Grants Policy and Management Training for Foreign Investigators

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Part 5. Compliance

This is Part 5 of the Grants Policy and Management Training for Foreign Investigators.

As an NIH grantee, you must comply with all policies that affect your grant, many of which are based on U.S. law. It's critical that you understand policies from NIAID, NIH, and U.S. and local governments.

Table of Contents

• Complying With Policy
  • Know These Government Regulations
    • Code of Federal Regulations
    • Administrative Standards
    • Cost Principles
  • Know NIH and NIAID Policy Requirements
  • NIAID Select Agent Policy
  • New NIH Policies Not in the Grants Policy Statement
• How to Keep Up With Policy Changes
• Keep People in Your Institution Informed

Complying With Policy

As an NIH grantee, you must comply with all policies that affect your grant, many of which are based on U.S. law. We covered your responsibilities in Part 2. Getting Your Initial Award.

In signing the application face page, the institutional business official certifies that the grantee organization will do the following:

• Comply with NIH policies, assurances, and certifications.
• Assume responsibility for the performance of the research.

Keep in mind that a grant is legally binding. NIAID may suspend or terminate an award, debar individuals or institutions, impose criminal penalties, or take other actions if an organization or involved person deliberately withholds, falsifies, or misrepresents information related to a grant that we have funded.

In the following sections, we tell you how to meet NIH's compliance requirements.

Know These Government Regulations

The U.S. government issues regulatory documents called circulars that detail administrative and fiscal requirements for grants the government funds.

We expect institutional business officials and principal investigators to know and follow these regulations:

Code of Federal Regulations

• 42 CFR Part 52 -- Grants for Research Projects.
• 45 CFR Parts 74 and 92 -- Public Welfare, Administrative Requirements.
• 45 CFR Part 46 -- Public Welfare, Protection of Human Subjects.

Administrative Standards

• OMB Circular A-110 -- Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations.

Cost Principles

Costs that may be charged to a grant differ by organization type. See the links below for details.

Know NIH and NIAID Policy Requirements

You can find many NIH policies in Part II: Terms and Conditions of NIH Grant Awards of the NIH Grants Policy Statement (published in 2003). The table on that page shows you which requirements apply to foreign organizations.

In addition, you need to keep up with:

• Policies NIH issued since the last version of the Grants Policy Statement.
• New NIH policies.
• NIAID policies.

Read the following sections for more information.

NIAID Select Agent Policy

If you are using select agents, many regulations and procedures will apply to your research. While some of them are federalwide, others are specific to this Institute. Follow these procedures.

• If you plan to study an agent on the HHS and USDA Select Agents and Toxins list, complete requirements listed below unless the strain is excluded -- go to the Notification of Exclusion list of the U.S. Centers for Disease Control and Prevention (CDC).
• Stay familiar with the latest HHS and USDA Select Agents and Toxins list because new items are added periodically.
• Document your registration with Centers for Disease Control and Prevention or the U.S. Department of Agriculture (USDA), depending on the strain.
• Read and follow the NIAID Select Agent Award Policy and other policies. Find them at Biodefense and Biosecurity.
• If you are proposing research involving select agents in your progress report, fill out the Select Agent Research attachment to the PHS 398 Research Plan form.
• Investigators at foreign institutions need to send NIAID additional information at the time of award. Read the information below and the Select Agent Awards SOP for details.
  • Both domestic and foreign institutions using select agents or toxins are subject to a Select Agent Terms of Award for NIAID Grants or Select Agent Language for NIAID Contracts and RFPs stating a grantee's or contractor's responsibility to comply with NIAID's select agent policy if they possess, use, or transfer select agents or toxins.
  • Assign someone in your organization to ensure compliance with regulations involving restricting access to select agents, security, biosafety, restricted experiments, incident response, training, transfer, records, notification of incidents, and penalties.
  • As a foreign institution, you must provide information satisfactory to NIAID that you have safety, security, and training standards equivalent to those described in 42 CFR Part 73, 7 CFR Part 331 and 9 CFR Part 121 in place.
  • All foreign institutions that are either primary awardees, subcomponents, or subcontractors must do the following:
    • Provide information required by the NIAID select agent policy for foreign institutions.
    • Have an NIAID representative from CDC inspect facilities where select agents will be involved. An NIH-chaired committee of U.S. federal employees will review inspection reports and submitted information. The results will be presented to NIAID for approval. You cannot use NIH funds for select agent work if approval is denied.
    • If you are engaged in select agent research, you should read the following documents:
      • Select Agent Research Review and Approval for Grants That Include Foreign Institutions.
      • Select Agent Review and Approval Procedure for New and Existing Contracts That Include Foreign Institutions.
      • NIAID Select Agent Policy for Foreign Institutions questions and answers.

