July 15, 2015

Feature Articles

Responding to Emerging Health Threats

Opportunities and Resources

In The News

Advice Corner

Caution: Roles Determine Eligibility and Other Requirements
Reader Questions
- When a program announcement expires with no reissue, do I have any recourse for funding?
- Can the PD/PI on a competitive renewal application change his or her effort without restriction?

New Funding Opportunities

See the list

Responding to Emerging Health Threats

When it comes to NIAID's strategy for responding to emerging health threats, you could say we follow the Scout motto "Be Prepared." We do that by having services and resources readily available to help researchers tackle diseases like Ebola, Middle East Respiratory Syndrome (MERS), and H1N1 influenza.

Using What's Already in Place

In the event of outbreaks, epidemics, and pandemics, responding quickly is key. Since time is of the essence, we turn to existing NIAID-supported grants and contracts rather than new funding opportunity announcements or contract solicitations, which can take quite some time between development and award.

For grants that have already been funded, we can award administrative supplements for specific purposes. As for contracts, many are negotiated with options we can activate if necessary. For example, a base contract may be for Organism X with an option to support research and/or development work for Organism Y. If Organism Y becomes a public health emergency, we can exercise the option.

Mostly, however, we use existing contracts to provide a series of services that can accommodate a wide range of needs.

What Can Our Contracts Provide? Quite a Bit

NIAID-supported contracts offer researchers a wide array of tools, services, and resources. Here's a look at some of them. Find others at Resources for Researchers.

Biosafety Laboratories

Investigators may use one of several National Biocontainment Laboratories and Regional Biocontainment Laboratories that respectively, provide BSL-4/3/2 and BSL-3/2 biocontainment facilities.

Having these labs available can be useful to researchers who don't have the capability to work with infectious disease agents. For example, someone interested in studying Ebola would have to go through a lengthy process to be able to do so, including registering with CDC. Our existing national biocontainment labs have CDC registration and biosafety level 4 facilities needed to work with Ebola.

For more information, including biocontainment lab sites, go to Extramural Construction of Biosafety Laboratories.

Model Animals

NIAID also has in place contracts that provide animal models that can be used, for instance, to quickly test candidate vaccines.

Animal models include mice, rabbits, swine, and nonhuman primates. Learn more at Model Animals.

Drug and Vaccine Development

Through various contracts, NIAID has services that cover several aspects of drug and vaccine development, such as formulation work, toxicology studies, and pharmacokinetic/pharmacodynamic analysis.

In fact, when the Ebola outbreak was developing, we'd been working with a company to do toxicology studies on the monoclonal antibody cocktail Zmapp.

Go to Vaccines, Diagnostics, and Therapeutics to find out what we offer.

Cell, Tissue, and Organism Repositories

Through several repositories, researchers can share and access cells, tissues, and organisms. For example:

BEI Resources Repository—supplies organisms and reagents to microbiology and infectious diseases researchers.
Filariasis Research Reagent Repository Center (FR3)—provides filariasis parasites and molecular reagents.
HIV/AIDS Specimen Repository—through networks, programs, and studies, provides access to specimens, such as plasma, serum, and saliva.

See Cell, Tissue, and Organism Repositories for a complete listing of these repositories.

Can We Handle a New Infectious Agent?

Our contract resources have been effective in helping us fight known viruses like Ebola and are equipped to help handle the unknown as well since they've been set up in a "disease agnostic" way.

If a new infectious agent were to emerge, it likely wouldn't stay new for long, thanks to our diagnostic and sequencing capabilities, which will quickly tell us if the agent is one we've never seen before.

Also, several contracts are working with different kinds of animal models and different kinds of infectious agents, so should something new arise, we already have in place lab facilities and technical expertise in that agent (or one that's related) that can conduct rapid assessments for us.

In Summary

These tools and services provide NIAID with the necessary resources to quickly and nimbly respond to an emerging public health threat in a manner that can scale and adapt as the threat evolves.

RFP on Process and Analytical Support for HIV Vaccines

If you have the expertise and resources to help move promising preventive HIV vaccine concepts through the development process, you might want to consider a recently released contract solicitation.

The awardee will provide targeted specialized expertise and resources for process development and analytic characterization, carrying out tasks in the following areas:

Coordination of task orders for process development and analytical characterization and technical support (central functions)
Analytical characterization and method development
Process development

These services help investigators obtain critical process and analytical data to complete activities needed to move into good manufacturing practice, fulfill regulatory requirements, and complete the development activities needed before entering clinical trials.

Read the June 16, 2015 solicitation for more information, including proposal instructions, clarifications, and contacts.
The proposal deadline is 3:00 p.m. local time on September 17, 2015.

