Source: http://www.niaid.nih.gov/researchfunding/int/grantspolicy/Pages/gm05.aspx
Timestamp: 2016-05-29 15:22:06
Document Index: 702115593

Matched Legal Cases: ['art 5', 'art 4', 'art 6', 'art 5', 'art 5', 'art 2', 'art 52', 'arts 74', 'art 46', 'art 74', 'art 31', 'art 31', 'art 73', 'art 331', 'art 121', 'art 7', 'art 4', 'art 6']

Part 5. Compliance -- Grants Policy and Management Training for Foreign Investigators -- NIAID Research Funding
applicable clinical trial big grant application Centers for Disease Control and Prevention (CDC) conflict of interest detailed budget direct costs financial conflict of interest grantee independent ethics committee (IEC) institutional business official institutional review board (IRB) investigator-initiated NIH Guide notice PHS 398 Research Plan form principal investigator (PI) PubMed Central restricted experiment Research Performance Progress Report (RPPR) select agent significant financial interests U.S. Department of Agriculture (USDA) See the Glossary for more terms.
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What to do to comply with policies. Federal requirements. NIH and NIAID requirements. How to keep up with policy changes. 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 NIH Policy on Financial Conflicts of Interest NIAID Select Agent Policy NIH Policy on Dual Use Research of Concern (DURC) Public Access Policy How Do You Know What Policies Apply To You? Keep People in Your Institution Informed 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 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
45 CFR Part 74, Appendix E
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 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 through the FCOI Module of the eRA Commons.
There are more requirements to ensure full compliance with FCOI policy. For details, read our Financial Conflicts of Interest for Awardees SOP. Also see the April 18, 2014, Guide notice.
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. 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.
For grants with a start date of July 1, 2013, or beyond, 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’s 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 Web site.
In your progress report, you have to demonstrate compliance with the policy for all applicable papers. Read more in Progress Report Summary in Part 7. 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? Find additional details at Submission Methods on NIH’s Public Access Web site.
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 NIH's Public Access Web site. 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 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. 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, follow our Top Policy Changes, and Subscribe to NIAID Funding News 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 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 NIH's Office of Policy for Extramural Research Administration.
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Last Updated March 31, 2016Last Reviewed August 13, 2014