[September 18, 2014] Given the NIH’s new resubmission policy, do I need to change the title when submitting my NIH application again as a new proposal? No, the title does not need to be changed. NIH will not assess the similarity of the science in the new (A0) application to any previous submission. Investigators are encouraged to take into account critiques from the previous review and advice from program staff, and revise the proposal accordingly. However, you should NOT directly reference the previous review at all in the new application as this will result in having the proposal returned without review. More>> [Faculty, Postdocs and Resadmin 9/18/2014]
[July 17, 2014] When would be the best time to alert SR-PD of your plans to submit a sponsored research application? If you are considering submitting an application, we advise alerting your lab’s assigned Grants Management Specialist (GMS) at SR-PD as early as possible. Your GMS, our Director and/or Program Development would then be able to guide you on the specific funding opportunity (e.g. unusual sponsor requirements, success rates, need to contact sponsor for clarifications) and provide better support of your submissions. Advance knowledge of expected applications enables SR-PD to be most prepared for upcoming deadlines and serve all investigators equally well. [Faculty, Postdocs and Resadmin 7/17/2014]
[June 5, 2014] What is an NIH renewal application? An NIH renewal application (previously termed ‘competing continuation’) is a request for funding for a new award period, to continue an existing NIH-funded project. Renewal applications undergo peer review, and while they compete for funds with other renewal applications, new applications and supplements, renewal applications and new applications have different standard due dates. Principal Investigators are advised to consult with an NIH Program Official before deciding whether to submit a renewal application or a new application. More>> [Faculty, Postdocs and Resadmin 6/5/2014]
[June 5, 2014] What is an NIH non-competing continuation? Non-competing continuations are progress reports that are required for most NIH-funded projects. The non-competing continuation application constitutes a request for funding for the subsequent budget period and includes a progress report on the previously funded budget period. Used to maintain continued support of NIH-funded projects from one budget period to the next, non-competing continuations/progress reports do not compete for funds, are typically submitted annually, and are reviewed by the assigned NIH Program Official. With federal sponsors transitioning to Research Performance Progress Report (RPPR) for non-competing continuations/progress reports, investigators will be required to use the RPPR format for almost all NIH progress reports as of October 17, 2014. More>> [Faculty, Postdocs and Resadmin 6/5/2014]
[May 22, 2014] Does the NIH require investigators to include training grants in the Other Support section? No, when submitting Other Support to the NIH, training grants should not be included. This applies to both Principal Investigators and mentors involved in training grants. More>>> [Faculty, Postdocs and Resadmin 5/22/2014]
[May 22, 2014] Is Other Support required for NIH Research Performance Progress Reports (RPPR)? Other Support is required in the NIH Research Performance Progress Report (RPPR) when new/senior Key Personnel have been added to the grant. Additionally, updated Other Support is required for all senior/key personnel for whom there has been a change in Other Support since the last reporting period. If a previously active grant has terminated and/or if a previously pending grant is now active, update by annotating accordingly, following the NIH’s suggested format. More>> [Faculty, Postdocs and Resadmin 5/22/2014]
[May 8, 2014] Does the NIH allow the submission of a previously unsuccessful A0 application as new, without a resubmission (A1) first? Yes, this is a major NIH policy change that will allow researchers to pursue NIH funding for unsuccessful A0 applications provided their review is completed and summary statements issued. While the NIH continues to offer resubmission options and recommends that applicants consider benefits unique to resubmissions (e.g. addressing reviewer comments directly in an introduction), submitting a new application (A0) similar to an unsuccessful A0 application (e.g. same aims, same title) without a resubmission application (A1) first is now allowed. Peer reviewers are instructed to assess A0 submissions as new, and applicants are advised to address previous critiques only indirectly and not to reference previous applications. The NIH does not specify time constraints for an A0 application that follows an unsuccessful A0, but as before, NIH will not allow overlapping applications to be reviewed concurrently. PIs uncertain if and when to submit a new application (A0) without going through an (A1) resubmission, are strongly encouraged to discuss options with their NIH Program Official. Useful NIH links: FAQs, general resubmission page, Sally Rockey Blog. [Faculty, Postdocs and Resadmin 5/8/2014]
