Sharpening Your Focus: Tips on Grant Proposal Preparation

We shared information about ORCID (Open Researcher and Contributor Identification) in Sharpening Your Focus, NIH & ORCID: Connecting Productivity back in December of 2017. To review, ORCID iDs are unique, persistent digital identifiers that distinguish individual investigators, and connect researchers with their contributions across changes in names, location, and institutional affiliation.

Why are we revisiting this now? The NIH recently announced that beginning with grant receipt dates on or after January 25, 2020, applicants for individual fellowship and career development awards, including F and K mechanisms, will be required to have an ORCID iD. This requirement has been established to simplify applicant reporting, including improving tracking of career outcomes.

Therefore, for applications submitted on or after the January 25, 2020 deadline, prospective applicants must link their eRA profile to an existing ORCID account, or create an ORCID account and link it to their eRA profile. Applications that do not include a linked ORCID iD will NOT be accepted.

There are resources that can help you prepare for this requirement. The University of Michigan Library offers a guide with detailed information about ORCID, including guidance about setting up and populating an account. Links to resources are provided below. Don’t forget to mind your Fs and Ks. If you plan to submit a fellowship or career development proposal on or after January 25, 2020, you must have an ORCID iD linked to your eRA profile.

Resources

• NOT-OD-19-109
• U-M Library
• Open Mike
• ORCID

This article was written by MaryJo Banasik, J.D., Ph.D., Research Development Specialist.

You have identified a funding opportunity, and you have planned an innovative and exciting research project that you wish to pursue with a key collaborator. How do you know if a multiple-PI application is the right choice for you?

The decision to submit or participate in a multiple-PI application is up to the institution and to the individual investigators. The National Institutes of Health (NIH) intended the multiple-PI option to encourage collaboration among equals when this is the best way to address the scientific problem at hand. The NIH views all PIs equally, with shared responsibility to complete project goals. However, the PI who is listed first in the application will be recognized as the “Contact” PI who will be the main point of contact for communications between the agency and the leadership team.

If you think a multiple-PI application may be best for your project, you will want to keep the following in mind:

• You will need to complete a Multiple PI Leadership Plan describing the roles and areas of responsibility of the named PIs.
• Early Stage Investigator (ESI) and or New Investigator policies will only apply to applications where all PIs qualify as ESIs or New Investigators.

If you are unsure about whether you should submit a multiple-PI application, you are encouraged to contact your program officer to discuss whether this option is appropriate for your project.

Resources

• NIH – Multiple Principal Investigators
• NIH Frequently Asked Questions: Multiple Principal Investigators

If your NIH grant is eligible for renewal (R03s and R21s are not, for example, but many R01s are—check the FOA and talk a program officer), you will want to start planning your application well before you start running out of funding. Consider whether it makes sense to continue with the same long-term goal you began (science evolves, after all) and whether your overarching research question is still as significant as it was when you submitted your original proposal.

A successful renewal will offer new specific aims (and, often, a new title) toward an existing long-term goal—you should have made progress in the first 3-4 years of your grant and be ready to build on your work. A renewal is not about continuing the same work, nor about the fact that you did not finish your original work.

Consider a renewal application if you have found something novel in your previous project that warrants next steps; have found a new way to look at an old problem; or have a new collaborator that enables a new direction. As with any proposal, make sure you know the current literature. And even if you are submitting a proposal in the same field as before, a project that describes a new long-term goal will likely be a new application, not a renewal.

Keep in mind: reviewers will know your work by now and judge your proposal in relation to your previous research and the impact you’ve made on your field. They will consider your record of productivity, publications and new data and know if you’ve made meaningful progress.

Resources:

• NIAID: Apply for a Renewal
• Open Mike: Grant Renewal Success Rates

Based on feedback and outcomes from two years of implementation, NIH has revamped its Rigor & Reproducibility website to clarify requirements, reflect updated policies and provide expanded resources to support researchers.

Importantly, language in application instructions and review criteria has been updated to address some confusion around the term “scientific premise.” NIH intended this term to signify “rigor of prior research,” not only the hypothesis or rationale for the project. For applications due on and after January 25, 2019, the term “rigor of prior research” will replace “scientific premise” in the Significance section of most proposals. In that section investigators should describe the strengths and weakness of previous studies that serve as key support for the current proposal (e.g., failure to consider biological variables, inappropriate sample sizes, etc.); in the Approach section they should detail plans to address those weaknesses.

The improved NIH site is organized into four sub-pages, so researchers can quickly navigate to the information they need. Enhanced resources include guidance on authentication plans, pre-clinical animal model design, and calculating sample sizes, among other things. There are training videos, as well as a new podcast on Rigor, Reproducibility and Transparency in Research.

