National Institutes of Health (NIH) requires a data management and sharing plan effective for competitive grant applications for due dates on or after January 25, 2023.
For guidance refer to the GCO Website > Data Management and Sharing Plan
NIH Grants Policy on Overlap of Research Grant Applications - (06/01/2021)
Changes to NIH Biosketch and Other Support Pages for Due Dates on/after May 25, 2021
The NIH has issued a notice (NOT-OD-21-073) announcing substantive changes to the Biosketch and Other Support pages on competitive applications and Research Performance Progress Reports (RPPRs) with due dates on or after May 25, 2021. For detailed guidance and resources, refer to the GCO website - NIH Biosketch and Other Support Changes.
ISMMS Institutional Facts
Institutional Information
Refer to the Administrative Information Sheet for Institutional facts that may be required for grant and contract applications including information related to:
- Sponsored Projects
- Compliance (PPHS/IRB, IACUC, Research Integrity Officer, Institutional Biosafety Program)
- Finance
- GCO deadlines for review and approval
Grant Application Resource Center (GARC)
GARC provides Standardized Language describing the Mount Sinai Health System programs and resources for use in grant applications. This includes language for:
- Health System and Central Resources
- Institutes
- Centers
- Research
- Education
Vertebrate Animal Research
- Center for Comparative Medicine and Surgery - Standardized Language for Vertebrate Animals Section (scroll to the bottom of the page to Related Resources (VAS Fact Sheet )
- Boilerplate Language for Human Subject and Vertebrate Animals Sections of Competitive NIH Training Grant Applications
Human Subject Research
Preferred Name Use
Biosketches and MyNCBI
Changes to NIH Biosketch and Other Support Pages for Due Dates on/after May 25, 2021
The NIH has issued a notice (NOT-OD-21-073) announcing substantive changes to the Biosketch and Other Support pages on competitive applications and Research Performance Progress Reports (RPPRs) with due dates on or after May 25, 2021. For detailed guidance and resources, refer to the GCO website – NIH Biosketch and Other Support Changes.
For more information contact:
Amanda Amescua
Director, Grants and Contracts Office
amanda.amescua@mssm.edu
Cost-Sharing
What
Cost sharing occurs when a departmental or unrestricted fund account covers a project cost rather than the sponsored project budget. Examples of cost sharing are:
- ISMMS investigator contributing effort but his/her salary will be charged to an unrestricted account rather that the grant budget.
- Equipment that a department purchases for the PI to conduct the study, rather than the PI requesting the equipment funds on the grant budget.
How
If a proposal includes either mandatory or voluntary Cost-Sharing, the commitment becomes a requirement of the agreement and Mount Sinai must comply.
InfoEd Application Requirements: If applicable, a fully signed Cost-Sharing Form must be included in the InfoEd application. Failure to include a fully executed copy of the cost sharing form may result in delays processing and approving applications.
Resources
NIH and Foreign Influences on Research Integrity
What
A common misconception is that foreign involvement only occurs when there is a subaward to a foreign institution. The Foreign Component definition (in section 1.2) from the NIH Grants Policy Statement (NIHGPS) is much broader. It includes, 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.
Activities that would meet this definition include, but are not limited to:
- The involvement of human subjects or animals.
- Extensive foreign travel by recipient project staff for the purpose of data collection, surveying, sampling, and similar activities.
- Any activity of the recipient that may have an impact on U.S. foreign policy through involvement in the affairs or environment of a foreign country.
Examples of other grant-related activities that may be significant are:
- Collaborations with investigators at a foreign site anticipated to result in co-authorship.
- Use of facilities or instrumentation at a foreign site.
- Receipt of financial support or resources from a foreign entity.
How
Three ways to report foreign involvement:
- Reporting in Competitive Grant Applications
- Reporting in Annual Research Performance Progress Reports (RPPR)
- Prior Approval Request
For detailed information, refer to The NIH and Foreign Influences on Research Integrity guide.
NIH Genomic Data Sharing (GDS) Policy
What
The NIH Genomic Data Sharing (GDS) Policy, applies to all NIH-funded research (e.g., grants, contracts and intramural research) that generates large-scale human or non-human genomic data, regardless of the funding level, as well as the use of this data for subsequent research.
Large-scale data include genome-wide association studies (GWAS), single nucleotide polymorphisms (SNP) arrays, and genome sequence, transcriptomic, epigenomic, and gene expression data.
For more information, refer to the following references:
- Office of Science Policy - Institutional Certifications
- Office of Science Policy - Scientific Data Sharing
How
NIH Grant Applications: Refer to the GCO guidelines outlined in Procedures for NIH Grant Applications that Propose to Generate or Use Large-Scale Genomic Data.
IRB Requirements: Refer to the ISMMS PPHS guidelines listed under NIH Human Genomic Data Sharing (GDS) Policy and Guidelines.