[May 8, 2014] If an NIH Fellowship or Career Development application is unsuccessful, may a subsequent application with the same mentor and the same training plan be submitted as a new application (A0)? Yes, provided the NIH peer review of the original application (A0) is completed and the summary statement issued. Unless a Funding Opportunity Announcement (FOA) specifies different requirements, the NIH’s new resubmission policy applies to all mechanisms including fellowship, training, and career development awards. More>> [Faculty, Postdocs and Resadmin 5/8/2014]
[April 24, 2014] NIH FAQ: My resubmission application was not funded. May I now submit it as a new application? Yes. Investigators should take into account the scores of the previous application, the reviewer comments, and advice from NIH program staff when deciding whether to submit the application as new. Should you decide to submit the application as new, take advantage of the comments from reviewers to reshape your application, but remember, you should not directly reference the previous review in the new application. More>> [Faculty, Postdocs and Resadmin 4/24/2014]
[April 24, 2014] NIH FAQ: My resubmission of a competing renewal application (Type 2 A1) was not funded. Will it still be considered a renewal application if I submit it as new? After a resubmission of a competing renewal (Type 2) application that is not funded the next submission should be submitted as a new application (Type 1 A0) on the new application due date, and it will lose any association with the previously funded grant. As a new Type 1, the application would be due on the new application due date, not the renewal application due date, and would not contain a Progress Report or introduction in response to previous critiques. More>> [Faculty, Postdocs and Resadmin 4/24/2014]
[April 10, 2014] Is it allowable to withdraw an NIH application before peer review? Yes, an applicant may withdraw an application from consideration before the review. An NIH application withdrawn before the initial peer review will not count as one of the two allowed submissions. NIH requires the Program Director/Principal Investigator and their Institutional Official to sign on all withdrawal requests. More>> [Faculty, Postdocs and Resadmin 4/10/2014]
[April 10, 2014] Is it allowable to withdraw an NIH application after peer review? Yes, an applicant may withdraw an NIH application after it was reviewed. If a new application (A0) is withdrawn after receiving the summary statement, then a resubmission is allowed. However, when applicants withdraw their new application after peer review but before their summary statement is released, they will not have access to their summary statement and neither a resubmission (A1) nor a duplicate application as a new submission is allowed. More>> [Faculty, Postdocs and Resadmin 4/10/2014]
[March 27, 2014] Why is it vital to review general sponsor guidelines and the specific Funding Opportunity Announcement (FOA) when preparing a sponsored research funding application? Together, sponsor guidelines and the FOA offer important guidance on the submission process, each section of the application, program-specific requirements, key dates, and more. If requirements are not met, the sponsor may return an application without review. More>> [Faculty, Postdocs and Resadmin 3/27/2014]
[March 27, 2014] Why is it vital to provide the general sponsor guidelines and the specific Funding Opportunity Announcement (FOA) when submitting a sponsored research funding application to SR-PD? Different programs, even within the same sponsor, may have different guidance and instructions, and some may have special requirements. Therefore, whether RU is the Prime or Sub institution, SR-PD reviewers must consult the sponsor guidelines and the relevant FOA to verify that an application meets all requirements. More>> [Faculty, Postdocs and Resadmin 3/27/2014]
[March 27, 2014] Does a change in effort of senior/key personnel on NIH awards require NIH prior approval? A reduction of effort by 25% or more for the Program Director/Principal Investigator (PD/PI) or any other senior/key personnel named on the Notice of Award, relative to the effort currently approved, always requires prior approval (details in NIH Grants Policy Statement). When a minimal level of effort is mandatory for key and other personnel (as explained in our 12/5/13 Tip) the NIH will not consider prior approval requests for effort reductions below the required level. Prior approval requests are prepared by the PD/PI and submitted by an institutional signing official. These requests must provide a science-driven justification for the need for change and alternate arrangements envisioned by the PD/PI. More>> (This is a correction to our 1/2/2014 tip, following recent NIH clarifications.) [Faculty, Postdocs and Resadmin 3/27/2014]
