National Institutes of Health (NIH)

Last updated: 
06 April 2017
Keywords: 
Life Sci
RGP Contact Person: 

 

NEW!!!

Implementation of the NIH Genomic Data Sharing Policy Begins January 25, 2015: Impact on Applicants
The NIH expects Investigators preparing grant applications involving the generation or use of large-scale genomic data to:

  1. State in the cover letter that the studies proposed will generate large-scale human and/or non-human genomic data, and include a genomic data sharing plan in the application;
  2. Briefly address their plans for requesting access to the data, and state their intention to abide by the NIH Genomic Data User Code of Conduct in the Research Plan of the application, in the event applicants plan to use controlled-access human genomic data from NIH-designated data repositories as a secondary user to achieve the specific aims in the application;
  3. Make every effort to include a genomic data sharing plan in the application that outlines plans to comply with the expectations outlined in the Policy, and
  4. Plan to transition to a consent for future research uses and broad sharing, if possible, if the studies involve human participants and were initiated before the Policy's effective date and used consents that do not meet the expectations of the GDS Policy, in the event that the applications involve research funded prior to the Policy's effective date.
ASSIST (Application Submission System & Interface for Submission Tracking) is NIH's online system for the preparation, submission and tracking of grant applications through Grants.gov to NIH. For further information please see here.

 

SCIENTIFIC AREAS

The NIH places a high priority on international, interdisciplinary research and training programs. Many such international programs are sponsored through and within the NIH's Centers and Institutes. Each institute within the NIH has a mandate with well-defined priorities that address science and health from a specific perspective, a disease area (such as cancer) or an area of concern (such as aging). A list of NIH Institutes and Centers is available on the NIH website.

SUBMISSION DATES

All new applications (investigator-initiated or in response to a Request for Applications (RFA) or a Program Announcement (PA) are to be submitted by one of the official NIH submission deadlines, unless another deadline is mentioned specifically in the RFA or PA. For investigator-initiated R01's, there are three standard submission deadlines throughout the year: February 5, June 5, and October 5. Initial successful "on-time" submission to Grants.gov must have a timestamp on/before 5:00 p.m. local time of the applicant organization (i.e. Israel time) on the receipt date.

ELIGIBILITY

In general, NIH grants may be awarded to organizations that are domestic or foreign, public or private, or non-profit or for-profit. Eligible organizations include governments, including Federal institutions, institutions of higher education, other non-profit organizations, hospitals, and, in rare occasions, individuals (see Completing the Pre-Award Process).

Any special criteria for applicant eligibility or requirements concerning the qualifications of the PD/PI or other staff or participants will be specified in the FOA, program guidelines, or other publicly available documents. For further information, refer to the NIH policy statement regarding foreign awards.

AMOUNT AND SUPPORT PERIOD

The total project period consists of the initial competitive segment, any additional competitive segments authorized by approval of a competing continuation application, and any non-competing extensions. NIH policy limits each competitive segment to a maximum of 5 years (exclusive of non-competing extensions). 

  • Investigator-initiated applications:
    Any applicant requesting $500,000 or more in direct costs (excluding consortium F&A costs) in any one budget period is required to contact the Institute Center (IC) Program Officer (PO), in writing or by telephone, as early as possible during development of the application but no later than 6 weeks before submission for prior approval. This requirement applies to a single grant application, whether a new, renewal, revision, or resubmission application, under any NIH support mechanism. The PI must include a cover letter with the application identifying the PO contacted and the IC that has agreed to accept assignment of the application. An application subject to this policy that does not include the required information in the cover letter will be administratively withdrawn by the NIH and will not be reviewed or considered for funding.
  • Requests for applications:
    This policy does not apply to applications submitted in response to Request for Applications or to other announcements that include specific budgetary limits. However, any such application must be responsive to budgetary limits specified or NIH will administratively withdraw the application and it will not be reviewed or considered for funding.