New NIH Policies Not in the Grants Policy Statement

NIH regularly issues new policies that affect grantees.

NIH published the latest NIH Grants Policy Statement in 2003 and does not update it between versions. So some policies are missing, and some of the information is incorrect.

It's always a good idea to check with your grants management specialist for questions about an NIH policy.

Here are new policies NIH issued since 2003.

• Sharing resources. You must describe plans to share and distribute research resources or state reasons why you cannot for the following areas:

• Model organisms. If you are using NIH funds to produce new, genetically modified variants of model organisms, include a plan for sharing and distributing these resources or provide reasons why sharing is restricted or not possible.
• Data sharing. Include a data sharing plan in the application if requesting $500,000 or more in direct costs in any year. (You will also need to get NIAID approval before submitting any investigator-initiated application requesting that level of funding. For details, see the Big Grants SOP.)
• Data sharing for genome-wide association studies. Include a data sharing plan in the application for a study of variation across the entire human genome to identify genetic associations with observable traits or the presence or absence of a disease or condition. You'll need institutional review board or independent ethics committee certification for this plan.

• Public Access to Publications. There are two parts to this policy for sharing research data with the public.
  • You must submit to NIH's PubMed Central (PMC) database an electronic version of any final peer-reviewed manuscript accepted for publication that resulted from NIH-funded research.
  • NIH requires grantees to cite PMC identification numbers in all NIH applications, including progress reports, when citing a paper funded by NIH. Read the Public Access of Publications SOP for details.
• ClinicalTrials.gov Registration. You must register applicable clinical trials in ClinicalTrials.gov and certify that you have done so in your grant application or progress report.
• Some grantees may use grant monies to pay costs of inventions, licensing and patents. Items include licensing fees, attorney's fees for preparing or submitting patent applications, and fees paid to the U.S. Patent Office.

How to Keep Up With Policy Changes

At any point during your grant, NIH can institute a new policy that affects you.

To stay informed, do the following:

• NIH -- check the NIH Guide. Subscribe to the Guide Listserv to receive the table of contents for each weekly issue of the Guide, and sign up for the electronic submission listservs at Get Connected.
• NIAID -- read our bimonthly NIAID Funding News newsletter, follow our Top Policy Changes, and Subscribe to NIAID Funding News Email Alerts to receive the newsletter and other notices by email.

Keep People in Your Institution Informed

Many people involved in NIH-funded research need to be aware of the policies that affect the project. Do the following to make sure people in your organization understand what NIH expects of them.

• Train and educate staff about NIH grants management requirements.
• Have written institutional policies and procedures, and train staff to follow them.
  • Cover topics such as conflicts of interest, time and effort reporting, and consulting.
  • Clearly identify roles and responsibilities.
  • Establish financial systems and internal controls.

If you have questions about compliance issues, talk to your grants management specialist or contact Kathy Hancock, assistant grants compliance officer in NIH's Office of Policy for Extramural Research Administration, at +1-301-435-1962 or hancockk@od.nih.gov.

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