{"id":12261,"date":"2023-08-16T09:34:23","date_gmt":"2023-08-16T13:34:23","guid":{"rendered":"https:\/\/research.ncsu.edu\/administration\/?page_id=12261"},"modified":"2024-08-30T10:27:12","modified_gmt":"2024-08-30T14:27:12","slug":"covered-individuals-and-senior-personnel","status":"publish","type":"page","link":"https:\/\/research.ncsu.edu\/administration\/policies-and-guidance\/covered-individuals-and-senior-personnel\/","title":{"rendered":"Covered Individuals and Senior Personnel"},"content":{"rendered":"\n\n\n\n\n<h2 class=\"wp-block-heading\">Overview<\/h2>\n\n\n<aside class=\"floated-spotlight-aside-container\">\n  <div class=\"floated-spotlight-contents\">\n    <div class=\"ncst-content-card wp-block-ncst-spotlight-box has-reynolds-400-background-color\">\n  \n\n    \n    <div class=\"content-card__text-container\">\n      \n                        <h3 class=\"content-card__headline\">PINS Guidance<\/h3>\n              \n\n              \n\t      \t        <p class=\"content-card__teaser\">All Senior Personnel, other than the Principal Investigator should be entered into PINS as a &ldquo;Co-Investigator&rdquo;.<\/p>\n\t      \t    \n          <\/div>\n\n  <\/div>\n  <\/div>\n<\/aside>\n\n\n\n<p>Covered Individuals, per <a href=\"https:\/\/trumpwhitehouse.archives.gov\/presidential-actions\/presidential-memorandum-united-states-government-supported-research-development-national-security-policy\/\">NSPM 33<\/a> and <a href=\"https:\/\/www.aau.edu\/key-issues\/section-223-fy-2021-national-defense-authorization-act\" class=\"broken_link\">NDAA FY2021 Sec 223<\/a>, are those people who contribute in a substantive, meaningful way to the scientific development or execution of a research and development project proposed. These individuals have responsibility for the design, conduct and reporting of the research. Covered Individuals includes: PIs, Co-PIs, and a third category identified as \u201cSenior Personnel\u201d.<\/p>\n\n\n\n<p><a href=\"https:\/\/www.whitehouse.gov\/wp-content\/uploads\/2022\/01\/010422-NSPM-33-Implementation-Guidance.pdf\" class=\"broken_link\">NSPM-33 Implementation Guidance<\/a> requires that Covered Individuals submit information on the following at proposal stage:<\/p>\n\n\n<aside class=\"floated-spotlight-aside-container\">\n  <div class=\"floated-spotlight-contents\">\n    <a\n    class=\"ncst-content-card wp-block-ncst-spotlight-box has-reynolds-400-background-color with-cta\"\n    href=\"https:\/\/research.ncsu.edu\/administration\/proposals\/federal-disclosures\/\"\n    data-ua-cat=\"Content Card\"\n    data-ua-action=\"Content Card Click\"\n    data-ua-label=https:\/\/research.ncsu.edu\/administration\/proposals\/federal-disclosures\/\n  >\n  \n\n    \n    <div class=\"content-card__text-container\">\n      \n                        <h3 class=\"content-card__headline\">Federal Disclosures<\/h3>\n              \n\n              \n\t      \t        <p class=\"content-card__teaser\">Information on specific federal agency disclosure requirements for Covered Individuals<\/p>\n\t      \t    \n              <p class=\"content-card__cta\"><span class=\"text\">More about Federal Disclosures<\/span><span class=\"arrow-indicator\"><svg class=\"wolficon wolficon-arrow-right-bold\" role=\"img\"  aria-hidden=\"true\">\n\t\t\t\n\t\t\t<use xlink:href=\"#wolficon-arrow-right-bold\">\n\t\t<\/svg><\/span><\/p>\n          <\/div>\n\n  <\/a>\n  <\/div>\n<\/aside>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Disclosure of Organizational Affiliations\/Employment Position\/Appointments;<\/li>\n\n\n\n<li>Disclosure of relationships with any foreign government-sponsored talent recruitment programs;&nbsp;<\/li>\n\n\n\n<li>Disclosure and certification of Current and Pending Other Support<\/li>\n<\/ul>\n\n\n\n<p>NSPM-33 is currently in