NIAID Funding News November 5, 2014

Feature Articles

Opportunities and Resources

In The News

Advice Corner

New Funding Opportunities

Header: Feature Articles.

Putting "Effort" Into Your Application

We regularly receive questions about managing your level of effort. Hopefully, the following advice will help clarify an oft-confusing policy.

Our advice today relates calculating and justifying your level of effort in your application. In an upcoming issue, we'll delve into the topic of changing effort on a funded grant.

Know What "Effort" Means

In the context of your grant application, "effort" refers to the amount of time your PI activities will take.

Reviewers use this figure to assess whether you can complete your research with the amount of effort you plan to commit to a proposed project.

NIH uses this figure to calculate how much of your PI salary it will pay.

For example, if you estimate you'll spend 50 percent of your professional time on your grant, NIH will pay for 50 percent of your salary, up to the federal limit.

Read Your FOA

Always check whether your funding opportunity announcement (FOA) has special rules about effort.

Certain types of awards—mentored career development and small business, among others—require a minimum level of effort.

And, some requests for applications have their own instructions about effort.

Our advice is written for FOAs that do not have unique requirements (e.g., investigator-initiated R01s, R21s, and P01s).

Contact Your Business Office First

Consult with your institution's business office before you apply.

Your institution may have rules or guidelines on the following topics:

  • How to calculate effort.
  • How to balance effort with your other institutional responsibilities and non-NIH projects.
  • How to manage your salary and support if funded. 

Align Your Effort With the Work You Propose

Calculating effort isn't an exact science, but you need to make an appropriate estimate.

Make sure your effort falls in line with what a competent researcher would need to manage the work you propose in your application.

Request a level of effort that fits your actual needs.

  • If your effort is too high, reviewers will recommend cutting your budget.
  • If it's too low, reviewers will question your commitment to the project.
  • If your request is way out of step with what reviewers would expect, they'll question your competence and will factor that into your overall impact score.

Include only your own work as PI.Calculate the effort of your key personnel separately.

Never ask for more than 100 percent effort on a single grant.You cannot include overtime or claim you're efficient enough to do more than one year's worth of work over the course of a year.

If you're submitting more than one application, you may ask for a combined level of effort that exceeds 100 percent (e.g., 60 percent on one application and 60 percent on another). If both applications are funded, we'll adjust your effort to be no more than 100 percent when we negotiate your award.

Keep in mind that when you take this route, you risk having to cut your aims, reduce your effort on one of your other awards, or decline your award.

If you're submitting a multiproject application that requires your effort on an administrative core,include this in your effort calculation.

New Investigators, Take Note

As a rule of thumb, put in at least 25 percent effort on each application you submit.

Reviewers may accept lower levels of effort from well-established, high-performing PIs who have demonstrated stellar research performance over a long period of time.

Since you don't yet have a comparable track record, they'll likely raise concerns over a low level of effort.

Don't worry if your effort changes over the course of your grant. Reviewers know that can happen, and NIAID allows you to change your effort as your work progresses (with some limitations we'll discuss in a future issue).

Justify Thoroughly

Make sure your budget justification includes enough information for reviewers to understand why you need the time you request and what you'll do with it.

We recommend the following approach:

  • Detail the work you'll have to do as PI.
    • List specific activities.
    • Include time you'll spend collaborating with other investigators, training your team, and building your infrastructure.
    • Note work that others will do, but don't apply this toward your level of effort as PI.
  • Estimate how much time your PI activities will take, in person months.
    • To calculate person months, multiply the percentage of your time associated with the project by the number of months of your appointment.
    • Use NIH's Percent of Time and Effort to Person Months Calculator.
    • Your institution's business office may have guidelines to help you calculate this.
  • Include all this information in the personnel section of your budget justification. Make sure you describe effort for each key personnel as well as yourself.

If your total level of effort on all projects will exceed 100 percent if we fund all your applications, explain how you will bring your total effort down to 100 percent.

  • For example, let's say you've already committed 60 percent effort to other research projects.
  • You then apply for two new grants at 25 percent effort each.
  • In this case, you may want to state that you will reduce the level of effort so that your overall effort is 100 percent if both are selected for funding.

If your level of effort will change over the course of your grant, indicate this in your justification.

However, if you're not certain your effort will change, don't mention anything. You can change your level of effort later, when preparing the just-in-time request and during the negotiation of the award. We'll have more on that in a future issue.

Related Links

Header: Opportunities and Resources.