Resources
NIH Other Support
Changes to NIH Biosketch and Other Support Pages for Due Dates on/after May 25, 2021
The NIH has issued a notice (NOT-OD-21-073) announcing substantive changes to the Biosketch and Other Support pages on competitive applications and Research Performance Progress Reports (RPPRs) with due dates on or after May 25, 2021. For detailed guidance and resources, refer to the GCO website – NIH Biosketch and Other Support Changes.
What
According to the NIH, other support includes all financial resources, whether Federal, non-Federal, commercial or institutional, available in direct support of an individual’s research endeavors, including but not limited to research grants, cooperative agreements, contracts, and/or institutional awards. Training awards, prizes or gifts do not need to be included.
Who
The NIH requests Other Support pages for senior/key personnel designated in the application.
When
Other support requests may be made during the Just in Time (JIT) process and during the Research Performance Progress Report (RPPR) submission.
How
For detailed guidance and resources, refer to the GCO website – NIH Biosketch and Other Support Changes.
Resources
Research Using Vertebrate Animals
Investigator proposals which involve the use of vertebrate animals are required to include a Vertebrate Animal Sections (VAS) section in their grant application, contract proposals and cooperative agreements. This includes animals used for harvesting tissue and the generation of custom antibodies.
For guidance, contact the IACUC Office and Center for Comparative Medicine and Surgery (CCMS).
Resources
- NIH Office of Laboratory Animal Welfare - Vertebrate Animal Section
- NIH Grants & Funding
- Boilerplate Language for Human Subject and Vertebrate Animals Sections of Competitive NIH Training Grant Applications
- Center for Comparative Medicine and Surgery - Standardized Language for Vertebrate Animals Section (scroll to the bottom)
- Guide for the Care and Use of Laboratory Animals
Research Involving Biohazardous Agents
Investigator proposals that involve biohazardous agents, including recombinant DNA/synthetic nucleic acids, infectious organisms, biological toxins, etc., are required to address Biohazards in their grant application, contract proposals, and cooperative agreements. Research involving biohazardous agents must be described in an eSafety research registration.
For guidance on preparing a Biohazard statement, contact the ISMMS Biological Safety Program.
Last Updated: July 2023
Subawards
Outgoing Subawards (ISMMS is the Prime Institute)
What
When ISMMS is the Prime Institution applying for a project with a subaward, the following information and documentation is required from sub-recipient organizations:
- Signed Statement of Intent (SOI) or PPH 398 Face Page
- Statement of Work (SOW)
- Certificate of Compliance with HHS Financial Conflict of Interest (COI) Rules and Regulations
- Budget and budget justification
Additional Information Required for NIH Applications
- Performance site information
- Resources and facilities page
- Biosketches for key personnel including other significant contributors
- Letter of support
- Single IRB (sIRB) reliance statement, if applicable
- Inclusion enrollment report data for projects with human subjects, if applicable
- Multiple PI (MPI) plan, if applicable
- Consortium/contractual arrangements
When
The above documents are required for the InfoEd application. The GCO recommends receipt of required documents from the sub-recipient at least 10 business days before the NIH deadline.
How
For detailed instructions and guidance, refer to Documentation and Instructions for Sponsored Projects with Subawards When ISMMS is the Prime Institution.
Incoming Subawards (ISMMS is a Subaward)
What
When ISMMS is a subaward or sub-recipient on a sponsored project application the following documentation may need to be provided to the prime institution and/or to the GCO:
- Statement of Intent (SOI) (ISMMS prepares and signs this)
- Statement of Work (SOW)
- Budget for new/competitive and non-competitive applications
- Budget Justification for new/competitive applications
Additional Information Required for NIH Competitive Applications
- Certificate of Compliance with HHS FCOI
- Performance Site Information
- Resources and facilities page
- Biosketches for key personnel including other significant contributors and consultants
- Letters of Support
- Single IRB (sIRB) Reliance Statement (if applicable)
- Inclusion Enrollment Report Data for projects with human subjects (if applicable)
- Multiple PI/PD Leadership Plan (if applicable)
How
Any documents that the prime institution requires must be included in the InfoEd application to the GCO. For detailed guidance, refer to Subawards: ISMMS as the Subawardee.
Resources
International Research
For NIH grants - State Department Clearance might be needed. For guidance about working with a Foreign Component and other information concerning foreign influences, refer to NIH and Foreign Influence on Research Integrity.
Consent Language - Ensure consent language takes the General Data Protection Regulation (GDPR) into account when dealing with European entities.
NIH Grant Budgets - Foreign institution can receive a 8% indirect cost. For more information, refer to the NIH Grants Policy Statement.
Questions
Contact your GCO Assigned Departmental Grants Specialist.
External Grant Submission Systems
With the exception of the National Science Foundation (NSF) and NASA NSPIRES, all federal single project, competitive applications are prepared and submitted in InfoEd and sent directly to the agency. These are called System to System (S2S) applications. Users still need to register for accounts on the external online software system. However, do not log onto the agency’s system to submit the applications.
Compliance (IRB and IACUC) Instructions
Guidelines for when to submit the IRB/IACUC applications.
Research 411 Portal
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