Category: Research Administration

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Heads-up: New Application Forms for Human Subjects Research

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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.

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

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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

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Heads-up: FORMS-E Coming Soon

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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.

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Five MIRA Myths

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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.

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

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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.

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Transfer of Science Education Partnership Awards to NIGMS

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I’m pleased to announce that NIGMS is the new home for the Science Education Partnership Awards (SEPA). These awards, which were transferred from NIH’s Division of Program Coordination, Planning, and Strategic Initiatives, support research and educational activities that complement other workforce diversity and training programs within NIH mission areas. The change will allow the SEPA program to be better integrated with other NIGMS capacity-building and research training programs and will increase opportunities for synergies between them.

The SEPA program promotes partnerships between biomedical and clinical researchers and pre-kindergarten to grade 12 teachers and schools, museums and science centers, and other educational organizations. In addition, the program provides students from underserved communities with opportunities to learn about research careers; supplies teachers with professional development in science content and teaching skills; and improves community health and science literacy through its science centers and museum exhibits.

SEPA will be housed in our Center for Research Capacity Building (CRCB), which supports research, research training, faculty development and research infrastructure improvements in states that historically have not received significant levels of research funding from NIH. It also supports faculty research development at institutions that have a historical mission focused on serving students from underrepresented groups.

We do not plan to alter the mission or goals of SEPA as a result of the transfer, and the program will continue to be administered by Tony Beck, who has served as its program director since 2001.

If you have any questions about the transfer, please contact Tony Beck or Fred Taylor, acting director of CRCB.

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Why Is It important to Accurately Acknowledge NIGMS Grants in Publications?

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As we’ve pointed out, it’s important to acknowledge your NIH funding in all your publications, including research articles, press releases and other documents about NIH-supported research. Your Notice of Award includes information about such acknowledgements (also see Requirements for Acknowledging NIH-Supported Research and Attribution of NIH/NIGMS Support).

If you have more than one NIGMS or NIH award, you should only cite the grant(s) that supported the research described in the publication. The specific aims should be the determining factor. This would apply even in cases where one of the authors on the article (e.g., a technician) works on multiple projects and is paid through multiple grants, or when equipment used in the reported work was purchased on a different grant.

Acknowledging multiple awards in a publication may be taken as an indicator of scientific overlap among the cited projects. This becomes important when your next application is being considered by reviewers, NIGMS Advisory Council members and NIGMS staff. For example, when considering support of research in well-funded laboratories, our Advisory Council expects the Institute to support projects only if they are highly promising and distinct from other funded work in the laboratory.

So, please take a moment to make sure that you are citing your grants accurately in your publications and avoid pitfalls when you send in your next application.

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Five Reasons to Submit a Cover Letter with Your Grant Application

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I recently attended a scientific meeting where I had the opportunity to talk with investigators at all stages of their scientific careers. I was surprised to learn that many didn’t know that they could submit a cover letter with their electronic grant application. Here I briefly explain some reasons to provide a cover letter, including situations that require one.

1. Suggest a particular review group for your application.

The NIH Center for Scientific Review (CSR) assigns applications to scientific review groups (SRGs), but sometimes an application could be a scientific match for more than one study section. In a cover letter, you can request assignment to a particular study section and explain why you think that study section would be the best fit. Appropriate assignment requests are honored in the majority of cases. Study section descriptions, recent study section rosters and the NIH RePORTER database of funded grants can help you identify an SRG suitable for your application.

2. Suggest a particular institute or center (IC) for funding your research.

Your research might be relevant to the mission of more than one NIH IC. You can use a cover letter to suggest that your application be assigned to a specific IC. The NIH RePORTER database is a good place to investigate the types of research supported by different ICs. Before making a request in a cover letter, you should also consult with program officers at the IC to determine whether your application would be an appropriate scientific match.

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Talking to NIH Staff About Your Application and Grant: Who, What, When, Why and How

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Update: Revised content in this post is available on the NIGMS webpage, Talking to NIH Staff About Your Application and Grant.

During the life of your application and grant, you’re likely to interact with a number of NIH staff members. Who’s the right person to contact—and when and for what? Here are some of the answers I shared during a presentation on communicating effectively with NIH at the American Crystallographic Association annual meeting. The audience was primarily grad students, postdocs and junior faculty interested in learning more about the NIH funding process.

Who?

The three main groups involved in the application and award processes—program officers (POs), scientific review officers (SROs) and grants management specialists (GMSs)—have largely non-overlapping responsibilities. POs advise investigators on applying for grants, help them understand their summary statements and provide guidance on managing their awards. They also play a leading role in making funding decisions. Once NIH’s Center for Scientific Review (CSR) assigns applications to the appropriate institute or center and study section, SROs identify, recruit and assign reviewers to applications; run study section meetings; and produce summary statements following the meetings. GMSs manage financial aspects of grant awards and ensure that administrative requirements are met before issuing a notice of award.

How do you identify the right institute or center, study section and program officer for a new application? Some of the more common ways include asking colleagues for advice and looking at the funding sources listed in the acknowledgements section of publications closely related to your project. NIH RePORTER is another good way to find the names of POs and study sections for funded applications. Finally, CSR has information on study sections, and individual institute and center websites, including ours, list contacts by research area. We list other types of contact information on our website, as well.

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New Biosketch Formats for Applications Due May 25 and Later

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Sample biosketch
See sample biosketches: predoctoral, postdoctoral, general.

With several training and other grant application receipt dates right around the corner, I want to be sure you know that all competing and noncompeting applications submitted for due dates on or after May 25 must use a new biosketch format.

There are two versions of the biosketch:

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