Check Out FOA for Hepatitis C Cooperative Research Centers

Initiated almost 20 years ago, NIAID's Hepatitis C Cooperative Research Centers (HepC Centers) program has been instrumental in not only elucidating the biology of hepatitis C virus (HCV) infection and replication but also providing key insights into the immune response to infection.

Now, the program continues with a reissued funding opportunity announcement (FOA) to support research on defining immune requirements for protection against and clearance of HCV infection.

Examples of research areas supported under this FOA include the role of:

  • Non-parenchymal liver cells (e.g., Kupffer cells, NK cells) and hepatocytes in HCV infection; initiating and maintaining antiviral immune responses, and regulating T-cell and B-cell responses.
  • Virus-specific CD4+ helper T cells in antiviral responses and the significance of their rapid depletion with the onset of chronicity.
  • Neutralizing and non-neutralizing antibodies against HCV in protecting against infection and virus control.

Each HepC Center must incorporate studies using well-defined cohorts of HCV-infected patients and well-characterized clinical samples. Studies may include the use of relevant in vitro and available in vivo models. Note that this FOA will not support clinical trials.

We strongly encourage applicants to contact Dr. Rajen Koshy, the FOA's Scientific/Research contact, to discuss the responsiveness of their proposed research.

For complete details, read the October 8, 2014, Guide notice. Note that optional letters of intent are due by January 3, 2015. The application deadline is February 3, 2015.

Since this FOA is for a multiproject application, we encourage you to learn more about multiprojects in our Multiproject Awards SOP and Guidance for Preparing a Multiproject Research Application.

Separator line

Innovating Diagnostic Technologies for Acute Febrile Illnesses

Current diagnostics used for patients with fever symptoms are inadequate in terms of time-to-answer, cost, sensitivity, and specificity. To advance innovation of febrile illness diagnostics, NIAID intends to fund 15 to 20 phased innovation (R21/R33) awards in FY 2016.

We are especially interested in technologies that can analyze clinical samples more accurately and rapidly than current diagnostic platforms, measure in vivo analytes, use integrated sample-to-answer sequencing-based platforms, or simultaneously detect multiple biomarkers. Ultimately, the new diagnostics should improve upon the sensitivity and specificity of current FDA-cleared diagnostics, while also maintaining ease of use, cost effectiveness, test times under one hour, and culture independence.

Examples of potential activities that could be supported include:

  • Rapid, integrated sample-to-answer sequencing-based technologies.
  • Novel and improved sample processing for clinical samples.
  • Use of integrated nanosensors and microfluidics for detecting analytes and pathogens as well as diagnosing infectious diseases.
  • Improved technologies for data analysis-based information platforms compatible with mobile phones, tablet computers, or portable electronic devices.
  • In vivo imaging technologies for precisely visualizing and identifying pathogens or host biomarkers in vivo.

This FOA will not support applications that propose:

  • Technologies that rely solely on nucleic acid amplification followed by a hybridization detection step, or immunochromatographic lateral flow devices for detection of a pathogen-specific antigen or a host-response antibody.
  • Diagnostics that require culture-bottle or streak plate incubations.
  • Clinical trials. (You may include clinical development strategies within an overall project—the FOA permits and encourages the use of human-derived material in preclinical studies in support of compliance with regulatory requirements.)
  • Diagnostics for HIV.
  • Environmental or workplace pathogen or toxin detection technologies.

Remember, the ultimate goal of your proposal should be to detect and identify pathogens in human clinical samples.

Your application’s proposed project period should not exceed five years, with the R21 phase limited to two years and the R33 phase limited to three. The R21 phase cannot exceed $275,000 in direct costs over the two-year project period. The R33 phase is limited to $300,000 in direct costs annually for up to three years. We anticipate that approximately 50 percent of the funded R21 phase awards will transition to the R33 award.

Send an optional letter of intent by January 2, 2015. Your application is due on February 2, 2015.

For full details, read the October 15, 2014, Guide notice. For more information about phased innovation awards, read theR21/R33 Phased Innovation Award SOP.

Separator line

Women's Health Is Focus of Career Development Award FOA

In case you missed it, NIH reissued a funding opportunity announcement (FOA) for Building Interdisciplinary Research Careers in Women's Health (BIRCWH). It's worth a look if you're interested in developing and implementing a program that supports the mentored career development of junior faculty members (BIRCWH Scholars) who want to focus on women's health.

