Analysis of NIGMS Support of Research Organisms

NIGMS is committed to supporting a wide-ranging portfolio of biomedically relevant fundamental research. As we discussed in a previous Feedback Loop post, we see this approach as the best way to increase our understanding of life. For many years, one important dimension of diversity in our scientific portfolio—the organisms scientists use to conduct their research—was limited by technical considerations. However, recent advances such as the decreasing cost of genome sequencing and the development of the CRISPR system for genetic modification now make it possible to use an expanded range of research organisms.

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NIGMS Transitions AREA Support to Undergraduate-Focused Institutions

NIGMS is realigning its support of the Academic Research Enhancement Award (AREA) program to focus on providing research experiences to undergraduate students in scientific areas within its mission. Accordingly, we’ve published a new undergraduate research-focused AREA funding opportunity announcement (FOA) and are discontinuing our participation in the NIH Parent AREA FOA. The undergraduate research-focused AREA FOA will allow us to continue to: 1) support small-scale meritorious research projects at institutions that do not receive substantial NIH funding (less than $6 million in total costs in 4 of the last 7 years), 2) enhance the research environment at eligible institutions, and 3) expose students to scientific research so that they consider careers in biomedical sciences. Unlike the Parent FOA, the new announcement allows NIGMS to place its emphasis specifically on undergraduate research.

This new AREA FOA limits eligibility to undergraduate student-focused institutions or academic components within an institution (e.g., School of Arts and Sciences) in which the undergraduate student enrollment is greater than the graduate student enrollment, and it excludes all types of health professional schools. Additionally, the research team must be composed primarily of undergraduate students. This FOA aligns the application instructions and review criteria with the goals of the AREA program. We expect that these clarifications will lead to applications that better fit the goals of the program and provide reviewers the tools they need to evaluate the program as designed.
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Planning to Apply for an NIGMS Established Investigator MIRA? Points to Consider

When NIGMS issued PAR-17-094, Maximizing Investigators’ Research Award (R35), in December 2016, we opened the established investigator MIRA mechanism to all NIGMS grantees whose single-PI R01-equivalent grants were set to terminate in the same or subsequent fiscal year as the MIRA application. The purpose of this post is to remind you of important points to keep in mind if you are eligible to apply for a MIRA. Before applying, we strongly encourage you to contact your program director, who can advise you on whether MIRA is the best funding program for you and can help estimate a project budget if your application does well in peer review.

Some key points to know if you are considering applying for a MIRA grant:

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Proposed Reorganization of NIGMS Scientific Divisions

UPDATE: The NIGMS reorganization became official in January 2018. Please see our Overview for more information. 

I’d like to make you aware of a proposed reorganization of the Institute’s scientific divisions that we are considering.

Currently, NIGMS has four scientific divisions: Biomedical Technology, Bioinformatics, and Computational Biology (BBCB); Cell Biology and Biophysics (CBB); Genetics and Developmental Biology (GDB); and Pharmacology, Physiology, and Biological Chemistry (PPBC). We would like to shift to a structure in which there are only three scientific divisions: Biophysics, Biomedical Technology, and Computational Biosciences (BBCB); Genetics and Molecular, Cellular, and Developmental Biology (GMCDB); and Pharmacology, Physiology, and Biological Chemistry.

In broad strokes, the current CBB cell biology branch and most of the grants it manages would move to the new Genetics and Molecular, Cellular, and Developmental Biology division, and the CBB biophysics branch would move to the new Biophysics, Biomedical Technology, and Computational Biosciences division. A few grant portfolios from CBB would be transferred to the existing Division of Pharmacology, Physiology, and Biological Chemistry.

This proposed reorganization does not reflect any change in scientific emphasis or interests by the Institute. Rather, it is an attempt to improve the efficiency and effectiveness of our support for fundamental biomedical research, consistent with two goals outlined in our strategic plan [PDF, 702KB]: enhance the effectiveness of our support for fundamental biomedical research and improve the efficiency of our internal operations.

