NIAID Funding News - October 5, 2016

Feature Articles

Opportunities and Resources

In The News

Advice Corner

New Funding Opportunities

Feature Articles

Maximize Research Funds and Fill Gaps With NIAID Resources

NIAID offers an array of resources to help investigators translate basic research findings into products to diagnose, treat, or prevent immune-mediated and infectious diseases.

Our Tools, Datasets & Services are available to you as an investigator in academia, a nonprofit organization, industry, or government in the United States or worldwide, whether funded by NIH or not.

Resources save you time and money by fulfilling a research need, such as obtaining a reagent, using state-of-the-art analytical tools to examine datasets, or accessing preclinical services. For small businesses especially, NIAID resources can be critical in advancing research.

Though most resources are free, you may need to pay production or shipping and handling costs in some cases. Before placing an order or requesting a service, verify eligibility and cost details on the resource’s website or touch base with the listed point of contact.

How To Find Resources

To identify potential resources, search Tools, Datasets & Services by function—such as bioinformatics or technology transfer and intellectual property—or by NIAID program division. If you cannot find an appropriate resource, ask Institute program staff in your area of science whether we offer the service you’re seeking. For assistance, see When To Contact an NIAID Program Officer.

Explore Your Options

For a sampling of NIAID’s broad range of resources, see the following division-specific lists.

Division of AIDS (DAIDS)

Databases, reagents, efficacy evaluations, and animal models are just some of the available resources; also consult HIV/AIDS Research Resources.

  • Chemical Synthesis, Analytical Chemistry, and Preclinical Services—Offering limited support for academic investigators who are moving products toward FDA licensure, these resources include evaluation of lead compounds and drug candidates in cell culture and animal models, drug formulation, and animal pharmacology and toxicology. To learn more, contact Dr. Joseph Fitzgibbon.
  • Comprehensive Resources for HIV Microbicides and Biomedical Prevention—Obtain preclinical product development services to help advance your promising non-vaccine biomedical prevention product or multipurpose prevention technology into clinical testing. Contact Dr. James Cummins to request access to the following:
    • Preclinical gap-filling services
    • HIV animal models supporting product development
    • Bioanalytical support services
    • Product manufacturing
    • Scientific, quality, and regulatory support services
  • Treatment of HIV Disease In Vivo Efficacy Evaluations—This service evaluates products in humanized mouse efficacy models. To be accepted as a candidate, your product must already demonstrate a potent and selective activity profile against HIV in vitro. Direct inquiries to Dr. Brigitte Sanders.
  • In Vitro Screening Resource for HIV Therapeutics and Topical Microbicides—If your project requires in vitro efficacy testing of anti-HIV therapeutics and topical microbicides, this popular service may be able to help. For details, contact Dr. Roger Miller.
  • Long Acting/Extended Release Antiretroviral Resource Program—Gain access to research results and resources and to subject matter experts in developing longer-acting antiviral drugs. 
  • NIH AIDS Reagent Program—Select from a catalog of critical research reagents and resources that are available at no cost to qualified investigators.
  • Quantitative Viral Outgrowth (QVOA) Service Resource—This new resource offers standardized assays that quantitate latent reservoirs of HIV. Address questions to Dr. Betty Poon.

Division of Allergy, Immunology, and Transplantation (DAIT)

Delve into DAIT’s extensive databases and other highlighted resources below. For more options, see Allergy, Immunology, Transplantation Research Resources.

