While NIH expects applications to be submitted by their deadlines, it may accept a late application and has recently announced a 2-week window of consideration for all types of applications. Beginning with applications due on or after January 25, NIH will consider accepting applications during this grace period provided a cover letter submitted with the application includes an appropriate justification for being late. The new policy includes submissions in response to most requests for applications and program announcements with special due dates. For exceptions, acceptable reasons and other details, see Simplifying the NIH Policy for Late Application Submission.
The annual Research Performance Progress Report (RPPR) is how we assess progress toward your funded project’s goals and whether your project is in compliance with guidelines set forth in the NIH Grants Policy Statement. The designated grants management specialist and program official (PO, also known as program director) review each progress report. After these staff members approve the report, we can issue a notice of award for the noncompeting continuation of the grant.
Typically, this administrative review is a straightforward process, but sometimes issues arise that can delay the processing of the award and create additional work for everyone involved. Here are some of the most common issues we encounter:
- Public access compliance: Before initiating the RPPR, you should enter all appropriate citations into your NCBI My Bibliography, associate them with the appropriate grant number and select the citations to include in this year’s RPPR. The RPPR software will then complete Section C.1 automatically. When noncompliant publications are identified, you should immediately begin (or complete) the process of bringing those publications into compliance.
- Publication reporting in the RPPR: List publications in Section C of the progress report, not in Section B.2, “What was accomplished…,” or elsewhere in the text. For more details, see Janna Wehrle’s post on Progress Reports and the Public Access Policy.
- Change in scope: A request for a change in project scope is a prior approval request that must be submitted by your Authorized Organizational Representative (AOR) and requires review by the grants management specialist and PO; this is done separately from the progress report review. Please remember that adding human subjects and/or vertebrate animals to a grant that previously did not have these activities is considered a change in scope.
- Discrepancies in answers to RPPR questions: Please double-check your responses to questions about the administrative aspects of your grant. Inconsistent answers to these questions often trigger a flurry of e-mails from us requesting clarification from the AOR and investigator. In my experience, the most common issues involve changes in other support, key personnel and vertebrate animal use, or they indicate a change when none exists.
- Description of collaborations: Please adequately describe how any collaborations contribute to the project. This is especially important for collaborations with foreign investigators and collaborations involving the sharing of samples from human subjects or vertebrate animals.
- Level of effort: Be sure to use whole numbers to report person-months of effort on a grant.
- New reporting requirements: Keep track of new reporting requirements, such as the new inclusion management system to report data on sex/gender, race and ethnicity in clinical research. Resources for staying up to date on such requirements are the NIH Guide and the Extramural Nexus blog.
Finally, your progress report should include a relatively brief description of the project’s scientific progress in the last funding period. We want to know what you think are your most impactful and exciting discoveries from the past year, as well as where the project is headed in the next funding period. Reading these descriptions is one of the most interesting parts of my job.
When in doubt on what to include in the progress report, contact your PO.
Jon Lorsch recently posted a message about the responsibility that our grantee community shares with us to help the research enterprise thrive. One way that we have addressed this is by taking a hard look at the funding of investigators who are already well supported. As most of you know, in an effort to increase efficiency and to support as many outstanding scientists as possible, we have long required special advisory council approval for any grant that, in combination with the principal investigator’s (PI’s) other research support, would provide over $750,000 in direct costs.
We have now developed guidelines that we will use in awarding R01s and other research grants to investigators with substantial levels of long-term, unrestricted research funding from any source. Unrestricted funding means that it is not project-based and may be used to conduct research on a broad topic at the PI’s discretion. We consider such support substantial and long-term if it is over $400,000 in direct costs (excluding the PI’s salary and direct support of widely shared institutional resources) and extends for at least 2 years from the time the NIGMS grant would be funded.
Abiding by these new guidelines will enable us to fund additional labs, increasing the likelihood of making significant scientific advances. The guidelines will take effect for applications submitted on or after January 2, 2016. If you might be affected by the new guidelines, I encourage you to discuss your plans with your program director.