The proposed restructuring also includes establishing the Center for Research Capacity Building as a full division, consistent with its unique place in the Institute. In addition, based on a recommendation from the Steering Committee of the Office of Emergency Care Research (OECR), we plan to transfer the office to the National Institute of Neurological Disorders and Stroke (NINDS). Because of NINDS’ strong expertise in and support for clinical research related to emergency medicine, it is extremely well-suited to promoting the mission of OECR.

You might wonder what the proposed reorganization will mean for your current or future funding. Our commitment to funding fundamental biomedical research and research capacity building programs remains the same, so the amount of money allocated to these areas will not change as a result of the proposed reorganization. We also expect that most grantees will continue working with their current program directors and grants management specialists.

Soliciting input from the community is among the steps that need to occur before any changes can be implemented. We invite you to share your thoughts on these plans by commenting here or by email. Input will be received through December 4, 2017.

Multiple Principal Investigator (MPI) Application – When Is it the Right Choice?

For some time now, NIH has offered the Multiple Program Director/Principal Investigator (PD/PI) Award, also known as the MPI award, as an option for investigators seeking support for research projects. At NIGMS, we’ve been thinking about collaborative research, and we want to share some of our observations so you can choose the grant mechanism that best fits your research goals.

An MPI application is a commitment by two or more investigators. Both/all have the authority to direct the research project, should agree on how they are going to accomplish this, and will describe their project leadership plan in the grant application. If awarded, both/all have the shared responsibility to direct the research and ensure that it remains on track both intellectually and logistically. Some examples of these shared tasks include experimental design, resource allocation, supervision of staff, financial management, data sharing, and submission of publications. The responsibilities can be rotated over time. If both/all investigators are not full and equal partners in the award, it isn’t really an MPI project.

The MPI award was developed to share credit among equals on research teams. In contrast, some applicants want to use MPI awards to accomplish unintended goals, for example, to elevate a junior scientist, to entice a luminary colleague who might not otherwise get involved, to add a new technical approach to the research, or to support a collaborator at another institution. However, there can be costs associated with such strategies:

  • A young scientist PD/PI will lose her/his early stage investigator (ESI) status, which offers the advantage of having an application grouped with other ESIs at the initial review group meeting, a higher priority funding consideration, and sometimes a fifth year of an award.
  • All PD/PIs will be considered under NIGMS’ policy for Support of Research in Well-Funded Laboratories, so that if any investigator has greater than $750,000 in direct costs awarded annually, then the entire application will receive extra scrutiny by our National Advisory Council.
  • Furthermore, any PDs/PIs who fall under NIGMS’ policy for funding Investigators with Substantial, Unrestricted Research Support may hold no more than one NIGMS research grant.

Other types of awards, including a single PD/PI regular research grant (R01), may be better alternatives to an MPI award for supporting collaborative research. Here are a few points that investigators should consider:

  • Collaborators often play an important role in a project and may commit specific effort and receive funds from an award. If at another institution, funds essential to accomplish the research can be delivered through a subcontract.
  • Another viable way to enable an individual to participate in a research project is to name a consultant in the necessary area of expertise. Consultants can receive a fee for their work, if appropriate.
  • Almost any relationship can be well-documented in a letter of support, so that the initial review group recognizes an established and committed scientific relationship.

The MPI award fills an important niche. But the mechanism can be misunderstood and may even be misused to the detriment of one or more of the PD/PIs. Always look carefully at the continuum of opportunities to support multidisciplinary research programs and collaborative research.

Starting this fall, NIGMS anticipates offering a new award called the Collaborative Program Grant for Multidisciplinary Teams (RM1), which is designed to support highly integrated teams of researchers working to achieve a shared objective. Watch the Feedback Loop posts and talk to your NIGMS program director to learn more.

Heads-up: New Application Forms for Human Subjects Research

Does your research involve human specimens or data? If so, there are new questions you’ll need to address next time you apply for an NIH grant. Here’s what you need to know about that and other changes to NIH grant application procedures.

Effective for application due dates on or after January 25, 2018, all applicants will have to use the new FORMS-E application package. A major goal of the FORMS-E application package is to consolidate information about human subjects research and clinical trials into one place—the new PHS Human Subjects and Clinical Trials Information form. This form will use a variety of form fields to collect information on eligibility criteria, age limits, study timeline and design, and many other aspects of the proposed human subjects research/clinical trial. Comprehensive information is available at Clinical Trial Requirements for NIH Grants and Contracts.

