RFI on Reagent-Related Barriers to Reproducible Research; FOAs for Administrative Supplements for Research on Sex/Gender Differences, Regional Consortia for High Resolution Cryoelectron Microscopy; Notice on Biomedical Technology Research Resource Application Due Dates

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
(NOT-OD-15-020)

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)
(PA-15-034)

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)
(RFA-GM-16-001)

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)"
(NOT-GM-14-136)

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

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

NIGMS Advisory Council meetingAt last week’s Advisory Council meeting, I presented a report on the comments we received in response to our request for information (RFI) on a potential new program for research funding.

As described in the blog post announcing the RFI, the Maximizing Investigators’ Research Award (MIRA) program would provide a single award in support of all of the projects in an investigator’s lab that are relevant to the NIGMS mission. A MIRA would be longer and larger than the current average NIGMS R01 award.

We received more than 290 responses through the official RFI comment site. We heard from individual investigators as well as several scientific organizations. Most of the responses were positive, and both established and early stage investigators indicated that they were very likely to apply.

The respondents identified the most valuable aspects of the proposed program as:

  • Increased flexibility to follow new research directions as opportunities and ideas arise,
  • Savings of time and effort currently spent on writing and reviewing applications, and
  • Enhanced stability of research support.

However, some responses expressed concerns, which we are taking into consideration. Despite the intention of the program to optimize the distribution of NIGMS resources, some respondents thought that it could lead to funds becoming concentrated in fewer labs at the most elite institutions. This was in part a reflection of the phased implementation plan, which would focus initially on investigators with more than one NIGMS grant. Respondents urged NIGMS to broaden the eligibility criteria as quickly as possible following the initial pilot phase. Other concerns that were raised related to peer review and program evaluation.

For more about the RFI results, including a breakdown of responses by question, watch my presentation, which begins at 2:18 on the archived videocast.

The Advisory Council discussed the MIRA proposal and then approved plans to proceed with developing the program. We plan to issue a funding opportunity announcement in early 2015, with the first awards being made in Fiscal Year 2016. We intend to evaluate the MIRA program and if it is successful, will broaden it.

Wanted: Input on Consideration of Sex as a Biological Variable in Biomedical Research

Although researchers have made major progress in achieving a balance between male and female subjects in human studies—women now account for roughly half of the participants in NIH-funded clinical trials—a similar pattern has not been seen in pre-clinical research involving animals and cells. To inform the development of policies that address this issue, NIH has issued a request for information (RFI) on the consideration of sex as a biological variable in biomedical research.

As NIH Deputy Director for Extramural Research Sally Rockey wrote in a recent blog post announcing the RFI, “Sex is a critical variable when trying to understand the biological and behavioral systems that fundamentally shape human health.” Appropriate representation of animals and cells is also relevant to NIGMS and NIH efforts to enhance scientific rigor and data reproducibility in research.

And in her own blog post about the RFI, NIH Associate Director for Research on Women’s Health Janine Clayton said that while many scientists have already expressed support for the policy change, she has also heard from many sources that it needs “to be carefully implemented, as a true benefit to science—and not become a trivial, bureaucratic box to check.” She noted that comments in response to the RFI will guide NIH in creating “meaningful change in a deliberate and thoughtful way.”

Since NIGMS supports a significant amount of basic biomedical science that utilizes animal models and cells, we encourage our grantees to submit their input on this topic by the October 13 deadline.

UPDATE: The deadline for submitting input has been extended to October 24.

Give Us Your Input on NIGMS Strategic Planning

In my first post as NIGMS director, I discussed the need to develop a new strategic plan to guide our efforts to ensure that we invest taxpayer money as efficiently and effectively as possible.

Since the publication of our previous strategic plan, the Institute has gone through some major programmatic, organizational and staffing changes. We’ve worked to rebalance our portfolio and bolster our commitment to investigator-initiated research.