  • Human Immunology Project Consortium (HIPC)—This network of researchers defines, analyzes, and correlates molecular profiles of varied human immune responses induced by infection or vaccination. Use ImmuneSpace, a data management and analysis engine, to explore and analyze HIPC-generated datasets using advanced computational tools. To learn more, see “Mine Immunology Data on New ImmuneSpace Website” in our February 10, 2016 issue.
  • Immune Epitope Database (IEDB)—Search this heavily used resource for experimental data characterizing antibody and T-cell epitopes studied in humans, nonhuman primates, and other animal species. The IEDB website provides tools to predict and analyze epitopes.
  • Immunological Genome Project (ImmGen)—Participating laboratories generate data on gene expression and its regulation in the immune system of the mouse. You can request individual normalized datasets from ImmGen or download raw datasets from the National Center for Biotechnology Information.
  • Immunology Database and Analysis Portal (ImmPort)—DAIT’s primary database supports the exchange of scientific data in all areas of immunological research. After registering on the portal, gain access to ImmPort’s shared research and clinical data, as well as its analytical tools.
  • Mutagenetix—This database of phenotypes and mutations produced in mice includes links to major repositories from which you can order stocks. See our news article below “Number of Archived Mouse Germline Mutations Jumps Ten-Fold.”
  • NIH Tetramer Core Facility (TCF)—Processing more than 300 requests each month, TCF produces and distributes major histocompatibility complex tetramers and related reagents for detecting T-cell responses to viruses, bacteria, parasites, tumors, auto-antigens, and other model antigens.
  • Nonhuman Primate Reagent Resource (NHP)—For researchers using nonhuman primate models, NHP identifies, develops, characterizes, and produces reagents for monitoring or modulating immune responses.

Division of Microbiology and Infectious Diseases (DMID)

Among the comprehensive resources provided by DMID are reagents, bioinformatics and genomics, and preclinical services to facilitate product development. For a complete listing of DMID’s resources, refer to Microbiology and Infectious Diseases Resources.

  • Animal Models of Infectious Disease—Resources are available to develop and refine animal models, conduct in vivo screening, and perform efficacy testing. Touch base with the appropriate DMID contact to discuss your preliminary data.
  • BEI Resources Repository—Select from a wide array of organisms and reagents to support microbiology and infectious diseases research. This popular repository also provides tools and information.
  • Bioinformatics Resource Centers—Public data repositories provide access to genomic and other diverse data sets generated from NIAID-funded Centers. These Centers provide publicly available datasets, bioinformatics and data analysis tools, and workspaces and training related to the following pathogens, including host-related data:
    • All bacterial species
    • All viral families including influenza virus
    • All eukaryotic pathogen species including fungi
    • Invertebrate vectors of human pathogens
  • Genomic Centers for Infectious Diseases—Participating centers sequence, assemble, and annotate the genomes of microorganisms from the NIAID Emerging Infectious Diseases/Pathogens list, related organisms, and hosts, and support next-generation sequencing and related technologies. In addition to providing high-throughput genomic technologies for sequencing, metagenomics and microbiome analysis, and microbial and targeted human genotyping, the Centers support the development of next-generation sequencing and related genomic technologies.
  • In Vitro Assessment for Antimicrobial Activity—This program tests antimicrobial activity of products against microbial pathogens and vectors, such as the Zika virus. You must have appropriate preliminary data to support advancing the product to be studied.
  • Therapeutics and Vaccine Development—A broad range of services facilitate the preclinical development of therapeutics and vaccines. Services include, but are not limited to, lead identification and development and medicinal chemistry work for therapeutics and safety and toxicity testing, as well as pilot and Current Good Manufacturing Practice manufacture work for vaccines.
  • World Reference Center for Emerging Viruses and Arboviruses (WRCEVA)—Providing reagents and supporting investigations of virus outbreaks across the globe, WRCEVA identifies and characterizes arboviruses and other suspected emerging viruses spread by insects and animals.

Opportunities and Resources

Are You Up for the Challenge...Competition?

A recently announced Challenge Competition could be for you if you can deliver what it seeks: in vitro diagnostic tests that would help health care providers better identify antibiotic-resistant bacteria and make more informed decisions on appropriate antibiotic use and infection prevention.  

The Challenge is cofunded by NIAID and the Biomedical Advanced Research and Development Authority (BARDA) of HHS's Office of the Assistant Secretary for Preparedness and Response.

The Antimicrobial Resistance Diagnostic Challenge* website is administered by Capital Consulting Corporation (CCC).

*Shortened to "Challenge" in this article.

Challenge Steps

In addition to registering and submitting a letter of intent (for more on those, see below), the Challenge has the following steps, as explained in greater detail in the Submission Requirements section on the Challenge website.

In Step 1 (Theoretical), you'll provide a description of your proposed in vitro diagnostic test. See the Participation Requirements. Judges will select semi-finalists to proceed to the next step.

  • Note: You may skip this step and submit an entry for Step 2 as long as you follow the Participation Requirements. By going this route, you miss a chance at being chosen a Step 1 semi-finalist and winning the associated prize amount (see Prize Descriptions, below).

