NIAID Funding News August 5, 2015

Feature Articles

Opportunities and Resources

In The News

Advice Corner

New Funding Opportunities

Header: Feature Articles.

Focus on Foreign Investigators: Foreign Components Explained

This article continues the Focus on Foreign Investigators series, which kicked off with the July 1, 2015 article “Focus on Foreign Investigators: Eligibility Requirements.” In that first article, we usedHigh-Priority Immunology Grants (R01) and Accelerating Improvements in the HIV Care Continuum (R01) as example funding opportunity announcements (FOAs) to demonstrate how to determine a foreign organization’s eligibility.

If you read Section III. Eligibility Information of the former FOA, you probably noticed that although foreign organizations are not eligible to apply, the FOA does allow for foreign components. What does that mean for foreign investigators? Here, we will review the NIH definition of foreign components, provide examples, and highlight key policies to keep in mind.

Definition

The NIH Grants Policy Statement officially defines a foreign component as:

"The performance of any significant scientific element or segment of a project outside of the United States, either by the recipient or by a researcher employed by a foreign organization, whether or not grant funds are expended."

Take Initiative

Foreign investigators: Every FOA will list whether foreign components are allowed in Section III. Eligibility Information. Suppose you find one that interests you, and it accepts foreign components but does not allow foreign organizations to apply. In such a circumstance, you should assess how your research capabilities and resources are unique from those found in the U.S., then use your professional networks to find a colleague at a U.S. institution who shares an interest in the same research area. Check out Researching Research Topics and Teammates for tips on finding collaborators.

Before your U.S. collaborator applies, you should both have a clear understanding of your roles and responsibilities to carry out the research project. If you are going to be paid or reimbursed for your participation, you should finalize a subaward/consortium agreement before your U.S. collaborator applies for the grant. To learn more, read the Subawards (Consortium Agreements) for Grants SOP, our November 20, 2014 article "A Refresher on Subawards," and Consortium Agreements in the NIH Grants Policy Statement.

Regardless of whether you will be paid, you will need to prepare a letter of support to detail your planned participation. Find example letters of support within our sample R01 application "Structural Controls of Functional Receptor and Antibody Binding to Viral Capsids."

Finally, keep reading. Most of the administrative duties that surround a foreign component belong to the U.S. institution, thus we switch to addressing those institutions below. Still, understanding the requirements NIH has for your U.S. collaborator may help you establish a successful partnership.

Examples

U.S. institutions: If your proposed research relies on resources that exist outside the U.S., whether they are research subjects, facilities and equipment, or collaborators, then your research has a foreign component.

When a foreign investigator is paid, interacts with animal or human subjects, or their expertise is integral to the project’s success, NIH considers their participation to be a foreign component. However, consulting with a foreign investigator by phone or email without reimbursement would not prompt NIH to label the project as having a foreign component.

Consider some additional situations. The following are examples of foreign components:

  • You involve humans or vertebrate animals at a foreign site.
  • You travel abroad for data collection, surveying, or sampling.
  • Your project receives funding support from a non-U.S. foundation in addition to NIH funding.
  • You carry out research at your institution’s branch site in another country.

Conversely, the following examples are not foreign components:

  • You analyze existing data originally gathered abroad.
  • You travel abroad exclusively for consultation.
  • A foreign investigator provides advice on your application’s research design. (A general rule of thumb is that consultation from a foreign investigator becomes a foreign component if there is an expectation of publication co-authorship.)

Administrative Matters

Keep in mind several rules and processes that apply to research with foreign components.

First, unallowable costs for foreign components include

  • Full facilities and administrative costs (NIH limits F&A costs to 8 percent of total direct costs, less only equipment.)
  • Alteration and renovations exceeding $500,000
  • Patient care costs
  • Customs and import duties

Next, foreign investigators who will serve as key personnel should write letters of support to include in the application. Provide funding and payment information in the formal agreement for any subawards or consortium agreements.

Know that peer reviewers will verify that all foreign components are necessary and justified. NIAID’s advisory Council will also review the application.

When an application with foreign components is selected for funding, NIAID begins an administrative process to approve the foreign component. Should a foreign site not receive clearance and funding, NIAID may support the domestic portion of a grant with a restriction on the foreign component if the domestic portion can stand on its own.

Similarly, applications with foreign components are not eligible to receive an R56-Bridge award unless the domestic portion of the research can stand on its own without the foreign component(s).

Finally, a grantee needs prior approval from NIAID to add a foreign component to a grant after award. Principal investigators can seek prior approval by contacting their program officer and grants management specialist to discuss the potential addition.

Related Links

Header: Opportunities and Resources.