an implementation phase and once fully implemented, will apply to all federal research funding agencies. Several federal and foundation sponsors require that Senior Personnel keep current on conflict of interest disclosures of financial conflicts of interest and conflict of interest training. NC&nbsp;State\u2018s Regulation&nbsp;<a rel=\"noreferrer noopener\" href=\"https:\/\/www.google.com\/url?q=https:\/\/policies.ncsu.edu\/regulation\/reg-01-25-01\/&amp;sa=D&amp;source=calendar&amp;ust=1693749162578887&amp;usg=AOvVaw09Pmy7za98pDky0y1GN3EL\" target=\"_blank\"><u>REG 01.25.01 \u2013 Conflicts of Interest and Conflicts of Commitment&nbsp;<\/u><\/a>states that annual disclosure is required by those \u201cresponsible for the design, conduct or reporting of research at NC&nbsp;State\u201d.&nbsp; Additionally, these individuals must report any \u201cSignificant Financial Interest\u201d that would reasonably appear to affect the proposed or funded research activities.&nbsp; <\/p>\n\n\n<blockquote class=\"wp-block-ncst-blockquote\"><p>Note: While federal sponsors are discussed in detail on this page, all individuals who meet the definition of Covered Individuals and Senior Personnel must be listed in the record as indicated in the guidance, regardless of the sponsor type. Sponsor\u2019s may refer to Senior Personnel in various ways, including Key Personnel or Covered Individuals.<\/p><\/blockquote>\n\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Senior Personnel at Proposal Stage<\/strong><\/h2>\n\n\n<aside class=\"floated-spotlight-aside-container\">\n  <div class=\"floated-spotlight-contents\">\n    <a\n    class=\"ncst-content-card wp-block-ncst-spotlight-box has-reynolds-400-background-color\"\n    href=\"https:\/\/docs.google.com\/document\/d\/1Y3lsw-OuF4Ycw9Usr0aCT5EIxcV9iGl2\/edit?usp=drive_link&amp;ouid=111628324854172758765&amp;rtpof=true&amp;sd=true\"\n    data-ua-cat=\"Content Card\"\n    data-ua-action=\"Content Card Click\"\n    data-ua-label=https:\/\/docs.google.com\/document\/d\/1Y3lsw-OuF4Ycw9Usr0aCT5EIxcV9iGl2\/edit?usp=drive_link&amp;ouid=111628324854172758765&amp;rtpof=true&amp;sd=true\n  >\n  \n\n    \n    <div class=\"content-card__text-container\">\n      \n                        <h3 class=\"content-card__headline\">Frequently Asked Questions<\/h3>\n              \n\n              \n\t      \t        <p class=\"content-card__teaser\"><span class=\"text\">Unitiy ID Required.<\/span><span class=\"arrow-indicator\"><svg class=\"wolficon wolficon-arrow-right-light\" role=\"img\"  aria-hidden=\"true\">\n\t\t\t\n\t\t\t<use xlink:href=\"#wolficon-arrow-right-light\">\n\t\t<\/svg><\/span><\/p>\n\t      \t    \n              <p class=\"content-card__cta\"><\/p>\n          <\/div>\n\n  <\/a>\n  <\/div>\n<\/aside>\n\n\n\n<p>Sponsor guidelines define who must be named as \u201cSenior Personnel\u201d on the proposal. In order to go through the proper routing process and obtain required certifications, all individuals that are key to the project need to be listed in the PINS Record.<\/p>\n\n\n\n<p>Therefore, all Senior Personnel, other than the Principal Investigator should be entered into PINS as a \u201cCo-Investigator\u201d.<\/p>\n\n\n\n<p>Each Covered Individual must certify any proposal in which they are participating.&nbsp;<\/p>\n\n\n\n<p>PINS records that include Senior Personnel, other than those serving in the role of Principal Investigator and Co-Investigator must include an internal <a href=\"https:\/\/docs.google.com\/document\/d\/1iKzjPU6oY_eYPIDQhn-J7_mwGeg_OKDJU4ukRHeFDSc\/edit\">Project Personnel<\/a> document upload. Only Senior Personnel need to be listed within the document.<\/p>\n\n\n\n<p>The document should be titled &#8220;Project Personnel&#8221; and uploaded as Category: Proposal Documents; Type: Other.