The initial Notice of Award (NoA) provides funds for the project during the first budget period. Budget periods usually are 12 months long; however, shorter or longer budget periods may be established for compelling programmatic or administrative reasons. The NoA that documents approval of a project period that extends beyond the budget period for which funds are provided (including anticipated levels of future support) expresses NIH's intention to provide continued financial support for the project. The amounts shown for subsequent years represent projections of future funding levels based on the information available at the time of the initial award. Such projected levels of future support are contingent on satisfactory progress, the availability of funds, and the continued best interests of the Federal government. They are not guarantees by NIH that the project will be funded or will be funded at those levels and create no legal obligation to provide funding beyond the ending date of the current budget period as shown in the NoA.

Grantees are required to submit an annual progress report as a prerequisite to NIH approval and funding of each subsequent budget period (non-competing continuation award) within an approved project period (see http://grants.nih.gov/grants/policy/nihgps_2013/nihgps_ch8.htm#_Non-Competing_Grant_Progress). A decision to fund the next budget period will be formalized by the issuance of the NoA indicating the new budget period and the amount of new funding. The NoA also will reflect any remaining future-year commitments. NIH may decide to withhold support for one or more of the reasons cited in section 8.5 of Administrative Requirements.

FUNDING STATS FOR 2013

  1. Overall NIH success rates for R01-equivalent applications decreased to a historic low at 17.5%, amounting to 4,902 awards made worldwide.
  2. The average size of funding per grant *in constant USD* is the lowest ever.
  3. While the total number of research grants applications received by the NIH has increased in the past 15 years, it decreased by a few thousands in 2013 compared to 2012.
  4. The NIH made 14 direct awards to 6 Israeli institutions, 4 of which went to the Weizmann Institute.

MODE OF APPLICATION

The vast majority of NIH competing applications require an electronic application submission. The Funding Opportunity Announcement (FOA) will identify whether the application requires electronic or paper submission. Electronic submissions require the use of a unique set of application forms that combine SF424 (R&R) forms with agency-specific forms (e.g., 398 component forms, Fellowship supplemental component form). For electronically submitted applications, the applicable forms package and instructions is attached to a specific FOA.

eRA Commons USERID:
The submission of an online application to the NIH requires prior registration by the PI on the NIH eRA Commons. PLEASE CONTACT THE RGP OFFICE if you do not yet have a userid for the NIH eRA Commons. The RGP Office will create one for you, which is properly associated with the Weizmann Institute of Science.

Software requirements:
Completion of the electronic application form SF424 (R&R) requires prior installation of the appropriate software and use of the correct form versions. Further to instructions from the Grants.gov helpdesk, make sure NOT to use Adobe Acrobat Pro software at any point to open the application package, but rather, only one of the Adobe Reader versions listed on the Grants.gov site as being compatible!

SF424 Electronic Application Package:
The application package should be completed by the applicant and submitted to the RGP as a SINGLE FILE for review and final submission via Grants.gov. Application packages are specific to individual funding opportunity announcements (FOA). You cannot reuse application forms from one opportunity to another. The application package for a given FOA will be available for download from within that FOA. In the case of "unsolicited" or "investigator-initiated" applications for the various funding mechanisms (e.g. for submitting an R01 on one of the 3 standard deadlines), the application packages can be downloaded from the Parent Announcement webpage.

Automated checks:
Due to the nature of the NIH's online submission system via Grants.gov and the subsequent automated application checks by the NIH, which may require a few submission iterations before the application is accepted for review, it is imperative that you submit all relevant documents to the RGP Office for review TWO WEEKS PRIOR TO THE DEADLINE in order that the submission be performed no less than 72 hours prior to the deadline (further to the recommendations of the NIH, Grants.gov, and the RGP). Failure to comply with this request may result in our inability to process the application in time for submission.

Please Note: There is only one Authorized Organization Representative (AOR) for the Weizmann Institute authorized to submit the application: the RGP Office. Thus, the final completed application package MUST be submitted to the RGP office for final submission to the agency.