[February 27, 2014] Why is my NIH award subject to the SNAP? SNAP stands for Streamlined Non-Competing Award Process and it applies to most NIH non-competing continuation awards. NIH implemented the SNAP in 1995 and many NIH awards have been issued under it since then. SNAP awardees submit annual progress reports, now referred to as Research Performance Progress Reports (RPPR), that do not include budgetary details; they are permitted to carry over unobligated balances that are up to 25% of the total direct costs without NIH prior approval; and financial reporting on their awards is required only at the end of a competitive cycle. To determine if an NIH award is subject to the SNAP and must be submitted using RPPR, refer to your Notice of Award, Section II Terms and Conditions. More>> [Faculty, Postdocs and Resadmin 2/27/2014]
[February 27, 2014] Why is knowing and following your sponsored research Notice of Award (NoA) critical? Sponsors’ NoAs are legally binding documents that inform grantees - Principal Investigators (PIs) and their institutions – of the funding of their application, of applicable terms and conditions, and other pertinent details about the grant (e.g. NIH NoA). In addition to receiving a sponsor’s NoA, at the time of award PIs and their laboratory administrators will receive an internal Award Summary from SR-PD/Post-Award. This Summary recaps award funding and budget periods, associated compliance requirements and reporting due dates, and highlights project-specific restrictions that might have been placed by the sponsor.
The internal Award Summary complements the sponsor’s NoA and, together, they offer the PI, the laboratory and the institution an integrated blueprint for responsible award administration (more details in our Post-Award area). Knowing the terms and conditions of your award throughout its lifetime enables its effective management. More>> [Faculty, Postdocs and Resadmin 2/27/2014]
[February 13, 2014] Is there a cap on budget requests for NIH Competing Renewals? There may be. Policies that limit how much of a direct cost increase may be requested for NIH competing renewal applications vary amongst NIH Institutes and Centers (ICs). Terms and conditions specified in the active award’s Notice of Award would often indicate whether any such cap applies and ways to calculate allowable budget levels. Additionally, applicants are urged to speak to their Program Official early in the planning stage of their renewal application (at least 60 days prior to the intended submission) to discuss available options and to verify the maximum budget permissible/feasible for their award renewal. The NCI, and NIAID are among the ICs requiring a cap on budget requests for NIH competing renewals. More on ‘Dealing With a Budget Cap’. [Faculty, Postdocs and Resadmin 2/13/2014]
[January 30, 2014] Does the NIH allow special characters in applications’ project titles and/or file names? The NIH does NOT allow special characters in application titles nor in names of associated files. Filename characters are validated and enforced by Grants.gov. Valid file names may only include A-Z, a-z, 0-9, underscore (_), hyphen (-), space, and period. If special characters are included in applications’ project titles and/or file names, they can translate into garbled text in the assembled application at the eRA Commons, causing ERRORs and rejections. (The use of special characters and symbols in the body of your research plan is allowed and expected as needed.) More at NIH PDF Guidelines. [Faculty, Postdocs and Resadmin 1/30/2014]
[January 2, 2014] Does a change in effort of key personnel on NIH awards require NIH prior approval? A reduction of effort by 25% or more for the Principal Investigator or any other key personnel named on the Notice of Award, relative to the effort approved at award time, always requires prior approval (details in NIH Grants Policy Statement). When a minimal level of effort is mandatory for key and other personnel (as explained in our 12/5/13 Tip) the NIH will not consider prior approval requests for effort reductions below the required level. Prior approval requests are prepared by the Principal Investigator and submitted by an institutional signing official. The requests must offer a science-driven justification for the need for change and alternate arrangements envisioned by the Principal Investigator. More>> [Faculty, Postdocs and Resadmin 1/2/2014]
Joint Tips with Other Departments
[July 17, 2014] Finance/SR-PD: Can I pay graduate students using my sponsored research grants? RU's graduate students' salaries/stipends may not be requested on research grants submitted from and awarded to RU investigators. For questions contact Finance or the Dean's office; for questions about grants submissions contact your GMS. [Previously sent 2/16/2012; Faculty, Postdocs and Resadmin 7/17/2014]
[July 3, 2014] RUIT/SR-PD: How can investigators gain authorized access to the NIH database of Genotypes and Phenotypes (dbGaP)? Investigators may submit a request for authorized access to dbGaP by using their eRA Commons username and password, provided they have the role of Principal Investigator (PI) in the eRA Commons. Within the dbGaP environment, applicants must complete a Data Use Certification (DUC). Either an IRB approval or a letter of exemption from the IRB is also required.
