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Comment on Proposed Pilot to Support NIGMS Investigators’ Overall Research Programs

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We’re planning an experiment in how we fund research, and we want your input. As outlined in the Request for Information (RFI) included below, we propose to create a pilot program called Maximizing Investigators’ Research Award (MIRA) that would support all of the projects in an investigator’s lab that are relevant to the NIGMS mission.

We expect that the MIRA program will offer a number of benefits. For instance, investigators would not have to break their work into smaller, strictly prescribed increments. In addition, the program could improve funding stability and enhance grantees’ flexibility to follow new research directions as opportunities and ideas arise.

It’s important to note that MIRAs are not intended to be a method for supporting only a perceived elite group of investigators or promoting only high-risk, high-potential-reward research.

Our intent is to pilot a program that might transform how we support fundamental biomedical research, creating a more productive, efficient and sustainable enterprise. I encourage you to read the proposal and share your comments using the RFI input form (no longer available) by the August 15 deadline. We welcome responses from both individuals and organizations.

Request for Information (RFI): Soliciting Comments on a Potential New Program for Research Funding by the National Institute of General Medical Sciences

Notice Number: NOT-GM-14-122

Key Dates

Release Date: July 17, 2014

Response Date: August 15, 2014

Related Announcements

None

Issued by

National Institute of General Medical Sciences (NIGMS)

Purpose

This is a time-sensitive Request for Information (RFI) directed at obtaining input to assist the National Institute of General Medical Sciences (NIGMS) in its planning for a potential new program tentatively named Maximizing Investigators’ Research Award (MIRA). This award would be a grant in support of all of the research supported by NIGMS in an investigator’s laboratory.

Background

Supporting basic research by funding individual projects has a number of consequences for the efficiency and effectiveness of the basic biomedical research enterprise in the U.S. (Alberts, 1985; Ioannidis, 2011;  Vale, 2012; Bourne, 2013; Alberts et al., 2014). To address these issues and increase the efficiency and efficacy of its funding mechanisms, NIGMS is considering a pilot program to fund investigators’ overall research programs, which represents a compilation of the investigator’s research projects. It is hoped that this new funding mechanism will achieve the following:

  • Increase the stability of funding for NIGMS-supported investigators, which could enhance their ability to take on ambitious scientific projects and approach problems creatively.
  • Increase flexibility for investigators to follow important new research directions as opportunities arise, rather than being bound to specific aims proposed in advance of the studies.
  • Improve the distribution of funding among the nation’s highly talented and promising investigators to increase overall scientific productivity and the chances for important breakthroughs.
  • In the long term, reduce the time spent by researchers writing and reviewing grant applications, allowing them to spend more time conducting research.

