As an NIH grantee, you must comply with all policies that affect your international 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.
Complying With Policy
Keep in mind that a grant is legally binding.
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 Negotiation and 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 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.
- OMB Circular A-110—Uniform Administrative Requirements for Grants and Other Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations.
Costs that may be charged to a grant differ by organization type. See the links below for details.
|OMB Circular A-21
|OMB Circular A-122
|45 CFR Part 74, Appendix E
|State and Local Governments
|OMB Circular A-87
|FAR Part 31 codified as 48 CFR part 31.2
Know NIH and NIAID Policy Requirements
Keep up with existing and new policies.
You can find many NIH policies the NIH Grants Policy Statement.
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 (FCOI), here is a definition:
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.
There are more requirements to ensure full compliance with 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 U.S. Department of Health and Human Services (HHS) and U.S. Department of Agriculture (USDA) Select Agents and Toxins list, complete requirements listed below unless the strain is excluded—go to Select Agents and Toxins Exclusions of the 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 CDC or the USDA, depending on the strain.
- Read and follow the NIAID Select Agent Award Policy and other policies. Find them at Research Using 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 Solicitations and Contracts stating a grantee's or contractor's responsibility to comply with NIAID 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:
NIH Policy on Dual Use Research of Concern (DURC)
Dual Use Research of Concern (DURC) is research that could be misused to pose particular risks to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.
Read more in the November 21, 2014, Guide notice.
Public Access Policy
When you send in your Research Performance Progress Report (RPPR), you must include a list of peer-reviewed journal articles that resulted from the grant's direct funding for which you are writing the progress report.
If you fail to do this, you are not in compliance and NIH will delay processing your award. This is part of NIH public access policy.
Under this policy, you must submit to PubMed Central (PMC) final peer-reviewed journal manuscripts that arise from NIH funds upon acceptance for publication. For more information on this, go to the NIH Public Access website.
In your progress report, you have to demonstrate compliance with the policy for all applicable papers. Read more in the Progress Report Summary section in Annual Progress Report.
We encourage you to ensure compliance well before your progress report is due. That means 1) ensuring all publications arising from your awards are posted to PubMed Central and 2) using your My NCBI account to track compliance for publications.
Posting to PMC
Starting as early as when you plan to submit papers for publication, think about how they will reach PubMed Central. At that point, consider the following:
- How will your paper be submitted to PMC?
- What version of the paper, e.g., final published article, final peer-reviewed manuscript, will be made available on PMC?
- Who will submit the paper?
- When will it be submitted?
- Who will approve the submission?
- When can the paper be made public on PMC?
Familiarizing Yourself With My NCBI
With the Research Performance Progress Report (RPPR), you'll have to use My NCBI to track compliance and identifiers as well as ensure your citations are in the correct format.
When authors link a paper to your grant in My NCBI, it will show up as a suggestion in your My NCBI account to help you track and report the paper. This can be particularly helpful when you do not author all papers arising from your award. It also helps you monitor whether a paper was wrongly affiliated with your award, so the error can be corrected in a timely manner. You can also delegate My NCBI tasks.
To acquaint yourself with My NCBI, see My NCBI and My Bibliography Training Materials on the Training/Communications page of the NIH Public Access website. Learn about My NCBI's role in Managing Compliance to the NIH Public Access Policy. For additional information on reporting publications in the RPPR, see Frequently Asked Questions.
How Do You Know What Policies Apply to You?
New policies are not necessarily in the latest Grants Policy Statement.
NIH regularly issues new policies that affect grantees. We list them at Stay Informed About Policy Changes & News, 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.
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 News and Subscribe to NIAID Funding News Email Alerts to receive the newsletter and other notices by email.
- Learn more in the Keep Up With Policy Changes section of Manage Your Grant.
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
Educate your staff about grants management requirements.
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 the NIH Office of Policy for Extramural Research Administration.