Opportunities for Collaborative Research at the NIH Clinical Center

As part of efforts to enhance the translation of basic biological discoveries into clinical applications that improve health, NIH reissued two companion funding opportunity announcements (FOAs) that encourage extramural investigators to collaborate with intramural researchers and take advantage of the special resources at the NIH Clinical Center.

These resources include

  • Diverse cohorts of patients, including studies of >500 rare diseases
  • A good manufacturing practices pharmacy facility for new biological or clinical products
  • Available blood products for special research studies
  • A robust training curriculum in clinical research

For additional information, go to Research Resources at the NIH Bethesda Campus.

Two FOAs, Two Activity Codes

Activity codes for the FOAs are X02 (pre-application) and U01 (cooperative agreement). NIH recommends—but does not require—submitting a preapplication in response to the X02 FOA before applying for the U01.

You should read both FOAs and consult with the appropriate scientific/research contacts to discuss the program's scope and goals as well as your application and proposed project.

Speaking of which, propose science that shows the potential to either result in understanding an important disease process or lead to a new therapeutic intervention.

While participating institutes and centers do not list specific areas of research interest, your project should align with their missions. See the FOA for those, and for NIAID, also go to Mission and Planning.

The X02 Opportunity

As we mentioned above, the X02 is the recommended—but not required—first step in applying for the companion FOA. If your X02 application:

  • Is deemed meritorious and the proposed project would be suitable for funding under this program, it will give you sufficient reason to follow up with the full U01 application.
  • Does not engender much interest from the Institute, your U01 application may not receive an outstanding score. Nevertheless, you can still submit a U01 application if the X02 is not well received.

As part of your X02 preapplication, you will need to include a Collaboration Plan that describes how you will maintain the proposed collaboration with your intramural investigator throughout the award duration. Among the items you should address: organizational structure, planned interaction and responsibilities of key personnel, and methods by which research teams will communicate.

Note these key points about the X02 opportunity:

  • Attachments related to clinical trials, e.g., Clinical Protocol, Data and Safety and Monitoring Plan, are not required for the X02 preapplication but are for the U01.
  • Since this FOA is for preapplications, NIH will not make any awards under this announcement.
  • X02 preapplicants will receive a letter from NIAID and a letter from the NIH Clinical Center that address whether the proposed project would be supported by NIAID and can be conducted at the NIH Clinical Center, respectively.
  • The first of three annual deadlines is December 15, 2015.

For complete details, read the June 24, 2015 Guide announcement.

The U01 Opportunity

To be eligible, your application must have a collaborating investigator from the NIH Intramural Program. The intramural investigator(s) should be actively involved in planning and executing the project, for which some of the research must be conducted at the NIH Clinical Center.

Read the FOA for required content and forms, such as a Collaboration Plan (like the X02; see above) and the following information:

  • Clinical Protocol Synopsis
  • Statistical Analysis Plan
  • Data and Safety Monitoring Plan
  • Milestone Plan and Complete Clinical Protocol for Projects Involving Clinical Trials

Also note that letters of collaboration from the intramural and Clinical Center investigators should be included in the application. Budgets are limited to $500,000 in direct costs each year, which include costs for the Clinical Center and intramural investigator—project-specific costs incurred by the intramural lab and paid out of the extramural grant budget. These costs can include equipment and supplies that are to be used specifically for the funded project. These do not include costs that the intramural lab would otherwise incur. The maximum project period is four years.

For multicenter clinical trials conducted at extramural sites and with NIAID intramural investigators at the NIH Clinical Center, take into consideration the requirements the NIAID extramural division, NIAID intramural, and NIH Clinical Center have. Consult the NIH Clinical Center and NIAID scientific/research contacts to learn what these requirements are.

The first of three annual due dates is April 11, 2016. Find more information in the June 24, 2015 Guide announcement.

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RFP Supports Comprehensive Resources for HIV Microbicides and Biomedical Prevention

Consider a recently released request for proposals (RFP) if you can provide preclinical product development services for candidate products for HIV prevention. Your efforts could help fill critical development gaps and advance promising non-vaccine biomedical prevention products and multipurpose prevention technologies into clinical testing.

Successful contractors will fill task orders in the following areas:

  • Preclinical gap-filling services
  • HIV animal models supporting product development
  • Bioanalytical support services
  • Product manufacturing
  • Scientific and quality/regulatory support services

We plan to award multiple Indefinite Delivery/Indefinite Quantity (ID/IQ) contracts for the first four task areas above. For the last task area, we plan to award a base ID/IQ contract to a single contractor.

Read the July 10, 2015 solicitation for more information, including proposal instructions, clarifications, and contacts. The proposal deadline is 3:00 p.m. local time on September 24, 2015.