You may be interested in these following NIH Guide announcements:
Request for Information (RFI): Inviting Comments and Suggestions on the Reagent-Related Barriers to Reproducible Research
Purpose: Provide input on reagent-related barriers to reproducible biomedical research
Response date: December 22, 2014
NIH contact: Questions concerning this RFI should be directed to NIHReproducibilityEfforts@nih.gov
Administrative Supplements for Research on Sex/Gender Differences (Admin Supp)
Purpose: Request supplemental funds to existing grants to study the impact of sex/gender differences (or similarities) and/or sex and gender factors in human health and disease processes, including basic, preclinical, clinical and behavioral studies to inform the development and testing of preventative and therapeutic interventions
Application due date: January 12, 2015
NIGMS contact: Regine Douthard, 301-435-1759
Regional Consortia for High Resolution Cryoelectron Microscopy (U24)
Purpose: Provide regional access to state-of-the-art data collection capabilities to cryoelectron microscopy (cryoEM) laboratories; more information is available on the Guidance for Applicants Web page
Letter of intent due date: December 27, 2014
Application due date: January 27, 2015
NIGMS contact: Paula Flicker, 301-594-0828
Change in Application Due Dates for PAR-14-021 "Biomedical Technology Research Resource (P41)"
Purpose: Notice that applications for Biomedical Technology Research Resource grants will no longer be accepted for the September 25 due date; applications will continue to be accepted for the January 25 and May 25 due dates
NIGMS contact: Douglas Sheeley, 301-451-6446
NIGMS supports research in certain clinical areas, primarily those that affect multiple organ systems. To help investigators plan and prepare for clinical research projects, we offer planning grants for clinical trials of high relevance to the NIGMS mission. These planning grants, which we discussed in an earlier Feedback Loop post, can be used to develop management strategies and assemble regulatory documents for large-scale clinical trials.
We recently reissued the funding opportunity announcement for these planning grants. The next application deadline is December 18, with optional letters of intent due by November 18.
If you’re interested in applying for a clinical trial planning grant, we strongly recommend that you consult with the appropriate NIGMS program staff before you apply to determine whether the goal of the proposed trial aligns with the NIGMS mission and scientific priorities.
For more information, see our Clinical Studies and Trials Web page, which includes links to other useful resources like the NIGMS Guidelines for Data and Safety Monitoring in Clinical Trials. In addition, please note that NIH recently revised its definition of “clinical trial” to make a clearer distinction between clinical trials and clinical research studies and to enhance the precision of the clinical trial information NIH collects, tracks and reports.
If you have any questions about NIGMS’ support of clinical trials, please contact me.
NIGMS and the National Institute of Dental and Craniofacial Research are leading the new NIH Common Fund glycoscience program that is focused on the development of accessible and affordable tools and technologies for studying carbohydrates and their functions. The overall objective is to enable researchers in all biomedical fields to dramatically advance understanding of the roles of these complex molecules in health and disease.
The NIH Common Fund recently issued four funding opportunity announcements from this program:
- Data Integration and Analysis Tools: Accessible Resources for Integration and Analysis of Carbohydrate and Glycoconjugate Structural, Analytical, and Interaction Data in the Context of Comparable Gene, Protein, and Lipid Data (R34)
- Novel and Innovative Tools to Facilitate Identification, Tracking, Manipulation, and Analysis of Glycans and their Functions (U01)
- Novel and Innovative Tools to Facilitate Identification, Tracking, Manipulation, and Analysis of Glycans and their Functions (R21)
- Facile Methods and Technologies for Synthesis of Biomedically Relevant Carbohydrates (U01)
The application deadline for each announcement is December 10, with optional letters of intent due by November 10. For more information about the glycoscience program, view the technical assistance Webinar or contact either one of us at email@example.com or firstname.lastname@example.org.
We were excited to learn this morning that our grantee William E. Moerner will share the 2014 Nobel Prize in chemistry with Eric Betzig and Stefan W. Hell "for the development of super-resolved fluorescence microscopy." We congratulate them on this well-deserved recognition of their pioneering work, which has provided an unprecedented window into the cell and paved the way for understanding a range of biological processes.
I’m particularly thrilled with today’s news because it highlights an NIGMS-supported field that I’ve been closely involved in for more than 15 years. I remember my first conversation with W.E. on moving single-cell spectroscopy into biology, which led to a 2000 workshop we held to explore the state of the art in—and potential for—research in single molecule detection and manipulation. The recommendations from that workshop informed the development of a number of initiatives to apply the tools and approaches of the physical sciences to biological problems. The initiatives include our single molecule detection and manipulation program announcement and an NIH Roadmap for Medical Research program on the development of high-resolution probes for cellular imaging.
Since then, we have witnessed an explosion in the use of optical methods to look at single molecules at the nanoscale level and are gaining a wealth of insights as a result.
A statement from NIGMS on the prize is at http://www.nigms.nih.gov/news/results/pages/20141008.aspx. More information about our support of Nobel Prize winners is at http://www.nigms.nih.gov/education/pages/factsheet_NIGMSNobelists.aspx and at http://www.nigms.nih.gov/pages/GMNobelists.aspx.
The NIH Extramural Nexus blog has published posts on video resources that you may find helpful:
New Webinars Connect Applicants to NIH Peer Review Experts: The Center for Scientific Review is hosting webinars in early November to give R01, R15, SBIR/STTR and fellowship grant applicants and others useful insights into the submission and review processes. Register by October 28.
New Video Tutorials Can Help You Navigate eRA Commons: A 10-part series of short video tutorials walks you through the steps for submitting just-in-time information, a no-cost extension, a relinquishing statement and more. Watch the tutorials on the NIH Grants playlist on YouTube.