. For applications also subject to the Genomic Data Sharing (GDS) Policy, address genomic data sharing considerations in your DMS Plan.
    • Multi-project applications: include the DMS Plan in the Overall component only.

• Estimate and request funds for data management and sharing activities if not already covered by the institution or other sources.
  • Request “Data Management and Sharing costs”
    • Modular budgets: use the Additional Narrative Justification attachment of the PHS 398 Modular Budget Form.
    • Detailed budgets: include “Data Management and Sharing Costs” line item under F. Other Direct Costs “8-17 Other” on the R&R Budget Form.
    • Multi-project applications: at least one component must include a “Data Management and Sharing Costs” line item with either all DMS costs incurred, including personnel costs (e.g., personnel who will be curating data for the project) or 0 if no cost is incurred.
  • Justify DMS costs and provide a brief (half page or less) summary of the DMS Plan within section L. Budget Justification in a section titled “Data Management and Sharing Justification”.
    • Modular budgets: use the Additional Narrative Justification attachment of the PHS 398 Modular Budget Form
    • Detailed budgets: use the Budget Justification attachment of the R&R Budget Form.
    • Multi-project applications: include a justification within any component that includes the “Data Management and Sharing Costs” line item

• Upon submission check all applicable application files in eRA Commons (e-Application; Data Management and Sharing (DMS) Plan; eSubmission-PHS Assignment Request Form; cover letter)
  • Note: Unless indicated in the funding announcement, the Data Management and Sharing Plan is not evaluated at time of peer review but is evaluated prior to award. Although part of the official submission, when not considered during peer review the attachment is maintained as a separate “Data Management and Sharing (DMS) Plan” document in the grant folder viewable via the Status Information screen in eRA Commons. This document is viewable by authorized users and is not part of the assembled e-Application.

Additional Resources

• FORMS-H Forms & Instructions
  • How to Apply – Application Guide
  • Annotated Forms Sets
  • High-level Summary of Form Changes in FORMS-H Application Packages
  • Do I Have the Right Form Version For My Application?
  • Applying Electronically FAQs
• Data Sharing
  • NIH Data Sharing Website
  • Genomic Data Sharing Policy
  • Data Management and Sharing Policy
  • Writing a Data Management & Sharing Plan – Applications for Receipt Dates ON/AFTER Jan 25 2023
  • Scientific Data Sharing FAQ

https://nexus.od.nih.gov/all/2022/10/31/forms-h-instructions-forms-and-a-handy-checklist/feed/ 0 23718 https://nexus.od.nih.gov/all/2022/10/31/human-subjects-research-policies-clinical-trials-inclusion-on-december-6-7/ https://nexus.od.nih.gov/all/2022/10/31/human-subjects-research-policies-clinical-trials-inclusion-on-december-6-7/#respond Mon, 31 Oct 2022 17:00:57 +0000 https://nexus.od.nih.gov/all/?p=23715 Are you working with human subjects in your research and wondering about how HHS regulations and NIH policies apply, how to prepare a research proposal, or how to develop inclusion plans? Join experts from the NIH Division of Human Subjects Research and HHS Office of Human Research Protections (OHRP) for answers to these questions and more at the Human Subjects Research: Policies, Clinical Trials, & Inclusion event on December 6 and 7, 2022. During this 2-day virtual event, these NIH and HHS experts will share policies, resources, guidance, and case studies in this informative and engaging, live event. Check out the full agenda on this page for a detailed list of topics covered.

Registration is free and is included in your personal “All Access Pass” to the virtual NIH Grants Conference 2022-2023 season. The Conference begins with monthly PreCon Events, such as this one on International Collaborations, which are designed to dive deeper into select grant-related topics. These events culminate with the 2-day NIH Grants Conference, Feb 1-2, 2023, which includes over 25 different topics on funding, policies, and processes shared by NIH and HHS experts. You only need to register once for the NIH Grants Conference Center. Once registration is complete, just log into the site and save upcoming events to your calendar, gather resources from over 45 NIH Institute, Center, and Office booths in the virtual Exhibit Hall, and come back to visit any time during the conference season.

Be sure to view all of the upcoming pre-conference events on the NIH Grants Conference website to see what may be of interest. Next up:

• Making the Most of the 2023 Virtual NIH Grants Conference – January 12, 2023
• 2023 NIH Grants Conference – Feb. 1-2, 2023

Interested? Register today and share information about the conference events with colleagues, students, trainees, those newer to NIH grants, and others who may not normally receive these invitations. Presentation materials are provided in advance in the conference center and (just in case you missed one) recordings are posted 5-7 business days after the event. We hope to see you there! #NIHGrantsConf

https://nexus.od.nih.gov/all/2022/10/31/human-subjects-research-policies-clinical-trials-inclusion-on-december-6-7/feed/ 0 23715 https://nexus.od.nih.gov/all/2022/10/28/november-11-friday-2022-nih-closed-for-the-federal-holiday/ https://nexus.od.nih.gov/all/2022/10/28/november-11-friday-2022-nih-closed-for-the-federal-holiday/#respond Fri, 28 Oct 2022 19:09:11 +0000 https://nexus.od.nih.gov/all/?p=23713 NIH (including help desks) will be closed on Friday, November 11, 2022 for the federal holiday (Veterans Day). If a grant application due date falls on a federal holiday, the application deadline is automatically extended to the next business day.