In Step 2 (Delivery of Prototype and Analytical Data), you will submit data and a prototype device that support the ability of your diagnostic device to meet the target product profile for analytical and performance characteristics in nonclinical testing as well as confirm analytical performance.

  • Note: You may still submit for Step 2 if you were not among the Step 1 semi-finalists or, as we mentioned above, you did not submit for Step 1.

If you are a Step 2 semi-finalist, you will proceed to Step 3 (Performance Testing in CLIA-Certified Laboratories) and provide sufficient prototypes and other materials for testing in two independent Clinical Laboratory Improvement Amendments-certified laboratories.

Proposal Information

Proposed in vitro diagnostic tests should:

  • Be novel, innovative, accurate, rapid, and cost-effective.
  • Be appropriate for outpatient and/or inpatient settings.
  • Demonstrate a clinically significant advance in diagnostic test performance and address gaps or deficiencies in current capabilities that may include ease of use, time to result, significant advances in sensitivity and specificity, and ability to process a broad range of specimen types.
  • Allow health care providers to:

Do not propose solutions that describe existing, well-established, or currently supported approaches, especially commonly used strategies—unless you can show that 1) potentially clinically significant, quantifiable advances are achievable and/or 2) the methods and measures are used in unique combinations that have not been previously tested together for detecting or diagnosing drug-resistant bacteria. 

Registration

To participate in the Challenge competition, you must register. Go to New User Registration on the Challenge website.

Letter of Intent

You must submit a letter of intent by December 23, 2016, for Step 1.

Use the AMR Diagnostic Challenge Letter of Intent Form. It has instructions on saving and submitting the form, which you will do through Antimicrobial Resistance Rapid Point of Care Diagnostic Letter of Intent on the Challenge.gov website.

Prize Descriptions

The amount of prizes is as follows:

  • Step 1:  Up to $50,000 per semi-finalist (maximum of 20 semi-finalists)
  • Step 2:  Up to $100,000 per semi-finalist (maximum of 10 semi-finalists)
  • Step 3:  Equal to or greater than $18 million to be divided among a maximum of three awardees based on the number of prizes awarded to Step 1 and 2 semi-finalists from a total pool of $20 million.

Judges will determine the number of prizes for the Step 1 and 2 semi-finalists and Step 3 winner(s).

Deadlines

The submission deadline for Step 1 is January 9, 2017, at 11:59 p.m. Eastern Time. For other key dates, see the Challenge Timeline on the Challenge page.

More Details

For additional information, read the September 8, 2016 Guide notice  as well as the October 3, 2016 Guide notice that clarifies and corrects several components of the Challenge.

If you have questions about the Challenge, contact NIAID’s Dr. Robert W. Eisinger.

An Opportunity to Examine the Role of T-Cell Epitopes in Allergic Diseases

Apply to a new funding opportunity announcement (FOA) if you can propose research to study the role of allergen epitope-specific T-cell responses in the pathogenesis and treatment of allergic diseases using allergen epitope-specific reagents.

Examples of responsive research projects include:

  • Novel T-cell epitope identification, characterization, and validation of important food allergens and aeroallergens that have not yet been studied
  • New Phase I and small-scale Phase II clinical trials. If proposed, these clinical trials must focus on immune-based therapies or interventions involving experimental allergen exposure.
  • Projects proposing to use or develop novel sample sparing technologies that can enhance research in children and infants

The initiative’s ultimate goal is to use T-cell epitopes either as biomarkers predicting disease development and severity or as therapeutic targets for immune tolerance. 

This FOA will be funded through a U19 cooperative agreement, which means there will be substantial NIAID staff involvement. To learn more about this type of award, refer to “Just for "U": A Closer Look at Cooperative Agreements” in our May 4, 2016 issue.

Research Requirements

For this FOA, you will propose an Administrative Core and two or three highly synergistic Research Projects centering on the common theme of epitope validation. You may also propose optional Clinical, Data Management and Analysis, or additional Scientific Cores.   

All projects in your application must focus on human disease and may involve subjects with allergic rhinitis, asthma, or food allergy. Human specimens from outside studies can be used if high-quality clinical phenotyping was performed and all information is available to the applicant investigators.