The goals of this FOA are to 1) help lead more investigators to an independent scientific career that will benefit the health of women, 2) advance research on sex/gender influences on health, and 3) encourage interdisciplinary research methodology.

In designing a BIRCWH career development program, investigators must integrate interdisciplinary mentoring teams whose members collaborate and represent different perspectives and areas of expertise to support BIRCWH Scholars in the transition from trainee to independent researcher.

Qualifications of PI, Program Faculty

The PI should be an established investigator in the scientific area in which the application is targeted and be able to provide administrative and scientific leadership to develop and implement the proposed program.

Other faculty involved in the program should have strong records as researchers, including recent publications, as well as a record of research training, e.g., former junior faculty who have established productive careers relevant to the NIH mission.

Scholar Eligibility

To be a BIRCWH Scholar, candidates must meet several eligibility criteria, including the following:

  • Have a clinical doctorate or Ph.D. degree or its equivalent.
  • Completed any postgraduate training normally expected for a faculty appointment in their field (including clinical or postdoctoral fellowship training, or residency if they have chosen not to subspecialize).
  • Have no more than six years of research or research training experience beyond their last doctoral degree.

More Information, Deadlines

For complete details, read the October 10, 2014, Guide notice.

Optional letters of intent are due by December 5, 2014. Applications are due by January 5, 2015.

Header: Other News.

NIH Gives Submission Extension to PIs Responding to Ebola Outbreak

NIH will provide additional time for application submission and grant-related reporting for investigators who travel to West Africa to participate in the Ebola outbreak response and other Ebola-related public health emergencies.

If this circumstance applies to you, you do not need advance permission to submit a late grant application on which you are a principal investigator to any open funding opportunity announcement with standard due dates (this excludes requests for applications). When you apply, be sure to include a cover letter and documentation that shows you served in West Africa as part of the response to the Ebola outbreak at the time of the application due date.

NIH considers late applications based on the amount of delay caused by the emergency response and the processing time required to prepare each submitted application for peer review. Your application will be reviewed no later than 120 days after receipt and assigned to the next possible Council meeting following review. If time permits, it may be moved to an earlier Council.

To address delays in progress, financial, or invention reporting caused by your participation in the Ebola outbreak response, communicate directly with the contact listed on your Notice of Award.

Depending on your situation, you might also consider taking advantage of no-cost extensions, carryovers of unobligated balances, or cost-related prior approvals to redistribute your current research funding. See sections 8.1 Changes in Project and Budget and 8.2 Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Research Resources of the NIH Grants Policy Statement for more information.

For full details about these special accommodations, read the October 16, 2014, Guide notice.

Separator line

Change to CTSA Program May Impact NIAID-Funded Investigators

The Clinical and Translational Science Award (CTSA) program, which is administered by the National Center for Advancing Translational Sciences (NCATS), spurs innovative methods, training, and career development in translational and clinical research around the country. As made clear in a new funding opportunity announcement (FOA), the CTSA program is now undergoing several changes to better connect the 62 largely independent CTSA awardees into a unified national network.

Institutions with CTSA awards, referred to as hubs, are meant to function as catalysts to improve the quality of translational and clinical research. NCATS plans to use centers to support the hubs through improved resource and software sharing. For example, CTSA hubs will rely on a centralized institutional review board.

Many NIAID-funded researchers have received support from CTSA funds in the past. Going forward, you can continue to use CTSA funds for clinical research infrastructure, but funding available for clinical research will diminish. For example, the FOA lists space, beds, and patient evaluations (lab tests and imaging); inpatient and outpatient care costs; and study-specific staff as unallowable costs. Those costs should be paid using an alternative source of funding, such as a research project grant.

For more information, read the September 12, 2014, Guide notice and FAQ About CTSA RFA-TR-14-009.

Separator line

Reminder of Invention Implementation Regulations

As NIH did in a Guide notice last month, we want to remind you of the Bayh-Dole Act and its implementing requirements. It's important to be familiar with both should an invention arise from your research.

In short, under the Bayh-Dole Act of 1980 (U.S.C. 18 200-212), funding recipients, e.g., grantees, have the right to retain title to inventions made under federally funded research but must comply with regulations to ensure the timely transfer of the technology to the private sector.

Funding recipients must also report inventions to NIH and can do so electronically through iEdison. For details of reporting responsibilities, see section 8.2.4 Inventions and Patents of the NIH Grants Policy Statement.