Overview of the proposed NIGMS MIRA program

  • An NIGMS MIRA would provide support for a lab’s research program, which represents a compilation of the investigator’s NIGMS research projects (research areas supported by NIGMS are outlined at our website). Researchers would have the freedom to explore new avenues of inquiry that arise during the course of their work as long as those avenues are relevant to the mission of the Institute and do not require additional review for regulatory compliance (e.g., new human subjects research).
  • An NIGMS MIRA would be renewable.
  • Funding would range from $150,000-$750,000 (direct costs/year), depending on recommendations of the study section and the National Advisory General Medical Sciences Council as well as staff evaluation of the needs and expected productivity and impact of the program. Support for the investigator from sources other than NIGMS would be taken into consideration when deciding on funding levels for an NIGMS MIRA.
  • Up to $150,000 in administrative supplement support for the purchase of new equipment could be requested by an NIGMS MIRA grantee per grant cycle. Decisions on these requests would be made by NIGMS staff and the National Advisory General Medical Sciences Council based on an assessment of need and the potential impact of the new equipment on the research. The number of supplements given would depend on the available funds.
  • The median direct costs for NIGMS MIRAs would be higher than the current median R01 direct costs at NIGMS.
  • The length of an NIGMS MIRA would be 5 years, which is longer than the current average for an NIGMS R01 of close to 4 years.
  • A researcher funded by an NIGMS MIRA would not be given any other sources of NIGMS funding with the following exceptions:
  • Grants supporting research resources
  • Grants supporting training, workforce development or diversity building
  • Funding for clinical trials
  • SBIR/STTR grants
  • Conference grant
  • The Program Director/Principal Investigator (PD/PI) would be expected to commit at least 50 percent research effort to the NIGMS MIRA.
  • Revision applications to allow new collaborative work might be included as part of this program.
  • Review of the application would emphasize a holistic evaluation of the investigator’s track record and the overall potential importance of the proposed research program, without focusing on specific project details. Specific aims would not be required. The process would include peer review using existing criteria and processes but would be tailored to address the particular features of the MIRA (see the section below on the Possible Peer Review Process).
  • To avoid the abrupt termination of research groups from an adverse round of peer review, NIGMS MIRAs could be ramped down from one funding level to a lower one that is more consistent with the recent and perceived future productivity of the group and the importance of the work, as assessed by the study section. Conversely, a renewing program could have its budget increased if the perceived productivity, impact and needs merited it. As per standard grants policy, NIGMS program staff would make decisions on funding levels, guided by the recommendations from study sections and the National General Medical Sciences Council.

Possible Peer Review Process

In addition to the standard review criteria, among the considerations reviewers would be asked to address in reviewing MIRA applications are whether:

  • The proposed research effort is substantive, broad and ambitious.
  • A PD/PI’s record shows evidence of productivity, creativity, adaptability, service and excellence in mentoring.
  • For Early stage Investigators (ESIs), there is evidence of productivity, independent research and contributions to the design and direction of past research efforts.
  • The proposed research includes evidence of creativity and the incorporation of novel approaches as appropriate.
  • There are sound bases and generally well-thought-through and reasoned approaches for the proposed research effort.
  • There is evidence that the PD/PI has considered alternative approaches, outcomes, models and directions that might inform the scientific questions being posed.
  • The work will be conducted carefully and cost-effectively, with good stewardship of the data generated.
  • For ESIs, there is evidence of institutional support and mentoring.

Possible Implementation Plan

Because this is a pilot program, implementation must be carefully phased in and outcomes and unintended consequences assessed along the way. One possible implementation plan, consisting initially of two paths, is outlined below.

  • In lieu of a competitive renewal (Type 2), PDs/PIs who currently have two or more NIGMS R01s could apply for an NIGMS MIRA. Application for a MIRA would be evidence of a willingness to relinquish all other NIGMS research grants upon award. Award of the MIRA would be contingent on relinquishing other current NIGMS research grants in favor of the MIRA. Applicants proposing to consolidate their NIGMS awards would have to submit a MIRA application that would undergo peer review. The budget would be higher than that for any of the individual awards the PD/PI has, but usually less than the total of all of his or her NIGMS support. The length of the NIGMS MIRA would be 5 years.
  • The program could be open to applications from ESIs. This would bring a cadre of ESIs into the system who could be directly compared to other NIH-supported ESIs funded through traditional mechanisms. MIRA would be considered a substantial, independent NIH research award that disqualifies an individual from classification as an ESI.

The MIRA Funding Opportunity Announcement, when ultimately published, will include metrics that will be used to evaluate the success of the program. Once the program is established and indications of success have been measured, additional groups of investigators would be invited to apply for NIGMS MIRAs. If the program becomes successful, it would ultimately be open to applications from all investigators working on topics relevant to the mission of NIGMS and could become the primary research funding mechanism used by the Institute.

Information Requested

NIGMS is planning to issue a Funding Opportunity Announcement (FOA) to test this new program on a pilot scale. To aid in planning, the Institute is seeking feedback from the scientific community. NIGMS invites comments on the topics below; however, comments are not limited to these topics.