Resources:

• NIH Rigor & Reproducibility website
• Training and Other Resources
• Experimental Design Assistant (pre-clinical studies)
• UMMS Rigor & Reproducibility website

It has been two years since the National Institutes of Health (NIH) implemented standards to increase the reproducibility and transparency of NIH-funded research. Dr. Michael Lauer, Deputy Director for Extramural Research, recently used his “Open Mike” blog to promote the comprehensive resources that exist to help researchers develop better proposals and to describe how NIH is planning to further support investigators.

There are clarifications forthcoming around Scientific Premise, one of the four pillars of the 2016 Enhancing Reproducibility policy; this one addresses prior research (i.e., studies on which the proposed project is founded). A previous study, for example, might have failed to consider biological variables like sex, or might have had an inappropriate sample size. For grant applications due in January 2019, guide notices will specify use of the Significance section for describing strengths and weaknesses of prior research that serves as key support for the current proposal. In Approach, researchers should describe plans to address weaknesses in the rigor of previous work.

Additionally, NIH hopes to share examples of particularly strong Authentication of Key Resources plans and keep us updated on pilot programs to integrate rigorous experimental design and transparency in pre-doctoral training programs. The agency will continue to assess needs of researchers in meeting proposal guidelines toward robust scientific practice.

Resources:

• NIH Rigor & Reproducibility website
• Training modules for Data Reproducibility
• Experimental Design Assistant (pre-clinical studies)
• UMMS Rigor & Reproducibility website

NIH resubmissions (A1s) require a 1-page introduction that carefully summarizes changes in the revised proposal. Demanding precision, confidence, and tact, the letter is a balancing act - and arguably the most important section of a resubmitted application.

Scientific clarity is often the easy part; being politic can be the challenge. If you disagree with your reviewers' critiques, you must still be gracious in your response. If the tone of your introduction can be read as insincere, incredulous, obstinate, or dismissive, your proposal will not likely be re-reviewed favorably.

Suggestions for drafting an effective introduction:

• Acknowledge reviewers' efforts and how your project will benefit from their insight
  • E.g., "We want to thank the reviewers for their many positive comments...," "We are pleased the reviewers recognized..."
• Summarize substantial additions, deletions, and changes in the revision
• Organize points by section, if appropriate (e.g., from Specific Aims to Significance to Innovation to Approach, etc.)
• Respond point by point to reviewers' major comments; you can paraphrase or condense original comments for reference
  • If you agree with reviewers: change your proposal accordingly and refer to that section in your revised proposal
  • If you disagree, explain why (be respectful, not defensive or flippant) and/or provide additional rationale
    • E.g., if the critique states, "There is a lack of established collaboration between members of the research team," respond, "Research collaborations are now highlighted in Personal Statements of the biosketches."
• Have an objective reader vet the introduction for tone and clarity prior to resubmission!

For further examples and information:

• UMMS Grant Proposal Sampler (e.g., Dewaraja, Hershenson, Moore, Varani)
• NIH Resubmission Applications
• NIAID Resubmissions & Samples

The non-profit organization ORCID (Open Researcher and Contributor Identification) has been working to help researchers streamline the collection and connection of their professional activities for application, manuscript, and biosketch purposes. The system creates a "personal digital identifier" that distinguishes researchers from those with similar names, links investigators to their specific outputs, and ensures researchers get credit for their work. More than 7,000 journals currently include ORCID in their workflows, and ORCID's user base is now 10 times larger than NIH's eRA Commons system.

To further reduce the burden of curating the same biographical and professional data in many places, NIH has expanded its partnership with ORCID. While researchers have been able to link their ORCID with SciENcv (Science Expert Network Curriculum Vitae) to create a biosketch, they can now use a real-time link to associate ORCID with their eRA accounts. 

The functionality of this connection is intended to grow, eventually allowing ORCID to populate NIH applications and reporting requirements, and allowing public data on NIH grant awards to populate ORCID.

The two organizations also will partner on ORBIT (ORCID Reducing Burden and Improving Impact Tracking), an effort to expand the ORCID hub to include all products and activities found on typical CVs, such as grants, teaching, presentations, etc.

More information:

• U-M Library resource
• Open Mike
• ORCID

Next Generation: Toward addressing a hypercompetitive funding climate and increasing chances for young researchers to stabilize their career trajectories, NIH has released policies to support the Next Generation of Researchers Initiative (PAR-17-101). These steps are intended to help early stage investigators achieve independence and help them maintain funding in their early careers. Junior scientists have been able to claim Early Stage Investigator (ESI) status to have funding priority for R01-equivalents, but NIH is allotting more money for ESIs and plans to fund 200 more in FY17 than in FY16.