<\/p>\n\n\n\n<p>Due to the increased administrative burdens imposed by the sponsor and the additional audit risk to NC State University, Principal Investigators are discouraged from listing project participants other than those individuals deemed essential to carrying out the work of the project.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Managing Senior Personnel for the Life of the Award<\/h2>\n\n\n\n<p>Sponsor requirements for tracking Senior Personnel vary widely \u2013 see the sponsor-specific guidance below. Most federal sponsors require that we track effort for Senior Personnel and notify sponsors when there is a significant reduction in effort (25% or more) or when one of the Senior Personnel leaves the project.&nbsp;<\/p>\n\n\n\n<p id=\"grid\">PIs and CROs are responsible for tracking effort for Senior Personnel and notifying SPARCS of significant changes. Such requests should be handled through the PMR process.<\/p>\n\n\n\n<div class=\"wp-block-ncst-link-grid ncst-link-grid has-red-400-background-color\"><div class=\"link-grid__heading-section\"><h2>Federal Agencies<\/h2><p>Use the links to jump to Senior Personnel guidance.<\/p><\/div><ul class=\"link-grid__link-list\"><li class=\"ncst-component__bold-link-container wp-block-ncst-bold-link\">\n      <a \n      href=\"#nsf\"\n      class=\"ncst-component__bold-link text-link\"\n                >\n    <span class=\"text\">National Science Foundation (NSF)<\/span><span class=\"arrow-indicator\"><svg class=\"wolficon wolficon-arrow-right-bold\" role=\"img\"  aria-hidden=\"true\">\n\t\t\t\n\t\t\t<use xlink:href=\"#wolficon-arrow-right-bold\">\n\t\t<\/svg><\/span>\n    <\/a>\n      <\/li>\n  \n\n<li class=\"ncst-component__bold-link-container wp-block-ncst-bold-link\">\n      <a \n      href=\"#nih\"\n      class=\"ncst-component__bold-link text-link\"\n                >\n    <span class=\"text\">National Institutes of Health (NIH)<\/span><span class=\"arrow-indicator\"><svg class=\"wolficon wolficon-arrow-right-bold\" role=\"img\"  aria-hidden=\"true\">\n\t\t\t\n\t\t\t<use xlink:href=\"#wolficon-arrow-right-bold\">\n\t\t<\/svg><\/span>\n    <\/a>\n      <\/li>\n  \n\n<li class=\"ncst-component__bold-link-container wp-block-ncst-bold-link\">\n      <a \n      href=\"#doe\"\n      class=\"ncst-component__bold-link text-link\"\n                >\n    <span class=\"text\">Department of Energy (DOE)<\/span><span class=\"arrow-indicator\"><svg class=\"wolficon wolficon-arrow-right-bold\" role=\"img\"  aria-hidden=\"true\">\n\t\t\t\n\t\t\t<use xlink:href=\"#wolficon-arrow-right-bold\">\n\t\t<\/svg><\/span>\n    <\/a>\n      <\/li>\n  \n\n<li class=\"ncst-component__bold-link-container wp-block-ncst-bold-link\">\n      <a \n      href=\"#dod\"\n      class=\"ncst-component__bold-link text-link\"\n                >\n    <span class=\"text\">Department of Defense (DOD)<\/span><span class=\"arrow-indicator\"><svg class=\"wolficon wolficon-arrow-right-bold\" role=\"img\"  aria-hidden=\"true\">\n\t\t\t\n\t\t\t<use xlink:href=\"#wolficon-arrow-right-bold\">\n\t\t<\/svg><\/span>\n    <\/a>\n      <\/li>\n  \n\n<li class=\"ncst-component__bold-link-container wp-block-ncst-bold-link\">\n      <a \n      href=\"#nasa\"\n      class=\"ncst-component__bold-link text-link\"\n                >\n    <span class=\"text\">National Aeronautics and Space Administration (NASA)<\/span><span class=\"arrow-indicator\"><svg class=\"wolficon wolficon-arrow-right-bold\" role=\"img\"  aria-hidden=\"true\">\n\t\t\t\n\t\t\t<use xlink:href=\"#wolficon-arrow-right-bold\">\n\t\t<\/svg><\/span>\n    <\/a>\n      <\/li>\n  <\/ul><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"nsf\">National Science Foundation (NSF)<\/h2>\n\n\n\n<p>The NSF defines <a href=\"https:\/\/new.nsf.gov\/policies\/pappg\/23-1\/ch-2-exhibit-3\" class=\"broken_link\">Senior Personnel<\/a> as, \u201cindividuals designated by the proposer\/awardee organization and approved by NSF, who contribute in a substantive, meaningful way to the scientific development or execution of a research and development project proposed to be carried out with a research and development award\u201d.