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Understanding HIV Persistence in Infants

Through a recent R01 funding opportunity announcement, you can help address an important aspect of HIV research: the pathogenesis of perinatal HIV-1 infection and infant immune response as they relate to establishing HIV-1 reservoirs.

Understanding mechanisms by which HIV-1 alters the developmental changes in infant immunity and how this in turn affects the natural history of HIV-1 in this unique population may lead to remission strategies that can reduce the burden of HIV disease in children.

We encourage highly innovative studies and therefore do not require extensive preliminary data or a proven track record in neonatal immunology. We also encourage research with human cells and tissues, though we will accept studies using appropriately justified infant animal models.

Areas of interest include:

  • Development of the infant immune system, including age-dependent maturation of innate and adaptive immune responses to HIV-1 infection
  • Acquisition and development of broadly neutralizing HIV-1 antibodies (bNAbs) to HIV-1 in early life
  • Mucosal immune responses
  • Role of immune activation, inflammation and their mediators in various tissues or microbiomes on HIV-1 persistence in infants

Note that the FOA does not support:

  • Projects that focus on non-immune mechanisms of perinatal HIV-1 infection
  • Clinical trials (clinical studies that test novel interventions in humans)
  • Epidemiological studies

For complete details, read the June 5, 2015 Guide announcement. For application deadlines, see Standard AIDS Dates.

Send questions to the FOA's scientific/research contacts: Ellen DeCarlo and Judi Miller.

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Funding To Study the Intersection of HIV/AIDS and Aging

NIAID seeks grant applications using the R01 or R21 activity codes that propose to study HIV infection, HIV treatment, HIV-associated conditions, or associated biobehavioral or social factors in the context of aging and/or in older adults.

Preferred research approaches include clinical, translational, observational, and intervention studies in domestic or international settings.

This FOA encourages applications with the following characteristics:

  1. Clinical orientation—Integrate animal models and in vitro studies with human studies or demonstrate direct relevance to clinical features of HIV/AIDS.
  2. Focus on aging—Use a range of older individuals; make comparisons to younger, HIV-infected or older, non-HIV-infected populations.
  3. Geriatric outcomes—Include measures valued in geriatric medicine and gerontology, such as physical function, cognitive status, quality of life, and social support.
  4. Leveraging existing resources—Employ NIH-funded resources, such as clinical networks, to test hypotheses or generate relevant data for further studies, when possible.
  5. Appropriate controls—Justify your selection of control groups, considering factors like comorbidities, treatment regimens, lifestyle, and social support.
  6. Characterization of phenotypes—Maximize the homogeneity of subgroups by defining specific phenotypes of HIV in aging in analyses.

Among the sponsoring institutes, NIAID is primarily interested in

  • HIV in the aging population where the primary focus is the HIV virus itself or behaviors that facilitate transmission of HIV
  • The pharmacokinetics, pharmacodynamics, safety, and efficacy of therapeutic and non-vaccine biomedical HIV prevention products in aging individuals
  • HIV infection and related immune function, vaccine responses, and treatment-related comorbidities in aging individuals

This program will not use set-aside funds; awards are contingent upon NIH appropriations and meritorious application scores. Follow the Standard AIDS Dates when applying for either opportunity.

Read the June 18, 2015 R01 and R21 Guide announcements for complete details.

Questions? Contact Dr. Robin Huebner.

Header: Other News.

Loan Repayment Programs: New Notices Issued, New Application Cycle to Begin

NIH's Loan Repayment Programs (LRP) can ease some of the burden from your student loans.

If you're an eligible doctoral-level clinician or researcher who's committed to conducting qualified research for at least two years, you can get up to $35,000 to offset your educational debt each year.

Get more details in the July 7, 2015 Guide notices for the two programs NIAID supports:

You may apply from September 1 through November 16.

See NIAID's Loan Repayment Programs for an overview. NIH's Loan Repayment Program offers these resources:

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RFIs Seek Your Input on NIH-Wide Strategic Plan, Child Health Outcomes

At the request of Congress, NIH is developing a five-year NIH-wide strategic plan, due to Congress in December 2015.

Late last month, NIH issued Request for Information (RFI): Inviting Comments and Suggestions on a Framework for the NIH-Wide Strategic Plan. The RFI solicits public feedback on a proposed framework for the strategic plan, which includes a list of crosscutting research themes that exemplify the breadth of NIH priorities.

Weigh in by completing the RFI's comment fields before the August 16, 2015 deadline.

NIH also wants your input for Request for Information (RFI): Inviting Comments and Suggestions on the Environmental Influences on Child Health Outcomes (ECHO) Program (the National Children's Study Alternative). Specifically, the RFI seeks feedback on the program's FY 2016 plan, which emphasizes synergistic, longitudinal studies using extant cohorts that represent variable environmental exposures. The studies will focus on four key pediatric outcomes, share standardized research questions, collect standardized, targeted data, and will be managed through a Coordinating Center.