RESUBMISSIONS

A resubmission is an unfunded application that the applicant has modified following initial review and resubmitted for new consideration. Before a resubmission application can be submitted, the PD/PI must have received the summary statement from the previous review. A resubmission application may be submitted for any of the three preceding types of applications. See Application Information and Processes—Policies Affecting Applications for other policies affecting Resubmissions. NIH allows only one resubmission application.

BUDGET

As it is a Weizmann Institute requirement that the Finance Division approve the budget before the RGP can endorse an application, it is strongly recommended that the budget be submitted for approval as early as possible. Since on occasion the budget must be modified by the researcher further to input received by the Finance Division, the RGP recommends that with the assistance of the Departmental Administrator (Minhalan), the budget be prepared and submitted for approval to the Finance Division, if possible, even before the scientific parts of the application are complete.

APPROVED OVERHEAD BY FOUNDATION

(Facilities and Administrative [F&A] Costs): For foreign awards, 8% of total direct costs excluding equipment both on new and competing continuation awards as well as subcontracts. In the case of non-competing continuation awards funds may be rebudgeted to cover indirect costs.

SALARIES AND WAGES

Allowable. Compensation for personal services covers all amounts, including fringe benefits, paid currently or accrued by the organization for employee services rendered to the grant-supported project. Compensation costs are allowable to the extent that they are reasonable; conform to the established policy of the organization consistently applied regardless of the source of funds; and reflect no more than the percentage of time actually devoted to the NIH-funded project. Salary and wage amounts charged to grant-supported projects for personal services must be based on an adequate payroll distribution system that documents such distribution in accordance with generally accepted practices of like organizations. Briefly summarized, an acceptable system (for Non-Profit Organizations) is as follows: Monthly after-the-fact reports, including a signed certification, by the employee, or by a responsible supervisory official having first-hand knowledge of the work performed, that the distribution of activity represents a reasonable estimate of the actual work performed by the employee during the periods covered by the reports. Each report must account for the total activity required to fulfill the employee's obligations to the organization as well as the total activity for which he or she is compensated. Stipends are not allowable under research grants, even when they appear to benefit the research project.

Salary limitation for NIH grant (i.e. base salary - exclusive of fringe benefits and facilities and administrative (F&A) expenses), which was set at USD 181,500, will be increasing to USD 183,300 effective January 11, 2015. See here for further information.

TOSEFET MEHKAR ALLOWANCE

The NIH allows in its guidelines for the budget submitted for approval to include an explicit sum to be used to pay partially for the salary of PIs (please contact the Finance Division for details regarding tosefet mehkar allowance on NIH grants). Consequently, in the budget application to this foundation, you may request Tosefet Mehkar Aleph (i.e. a salary supplement which will be paid to you at the expense of the budget approved by the foundation in accordance to the explicit sums which appear in the approved budget for salary to the PI[s]). Please note that further to VATAT regulations, if Tosefet Mehkar Aleph is not requested on a grant from an agency whose guidelines allow for the partial reimbursement of the PI salary, you will NOT be eligible to receive Tosefet Mehkar Bet on grants from this agency.

Note: This is to remind you that according to national agreements, all Academic Staff may supplement their salary by Tosafot Mehkar. The sum total of Tosefet Mehkar Aleph allowances may reach a 50% addition to the basic salary of an academic staff member!

EFFORT REPORTING

The NIH has introduced a new business practice for measuring effort devoted to a project: person months.

Person months - Is the metric for expressing the effort (amount of time) PI(s), faculty and other senior personnel devote to a specific project. The effort is based on the type of appointment of the individual with the organization; e.g., calendar year (CY), academic year (AY), and/or summer term (SM); and the organization's definition of such. Normally, Weizmann researchers work on a 12 calendar month basis.