To begin the new strategic planning process, we formed a steering committee and the following subcommittees:

  • Research Funding Policies and Mechanisms
  • Training, Education, Workforce Development and Diversity
  • Capacity Building, Research Resources and Technology
  • Communications and Outreach
  • Management and Business Processes

Each subcommittee developed goals and objectives within its area of responsibility. The steering committee then consolidated this material into a draft statement of broad goals and objectives. As we work on developing our specific strategies and finalizing our plan, we’d like to hear your comments and suggestions.

You may give input using the online form (no longer available), which provides the option to remain anonymous, or via e-mail.

Funding Opportunity to Create Training Modules to Enhance Data Reproducibility

In February, we asked for input on training activities relevant to enhancing data reproducibility, which has become a very serious issue for both basic and clinical research. The responses revealed that there is substantial variation in the training occurring at institutions. One reason is that “best practices” training in skills that influence data reproducibility appears to be largely passed down from generation to generation of scientists working in the laboratory.

To increase the likelihood that researchers generate reproducible, unbiased and properly validated results, NIGMS and nine additional NIH components have issued a funding opportunity announcement to develop, pilot and disseminate training modules to enhance data reproducibility. Appropriate areas for the modules include experimental design, laboratory practices, analysis and reporting of results, and/or the influence of cultural factors such as confirmation bias in hypothesis testing or the scientific rewards system. The modules should be creative, engaging, readily accessible online at no cost and easily incorporated into research training programs for the intended audience, which includes graduate students, postdoctoral fellows and beginning faculty.

The application deadline is November 20, 2014, with letters of intent due by October 20, 2014. Applicants may request up to $150,000 in total costs to cover the entire award period. For more details, read the FAQs.

Give Input on Data-Related Standards Widely Used in Biomedical Science

A current research challenge is harmonizing vast amounts of heterogeneous biological data so that it can be stored, extracted, analyzed, presented and shared in a broad, uniform manner. An important step to overcoming this obstacle is creating data-related standards.

Toward this goal, NIH has issued a request for information (RFI) seeking comments on information resources for data-related standards widely used in biomedical science. Feedback on standards considered most critical, as well as existing relevant resources, could inform plans to develop a publicly available, Web-based information resource on data-related standards.

The deadline for responding to the RFI is September 30, 2014.

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

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

Funding Opportunities: Undiagnosed Diseases Network Gene Function Research, NIH Blueprint Program for Enhancing Neuroscience Diversity; Request for Information: Clinical Questions in Post-Resuscitation Hypothermia

You may be interested in the following announcements:

Undiagnosed Diseases Gene Function Research (R21)
(RFA-RM-14-005)

Purpose: Investigate the underlying genetics, biochemistry and/or pathophysiology of newly diagnosed diseases in association with the respective gene variant(s) identified through the Undiagnosed Diseases Network
Letter of intent due date: May 23, 2014
Application due date: June 23, 2014
NIGMS contact: Donna Krasnewich, 301-594-0943

NIH Blueprint Program for Enhancing Neuroscience Diversity through Undergraduate Research Education Experiences (R25)
(RFA-NS-14-010)

Purpose: Enhance biomedical research workforce diversity through the development of creative educational activities primarily focused on research experiences, skills development courses and mentoring activities
Letter of intent due date: April 28, 2014
Application due date: May 28, 2014
NIH contact: Michelle D. Jones-London, 301-451-7966

Request for Information: Current Clinical Questions in Post-Resuscitation Hypothermia
(NOT-GM-14-112)

Purpose: Provide feedback on the clinical research questions that need to be answered surrounding post-resuscitation therapeutic hypothermia
Response due date: May 30, 2014
Send responses to: Jeremy Brown, 301-594-2755

Give Input on Structural Biology Resource and Infrastructure Needs

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.

Give Input on Training Activities Relevant to Data Reproducibility

Data reproducibility is getting a lot of attention in the scientific community, and NIH is among those seeking to address the issue Exit icon. 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.