Grants Policy and Management Training for Foreign Investigators

<< Part 4. Subawards · Training Index · Part 6. Receiving and Spending Money >>

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
• How Do You Know What Policies Apply To You?
• 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 Other 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.

Organization Type	Cost Principles
Universities	OMB Circular A-21
Non-Profit Organizations	OMB Circular A-122
Hospitals	45 CFR Part 74, Appendix E
State and Local Governments	OMB Circular A-87
Commercial (for-profit) Organizations	FAR Part 31 codified as 48 CFR part 31.2

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. 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.

Here are examples of an NIH and an NIAID policy.

NIH Policy on Financial Conflicts of Interest

If you don’t know what we mean by financial conflict of interest, here is a definition from our Glossary of Funding and Policy Terms and Acronyms:

Significant financial interests that would likely bias NIAID grantees or contractors. By law, institutions must manage, reduce, or eliminate these conflicts.

NIH takes financial conflicts of interest so seriously that it may suspend funding if an institution does not adhere to FCOI rules.

Investigators must report all significant financial interests to their institution. In turn, institutions must report conflicts of interest to NIH, which is just one requirement they must meet to comply with the FCOI policy.

For details, read our Financial Conflicts of Interest for Awardees SOP.

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 Select Agents.
• 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.

How Do You Know What Policies Apply To You?

NIH regularly issues new policies that affect grantees. We list them at Top Policy Changes, so check that page frequently.

NIH publishes the NIH Grants Policy Statement and does not update it between versions. So some new policies will be missing.

Your Notice of Award is issued in association with a certain version of the NIH Grants Policy Statement, as explained in the October 15, 2010, NIH Guide notice. However, all new policies announced in the NIH Guide also apply to you. So you can use the Grants Policy Statement as a reference, but you should also be watching the NIH Guide.

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 biweekly NIAID Funding Newsletter, follow our Top Policy Changes, and Subscribe to NIAID Funding Newsletter Email Alerts to receive the newsletter and other notices by email.

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

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.

<< Part 4. Subawards · Training Index · Part 6. Receiving and Spending Money >>