Planning for Maximizing Investigators’ Research Award (MIRA) Renewals

As we work on issuing a new funding opportunity announcement (FOA) for the established investigator (EI) MIRA program, we thought it would be useful to address a few common questions we’ve been hearing. The new FOA will allow applications from NIGMS grantees who have one or more single-Principal Investigator (PI) R01-equivalent awards, just as the current FOA does. In addition, the new FOA (to be published by Fall 2019) will allow renewal applications from PIs who already have MIRA grants.

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Update on NIH’s Efforts to Address Sexual Harassment in Science

I’d like to draw your attention to a very important statement issued yesterday outlining actions NIH is taking to address the issue of sexual harassment in science. The full statement is also available below. For additional information, please visit NIH’s webpage: Anti-Sexual Harassment: for NIH Awardee Organizations and Those Who Work There.

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NIH Statement: Changing the Culture of Science to End Sexual Harassment

Last week, NIH Director Francis S. Collins issued a statement about the pervasive problem of sexual harassment in science and reaffirmed NIH’s commitment to address it. He noted that NIH is working to bolster its policies and practices to foster a culture of respect wherever NIH research activities are conducted, and to ensure that sexual harassment is not tolerated or ignored.

NIH has launched a new website on anti-sexual harassment activities. I encourage you to explore the site and become familiar with NIH’s policies, practices, and initiatives.

Consistent with NIGMS’ strong commitment to research training, the Institute recently announced that applications for our predoctoral T32 training programs must include in their required institutional support letters information about the institution’s policies and procedures to prevent discriminatory harassment and respond appropriately to allegations or findings of discriminatory harassment. Moving forward, NIGMS will require this information in institutional support letters for applications for all of our training programs.

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