Even if you indicate on the Research & Related Other Project Information form that human subjects are not involved in your project, you will need to address an additional question on the new PHS Human Subjects and Clinical Trials Information form:

If No to Human Subjects, Does the proposed research involve human specimens and/or data?
If the applicant answers YES to this question, an additional attachment describing why the proposed human specimens and/or data are not considered human subjects research must be included in the grant application.

Another change beginning with the January 25 application due date is that all applications involving one or more clinical trials must be submitted through a funding opportunity announcement (FOA) specifically designed for clinical trials. Accordingly, all new FOAs and all parent announcements will specify the allowability of clinical trials in the FOA title. Please see Clinical Trial-Specific Funding Opportunities for more information about the changes to FOAs.

It is a good idea to discuss the new Human Subjects and Clinical Trial form with your grants administrators and institutional business officials and to allow extra preparation time for your first FORMS-E grant submission. Your NIGMS program director will be able to help you identify the correct FOA for your proposed research. If you have any questions about human subjects policy or NIGMS’ support of clinical trials, please contact me.

Attention NI/ESI MIRA Recipients: This Webinar Is for You.

UPDATE: The video and slides from the NI/ESI MIRA webinar have been posted.

If you are a new investigator (NI) or an early stage investigator (ESI) who received a Maximizing Investigators’ Research Award (MIRA) in 2016 or 2017, you may be wondering how having a MIRA affects your ability to initiate collaborations or apply for other grants. Or, you may be curious how much flexibility you really have to deviate from your original research plans. You may also be thinking a few years ahead about a competing renewal application. Because MIRA is a new grant mechanism, NIGMS will host a webinar designed specifically to address these and other topics of interest to NI/ESI MIRA principal investigators (PIs). NIGMS program, grants management and review staff will be on hand to provide information and answer your questions. We invite NI/ESI MIRA PIs and their business officials to participate.

The webinar (link no longer available) will be held on Tuesday, September 26, from 2:00 to 3:45 p.m. EDT. The site is compatible with mobile devices. Participants will be able to submit questions through the chat function. For an audio-only presentation, call 1-866-815-0443 and enter passcode 3268089. We will post the archived webinar and slides on the MIRA webpage after the event.

NIGMS Staff Participating in the September 26 Webinar

Vernon Anderson, Program Director

Oleg Barski, Program Director

Lisa Dunbar, Scientific Review Officer

Judith Greenberg, Deputy Director

Lisa Moeller, Grants Management Officer

Peter Preusch, Acting Director, Division of Cell Biology and Biophysics

Kristine Willis, Program Director

Heads-up: FORMS-E Coming Soon

The application package for submitting all types of grant applications is about to change. Effective for receipt dates on or after January 25, 2018, applicants will have to use FORMS-E application packages. NIGMS is urging applicants to direct their attention to NOT-OD-17-062 and be ready for the change.

The change will apply to all funding opportunity announcements (FOAs) and all application types (new, resubmission, renewal, revision). Applications submitted using the wrong forms will automatically be withdrawn by the Division of Receipt and Referral within the NIH Center for Scientific Review and will not be reviewed. Application guides for FORMS-E application packages will be posted on the How to Apply – Application Guide page no later than October 25, 2017.

One of the best resources to help applicants stay on top of new and upcoming changes for grants and contracts at NIH is the Notices of NIH Policy Changes located on the Office of Extramural Research website. Please check this page frequently and, as always, contact NIGMS program and review staff with any questions.

Five MIRA Myths

Our Maximizing Investigators’ Research Award (MIRA) program is still relatively new, so it’s not surprising that NIGMS staff frequently hear misconceptions about it. This post dispels five common MIRA myths.

Myth 1: Once an investigator is awarded a MIRA, the budget will never increase.

MIRA budgets may increase. At the time of the competing renewal application, a principal investigator (PI) may request an increase in funding. MIRAs with modest budgets that have been very productive and score very well could receive budget increases. Study sections will be asked to look at budget requests, and NIGMS staff will make determinations based on the reviewers’ recommendations and available funds.