Preclinical Assays Needed to Predict Vaccine Efficacy

Promising preclinical data for a candidate vaccine does not guarantee efficacy in phase II/III clinical trials. Thus, NIAID seeks novel preclinical assays capable of better predicting the likelihood of success in human clinical studies based on preclinical outcomes.

As researchers continue to identify new potential markers of protection, new opportunities to develop and qualify new or improved assays arise. These include:

Immunological assays to measure novel structural epitopes implicated in protection
Assays to measure promising markers of protection (e.g., cytokines, metabolites, glycosylation state) identified through systems biology approaches
Assays using in vitro-reconstituted immune systems
Organoid-based assays
Refinement of existing assays to measure a predictive marker of protection
Evaluation of assays to determine predicted protection from disease using well-documented clinical samples

Successful applications will focus on a single, well-characterized investigational or licensed vaccine against one of the NIAID Emerging Infectious Diseases/Pathogens for which promising predictive markers of protection have been identified in human clinical studies.

Examples of supported assay development activities include the following:

Developing or optimizing assays using new or novel targets (e.g., biomarkers, antigens, epitopes)
Applying an existing qualified assay to a new candidate vaccine, biomarker, or antigen
Developing assay technologies such as nanotechnology and microfluidic-based systems, multiplex systems, robotics, or point of use technologies
Developing or optimizing next generation assay technologies

Proposed assay development and validation must use existing, well-characterized human clinical samples.

Your application will be deemed nonresponsive if you fail to focus on a single vaccine against an NIAID emerging infectious disease or pathogen. Contact Dr. Michael Schaeffer if you have any questions.

Note that HIV/AIDS is excluded. Further, your application must not focus on biomarker discovery, propose clinical trials or to collect new clinical samples, lack access to appropriate human clinical samples, or target biomarkers that were not identified using human clinical samples.

Application budgets are limited to $750,000 in annual direct costs. You may, however, request up to an additional $300,000 in one year of the project for major equipment to ensure biohazard containment.

Applications are due by September 30, 2015. Send optional letters of intent by August 30, 2015. For complete details, read the June 10, 2015 Guide announcement.

Accounting for the Known Unknowns of Disease Spread and Transmission

Specialists in mathematics, statistics, and modeling, take note: NIAID is now participating in three reissued companion program announcements titled “Spatial Uncertainty: Data, Modeling, and Communication”—a research project grant (R01), a small grant (R03), and an exploratory/developmental research grant (R21) opportunity.

The program is premised on the idea that spatial uncertainty, and uncertainty about the spatial relationship among neighboring objects, complicates analysis of public health data. Since the spread of infectious agents (e.g., via spore release, infected vector, infected host) exhibit spatial and temporal patterns, estimates of disease patterns or trends contain a certain degree of uncertainty that obfuscates identifying the source of exposure and calculating the amount of exposure.

NIAID aims to support the development of spatial and temporal models capable of predicting the spread and transmission of infectious diseases such as HIV/AIDS, malaria, tuberculosis, and other emerging and re-emerging infectious diseases. In time, such predictions can be used to guide local prevention efforts to ensure care relevance to the local population. Within the broad topics of spatial uncertainty in data, statistical methods to model spatial uncertainty, and communication of spatial uncertainty, NIAID seeks the development of

Statistical methods to analyze outbreak to determine whether there was a spatial pattern in the incubation periods
Statistical tests to compare incubation period distributions to determine if there is a significant distance effect
Mathematical models to study dispersion modeling at finer scales, such as within a building or within the vicinity of a release location
Methods to identify sources of spatial uncertainty and to evaluate the sensitivity of the methods developed
Methods for quantifying spatial uncertainty in identifying core hot and cold spots in disease transmission and intervention

The scope of your proposed research should determine whether you apply for funding through the R01, R03, or R21.

Activity Code	Annual Direct Costs Limit	Project Direct Costs Limit	Project Period Limit	Funding Opportunity Announcement Link
R01	N/A	N/A	Five years	October 10, 2014 Guide announcement
R03	$50,000	$100,000	Two years	October 10, 2014 Guide announcement
R21	$200,000	$275,000	Two years	October 10, 2014 Guide announcement

Note that if your R01 budget request will exceed $500,000 direct costs in any one year, you must follow the procedures listed in theBig Grants SOP, which stipulate a preapproval request.

NIAID’s scientific/research contact for this program is Dr. Misrak Gezmu. Contact her if you have questions about NIAID’s participation in the program.

Develop a Clinical Trial or Research Project to Study HIV and Substance Use

Apply for a planning grant worth up to $450,000 over three years for pilot or feasibility studies on one of the following topics:

New or adapted interventions to
- Prevent HIV/AIDS among populations where substance use may contribute to the spread of the disease.
- Improve care for those infected among populations where substance use is prevalent.
Improvements in established HIV interventions

You'll use this funding to generate data for further investigation, e.g., through a future R01.