If you propose a clinical trial (see NIH Definition of Clinical Trial) as part of this project, the proposed work must clearly define the central role of T-cell epitope analyses in the study hypothesis, design, and mechanistic assays.

Read the September 7, 2016 Guide announcement for full information on research objectives and scope, as well as types of projects that will be considered nonresponsive.

Application Details

Your application budget is limited to $600,000 in annual direct costs. The maximum project period is five years. 

Applications are due by March 3, 2017. Apply early to allow adequate time to correct any errors found in your application during the submission process.

Direct questions to Dr. Michael Minnicozzi, the FOA’s scientific/research contact.

Small Businesses: Apply Now for I-Corps™ Entrepreneurship Immersion Program

Your small business may do outstanding biomedical research, but if you’re unable to position your innovations in the market place and implement a successful commercialization plan, your business won’t realize its full potential.

To help grow and develop the entrepreneurial skills of small business grantees, NIH will sponsor the enrollment of nearly 50 organizations into its Innovation Corps (I-Corps™) program. The program uses a hypothesis-driven method of customer discovery to help participants learn the issues associated with technology commercialization. Each team will conduct a large number of interviews (i.e., 100+) with potential customers, strategic partners, and other third-party stakeholders, sharing feedback and lessons learned with the other participants.

The I-Corps™ training course also includes a three-day kick-off workshop, six four-hour Web-Ex courses, and a two-day final Course Closeout/Lessons Learned session.

To apply, your organization must be an active NIH or CDC Small Business Innovation Research or Small Business Technology Transfer Phase I grantee, as the program is supported through administrative supplements to the current grant. Your application budget cannot exceed $50,000 in direct costs.

I-Corps™ recommends that your small business’s team consist of a chief-level corporate officer, an industry expert, and a program director/principal investigator. Each team member should plan to spend at least 20 hours per week on I-Corps™ activities and learning exercises for the duration of the eight-week program.

The program will be split into two cohorts, one beginning February 5, 2017, and the other beginning April 23, 2017. The application due dates are November 1, 2016, and January 9, 2017, respectively.

  Cohort One Cohort Two
Application Due Date

November 1, 2016

January 9, 2017
Phone Interview (est.)

December 5 to 9, 2016

February 13 to 17, 2017
Notice of Award (est.)

January 6, 2017

March 17, 2017
Course Kick-off

February 5 to 8, 2017

April 23 to 26, 2017
Web-Ex Courses (1 p.m. to 5 p.m. ET)

February 14

February 21

February 28

March 7

March 14

March 21

May 2

May 9

May 16

May 23

May 30

June 6
Course Closeout and Lessons Learned

March 27 and 28, 2017

June 12 and 13, 2017
Cohort Size

24 teams

24 teams

For complete details, such as course curriculum and outcome evaluation, read the August 25, 2016 Guide announcement. Direct questions to NIAID’s scientific/research contact for the opportunity, Dr. Natalia Kruchinin.

In The News

Number of Archived Mouse Germline Mutations Jumps Ten-Fold

Need to know what a particular gene does? You might try to obtain a knockout, but not every gene has been targeted, nor has every gene been cryopreserved in a germline format (as embryos or sperm). Fortunately, the availability of mutations took a large leap forward last month thanks to a transfer of 175,000 cryopreserved germline mutations to the NIH-supported Mutant Mouse Resource and Research Centers (MMRRC), which collect, distribute, and cryopreserve scientifically valuable, genetically engineered mouse strains and mouse embryonic stem cell lines.

The contribution comes from the laboratory of Dr. Bruce Beutler, a Nobel Prize winning NIAID-supported investigator at the University of Texas Southwestern Medical Center, and increases the number of publicly available mutations in germline format ten-fold. 

The mutations, cryopreserved in sperm, affect more than 21,000 genes. More than 16,000 of the mutations are designated “probably null” and affect nearly 10,000 genes. Null alleles of many of these genes are available from no other source, and many more are slated for transfer.

Dr. Beutler and his colleagues created and archived these mutations over the past five years as part of their NIAID-funded ENU mutagenesis program. Dr. Chris Goodnow, a program grantee at Australian National University (ANU), also contributed many additional mutations.