Myth 2: Early stage investigators will receive more funding for their labs if they get an R01 than if they get a MIRA.

A MIRA PI who is an early stage investigator (ESI) has a higher probability of receiving more NIGMS funding than a non-MIRA ESI. Most ESI MIRA investigators receive $250,000 in direct costs per year. A recent analysis found that the vast majority of ESIs who have received an NIGMS R01 are initially awarded $200,000 or less, and most do not go on to receive a second NIGMS R01 during the first five years of their initial award. Thus, the total NIGMS funding for most relatively new investigators is higher with a MIRA.

Myth 3: MIRA discourages collaborative research.

NIGMS strongly endorses collaborative research, and this extends to the MIRA program. However, the MIRA concept is based on the idea that NIGMS will provide support to individual investigators’ research programs. Collaborators are expected to work together because of their mutual interest in a problem. The collaborator, in most cases, will support his or her efforts with independent funding, not through a subcontract from the MIRA. In cases where a collaborator’s efforts are well-justified, essential to the research program of the MIRA and cannot be supported by the collaborator, a consortium agreement can be included in the competing application.

NIGMS also encourages scientifically productive international collaborative research efforts. However, NIGMS will only provide funding for a foreign consortium arrangement when the collaboration is essential to the PI’s research program, represents a unique scientific opportunity and cannot be supported by the collaborator.

Myth 4: MIRA PIs cannot apply for administrative supplements.

MIRA PIs are eligible for Research Supplements to Promote Diversity in Health-Related Research and may be eligible for other types of administrative supplements, such as equipment supplements offered by NIGMS through notices in the NIH Guide for Grants and Contracts. In rare situations, NIGMS may provide a supplement for a piece of equipment that could not have been anticipated at the time the application was submitted.

Myth 5: MIRA PIs cannot apply for NIGMS training grants or conference grants.

MIRA PIs are eligible to apply for grants that support research resources, training, workforce development or diversity building, clinical trials, selected cooperative agreements, SBIR/STTRs, conference grants and the portion of a center grant or a P01 that is strictly a core. In addition, a MIRA PI may receive grants from other NIH institutes or centers, although when making funding decisions NIGMS always considers an investigator’s other support, as described on our Funding Policies page.

More information, including answers to frequently asked questions, is on the MIRA page.

Beware the New NIH Appendix Policy and How to Navigate the Changes

Trying to navigate changes in NIH grant application policy can be a daunting task. Moreover, when these policy changes bypass the radar of applicants, the result can be an unwelcome outcome. This was the case most recently for many grant applicants who did not follow the new NIH policy limiting the types of appendix materials allowed for applications with due dates on or after January 25, 2017. This policy was first advertised last August to allow sufficient time for applicants to absorb the change. Unfortunately, many of the grant applications assigned to NIGMS came in for the January 25 receipt date with non-compliant appendix materials, resulting in their withdrawal by NIH. We at NIGMS are very aware of the pain and frustration felt by applicants and institutional authorized officials when applications are withdrawn. In the hope of minimizing the number of withdrawals due to non-compliant appendices for upcoming receipt dates, here are some important reminders:

  1. Under the new policy, almost nothing is allowed as appendix material unless specifically requested in the funding opportunity announcement (FOA).
  2. The few remaining materials that are still allowed are very specialized and do not apply to most FOAs.
  3. If the FOA you apply for is one that does allow or specifically requests certain types of appendix materials, be sure to include only what is allowed. If you include any additional materials, your application will be considered non-compliant and will almost certainly be withdrawn.
  4. Do not use application sections that have unrestricted page limits (e.g., the Other Attachments section) as a surrogate location for appendix materials that are no longer allowed because this also will result in your application being withdrawn as non-compliant.
  5. Lastly, be sure you are reading the most up-to-date versions of the FOA and SF424 instructions, as the materials that are and are not allowed in an application may have changed from previous versions.

One of the best resources to help you stay on top of new and upcoming changes is the Notices of NIH Policy Changes on the Office of Extramural Research website—please check this site frequently. And, as always, NIGMS program and review staff are available to answer any questions.