Additionally, NIH has added priority for EEIs, or Early Established Investigators. EEIs are defined as a PD/PI who is within 10 years of receiving their first R01-equivalents as an ESI. An EEI may be prioritized for funding if the EEI has lost or is at risk for losing all NIH research support, or if the EEI is supported by only one active award.

Team Science: NIH's National Institute for General Medical Sciences (NIGMS) has announced the new RM1 funding opportunity for highly integrated teams of researchers - the Collaborative Program Grant for Multidisciplinary Teams (PAR-17-340). The RM1 grant is aimed at highly integrated teams of three to six PD/PIs who have "considerable synergy." The mechanism differs from a P01 in that the goals should not be achievable by a collection of individual projects, but advances a significant, far-reaching objective that can only be accomplished with an interdependent, multidisciplinary team of collaborators.Deadlines for this opportunity are January 25 and May 25, 2018.

To assist with planning complex projects like the RM1, the UMMS Office of Research offers up to $10,000 for preparation of large-scale proposals.
 

In 2015, NIH's National Institute of General Medical Sciences (NIGMS) began piloting an R35 funding mechanism called the Maximizing Investigators' Research Award (MIRA). After assessing MIRA for 2 years, the institute is broadening the program and intends eventually to shift most of its R01-type awards to renewable R35 MIRAs.

The MIRA award differs from an R01 because it funds an investigator's research program instead of a single years-long project. The MIRA is meant to increase efficiency and efficacy of NIGMS funding by increasing flexibility for investigators-the stability of funding allows them to follow new research directions as opportunities arise in the lab (rather than binding them to proposed specific aims)-i.e., they can go where the science takes them. NIGMS hopes this mechanism will increase innovation and important breakthroughs as investigators take on more ambitious, high-risk, and creative projects. The R35 will more widely distribute funding among talented and promising researchers, and enable investigators to devote less time to writing grants and more time to conducting research and mentoring junior scientists.

PAR-17-094 is restricted to investigators who have at least one R01 equivalent from NIGMS; upcoming deadlines are May 17, 2017, and January 17, 2018. Applications may request up to $750,000 direct costs per year (up to 5 years); awards generally will be commensurate with a PI's average NIGMS research funding over the past few years. 

The FOA for early career investigators is PAR-17-190; the annual deadline is October 3. Budgets are capped at $250,000 direct costs per year (up to five years). In August, NIGMS reported a 29.1% success rate for early stage investigator MIRAs.

More information: MIRA R35
MIRA Webinar with NIGMS Director
NIGMS: overview of research divisions

A new NIH policy will eliminate almost all appendix materials for proposals submitted to NIH, AHRQ, and NIOSH on or after January 25, 2017.

Appendices have not been prohibited in the past, but investigators were instructed not to use appendix materials to circumvent proposal page limits, i.e., append details that should have been included in the Research Plan. This new policy aims to enhance fairness in peer review and limit the burden on reviewers; eliminating most appendix materials is "intended to rectify inequities...that can arise from submission of inappropriate or excessive appendix materials."

Beginning January 25, 2017, only the below appendix materials will be allowed.

For applications involving clinical trials:

• Clinical trial protocols
• Investigators' brochure from Investigational New Drug (IND), as appropriate

For all applications: 

• Blank informed consent forms 
• Blank surveys, questionnaires, data collection instruments 
• FOA-specified items

Per NIH guidelines, always defer to individual FOA instructions, the details of which override general notices. In other words, if appendix materials are required per FOA instructions, applications that are missing those documents will be considered incomplete and will not be reviewed.

NOT-OD-16-129

The National Institutes of Health (NIH)'s 2016 Rigor & Reproducibility criteria require a new attachment to the updated SF424 form (soon to be FORMS-D). This document, called "Authentication of Key Biological and/or Chemical Resources," asks researchers to detail plans for authenticating resources that are integral to the proposed research -- resources that may differ from lab to lab (or over time), or have qualities that might influence results. Those resources include (but are not limited to) cell lines, specialty chemicals, reagents, antibodies, or other biologics.

According to NIH instructions, the document should be brief -- a page or less -- and should be limited to an investigator's plans to authenticate during the course of the project (not the actual results or data of resources already authenticated). Examples include plans to use flow cytometry or immunohistochemistry to identify primary cell lines, or using western blot analysis for antibody specificity.

Study section members will be asked to review this document, but at this point it will not affect impact scores. They may follow up with questions if more information is needed on meritorious proposals.