<\/p>\n\n\n\n<p>There are two categories of senior personnel as follows:&nbsp;<\/p>\n\n\n\n<p>1. (co) Principal Investigator (PI)&nbsp;<\/p>\n\n\n\n<p>2. Faculty Associate (faculty member) (or equivalent)<\/p>\n\n\n\n<p>Changes in effort of key personnel of 25% or more must receive prior approval from the sponsor (See <a href=\"https:\/\/new.nsf.gov\/policies\/pappg\/23-1\/ch-7-award-administration#7B2\" class=\"broken_link\">PAPPG Chapter 7.B.2<\/a>).<\/p>\n\n\n\n<p>Responsible and Ethical Conduct of Research (RECR) training is required for undergraduate students, graduate students, postdoctoral researchers, faculty, and other senior personnel.<\/p>\n\n\n\n<p>More information about NSF\u2019s Conflicts of interest policies can be found on the <a href=\"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/coi\/conflicts-in-research\/\">Research Compliance<\/a> website.<\/p>\n\n\n\n<p class=\"has-text-align-right\"><strong><a href=\"#grid\">Back to Top<\/a><\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"nih\">National Institutes of Health (NIH)<\/h2>\n\n\n\n<p>The NIH grant Policy Statement (GPS) defines <a href=\"https:\/\/grants.nih.gov\/grants\/policy\/nihgps\/HTML5\/section_1\/1.2_definition_of_terms.htm\">senior\/key personnel<\/a> as: \u201cThe PD\/PI and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they receive salaries or compensation under the grant.\u201d<\/p>\n\n\n\n<p>This includes Co-Investigators. Typically these individuals have doctoral or other professional degrees, although individuals at the masters or baccalaureate level may be considered senior\/key personnel if their involvement meets this definition.&nbsp;<\/p>\n\n\n\n<p>For NIH, senior\/key personnel must devote measurable effort to the project whether or not salaries or compensation are requested. &#8220;Zero percent&#8221; effort or &#8220;as needed&#8221; are not acceptable levels of involvement for those designated as Senior\/Key Personnel.<\/p>\n\n\n\n<p>Other Significant Collaborators (OSCs) are individuals who commit to contribute to the scientific development or execution of the project, but do not commit any specified measurable effort (i.e., person months) to the project. OSCs are not considered senior\/key personnel<\/p>\n\n\n\n<p>NIH program officials use discretion in identifying in the NoA senior\/key personnel other than the PD\/PI(s), and may identify individuals that are considered critical to the project, i.e., their absence from the project would have a significant impact on the approved scope of the project. The prior approval requirement for changes in personnel effort of 25% or greater applies only to those senior\/key personnel named in the Notice of Award (NoA). (See <a href=\"https:\/\/grants.nih.gov\/grants\/policy\/nihgps\/HTML5\/section_8\/8.1.2_prior_approval_requirements.htm#Change\">NIH GPS 8.1.2.6<\/a>)<\/p>\n\n\n\n<p>More information about NIH\u2019s Conflicts of interest policies can be found on the <a href=\"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/coi\/conflicts-in-research\/\">Research Compliance<\/a> website.<\/p>\n\n\n\n<p class=\"has-text-align-right\"><strong><a href=\"#grid\">Back to Top<\/a><\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"doe\">Department of Energy (DOE)<\/h2>\n\n\n\n<p>The DOE defines an <a href=\"https:\/\/www.energy.gov\/sites\/default\/files\/2021-12\/Interim%20COI%20Policy%20FAL2022-02%20to%20SPEs.pdf\">Investigator<\/a> as \u201cthe principal Investigator (PI) and any other person, regardless of title or position, who is responsible for the purpose, design, conduct, or reporting of a project funded by DOE or proposed for funding by DOE.