National Institutes of Health (NIH)

Last updated: 
08 January 2018
Keywords: 
Life Sci
RGP Contact Person: 
Reminder: Changes for 25 January 2018 Application Due Dates

Two major changes impact applications submitted for NIH due dates on or after 25 January 2018.

  • Applicants are required to use FORMS-E. Wondering what this means for late applications or reviewers submitting under the continuous submission policies? See NIH Guide Notice NOT-OD-17-062 to learn more.
  • Applications that include one or more clinical trials must be submitted in response to funding opportunity announcements that allow for clinical trials. See NIH Guide Notice NOT-OD-18-106 to learn more.

NEW!!!

ASSIST (Application Submission System & Interface for Submission Tracking) is NIH's new online system for the preparation, submission and tracking of grant applications. 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

Most NIH applications have standard due dates. To know the due date for an application or a resubmission as well as know the earliest start date for a project for which funding is requested, please consult the following link:
https://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/due-dates.htm

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). 

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. 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.

MODE OF APPLICATION

The submission of an application to the NIH requires the PI and usually other people included in the application to have an NIH eRA Commons User Name. 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.

NEW: The Application Submission System & Interface for Submission Tracking (ASSIST) system is used to prepare and submit grant applications electronically to NIH and other Public Health Service agencies. Prior to using ASSIST, applicants should identify a Funding Opportunity Announcement (FOA) to which they'd like to apply. For further information please see here.

Automated checks:
Due to the nature of the NIH's online submission system and the subsequent automated application checks by the NIH, 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.

Adobe Reader:
Adobe Reader software is needed to view PDF documents including the application image assembled by eRA systems. If using Grants.gov downloadable forms or workspace for your submission, be sure to use a version of Adobe Reader compatible with the Grants.gov forms. Users can identify and download compatible versions of Adobe Reader by visiting Grants.gov's Adobe Software Compatibility page.

PDF Generator:
You must use PDF format for all documents attached to application forms. Many word processing programs include options to save documents in PDF format. There are also free PDF conversion programs available on the internet.

Web Browser:

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 before the scientific parts of the application are complete.

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.

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.

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!

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. Most relevant are as follows:

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.

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.

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.

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).