In your application, focus on developing a solid hypothesis, proving you and your team can do the work you propose, and demonstrating that you have access to resources you'll need for your project. Preliminary data are not required, though they may strengthen your application.

You may propose topics on all types of substance use and behaviors associated with substance use, and your intervention may target direct transmission or high-risk behaviors.

If you want to run your idea past an NIAID program officer, contact Elizabeth Flanagan, our scientific contact for this funding opportunity.

For more details, including specific areas of research interest and application instructions, read the May 28, 2015 Guide announcement.

You may not already be familiar with the NIH Planning Grant Program (R34) activity code and its purpose. NIAID uses the R34 in two different ways: As a one-year clinical trial planning grant and as a three-year feasibility and pilot project grant. This funding opportunity supports the latter activity. (NIAID Clinical Trial Planning Grant (R34) supports the former activity.)

Use Standard AIDS Dates to figure out the application deadline that's best for you, and learn more about application timing at Timing Factors That Affect Your Application and Award in the Strategy for NIH Funding. Though written for R01 applications, the advice is applicable to this funding opportunity.

Maintain the Integrity of Peer Review

NIH published an important notice last month that's worth pointing out in case you missed it or need a reminder.

Briefly, attempting to influence the outcome of peer review through inappropriate or unethical means could result in serious consequences. That goes for investigators, officials at applicant institutions, and anyone named in an application.

To maintain the integrity of peer review, these parties should not—we repeat—should not:

Contact study section reviewers to request information about the review.

The scientific review officer (SRO) is the only person whom you should contact about the review.
In a reverse scenario, i.e., a reviewer contacts you to get or exchange information about a review or application, inform the SRO.

Send information or data directly to reviewers.

Instead, follow the instructions for post-submission materials outlined in the July 23, 2010 Guide notice and related notices.

Try to access review-related information in secure NIH computer systems.

If a fair review is deemed unfeasible because of a violation, NIH may defer an application for peer review or withdraw it. NIH may also take additional steps, such as pursuing a referral for government-wide suspension or debarment.

Get full details, including other possible consequences of violating rules, in the June 18, 2015 Guide notice. Also go to the NIH Office of Extramural Research's Integrity and Confidentiality in NIH Peer Review for more information.

News Briefs

Formatting Changes Ahead for Training Data Tables in RPPRs and Applications. To help PIs more easily compile tables for institutional training grant applications and Research Performance Progress Reports (RPPRs), NIH will move to an electronic xTRACT system in FY 2016. As part of the transition, the format of the training data tables will change.

NIH expects to release the new formats before October 1, 2015, and the changes will be in effect for RPPRs submitted December 1, 2015, or later and applications submitted for the May 25, 2016 due date and after. Expected changes include the following:

Reducing the maximum number of tables from 12 to 8
Minimizing the reporting of individual-level information
Extending the tracking of trainee outcomes from 10 to 15 years

RFI: Provide Input on ImmPort and Related Services. NIAID's Division of Allergy, Immunology, and Transplantation (DAIT) funds the Immunology Database and Analysis Portal (ImmPort), a public data sharing repository that aggregates and disseminates data sets from DAIT-funded projects. Help DAIT improve the accessibility and utility of ImmPort data by sending feedback by email to Dr. Johanna Schneider before July 31, 2015. Read the entire request for information in the June 30, 2015 Guide notice.

Matching Dollars to Diseases: New RePORTER Data Set. As you may know, each year NIH publishes Estimates of Funding for Various Research, Condition, and Disease Categories (RCDC). Recently, NIH examined how closely research funding aligned with the U.S. and global disease burdens. Read Information on Disease Burden to view the results. See also Burden of Disease and NIH Funding Priorities to learn more.

Keep Your Small Business In the Know. If your organization has an NIH SBIR contract or an SBIR/STTR award from another agency and you plan to apply for a Phase II or Phase IIB award, you may wonder what Federal Identifier you should enter on the SF 424 (R&R) application page. The answer is HL000000. For more answers to questions like this one, check out NIH SBIR/STTR Frequently Asked Questions.

Remember too that registration is open now for the 17th Annual NIH SBIR/STTR Conference

, which will take place October 27 to 29, 2015, in Seattle, Washington. Early-bird registration is available through August 20, 2015. The conference will be broken into three tracks to cater to varying levels of experience with SBIR/STTR funding policies.

Caution: Roles Determine Eligibility and Other Requirements

The scientific community uses many terms to describe different roles on a project. However, some terms aren’t used by NIH or are terms that cause confusion. The terminology you use might affect your eligibility for a funding opportunity announcement (FOA), as well as the information required in a grant application and to make an award.