  1. The merits of this funding program for established and early stage investigators.
  2. The likelihood that established and early stage investigators would apply for NIGMS MIRAs.
  3. Concerns about the NIGMS MIRA proposal.
  4. Suggestions for changes to improve the NIGMS MIRA proposal or associated processes.

Submitting a Response

All responses must be submitted to https://www.research.net/s/NewGrantProgram_gov (no longer available) by August 15, 2014. Responses are limited to 500 words per topic.

This RFI is for planning purposes only and should not be construed as a solicitation for applications or an obligation on the part of the government. The government will not pay for the preparation of any information submitted or for the government’s use of that information.

The NIH will use the information submitted in response to this RFI at its discretion and will not provide comments to any responder’s submission. However, responses to the RFI may be reflected in future funding opportunity announcements. The information provided will be analyzed and may appear in reports. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information or provide feedback to respondents with respect to any information submitted. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

Inquiries

Please direct all inquiries to:

Peter C. Preusch, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-0827

Helen R. Sunshine, Ph.D.
National Institutes of General Medical Sciences (NIGMS)
Telephone: 301-594-2881

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Protein Data Bank Passes 100,000-Structure Mark

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Protein Data Bank (PDB) counter showing 100,147 total number of entries.

The latest update brings the total number of PDB entries to 100,147.

The Protein Data Bank (PDB) Link to external web site just passed a major threshold—the release of its 100,000th entry. This free online repository of experimentally determined protein and nucleic acid structures, which NIGMS and other parts of NIH have helped fund since 1978, facilitates atomic-level insight into protein structure and function. PDB is widely used by the scientific community to study basic biological processes like transcription, translation, enzymology, bioenergetics and metabolism and also for more medically oriented investigations into disease mechanisms and drug design.

In addition to scientists, students and educators use the digital resource for their own explorations of protein structure, function and interactions as well as to gain greater knowledge about biology.

Number of structures available in the PDB per year, with selected examples. For details, see http://www.eurekalert.org/multimedia/pub/73206.php?from=267554.

Approximately 260,000 visitors access PDB each month. Scientists around the world currently deposit about 200 structures per week, which PDB staff review, annotate and augment with links to other relevant biological data. To meet the challenges posed by large structures, complex chemistry and use of multiple experimental methods, the repository recently launched a software tool for structure deposition and annotation Link to external web site.

If you aren’t already a PDB user, I encourage you to check out its resources to see if they could help advance your research.

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Change in NIH Application Resubmission Policy

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NIH has just announced a significant change in its policy for resubmission applications.

Effective immediately, for application due dates after April 16, 2014, following an unsuccessful resubmission (A1) application, applicants may submit the same idea as a new (A0) application for the next appropriate due date. NIH will not assess the similarity of the science in the new (A0) application to any previously reviewed submission when accepting an application for review.

NIH’s policy for accepting overlapping applications remains in effect (see NOT-OD-09-100), so it will not accept duplicate or highly overlapping applications under review at the same time. This means that NIH will not review:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

The NIH time limit for accepting resubmission (A1) applications remains in effect, as well (see NOT-OD-12-128 and NOT-OD-10-140). NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows.

Also remaining in effect is the NIH policy for new investigator R01 resubmission deadlines, described in NOT-OD-11-057.

Background and details on the new resubmission policy are in NIH Guide NOT-OD-14-074 and a blog post by NIH’s Sally Rockey.

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Give Input on Structural Biology Resource and Infrastructure Needs

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Earlier this year, I told you about the formation of two committees focused on Protein Structure Initiative (PSI) transition planning. These committees are charged with determining what unique resources and capabilities developed during the PSI should be preserved after the initiative ends and how this preservation should be done.

An important part of this process is getting input from the community, so we have just issued a request for information (RFI), NOT-GM-14-115, seeking comments about structural biology resources that have a high impact on the community, whether those resources have been supported through the PSI or by other means. We also want to hear what you think about the future of structural biology-related technology development, which has been an important feature of the PSI.

While the RFI invites comments on these specific topics, you should not feel limited to them—we welcome any comments that you feel are relevant.