\u201d<\/p>\n\n\n\n<p>DOE program offices have the discretion to expand the definition to include also any person who participates in the purpose, design, conduct, or reporting of a project funded by DOE or proposed for funding by DOE. Such expansion will be specified in the applicable funding opportunity announcement and\/or terms and conditions of the financial assistance award.<\/p>\n\n\n\n<p>DOE defines <a href=\"https:\/\/www.energy.gov\/sites\/default\/files\/2021-12\/Interim%20COI%20Policy%20FAL2022-02%20to%20SPEs.pdf\">Senior\/key personnel<\/a> as \u201cthe PI; any other person who significantly influences the design, conduct, or reporting of a project funded under a DOE award; and any other person identified as senior\/key personnel by the non-Federal entity in the application for financial assistance, approved budget, progress report, or any other report submitted to the DOE.\u201d<\/p>\n\n\n\n<p>Any changes in covered individuals require DOE prior approval.<br>More information about DOE\u2019s Interim Conflicts of interest policies can be found on the <a href=\"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/coi\/conflicts-in-research\/\">Research Compliance<\/a> website.<\/p>\n\n\n\n<p class=\"has-text-align-right\"><strong><a href=\"#grid\">Back to Top<\/a><\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"dod\">Department of Defense (DOD)<\/h2>\n\n\n\n<p>DOD defines a PI and Co-Principal Investigators in <a href=\"https:\/\/www.ecfr.gov\/current\/title-2\/subtitle-B\/chapter-XI\/subchapter-A\/part-1108\/subpart-B\/section-1108.295\">2 CFR 1108.295<\/a> as:&nbsp;&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The single individual whom an organization that is carrying out a research project with DoD support designates as having an appropriate level of authority and responsibility for leading and directing the research intellectually and logistically, which includes the proper conduct of the research, the appropriate use of funds, and compliance with administrative requirements such as the submission of performance reports to DoD; or<\/li>\n\n\n\n<li>If the organization designates more than one individual as sharing that authority and responsibility, the individual within that group identified by the organization as the one with whom the DoD Component&#8217;s program manager generally should communicate as the primary contact for scientific, technical, and related budgetary matters concerning the project (others within the group are \u201cco-principal investigators,\u201d as defined in this subpart).<\/li>\n<\/ul>\n\n\n\n<p>Specific solicitations will indicate whether or not to name senior personnel in grant proposals. Please review the request for proposal for more information. Per this 2019 <a href=\"https:\/\/www.aau.edu\/sites\/default\/files\/Blind-Links\/OUSDResearchProtectionMemo.pdf\">memorandum<\/a>, all senior personnel, whether or not the individuals&#8217; efforts under the project are to be funded by the DoD, must submit a current and pending other support document as part of their Senior Key Person Profile form.<\/p>\n\n\n\n<p>DOD requires prior approval for&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>A change in a key person specified in the application or award document.<\/li>\n\n\n\n<li>The absence for more than three months, or a 25 percent reduction in time devoted to the project, by the approved project director or principal investigator.<\/li>\n<\/ul>\n\n\n\n<p>DOD contracts typically include a clause that names specific individuals and describes the requirements for requesting sponsor approval for any change in key personnel.