NIH Clinical Trial Definition - How Will it Impact You?

What

The NIH revised the definition of a clinical trial in 2014. This new definition broadens the type of human subject research that meets the NIH criteria of a clinical trial, and may now include studies that have not been considered clinical trials in the past, such as behavioral and mechanistic studies.

Impact: Effective January 25, 2018, investigators applying for NIH funding are required to identify whether their study is a clinical trial based on this definition.

Why

Correctly identifying whether your study is a clinical trial is important for:

1. Selecting the correct NIH funding opportunity

Note: The NIH may reject your application if you choose the wrong funding opportunity announcement.

2. Completing NIH application requirements

3. Complying with NIH requirements

How

To help identify if your study is a clinical trial, use the following NIH tools and resources:

Still not sure if your study is a clinical trial? Contact your Program Official.

Resources

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

Human Subject Research

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:

  1. ISMMS investigator contributing effort but his/her salary will be charged to an unrestricted account rather that the grant budget.
  2. 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

Cost Sharing Policy

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:

  1. Reporting in Competitive Grant Applications
  2. Reporting in Annual Research Performance Progress Reports (RPPR)
  3. 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:

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

PPHS Guidance and Policies 

NIH Other Support

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

Just in Time (JIT)

Note
Other Support pages are different for JIT and PRRP submissions. Make sure you follow the correct instructions.

Resources

NIH Single IRB (sIRB) Requirement for Multi-Site Studies

The National Institutes of Health (NIH) has issued a policy (NOT-OD-16-094) requiring that multi-site studies using the same protocol to conduct non-exempt human subject research at more than one domestic site use a single IRB (sIRB). For more information, refer to the GCO sIRB Memo.

ISMMS IRB Criteria to serve as the sIRB of Record

The ISMMS IRB may serve as the sIRB if the application has:

  1. Five or fewer sites in addition to the ISMMS site
  2. All of the sites participate in the SMART IRB initiative

Requests to have ISMMS IRB serve as the reviewing IRB should be made well in advance of your grant submission. For detailed guidance, refer to Request for ISMMS to Serve (R2S) as the Reviewing IRB.

Note: For circumstances where the ISMMS IRB will not serve as the sIRB, the ISMMS IRB can advise the PI of alternative sIRBs that may be acceptable. Alternatives include:

  1. Participating Accredited SMART IRBs
  2. Commercial IRBs with which ISMMS has an existing master agreement
  3. NCI CIRB
  4. Trial Innovation Network (TIN) sIRB

Required Documentation for NIH Grant and Contract Applications

Refer to the ISMMS sIRB Memo for guidance on the documentation required to be included in applications.

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

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.

Certification of Compliance with HHS FCOI - Statement of Intent Form
If the Sub-Awardee Institution selects "My Institution agrees to comply with ISMMS COI policy"  on the Statement of Intent to Establish a Consortium Agreement Form, each investigator is required to complete the education presentation and a disclosure form. Signed COI forms must be uploaded in the Internal Documents Tab of the InfoEd application.

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.

External Grant Submission Systems

Note

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.

More Information

Compliance (IRB and IACUC) Instructions

Guidelines for when to submit the IRB/IACUC applications.

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.

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