https://nexus.od.nih.gov/all/2022/10/28/november-11-friday-2022-nih-closed-for-the-federal-holiday/feed/ 0 23713 https://nexus.od.nih.gov/all/2022/10/28/feedback-sought-on-strengthening-capacity-for-emergency-clinical-trials/ https://nexus.od.nih.gov/all/2022/10/28/feedback-sought-on-strengthening-capacity-for-emergency-clinical-trials/#respond Fri, 28 Oct 2022 13:05:24 +0000 https://nexus.od.nih.gov/all/?p=23706 The White House Office of Science and Technology Policy (OSTP) and National Security council recently released a Request for Information seeking ideas on strengthening the national capacity of clinical trial infrastructure and emergency clinical trials. An OSTP blog discusses the importance of having a robust clinical trial infrastructure prepared for an emergency as well as the importance of inclusive and well-designed studies.

Echoing the OSTP post, it is a good time to look back on our clinical trial efforts as the public health emergency moves into a new phase. What worked? What did not? How can we apply lessons learned moving forward? In my earlier reflections on whether NIH made fast and meaningful contributions to respond to the pandemic, I noted, for instance, the importance of (a) working closely with all partners to leverage existing infrastructure, (b) leveraging newly available funding to pivot rapidly in response to the pandemic, and (c) thinking about more than just awards and dollars but rather the generation meaningful results within a remarkably short time. More on our response during the pandemic may be found in these NIH Extramural Nexus posts.

What are your thoughts? Some areas OSTP is interested in include (from their post):

• What do institutions and scientists need to keep the research base warm and ready for action?
• How can we get the enterprise rowing in the same direction from day one, asking the right scientific questions, and efficiently coordinating resources?
• How do we ensure that all Americans and all communities have the opportunity to participate in high-quality, impactful clinical research studies?
• How can we make sure this is organized and governed appropriately, across public and private sectors?
• Are there opportunities to make advance agreements to streamline the research response in real time?

You are welcome to send ideas in response to the Request for Information via email to emergencyclinicaltrials@ostp.eop.gov (please include “Emergency Clinical Trials RFI” in the subject line).

https://nexus.od.nih.gov/all/2022/10/28/feedback-sought-on-strengthening-capacity-for-emergency-clinical-trials/feed/ 0 23706 https://nexus.od.nih.gov/all/2022/10/28/where-should-my-data-management-and-sharing-plan-be-included-in-my-application-for-funding/ https://nexus.od.nih.gov/all/2022/10/28/where-should-my-data-management-and-sharing-plan-be-included-in-my-application-for-funding/#respond Fri, 28 Oct 2022 12:28:28 +0000 https://nexus.od.nih.gov/all/?p=23704 For applications being developed for due dates on/after January 25, 2023, Data Management and Sharing (DMS) Plans will be collected in a NEW field called “Other Plans” on the PHS 398 Research Plan and Career Development Award forms. See Writing a DMS Plan for the details on what to include in a Plan.

Note that any costs to support data management and sharing should be accounted for in either the R&R Detailed Budget Form or the PHS 398 Modular Budget Form along with a brief justification of those costs. See Budgeting for DMS and the Application Instructions for details.

https://nexus.od.nih.gov/all/2022/10/28/where-should-my-data-management-and-sharing-plan-be-included-in-my-application-for-funding/feed/ 0 23704 https://nexus.od.nih.gov/all/2022/10/27/navigating-new-status-screens-in-era-commons/ https://nexus.od.nih.gov/all/2022/10/27/navigating-new-status-screens-in-era-commons/#comments Thu, 27 Oct 2022 21:50:20 +0000 https://nexus.od.nih.gov/all/?p=23692 Several Status screens in eRA Commons moved to a new visual appearance on October 27 [see Oct. 25 eRA News (screens for signing officials) and Oct. 3 eRA News (screens for both SOs and principal investigators)]. Note that this means that there are new ways to navigate to the information you need and new methods to quickly find what you are looking for in Status.

Here is a primer:

• Looking for action items? Click the three-dot ellipsis next to a grant number to see a drop-down menu of action items.
  

• Aiming to navigate to another module? Click the apps menu, located in the upper left of the blue header to see a dropdown of other modules you are authorized to see.
  

• Needing info quickly? Use the table filter to type a PD/PI name, a grant number, etc. and quickly locate the information.
  

The new Search screen has nine Search Type options presented in a dropdown menu instead of listing them at the left side of the screen. When an SO selects a particular search, the screen dynamically changes or redirects the SO to a new screen that reflects the search.

To help SOs become familiar with the new navigation and design, a new video, a Signing Official: Finding Information (SO Only) tutorial can be found on the eRA Videos page.