Read the official reminder from NIH in the October 2, 2014, Guide notice.

For more information, go to:

Separator line

Stay Tuned for BD2K News

It's been a while since we've told you about funding opportunities from NIH's Big Data to Knowledge (BD2K) program, an effort to develop new approaches, standards, methods, tools, software, and competencies to improve scientific use of big data.

NIH just issued its first round of awards, and we expect it will publish at least one new funding opportunity announcement within the next few months.

Meanwhile, keep up with BD2K using the follow methods:

Separator line

News Briefs

New Location, URLs for eRA Quick Queries. The four search options listed on eRA Commons Quick Queries will move this month to the eRA Commons home page (on the right side of the page, under Additional Links). If you have the old page bookmarked, replace it with Welcome to Public Search.

NIAID Participating in Small Business FOAs for Nucleic Acid Therapeutic Technologies. Small business applicants may be glad to know that NIAID is now participating in two funding opportunity announcements—one an SBIR, the other an STTR—on Platform Delivery Technologies for Nucleic Acid Therapeutics. Get full details on the opportunities in the August 4, 2014, R41/R42 and R43/R44 Guide notices.

OMB Issues Guidance on Student and Postdoctoral Researcher Roles. The Office of Management and Budget’s new set of Frequently Asked Questions emphasizes the importance of training for pre- and postdoctoral staff engaged in research. However, OMB notes that a specially appointed training position is not required to achieve recognition of a dual research and training role. This clarification applies to all NIH-funded awards. See the October 10, 2014, Guide notice for more information.

Header: Advice Corner.

Technical Glitches With Application Submission? Documentation Is Essential

As a follow up to our June 19, 2014, article "When NIH Accepts Late Submissions," we want to reiterate an important point about not being able to submit on time due to system issues.

To avoid being penalized when you encounter problems with a federal electronic submission Web site, e.g., Grants.gov and ASSIST, you must have a confirmed system issue and email the appropriate Help Desk immediately to document the issue and get a Help Desk ticket number. Get full details at Guidelines for Applicants Experiencing System Issues.

You should also submit your application well ahead of its due date, not only to resolve technical difficulties but also to address Grants.gov and eRA Commons validations as well as be able to make corrections, if needed, during the two-day viewing window of your application image.

Note that after 5:00 p.m. local time of the due date, you may only view your submitted application. You will not be able to make any changes or corrections. For further information, see Pass Electronic Validations in Submit an Application.

Lastly, a word about ASSIST, NIH's electronic submission portal for multiproject applications.

With these complex multiproject applications, you may see some submission problems with ASSIST, such as a duplicated application section, omitted or "flip-flopped" components in between sections, or an unrecognized special character. That's why you should submit well ahead of the due date to allow enough time to view the application and verify content. NIH won’t accept error corrections to the application after submission, as noted in the August 16, 2010, Guide notice.

If you haven't familiarized yourself with the system, we suggest you do before it comes time to submit. You have several resources, including:

To learn more about multiproject applications, go to our Guidance for Preparing a Multiproject Research Application.

Header: Reader Questions.

Feel free to send us a question at deaweb@niaid.nih.gov. After responding to you, we may ask your permission to include your question in the newsletter, incorporate it into the NIAID Research Funding site, or both.

"Can I apply for a K08 award while also being a principal investigator on an R03 award?"—Ramin Eskandari, Medical University of South Carolina

Yes, so long as you do not propose the same research in both applications.

Keep in mind, however, that if you receive a K08 award, you cannot receive salary support from the R03 but would still be required to provide effort. In addition, you need to devote nine person months to the research proposed in your K08 award. For help, see NIH's Usage of Person Months questions and answers.

For more information on K awards, go to the Career Development Awards.

"Do I need to send my PHS 398 forms for an administrative supplement through the mail?"—anonymous reader

No. We actually prefer that you send us the forms in an electronic format. Assuming your parent award has not moved to electronic submission, your signing official should send a scanned PDF of the signed original and the checklist directly to your NIAID program officer. Be sure to note the administrative supplement program announcement title and number from the funding opportunity announcement on the face page.

However, if your parent award has moved to electronic submission, you can also apply electronically through Grants.gov or the eRA Commons. These two options tend to provide a faster turnaround time.

Read our Administrative Supplements to Grants and Cooperative Agreements SOP to learn more.

Header: New Funding Opportunities.

See other announcements at NIAID Funding Opportunities List.

Content last reviewed on November 5, 2014