The mutations are described in detail on the Mutagenetix website under the tab Incidental Mutations. More than 350,000 mutations that affect coding or splicing function are individually described, along with all other mutations in the stock that contains them. You can also type the mouse genome informatics symbol into the “gene” window to find multiple alleles of the gene with detailed information about what the alleles are likely to do to the encoded protein. Still more information can be found at ANU’s Missense Mutation Library.

The Mutagenetix archive of phenotypes and mutations are available for order through MMRRC.

If you’re interested in requesting stock, start by registering a New User account at MMRRC. Then browse the Major Collections or use the Catalog Search to look for specific gene mutations. Once you’ve identified the strain you want, simply click the adjoining shopping cart icon, complete the request form and technology transfer agreements that follow, verify your contact and payment information, and submit your order. 

MMRRC also allows investigators to fulfill NIH resource sharing obligations by donating mouse strains. By donating, you can reduce animal housing costs, create a cryopreserved archive of a line, eliminate the need to ship mice to multiple requesting investigators, and possibly receive a fee payment.

To learn more about donating mice or cell lines, read the Review Criteria for Accepting Mouse Strains into the MMRRC. Note that there is an Application Stage that precedes Strain Acceptance.

NIH Issues Multiple New Policy Requirements for Clinical Trials

In September, NIH rolled out several new policies to ensure that common standards are met and upheld regarding the conduct of clinical trials.

Apply Only to Opportunities That Accept Clinical Trial Proposals

All applications that involve one or more clinical trials must be submitted through a funding opportunity announcement (FOA) specifically designed for clinical trials.

As you may know, NIAID already has a set of investigator-initiated clinical trial (IICT) FOAs through which we accept applications proposing clinical trials. The IICT FOAs complement the standard parent FOAs, which do not allow applications proposing clinical trials. Learn more at Investigator-Initiated Clinical Trial Resources.

Further, NIAID’s targeted initiatives (i.e., a request for applications or a program announcement with special receipt, referral or review criteria) state specifically whether they will accept applications proposing clinical trials.

If a FOA does not directly state that it will accept clinical trials, you should assume that clinical trials will be deemed nonresponsive and will not be reviewed. Again, this means that you cannot submit clinical trials to the Parent unsolicited R01 and R21 FOAs. 

While the new NIH policy does not go into effect until September 27, 2017, NIAID is implementing this policy immediately.

See the September 16, 2016 Guide notice (NOT-OD-16-147) and NIAID’s September 28, 2016 Guide notice (which we’ll cover in greater depth in our next issue).

Good Clinical Practice Training

NIH will soon require that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials be trained in Good Clinical Practice (GCP). The policy goes into effect on January 1, 2017.

As the September 16, 2016 Guide notice explains, GCP provides a standard for ensuring clinical trial compliance, implementation, data collection, monitoring, and reporting; outlines the responsibilities of institutional review boards, investigators, sponsors, and monitors; and addresses elements related to the design, conduct, and reporting of clinical trials.

The investigator responsible for conducting the clinical trial at a trial site will be responsible for ensuring that all clinical trial staff have completed GCP training and that each person’s training is refreshed at least every three years in order to remain current with regulations, standards, and guidelines.

GCP training may be achieved through a class or course, academic training program, or certification from a recognized clinical research professional organization.

For more information, read the September 16, 2016 Guide notice (NOT-OD-16-148).

Use of ClinicalTrials.gov

Finally, all investigators conducting clinical trials funded in whole or in part by NIH will ensure that these trials are registered at ClinicalTrials.gov and that information about the trials’ results is submitted to ClinicalTrials.gov. The policy is effective January 18, 2017.

This policy, which complements existing statutory and regulatory requirements, follows a significant public response to a notice of proposed rulemaking NIH issued in November 2014.

Having carefully considered that feedback, NIH believes a fundamental premise of all NIH-funded research is that the results of such work must be disseminated in order to contribute to scientific knowledge and public health. Further, in research involving human subjects, scientists have an ethical obligation to ensure that the burden and risk that volunteers assume demonstrates an outcome, at the very least by ensuring that others are aware of the study and that its findings contribute to the advancement of human health.

For full overviews of public comments and the final NIH policy, read the September 16, 2016 Guide notice (NOT-OD-16-149).