As you discuss the roles your colleagues can play in support of your planned research, use the guide below to ensure you have a shared understanding.

Here we cover five role-related terms that have caused confusion: co-PI, co-investigator, collaborator, consultant, and other significant contributor. At the end of the article, we offer advice on how to maximize clarity for reviewers.

Co-PI

Do not use the term co-PI. Because NIH doesn't recognize it as a role, it causes confusion since it’s unclear whether you mean PI on a multiple-PI award or co-investigator. And that confusion could affect your application; some FOAs have eligibility or level of effort requirements that affect only PIs.

Note that assigning someone the role of "Co-PD/PI" will not identify the application as a multiple PD/PI application. Colloquially, we sometimes hear the term co-PI used to indicate your fellow PIs on a multiple PI grant. But in that case, they should still be called PIs, not co-PIs.

You may have noticed that co-PI is one of the options listed on the SF 424 forms (standard grant application form). That's because other agencies use that role, but we don't.

Co-Investigator

Co-investigator is a term commonly used by the scientific community and in grant applications.

This role describes those involved with the PI in the scientific development or execution of the project, but they just don’t quite rise to the level of being principal investigators. They should be listed as key personnel.

Do not use “co-investigator” when you mean a PI on a multiple-PI application.

When deciding whether your application should have multiple PIs or a single PI with one or more co-investigators, there are no rules or percentages to go by. The decision should be based on the research proposed to ensure optimal management of the project. Assuming your chosen funding opportunity allows either option, we suggest discussing this with your colleague and business officials.

Collaborator

Collaborators always play an active role in the research, and the position is sometimes defined interchangeably with co-investigator. As a loose guideline, think of a collaborator as a scientist whose distinct expertise complements your own while a co-investigator shares your area of expertise and therefore contributes in guiding the scientific direction of the overall project. One provides unique expertise, the other umbrella expertise.

Still, many areas of science have their own expectations for each of these roles. So long as the role of each contributor is thoroughly explained in your Personnel Justification and the Letters of Support, your choice between the titles of "co-investigator" and "collaborator" won't be a point of contention for reviewers.

Collaborators are typically listed as key personnel. They may get part of their salary paid from the grant in person months. Collaborators at other institutions could have their salary paid through a consortium agreement (also called a subaward).

Some senior-level collaborators may choose to work part-time for credit (e.g., the potential of future publications), rather than pay.

Consultant

A consultant provides advice or services and may participate significantly in the research. Often he or she helps fill in smaller gaps by, for example, supplying software, providing technical assistance or training, or setting up equipment.

List consultants as key personnel only if they contribute substantively and measurably to the scientific development or execution of a project.

Consultants do not receive a salary from your grant but may receive a fee as a transaction for their service.

Other Significant Contributors

When you have people who commit to contributing to the scientific development or execution of the project but do not commit any measurable effort (i.e., person months) to the project, their role would be other significant contributor (OSC).

OSCs are typically presented at effort of “zero person months” or "as needed." If their effort is measurable, you may not list them as OSCs.

Biosketches are required for all personnel identified in the application as OSCs. However, other support information is not required. Consultants should be included as OSCs if they meet the definition.

In Conclusion

To maximize clarity for your reviewers when you apply, make sure your Personnel Justification and Letters of Support thoroughly describe what each person will be doing. Your reviewers need to be able to judge whether there is sufficient expertise to conduct the project.

Too often, we see Letters of Support that are enthusiastic and indicate a willingness “to collaborate” but don't provide enough details regarding the exact role of the person in the project. When that happens, we have to request additional information from you before we can make an award.

For more on the roles people can play in your project, check out Design a Project in Part 2 of the Strategy for NIH Funding. That page has a subsection on Consultants or Collaborators—How They Differ, plus advice at What About Expertise?

You could also discuss how to address gaps in expertise with your program officer or local mentors.

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.

“When a program announcement expires with no reissue, do I have any recourse for funding?”—anonymous reader

That depends on the program announcement's (PA's) activity code. If NIAID supports a parent PA of the same activity code, you can rewrite your application, removing references to the expired PA, and submit it as a new application to the parent PA.

Otherwise, you should contact a program officer to discuss alternative funding opportunities based on your research interests.

For more perspective, check out the National Institute on Aging's blog post "What Does It Mean When a Program Announcement Expires?"

“Can the PD/PI on a competitive renewal application change his or her effort without restriction?”—anonymous reader

Yes, unless your chosen funding opportunity announcement requires a certain minimum level of effort. Most FOAs do not.

We do, however, advise new investigators to assign at least 25 percent effort on each application. For well-established, high-performing PIs, reviewers may accept lower levels of effort. Find more advice on the topic of effort at Putting Effort Into Your Application and Grant.