The challenge, NIH has acknowledged, is that there is a lack of standards and best practices for authenticating some of the relevant resources. It is a hope that this push toward transparency and detailed reporting of practices will build a consensus in the research community around best practices for authenticating critical scientific resources.

For more information:

• Medical School Office of Research's Rigor & Reproducibility website
• NIH FAQs
• Open Mike: "Authentication of Key Biological and/or Chemical Resources in NIH Grant Applications"

There are many questions regarding how to address the National Institutes of Health (NIH)'s enhanced attention to rigor and reproducibility in new grant applications. Updated proposal requirements aim to strengthen scientific foundations and foster integrity of research, ensuring that investigators provide enough detail that other researchers can replicate and build on results. In other words, if outcomes cannot be successfully reproduced, how sound was the scientific premise?

The NIH defines scientific rigor as "the strict application of the scientific method to ensure robust and unbiased experimental design, methodology, analysis, interpretation and reporting of results." There is an expectation of transparency in reporting experimental details so that others may reproduce the findings under controlled conditions.

How to incorporate these new criteria into proposals:

• Significance: Describe the strengths and weaknesses of prior research being cited; consideration of strengths and weaknesses might include attention to rigor of previous experimental designs, as well as a discussion of relevant biological variables and authentication of key resources.
• Approach: Be as detailed as possible when describing research design and proposed methods. Address how 
• you will achieve robust and unbiased results. Provide enough detail that the research could be replicated.
• Biological Variables: Toward rigor and transparency, research plans should address sex and other biological variables, including strong justification from literature, preliminary data, or other sources for studying only one sex (or which biological variables are tested/controlled). Justify any exclusion of variables that may be relevant but are not considered in the research plan.

For more information on this and Authentication of Key Biological and/or Chemical Resources:

• Updated Application Instructions to Enhance Rigor & Reproducibility
• Rigor & Reproducibility FAQs
• NIH Rigor & Reproducibility

The National Institutes of Health (NIH) recently announced several changes to 2016 grant application policies, instructions and forms. The changes will take place in two phases:

• Phase I will apply to proposals submitted on or after January 25, 2016;
• Phase II will apply on or after May 25, 2016.

For Phase I details, please see the November 2015 Sharpening Your Focus article (listed above).
 
Phase II implementation further extends changes, incorporating updated application forms (FORMS-D). The current application packages (FORMS-C) will expire after the May 7 AIDS due date.
 
Towards "Rigor and Transparency" -- the effort to enhance reproducibility of scientific findings -- updated application forms will include an attachment for the new "Authentication of Key Biological and/or Chemical Resources" document. Additionally, PHS 398 Research Training Program Plans will require a new "Plan for the Instruction in Methods for Enhancing Reproducibility."
 
Other policy and application changes are as follows:

• The Vertebrate Animals section will add questions regarding euthanasia and will apply to all proposals in Phase II. (NOT-OD-16-006)
• The "Data Safety Monitoring Plan," required for clinical trials proposals, must be attached separately in the new forms.
• Research Training tables will be reduced from 12 to 8 tables, individual-level reporting will be minimized, and tracking of trainee outcomes will be extended to 15 years; NIH's new xTRACT system will help applicants prepare the new tables. (NOT-OD-16-007)
• Applicants will make assignment and peer review requests through the new PHS Assignment Request form. (NOT-OD-16-008)
• Clarification of some biosketch instructions include: URLs for publication lists must link to government websites (e.g., My Bibliography); publications may be cited in both Personal Statement and Contributions to Science; graphics, figures, and tables are not allowed in any section.
• New NIH flexibility on fonts. (NOT-OD-16-009)

Review these resources for more information:

• NOT-OD-16-004
• NOT-OD-16-011
• NOT-OD-16-012
• Rigor and Reproducibility FAQs
• Form Updates 2016 FAQs

The National Institutes of Health (NIH) recently announced several changes to 2016 grant application policies, instructions, and forms. The changes will take place in two phases:

• Phase I will apply to proposals submitted on or after January 25, 2016;
• Phase II will apply on or after May 25, 2016. 

The most significant Phase I changes address "Rigor and Transparency" of research strategies for NIH and Agency for Healthcare Research and Quality (AHRQ) proposals. In order to enhance reproducibility of scientific findings, investigators must augment two standard sections of the research plan as follows: 

• Significance: "Describe the scientific premise for the proposed project, including consideration of the strengths and weaknesses of published research or preliminary data crucial to the support of your application."
• Approach: "Describe the experimental design and methods proposed and how they will achieve robust and unbiased results. Explain how relevant biological variables, such as sex, are factored into research designs and analyses for studies in vertebrate animals and humans. For example, strong justification from the scientific literature, preliminary data, or other relevant considerations, must be provided for applications proposing to study only one sex."