Conversion of percentage of effort to person months is straight-forward: To calculate person months, multiply the percentage of your effort associated with the project times the number of months of your appointment. For example:

10% of a 12 month calendar appointment equals 1.2 (CY) person months (12 x 0.10 = 1.2)
35% of a 3 month summer term appointment equals 1.05 (SM) person months (3 x 0.35= 1.05)
10% of a 0.5 FTE 12 month appointment equals 0.6 (CY) person months (12 x .5 X .1 = 0.6)

For further details see Usage of Person Months Frequently Asked Questions and Percent Effort to Person Months Calculator Excel spreadsheet.

A complete listing of NIH public policy requirements and objectives and their applicability to foreign grants is included in Public Policy Requirements, Objectives, and Other Appropriation Mandates in IIA. Several of the public policy requirements and objectives are highlighted below:

HUMAN SUBJECTS

The human subjects requirements contained in Public Policy Requirements, Objectives, and Other Appropriation Mandates - Human Subjects Protections, including the requirement for an assurance pursuant to 45 CFR 46, apply to foreign grants and foreign consortium participants under domestic or foreign grants.

Please note that legal requirements to protect human subjects, according to both national and US federal regulations, apply to a much broader range of research than many investigators realize. These include (but are not limited to) research that uses bodily materials (such as cells, blood or urine, tissues, organs, hair or nail clippings, even if you did not collect these materials) or residual diagnostic specimens (including specimens obtained for routine patient care that would have been discarded if not used for research). Moreover, please note that these regulations are applicable even if you obtain all your specimens from collaborators. Please refer to the NIH policy for further details.

If, after consulting the above-mentioned policy document, you have determined that your research does indeed involve human subjects/specimens research, and further to the NIH requirement for education on the protection of human research participants for all investigators submitting NIH applications for grants for research involving human subjects, the PI and all personnel involved with the research project must complete, a priori, a US federal agency approved training course, such as the online Human Participant Protections Education for Research Teams provided for this purpose by the NIH-NCI (RGP Comment: this online training session should take no more than 2 hours to complete).

In addition, the PI should contact the RGP to ascertain that the Weizmann Institute has a Federalwide Assurance (FWA) that covers the work to be performed, and he/she will be required to sign a declaration (available for download from the Forms Section of the RGP website, as part of the required Internal Form) confirming that he/she and all relevant personnel have completed or will complete such a training course.

ANIMAL WELFARE

The animal welfare requirements contained in Public Policy Requirements, Objectives, and Other Appropriation Mandates - Animal Welfare apply to foreign grants, regardless of the requirements of the home country.

Foreign grantees must provide the Office of Laboratory Animal Welfare (OLAW) with an Animal Welfare Assurance for Foreign Institutions. This constitutes institutional assurance and certification of compliance with the applicable laws, regulations, and policies of the jurisdiction in which the research will be conducted, and a commitment to follow the International Guiding Principles for Biomedical Research Involving Animals.

While IACUC approval is not required of foreign grantees, when the grantee is a domestic institution and performance sites are foreign (i.e., domestic grant with a foreign component), PHS Policy requirements are applicable. Accordingly, the grantee remains responsible for animal activities conducted at the foreign site and must provide verification of IACUC approval (i.e., certification that the activities as conducted at the foreign performance site are acceptable to the grantee). The grantee IACUC may accept, as its own, the approval of a foreign organization's IACUC; however, the grantee IACUC remains responsible for the review. Additionally, the foreign site must obtain an Animal Welfare Assurance for Foreign Institutions as described in the preceding paragraph.

RESEARCH MISCONDUCT

The research misconduct requirements included in Public Policy Requirements, Objectives, and Other Appropriation Mandates - Research Misconduct apply to foreign grants.

FINANCIAL CONFLICT OF INTEREST

The financial conflict of interest requirements contained in Public Policy Requirements, Objectives, and Other Appropriation Mandates - Financial Conflict of Interest apply to foreign grants.

INCLUSIVENESS IN RESEARCH DESIGN

Foreign grants are subject to the requirements for inclusion of women, minorities, and children in research design as specified in Public Policy Requirements, Objectives, and Other Appropriation Mandates - Inclusion of Children as Subjects in Clinical Research and Inclusion of Women and Minorities as Subjects in Clinical Research and Reporting Sex/Gender and Racial Ethnic Participation.