Respond before the August 14, 2015 deadline by completing the RFI's comment fields.

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News Briefs

NIAID's Fiscal Year 2014 Fact Book Now Available. Hungry for data about NIAID's portfolio, budget, and spending? We've got just the thing: The Fiscal Year 2014 Fact Book, which is filled with graphs and charts that detail how NIAID funded research last fiscal year.

New Guidance for Investigators on Genomic Data Sharing Policy. Potential applicants and offerors, check out Guidance for Institutions Submitting Grant Applications and Contract Proposals Under the NIH Genomic Data Sharing Policy for Human and Non-Human Data to refresh your understanding of the Genomic Data Sharing (GDS) policy. Institutional officials, you'll also want to reviewGeneral Resources for institutions and institutional review boards.

ASSIST Expands To Institutional Training, Career Development, Conference, and Additional Research Applications. In line with the Target Timeline for Single-Project ASSIST Support, applicants can now use the Application Submission System and Interface for Submission Tracking (ASSIST) for a variety of institutional training, career development, conference, and other research awards (e.g., R15, R24, UM1). Read the July 20, 2015 Guide notice for full details.

Standardized Test Scores No Longer Required in F30, F31 Applications. Following changes to the fellowship biosketch format, scores from standardized exams (e.g., MCAT, GRE) are no longer required for parent F30, F31, or F31–Diversity grant applications. For the official word, see the July 7, 2015 Guide notice.

Updates to iEdison Reporting Requirements and Compliance Messages. To alleviate confusion about the status of subject inventions with unresolved compliance issues, an update to iEdison will no longer permit a user to waive title to an invention or patent until all outstanding compliance issues and notification messages are resolved. Nor can users waive an invention until all related patents have been waived and all reporting requirements satisfied. Learn more by reading the July 2, 2015 Guide notice.

Submit Entries for BioArt Competition. The Federation of American Societies for Experimental Biology is accepting entries for the annual BioArt: Scientific Image and Video Competition through August 31, 2015. To see last year's winners, check out The 2014 BioArt Winners.

Header: Advice Corner.

A Helpful Resource for Ensuring Public Access Policy Compliance

We often remind investigators that they must include a PubMed Central reference number (PMCID) at the end of citations for papers that fall under the NIH Public Access Policy. However, sponsoring institutions are ultimately responsible for complying with the policy, consistent with the terms and conditions of their notices of award.

Institutions have several public access policy obligations to fulfill. First, they must ensure that their PIs follow the public access policy. Second, they should train their authors and investigators on the existence and expectations of the public access policy. Third, institutions should support their authors and investigators by reviewing their publishing agreements. To learn more, read For Sponsored Programs.

Of course, an institution’s worth of investigators’ publications is a lot to track. To help, NIH created the Public Access Compliance Monitor.

The Monitor provides institutions with the current compliance status of all journal articles that are associated with the institution and fall under the public access policy. It classifies articles according to compliance status and provides detailed information about each article—a full citation; associated grants and principal investigators; the PMCID and related IDs where available; and a link to the PubMed record.

Information from PubMed Central, the NIH Manuscript Submission (NIHMS) System, and NCBI's My Bibliography is used to automatically generate lists of articles associated with an institution. Data updates take place twice weekly.

To learn more about the tool, read the NIH Public Access Compliance Monitor User Guide. It includes a series of helpful questions and answers that provide further guidance—for example, instructions on how to use the Monitor to create a list of noncompliant papers for each PI.

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.

“How should I indicate what I've updated when submitting a resubmission application?”—anonymous reader

Your best option is to outline any substantial scientific changes in your introduction, summarizing significant additions, deletions, and changes to the application as well as responding to major weaknesses raised in the summary statement.

Read the Application Resubmissions SOP and How to Resubmit in the Strategy for NIH Funding to learn more.

Note that identifying individual changes by using brackets, indents, or change of typography in the text of Specific Aims, Research Strategy, and other application attachments is no longer required (see the December 4, 2014 Guide notice), though NIH will continue to accept applications that contain specific mark-ups.

“If I move to an institution in Canada, can I transfer my K23 award there, provided all other criteria are met?”—anonymous reader

No, the Mentored Patient-Oriented Research Career Development Award (Parent K23) cannot be transferred to an institution in Canada. A foreign institution is not eligible for career development awards and can therefore not be a grantee (i.e., institution receiving a grant).

Header: New Funding Opportunities.

See other announcements at NIAID Funding Opportunities List.

Content last reviewed on August 5, 2015