Additionally, a new PDF attachment, called Authentication of Key Biological and/or Chemical Resources, will be required. Because key resources may differ between labs or over time, have qualities that influence research data, and are integral to proposed research, researchers should describe methods that identify and validate these resources (examples include, but are not limited to, cell lines, specialty chemicals, antibodies, and other biologics).
 
Reviewers will be asked to assess these additional requirements after January 25, 2016. Research Performance Progress Reports submitted after that date should also "emphasize rigorous approaches taken to ensure robust and unbiased results."
 
Other Phase I changes include:

• Simplification of Vertebrate Animals documents;
• Redefinition of "child" from 21 to 18 years of age; and
• Updates to PHS 398 Research Training Program Plan forms.

Review these resources for more information:

• NIH Extramural Nexus Newsletter
• NOT-OD-16-004
• NOT-OD-16-011
• NOT-OD-16-012
• Rigor and Reproducibility FAQs

The Significance section of a National Institutes of Health (NIH) R01 proposal is critical to the probability of funding -- after Approach, that section correlates highest to successful impact scores. Significance is up front; it makes your case; and it has the potential to win or lose the attention of reviewers.

NIH uses the following questions to spur thinking about Significance: 

• Does the project address an important problem or a critical barrier to progress in the field?
• If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?
• How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? 

In simpler terms, Significance answers the "So What?" of your proposed work. Why is it important? What is the impact? Whom does it affect? How does it advance your field?

For an R01 proposal, aim for 1-2 pages for this section. Describe the field as it stands; indicate that you are familiar with current research in the field, and aware of existing gaps, opportunities, and roadblocks. Include your preliminary data and long-term research plans.

Take time to scan the roster of your study section members and customize content accordingly. Consider citing their work, when appropriate. Conversely, the further removed reviewers are from your field, the more basic (and clear) information you need to provide on the science, importance, and latest findings relevant to your research.

Finally and importantly, strive to point out your work's significance throughout the application.

For more information check out these helpful resources:

• Writing Your Application from the NIH
• View the UMMS Grant Proposal Sampler for additional insight on proposal writing and development

Last year, the National Institutes of Health (NIH) updated its resubmission policy in response to researchers' fears that too many meritorious proposals were deemed ineligible by a two-strike system; until 2014, applicants were forced to overhaul ideas significantly before submitting new proposals.

The updated policy essentially allows for unlimited resubmissions: if an A1 (revised, resubmitted) application proves unsuccessful, researchers may resubmit the idea as an A0 (new application) without substantially changing content or scope. NIH hopes that increased feedback means increased strength, feasibility, and fundability of proposals.

It also means options. Read summary statements carefully. Minor revisions and clarifications warrant an A1 resubmission, but extensive overhauls may justify an A0.

Duplicate or highly overlapping applications are still prohibited; additionally, researchers may not submit A1s before A0 summary statements come back. But, A1s are not required before resubmitting (improved) ideas as A0s.

Compare options below:

For more information, please visit the NIH's Resubmission Frequently Asked Questions page.

Starting Monday, May 25, the National Institutes of Health (NIH) will require a new Biosketch format that uses short narratives to highlight what researchers have specifically accomplished in their fields.

Sally Rockey, NIH Deputy Director for Extramural Research, notes in her blog that the new qualitative format provides researchers -- especially early investigators -- "a platform for describing and framing the significance of their contributions" that will allow reviewers to better understand bodies of work.

What's New?
Under the section "Contributions to Science," investigators may describe up to five ways their work has influenced and advanced their fields. Each narrative may be annotated by up to four publications. Investigators should detail their most significant contributions and respective impacts, as well as what role they played in the research. The format also allows links to online bibliographies, and a new five-page limit.

What Now?
Reviewers will use "Contributions" to identify candidates with the strongest potential for success. This is a vital opportunity to showcase the highpoints of scientific résumés and emphasize capabilities.

Start crafting yours today:

• Take inventory of your publications/projects. Group and rank them by significance.
• Consider constructing titles for each entry that summarize/highlight importance and leave good first impressions.
• If applicable, note in narratives how many citations publications have received to show who has been building on your work.
• Have colleagues (mentors, staff) review/edit the section before your next proposal submission! 

Review the SF424 Application Format Pages to learn more. 

Click here to view the PDF.

Click here to view the PDF.

Click here to view the PDF.

Click here to view the PDF.