CIVIL RIGHTS

The civil rights requirements specified in Public Policy Requirements, Objectives, and Other Appropriation Mandates - Civil Rights do not apply to foreign grants.

LOBBYING

The requirements of Public Policy Requirements, Objectives, and Other Appropriation Mandates - Lobbying Prohibition, including disclosure reporting, apply to foreign grants.

DEBT

Foreign applicants are required to provide a certification of nondelinquency on debts owed to the United States as specified in Public Policy Requirements, Objectives, and Other Appropriation Mandates - Nondelinquency on Federal Debt.

DEBARMENT AND SUSPENSION

Applicants/grantees that are foreign governments or governmental entities, public international organizations, or foreign-government-owned or -controlled (in whole or in part) entities are not subject to the debarment or suspension certification requirement or to debarment or suspension under 2 CFR 376. All other foreign institutions and international organizations are subject to these requirements. See Public Policy Requirements, Objectives, and Other Appropriation Mandates - Debarment and Suspension for additional information on this requirement.

TRAVEL

The Fly America Act governs international travel paid for by the US government (and consequently applies to all NIH grantees). According to this act, foreign air travel funded with Federal dollars must be performed on US flag air carriers.

RIGHTS LIMITATION

To be able to retain rights and title to inventions made with Federal funds, so-called “subject” inventions, the grantee must comply with a series of regulations that ensure the timely transfer of the technology to the private sector, while protecting limited rights of the Federal government.

The regulations apply to any subject invention—defined as any invention either conceived or first actually reduced to practice in the performance of work under the Federal award—and to all types of recipients of Federal funding. This includes non-profit entities and small businesses or large businesses receiving funding through grants, cooperative agreements, or contracts as direct recipients of funds, or as consortium participants or subcontractors under those awards. Some of the steps required by the regulation to retain intellectual property rights to subject inventions include:

1. Report all subject inventions to NIH
2. Make efforts to commercialize the subject invention through patent or licensing
3. Formally acknowledge the Federal government’s support in all patents that arise from the subject invention
4. Formally grant the Federal government a limited use license to the subject invention

See the Patent Policy Information section of the Grants Policy Statement.

Details regarding invention reporting and iEdison are discussed under Administrative Requirements-Monitoring-Reporting-Invention Reporting. See also specific advice at the Weizmann Institute regarding Intellectual Properties Policy for this funding source (from the Vice President for Technological Transfer).

PUBLICATIONS POLICY

Compliance with the NIH Public Access Policy is a legal requirement and a term and condition for all active grants and contracts. The NIH Public Access Policy ensures that the public has access to the published results of NIH funded research. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central immediately upon acceptance for publication. To help advance science and improve human health, the Policy requires that these papers are accessible to the public on PubMed Central no later than 12 months after publication.

PD/PIs and grantee organizations are expected to make the results and accomplishments of their activities available to the research community and to the public at large. (See also Availability and Confidentiality of Information—Confidentiality of Information—Access to Research Data in Part I for policies related to providing access to certain research data at public request)

These announcements and additional relevant information, including Questions and Answers regarding copyright and other concerns, are available at the NIH Public Access website. In brief (see the aforementioned links for more details), the Policy requires all NIH-funded investigators to make their peer-reviewed author's final manuscripts available to other researchers and the public at the NIH National Library of Medicine's PubMed Central (PMC) immediately after the final date of journal publication, and to submit the final peer-reviewed manuscript to the NIH upon acceptance for publication at http://www.nihms.nih.gov (see the Submission Process for more information). In addition, when citing your NIH-funded papers in NIH applications, proposals or progress reports, you must include the PubMed Central reference number (PMCID) for each paper.

Please note that a third party (e.g. assistant, librarian, publisher, etc.), with the author's permission, can upload Public Access Policy related manuscripts to the NIHMS system on behalf of the author. To do so, click on "My NCBI" from http://www.nihms.nih.gov.