For additional details with screen shots, see Navigating and Using the User Interface in eRA Modules (or you can always view Status Module online help from within the module by clicking the question mark icon next to the screen header).

https://nexus.od.nih.gov/all/2022/10/27/navigating-new-status-screens-in-era-commons/feed/ 1 23692 https://nexus.od.nih.gov/all/2022/10/27/signing-officials-can-choose-to-bypass-2-day-viewing-window-for-administrative-supplements/ https://nexus.od.nih.gov/all/2022/10/27/signing-officials-can-choose-to-bypass-2-day-viewing-window-for-administrative-supplements/#respond Thu, 27 Oct 2022 20:43:14 +0000 https://nexus.od.nih.gov/all/?p=23695 To speed up the system processing of electronic administrative supplements, signing officials (SOs) have the option to bypass the 2-day application viewing window and allow the application to go straight to staff for processing (see NOT-OD-23-011).

The SO will use the Status module in eRA Commons to search for Recent/Pending eSubmissions, locate the administrative supplement application(s) within the 2-day window period and click the ‘Verify’ link in the Action column. Once the SO confirms the choice, the application will be immediately released for agency processing.

Note that once this bypass option is exercised, the SO cannot reject or make further changes to the application. Organizations must carefully review their applications prior to using the Verify action to avoid the need for resubmissions.

As always, applicants are encouraged to discuss administrative supplement requests with the awarding agency prior to submission.

Resources: 2-Day Window Skip topic in the eRA Commons online help; eRA News item.

https://nexus.od.nih.gov/all/2022/10/27/signing-officials-can-choose-to-bypass-2-day-viewing-window-for-administrative-supplements/feed/ 0 23695 https://nexus.od.nih.gov/all/2022/10/25/you-do-the-research-nih-repays-your-student-loans-apply-by-november-17/ https://nexus.od.nih.gov/all/2022/10/25/you-do-the-research-nih-repays-your-student-loans-apply-by-november-17/#comments Tue, 25 Oct 2022 19:33:26 +0000 https://nexus.od.nih.gov/all/?p=23688 If you’re going to be conducting research for the next two years, why not have your student debt taken care of while you work? In exchange for a commitment to conduct biomedical or behavioral research, the National Institutes of Health (NIH) will repay up to $100,000 of student loan debt with a two-year contract through the NIH Loan Repayment Programs (LRPs). NIH wants to keep highly qualified biomedical and behavioral scientists like you in the lab, so we’re here to pick up the tab on your student debt. Check if you’re eligible for an LRP award today and apply by November 17, 2022.

“It does not feel hyperbolic to say the NIH LRP was life changing for me, and I hope it will be for some of you too!”, said Dr. Emily Willroth, Assistant Professor of Psychological and Brain Sciences, Washington University in St. Louis.

Not funded the first time? Try, try again! On average, nearly 50% of all new LRP applications are funded. The LRPs are unique programs, with tremendous benefit to early-stage researchers, so we strongly encourage researchers that were not successful in getting their applications funded to apply again.

Changing institutions? LRP Awards are portable! Awardees get to bring their LRP awards with them when they move to a different research institution. LRP awards can also be renewed for one-or two-year periods until all educational debt is paid in full.

Ready to apply for an LRP award? The application cycle is now open until November 17, 2022.

Here’s a few helpful resources to get you started:

• LRP Application Webinar including tips from past recipients and Q&A
• Obtain an NIH eRA Commons ID. An eRA Commons ID is required to start an LRP application.
• Contact an LRP Ambassador
• Quick tutorials on preparing and submitting your application
• Contact an LRP Program Officer to discuss your research
• Discussion on #LRPchat features even more tips and FAQs

https://nexus.od.nih.gov/all/2022/10/25/you-do-the-research-nih-repays-your-student-loans-apply-by-november-17/feed/ 1 23688 https://nexus.od.nih.gov/all/2022/10/24/what-should-i-include-in-the-project-outcomes-section-of-my-progress-report/ https://nexus.od.nih.gov/all/2022/10/24/what-should-i-include-in-the-project-outcomes-section-of-my-progress-report/#respond Mon, 24 Oct 2022 19:26:52 +0000 https://nexus.od.nih.gov/all/?p=23685 The Project Outcomes section of the Research Performance Progress Report (RPPR) provides information about the cumulative outcomes or findings of the project. This information is made available to the public through NIH RePORTER, so take that into account when completing this section!

As noted in the RPPR Instruction Guide, Project Outcome summaries should not exceed half a page and must be written according to the following guidelines:

• Is written for the general public in clear, concise, and comprehensible language
• Is suitable for dissemination to the general public, as the information may be available electronically
• Does not include proprietary, confidential information or trade secrets

Importantly, recipients conducting NIH-defined Phase III Clinical Trials must also include results of valid analyses by sex/gender, race, and ethnicity in the Project Outcome Summary. For more information on valid analysis, see the Analyses by Sex or Gender, Race and Ethnicity for NIH-defined Phase III Clinical Trials (Valid Analysis) page.

Looking for an example to use as a reference? Check out our Sample Project Outcomes page for examples, including one that addresses the results of valid analysis by sex/gender, race, and ethnicity.

https://nexus.od.nih.gov/all/2022/10/24/what-should-i-include-in-the-project-outcomes-section-of-my-progress-report/feed/ 0 23685