As with any funding applications, by submitting an authorized access request the applicant and their institution consent to the sponsor’s requirements. dbGaP’s terms and conditions include specific security requirements, and Information Technology officials at the applicant institution (i.e. RUIT here) must confirm that local security practices meet dbGaP standards before an authorized access request may be submitted. Once all assurances are in place and the completed request with the associated Routing Form is reviewed by SR-PD, the institutional Signing Official at SR-PD submits authorized access requests to dbGaP on behalf of the PI and the institution. More>>
[July 3, 2014] RUIT/SR-PD: What is required to close out an authorized access award from the NIH Database of Genotypes and Phenotypes (dbGaP)? An award for authorized access to dbGaP is normally for one year and, unless renewed, must be closed out within 42 days of the project expiration date. An institutional IT confirmation that all dbGaP security measures were met upon project completion, including those applicable to data destruction, is a key element of the NIH dbGaP close-out. Therefore, RUIT will work with the PI to ensure and confirm compliance. Once all assurances are in place, the institutional Signing Official at SR-PD will submit the report. More>>
[March 13, 2014] IRB/RUIT/SR-PD: How to request access to data from the NIH DataBase of Genotypes and Phenotypes (dbGaP)? Access to data in dbGaP is managed via two levels: Open-Access data that can be browsed and/or downloaded freely and without prior approval. Controlled-Access data that is restricted and can be accessed only by investigators whose Data Use Certification (DUC) applications received a prior approval from an appropriate Data Access Committee (DAC). Specifically, investigators must complete an appropriate DAC's DUC and have their application co-signed and submitted by their institutional official. SR-PD processes Data Access requests and monitors Data Access agreements in the same manner as it does regular funding applications and awards. Before approving and submitting any data access request, SR-PD will need to confirm that all required compliance is in place (i.e. IRB approval, RUIT approval of data security requirements, other assurances as applicable). More>> [Faculty, Postdocs and Resadmin 3/13/2014]
[March 13, 2014] IRB/RUIT/SR-PD: How to submit data to dbGaP? When an investigator whose data was funded by an NIH Institute/Center (IC) applies to submit it to dbGaP, their application has to be sponsored by the funding IC, and the PI needs to contact their grant's Program Official to start the data submission process. Submitters whose data was NOT funded by the NIH need to work with dbGaP staff to identify an appropriate sponsoring IC for their submission and the NIH DAC that will review it. More in dbGaP’s submission process. [Faculty, Postdocs and Resadmin 3/13/2014]
[March 13, 2014] IRB/RUIT/SR-PD: How to comply with Controlled-Access dbGap data security requirements? The easiest way to be fully compliant with Controlled-Access dbGap data security requirements is to keep the data on a secured server or workstation and use only encrypted external media with limited and documented access to the stored data. More>> [Faculty, Postdocs and Resadmin 3/13/2014]