The following resources should also prove helpful:

News Briefs

NIAID To Host Workshop for Transitioning Career Development Awardees

Are you a career development (K) awardee preparing to transition to independent research? Then attend NIAID’s Fostering Science Leaders Workshop, a two-day program designed to ready attendees for their first research project (R) grant applications, on November 29 and 30, 2016, in Rockville, Maryland. Register now!

Complete NIAID Website Tree Test to Help Us Improve Site Navigation

If you have 15 minutes to spare, consider taking the NIAID Tree Test, a simple survey that evaluates how easily users can find funding information on the new NIAID website. The survey will remain open until October 17. If you have any questions, contact niaidwebteam@mail.nih.gov.

NIH Posts Q&A Following HHS SBIR Contract Webinar

Small business applicants planning to respond to HHS Small Business Innovation Research (SBIR) Program Solicitation PHS 2017-1 should review Amendment One, which lists government responses to questions about the solicitation, before the October 21, 2016 response deadline. For additional information, go to HHS SBIR Contract RFP Informational Webinar PHS 2017-1.

Consider the Latest Set of Grand Challenges From the Gates Foundation

The application deadline for Round 18 of the Gates Foundation’s Grand Challenges Explorations is November 9, 2016. NIAID’s research community may be especially interested in Accelerate Development of New Therapies for Childhood Cryptosporidium Infection.

Big Data to Knowledge Program Launches an Online Lecture Series

Researchers who want to learn the basics of data management, representation, computation, statistical inference, data modeling, and other topics relevant to “big data” in biomedicine should check out The BD2K Guide to the Fundamentals of Data Science Series, which posts new videos every Friday.

Advice Corner

Tips for Writing a Strong Multiple PI Leadership Plan

As you prepare to write your multiple PI application, give time and attention to the required Leadership Plan.

Reviewers judge its scientific merit and whether it promotes enough coordination and communication among PIs. They consider the appropriateness and quality of the plan in their evaluation and scoring of the investigators as well as the overall impact of the application.

Given all this, your plan needs to be as sound as possible, but how do you fill such a tall order? The following pointers may help.

Address What's Required

Before discussing your plan, much less writing it, you and your fellow PIs must know what items you should cover.

They include:

  • Rationale and justification for choosing the multiple PI approach
  • Governance and organizational structure of the team
  • Procedures for resolving conflicts
  • Process for making decisions on scientific direction and allocating resources and funds

We expand on a few of the required items in the section Know What Reviewers Want, Like, and Expect.

Follow a Few Tips

Here is some general advice to keep in mind as you approach and write your plan.

Ask questions. Approach the Leadership Plan as you would the Research Plan. That is, ask yourself and the other PIs some basic questions, such as: Why are we going to the trouble of making this a multi-PI application? How will we organize and execute the overall project? What will we do if we run into problems? What provisions can we make ahead of time against potential pitfalls?

Do more than what's required. While good plans address several points required by NIH, e.g., rationale for using the multi-PI approach, governance, conflict resolution, or intellectual property issues, the best plans go a step further. They cover additional ground by discussing potentially sensitive issues, such as data sharing between PIs, collaborative publication policies, contingency plans in case one PI changes institutions, and procedures for allocating resources.

Get organized. Just like exemplary Research Plans, the best Leadership Plans are typically organized into succinct sections or paragraphs with informative headings, for example, Rationale, Organizational Structure, and Procedures for Resolving Conflicts.

Dividing into sections and clearly labeling them not only makes for easy reading (which is important for reviewers who have many applications to evaluate), but also lets reviewers follow the applicants’ thought processes and find answers to questions they may have.

Since the Leadership Plan has no page limit and does not count toward the Research Strategy page limit, use the lack of space constraints to include what you need and present the information in an easy-to-find way. Do not use this section as a way to circumvent the page limit for the Research Strategy section.

Avoid pitfalls. Weaker Leadership Plans tend to suffer pitfalls: poor organization, lack of specifics on roles and responsibilities, omitting critical information like plans for deciding scientific direction or resolving conflicts, and projecting an attitude of “trust us, we’ve been working together for years.”

Another major pitfall is stating that all PIs will take joint responsibility for everything—finances, project direction, and necessary scientific expertise. Reviewers know that even the closest collaborations can run into problems and that there will be times when PIs do not agree. Therefore, reviewers will appreciate a sensible division of responsibilities much more than a frequently implemented conflict resolution procedure.