To respond to the RFI, send an e-mail to nigmspsirfi@mail.nih.gov by May 23, 2014. When we compile the responses, we’ll remove any personal identifiers like names and e-mail addresses and only use de-identified comments.

If you have any questions about the RFI or the transition committees, please let me know.

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Protein Structure Initiative Transition Planning Committees

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Shortly after NIGMS Director Jon Lorsch announced plans to sunset the Protein Structure Initiative after the completion of the PSI:Biology phase in 2015, he commissioned two committees to determine what unique resources and capabilities developed during the PSI should be preserved and how that should be done. The committees, which are working together, held their first meetings in December and expect to present their recommendations within the year.

The external committee, which includes practitioners of structural biology and biomedical researchers who use structural biology data and resources in their work, will primarily focus on community needs. It also will suggest emerging challenges and opportunities in structural biology.

The internal committee, which is composed of NIH staff, will focus on how to implement the priorities identified by the external committee. The group includes a member from each NIGMS scientific division as well as several representatives from other NIH institutes who have experience managing structural biology and large, complex research programs.

The work of these committees will help define how we can provide continued access to important structural biology resources and identify new directions for technology development with potential for broad biomedical impact.

As Jon wrote in a Feedback Loop post about bolstering support for investigator-initiated research and as also reported in a Nature news article, the decision to sunset a large set-aside program that has received substantial investments, such as the PSI, should not be interpreted as a lack of support for team science. Multidisciplinary collaborations are likely to become increasingly important as we delve deeper into complex biological problems, and we will continue to sponsor team approaches to biomedical research. We also remain committed to supporting structural biology research through investigator-initiated grant mechanisms, innovative technology development and access to critical resources.

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Give Input on Training Activities Relevant to Data Reproducibility

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Data reproducibility is getting a lot of attention in the scientific community, and NIH is among those seeking to address the issue Link to external web site. At NIGMS, one area we’re focusing on is the needs and opportunities for training in areas relevant to improving data reproducibility in biomedical research. We just issued a request for information to gather input on activities that already exist or are planned as well as on crucial needs that an NIGMS program should address.

I strongly encourage you and your colleagues to submit comments by the February 28 deadline (no longer available). The information will assist us in shaping a program of small grants to support the design and development of exportable training modules tailored for graduate students, postdoctoral students and beginning investigators.

UPDATE: NIGMS and additional NIH components have issued the Training Modules to Enhance Data Reproducibility (R25) funding opportunity announcement. The application deadline is November 20.

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NIGMS Training, Workforce Development, and Diversity Division Director Clif Poodry Retires

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Clifton Poodry, Ph.D.Clifton “Clif” Poodry, Ph.D., director of the NIGMS Division of Training, Workforce Development, and Diversity, retired earlier this month. Although he’s left federal service, Clif is continuing to pursue his long-held interest in improving science education as a senior fellow at the Howard Hughes Medical Institute.

Throughout his nearly 20 years at NIGMS, Clif championed—and in many cases, led—activities to build the biomedical research workforce of the future. This included initiatives for training and mentoring students from groups that are underrepresented in biomedical and behavioral research and advising on NIH-wide programs, such as the newly announced Building Infrastructure Leading to Diversity program.

Clif has long been committed to using scientific approaches to understand interventions that promote interest in and pursuit of research careers. He consistently encouraged staff and colleagues to read the scientific literature on training and workforce diversity in order to develop a better understanding of biomedical workforce issues and challenges so that we could create and/or modify programs accordingly.

Clif’s long and distinguished career includes time as a biology professor, department chair, associate vice-chancellor for student affairs, and NIGMS grantee at the University of California, Santa Cruz. In the early 1980s, he served a 2-year stint at the National Science Foundation, where he helped create a program that later became a model for the NIH diversity supplement program.

Clif is a great and natural mentor who has touched the lives of numerous students and colleagues across the country, as well as those of us here at NIGMS and NIH. Many of those he mentored have gone on to positions in academia, government and the private sector.