<br>DOD issued a <a href=\"https:\/\/media.defense.gov\/2023\/Jun\/29\/2003251160\/-1\/-1\/1\/COUNTERING-UNWANTED-INFLUENCE-IN-DEPARTMENT-FUNDED-RESEARCH-AT-INSTITUTIONS-OF-HIGHER-EDUCATION.PDF\">Risk-Based Security Reviews of Fundamental Research policy<\/a> outlining the risk-based measures the agency is using to assess potential undue foreign influence, conflicts of interest or conflicts of commitment.&nbsp; Risk-based security reviews shall be conducted, at a minimum, on all fundamental research project proposals that are selected for award based on technical merit.<\/p>\n\n\n\n<p class=\"has-text-align-right\"><strong><a href=\"#grid\">Back to Top<\/a><\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"nasa\">National Aeronautics and Space Administration (NASA)<\/h2>\n\n\n\n<p>NASA defines a <a href=\"https:\/\/www.nasa.gov\/sites\/default\/files\/atoms\/files\/2023_-_nasa_proposers_guide_-_final.pdf\" class=\"broken_link\">Principal Investigator<\/a> (PI) as the individual whom an organization designates as having an appropriate level of authority and responsibility for the proper conduct of proposed work effort,&nbsp; including the appropriate use of funds and administrative requirements such as the submission of progress reports to the agency. Every proposal shall identify a PI who is responsible for the quality and direction of the proposed work effort and for the proper use of awarded funds regardless of whether the PI receives support through the award.&nbsp;<\/p>\n\n\n\n<p>NASA policy strongly encourages one PI as the lead, only. The PI is the person with whom NASA will communicate and who will be responsible for relaying communications to other team members as needed.&nbsp;<\/p>\n\n\n\n<p>The proposing organization has the authority to designate the PI and to designate a replacement if that becomes necessary. After the proposal selection, the replacement of a PI requires NASA&#8217;s prior written approval.&nbsp;<\/p>\n\n\n\n<p>NASA does not use the term \u201cKey Person\u201d related to grants. They therefore do not have to be listed in PINS. However, every team member identified as a participant on the proposal&#8217;s cover page and\/or in the proposal&#8217;s Scientific\/Technical\/Management Plan must acknowledge their intended participation in the proposed effort.<\/p>\n\n\n\n<p class=\"has-text-align-right\"><strong><a href=\"#grid\">Back to Top<\/a><\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Take-Aways<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Sponsor guidelines define who must be named as \u201cSenior Personnel\u201d on the proposal.<\/li>\n\n\n\n<li>In order to go through the proper routing process and obtain required certifications, all Covered Individuals on a specific project need to be listed in the PINS Record.<\/li>\n\n\n\n<li>PIs are discouraged from listing project participants other than the PI and Co-PI as \u201cSenior Personnel\u201d since named personnel incur additional burden and audit risk.<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Overview Covered Individuals, per NSPM 33 and NDAA FY2021 Sec 223, are those people who contribute in a substantive, meaningful way to the scientific development or execution of a research&hellip;<\/p>\n","protected":false},"author":16,"featured_media":0,"parent":55,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"source":"","ncst_custom_author":"","ncst_show_custom_author":false,"ncst_dynamicHeaderBlockName":"ncst\/default-header","ncst_dynamicHeaderData":"{}","ncst_content_audit_freq":"","ncst_content_audit_date":"","ncst_content_audit_display":false,"ncst_backToTopFlag":"","footnotes":""},"tags":[],"class_list":["post-12261","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.3 - 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