Plans with faults like these may sometimes pass scrutiny by reviewers, but you don’t want to take a chance on undermining their confidence in your application by simply recycling a plan from another application.

Know What Reviewers Want, Like, and Expect

As we mentioned at the outset, you should cover several required bases in your Leadership Plan.

We focus on a few of those here and provide advice on how you might address them based on what reviewers expect to see.

Why Multiple PIs?

Reviewers like to see a solid, scientifically based answer to this question. Since the multiple PI option is for collaborative, usually multidisciplinary, research, they must understand why your proposed research requires bringing in and working with other PIs with distinct and complementary expertise.

In the absence of a clear scientific rationale, reviewers will likely question why you wouldn't be able to complete the research without the other PIs.

What to do. Provide a strong rationale and justification for choosing the multiple PI approach. For instance, describe why the Specific Aims of the project could not be accomplished without the combined leadership and expertise of all the PIs.

Who Will Do What?

Reviewers expect to see Leadership Plans that clearly and specifically delineate the PIs' respective roles and responsibilities. Those that do may receive more favorable evaluations than those that don't.

What to do. We touched on this above, but it's worth repeating. Rather than stating that the PIs will share all responsibilities equally, which reviewers usually view as unrealistic, describe specific "assignments": PI #1 will be responsible for Specific Aim #1 and be responsible for doing X, PI #2 will work on Specific Aim #2 and be in charge of Y, and so on.

Be sure to say who will serve as Contact PD/PI. That person must be affiliated with the institution submitting the application and will coordinate communication among all PIs and NIH as well as completion of progress reports.

Organizational Structure

Reviewers look for a sound organizational and governance plan. In the absence of one, they'll be concerned that the level of coordination and communication among the PIs might be insufficient to fully realize the collaborative aspects of the project.

When a multiple PI application includes an established researcher and a more junior investigator, reviewers will look for and carefully evaluate the time commitment and plans for decision making and resource allocation to determine whether they are appropriate and equitable. Although the level of effort of each PI on a multi-PI application—whether established or junior—does not have to be the same, it does need to be appropriate and justified for the work proposed.

What to do. In your governance plan, describe the process for deciding scientific direction and communication procedures, such as regularly scheduled meetings of the PIs, periodic evaluation of research progress and finances, and publication policies.

Conflict Resolution 

Reviewers like to see a carefully considered conflict resolution plan, which preferably includes the involvement of well-respected people outside of the project to mediate disputes if the PIs are unable to resolve the issues by themselves.

What to do. Disputes are likely to arise, so you'll need to describe how you'll handle them. If you can't come to an agreement, will you bring in an arbitration committee? If so, who and how many will be on it? Will you give a timeframe in which the conflict must be resolved?

Related Links

NIH

NIAID

Reader Questions

You can ask us a question at deaweb@niaid.nih.gov. After responding, we may ask your permission to include your question in the newsletter.

“Can I propose a clinical trial using the R21 activity code?”—anonymous reader

Not for investigator-initiated research proposals. Regardless of activity code, to propose a clinical trial you must apply in response to either an NIAID Investigator-Initiated Clinical Trial funding opportunity announcement or a targeted initiative that states it will accept applications proposing clinical trials (i.e., a request for applications or a program announcement with special receipt, referral or review criteria).

Refer to NIH Issues Multiple New Policy Requirements for Clinical Trials above or go to Investigator-Initiated Clinical Trial Resources to learn more.

“How can I tell if my research is eligible for a small business Fast-Track award?”—anonymous reader

The Fast-Track mechanism reduces the funding gap between Phase I and Phase II by having small business applicants submit Phase I and Phase II grant applications together for review as a single application.

There are no criteria for determining the eligibility of research for a Fast-Track award. (The eligibility criteria listed in funding opportunity announcements pertain to the grantee, not the research project.)

Instead, it’s up to you to justify why a fast-track award is appropriate for your research. Reviewers will then consider whether your application specifies clear, appropriate, measurable milestones to be achieved in Phase I before initiating Phase II.

For more information, check out NIH SBIR and STTR Application Types.

New Funding Opportunities

See other announcements at Opportunities & Announcements.

Content last reviewed on October 5, 2016