Clif has had a huge impact in many areas, including the education and training of students from underrepresented groups, and we look forward to building on his legacy.

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Judith Greenberg Named Acting Deputy Director of NIGMS

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Photo of Dr. Judith GreenbergI am pleased to tell you that Judith Greenberg has agreed to serve as acting deputy director of NIGMS while a search for a permanent deputy director takes place. A news announcement on her appointment is posted at http://www.nigms.nih.gov/News/Results/pages/
20131024a.aspx.

As most of you know, Judith has served in numerous leadership roles at NIGMS and NIH, including two stints as NIGMS acting director.

In her new role, Judith will provide advice and expertise on all Institute activities. She will also continue to serve as director of the Division of Genetics and Developmental Biology, a position she has held since 1988.

Once the job announcement for a permanent deputy director is posted, I will be sure to alert you via this blog.

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Resumption of NIH Extramural Activities

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One of the biggest challenges facing NIH after the government shutdown is that it occurred during a peak review period and caused the cancellation of several hundred peer review meetings. On October 22, NIH announced that most of these meetings would be rescheduled so as to minimize the disruption of the submission/review/Council/award timeline.

While NIH may not be able to preserve the timeline for all applications, at this point, it looks as though most will still go to January 2014 council meetings. More details are available in a new NIH Guide notice.

Most of the study sections run by the NIGMS Office of Scientific Review were not affected by the shutdown and will proceed as planned over the next few weeks. While a few meetings will have to be rescheduled, we expect the results of the rescheduled meetings to be available in time for our January council meeting.

The other big challenge facing NIH and the extramural community is the disruption in the application process, since funding opportunity announcements (FOAs) could not be accessed and applications could not be submitted during the shutdown. NIH has rescheduled the submission dates that were lost and extended the dates for those FOAs that were adversely affected. More details are available in the same NIH Guide notice.

Sally Rockey’s blog provides more on NIH’s efforts to minimize the disruption of the shutdown’s effects on the extramural community.

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Enabling Science through Data (Big and Otherwise)

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NIH’s recent focus on data-intensive and data-driven biomedical research makes this an exciting time for me to be joining NIGMS and leading its Division of Biomedical Technology, Bioinformatics, and Computational Biology (BBCB).

New steps toward harnessing the power of data began well before my arrival and include the NIH Big Data to Knowledge (BD2K) initiative. The overarching aim of this initiative is to enable, by the end of this decade, a “quantum leap” in the ability of the biomedical and behavioral research enterprise to use the growing volume of complex data to produce important insights into biological systems. This is an ambitious goal that requires the collective engagement and expertise of NIH’s many institutes, centers, and offices, including NIGMS, as well as the scientific community.

My colleagues from across NIH have already come together to discuss future solutions that will benefit NIH and the research community as a whole. We recognize that no one-size-fits-all solution will emerge as the “data quantum leap.” Our hope is that by engaging academic, industrial and other biomedical stakeholders, we will impact the volume, variety, velocity, viability and ultimately value of the data that NIH invests in.

To jumpstart this activity, NIH recently issued a new funding opportunity announcement (FOA) for Centers of Excellence for Big Data Computing in the Biomedical Sciences. The purpose is to establish an interactive consortium of centers that will develop approaches, methods and software tools for the aggregation, integration, analysis and visualization of data across NIH-funded research areas. NIH also has issued a request for information on the development of analysis methods and software for big data; responses are due by September 6.

NIGMS and the BBCB staff were actively involved in crafting the new FOA and, more generally, have played a central role in the creation and organization of the BD2K initiative. We will continue to be active partners in this endeavor.

Big data is just one example of the division’s efforts. We foster research in a range of fields, including computational biology, bioinformatics, mathematical and statistical biology, and biomedical technology development. We also support programs that train people in many of these areas.

I’m so happy to be involved in shaping the division’s activities, and I look forward to working together with many of you to continue innovating basic biomedical research.