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As a result, it may not include the most recent changes applied to the CFR. <a href="https://www.govinfo.gov/help/cfr#about">Learn more</a>. </p> </div><div class="seal-block seal-block-footer"><h6>Enhanced Content - Published Edition</h6></div></div></li> <li class="divider"></li> <li class="enhanced developer-tools" id="" tabindex="0"><span role="button" aria-label="Developer Tools" data-delay="{"show":300,"hide":0}" data-toggle="tooltip" data-placement="top" data-title="Developer Tools" class="icon-ecfr icon-ecfr-console "></span><span class="content-nav-label " role="button">Developer Tools</span><div class="box box-enhanced box-full dropdown-menu dropdown-menu-right" role="menu"><div class="seal-block seal-block-header"><div class="seal-content"><h6>Enhanced Content - Developer Tools</h6></div></div><div class="content-block "> <p> This document is available in the following developer friendly formats: </p> <ul class="list with-bullets enhanced"> <li><a data-turbo="false" href="/api/versioner/v1/structure/2024-11-25/title-42.json">Hierarchy JSON - Title 42</a></li> <li><a data-turbo="false" href="/api/renderer/v1/content/enhanced/2024-11-25/title-42?part=50&subpart=F">Content HTML - Subpart F</a></li> <li><a data-turbo="false" href="/api/versioner/v1/full/2024-11-25/title-42.xml?part=50&subpart=F">Content XML - Subpart F</a></li> </ul> <p> Information and documentation can be found in our <a href="/reader-aids/ecfr-developer-resources">developer resources</a>. </p> </div><div class="seal-block seal-block-footer"><h6>Enhanced Content - Developer Tools</h6></div></div></li> </ul> </div> <div class="col-xs-9 col-sm-10 content-col"> <div class="box box-published no-print-header compare-settings"><div class="seal-block seal-block-header"><div class="seal-content"><h6>eCFR Content</h6><div class="row seal-meta"><div class="seal-desc col-md-12 col-xs-12"><p><p>The <em>Code of Federal Regulations</em> (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the <em>Federal Register</em> by the departments and agencies of the Federal Government. The Electronic Code of Federal Regulations (eCFR) is a continuously updated online version of the CFR. It is not an official legal edition of the CFR.</p> <p><a href='/reader-aids/understanding-the-ecfr/what-is-the-ecfr'>Learn more</a> about the eCFR, its status, and the editorial process.<p></p></div></div></div></div><div class="content-block "> <div class="box box-enhanced slim toc-link no-footer"><div class="seal-block seal-block-header"><div class="seal-content"><h6>Enhanced Content</h6></div></div><div class="content-block "> <span class="icon-ecfr icon-ecfr-book "></span> View <a id="toc-utility-nav-link" href="">table of contents</a> for this page. </div><div class="seal-block seal-block-footer"></div></div> <div class="subpart" id="subpart-F"><h2 data-hierarchy-metadata="{"path":"/current/title-42/part-50/subpart-F","citation":"42 CFR Part 50 Subpart F"}">Subpart F—Promoting Objectivity in Research</h2> <div class="authority"><h4 class="inline-header">Authority:</h4><p class="inline-paragraph"><a href="https://www.govinfo.gov/link/uscode/42/216" class="usc external" target="_blank" rel="noopener noreferrer">42 U.S.C. 216</a>, <a href="https://www.govinfo.gov/link/uscode/42/289b-1" class="usc external" target="_blank" rel="noopener noreferrer">289b-1</a>, <a href="https://www.govinfo.gov/link/uscode/42/299c-4" class="usc external" target="_blank" rel="noopener noreferrer">299c-4</a>; Sec. 219, Tit. II, Div. D, <a href="https://www.govinfo.gov/link/plaw/111/public/117" class="publ external" target="_blank" rel="noopener noreferrer">Pub. L. 111-117</a>, 123 Stat. 3034. </p></div> <div class="source"><h4 class="inline-header">Source:</h4><p class="inline-paragraph"><a href="https://www.federalregister.gov/citation/76-FR-53283" class="fr-reference" data-reference="76 FR 53283">76 FR 53283</a>, August 25, 2011, unless otherwise noted. </p></div> <div class="section" id="50.601"> <h4 data-hierarchy-metadata='{"path":"/current/title-42/section-50.601","citation":"42 CFR 50.601"}'>§ 50.601 Purpose.</h4> <p>This subpart promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under Public Health Service (PHS) grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest.</p> </div> <div class="section" id="50.602"> <h4 data-hierarchy-metadata='{"path":"/current/title-42/section-50.602","citation":"42 CFR 50.602"}'>§ 50.602 Applicability.</h4> <p>This subpart is applicable to each Institution that is applying for, or that receives, PHS research funding by means of a grant or cooperative agreement and, through the implementation of this subpart by the Institution, to each Investigator who is planning to participate in, or is participating in, such research; provided, however, that this subpart does not apply to SBIR Program Phase I applications. In those few cases where an individual, rather than an Institution, is applying for, or receives, PHS research funding, PHS Awarding Components will make case-by-case determinations on the steps to be taken, consistent with this subpart, to provide a reasonable expectation that the design, conduct, and reporting of the research will be free from bias resulting from a financial conflict of interest of the individual.</p> </div> <div class="section" id="50.603"> <h4 data-hierarchy-metadata='{"path":"/current/title-42/section-50.603","citation":"42 CFR 50.603"}'>§ 50.603 Definitions.</h4> <p>As used in this subpart:</p> <div id="p-50.603(Disclosure%20of%20significant%20financial%20interests)"> <p class="indent-1" data-title="50.603 “Disclosure of significant financial interests”" data-term="true"><em class="paragraph-hierarchy">Disclosure of significant financial interests</em> means an Investigator's disclosure of significant financial interests to an Institution.</p> </div> <div id="p-50.603(Financial%20conflict%20of%20interest)"> <p class="indent-1" data-title="50.603 “Financial conflict of interest”" data-term="true"><em class="paragraph-hierarchy">Financial conflict of interest</em> (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.</p> </div> <div id="p-50.603(FCOI%20report)"> <p class="indent-1" data-title="50.603 “FCOI report”" data-term="true"><em class="paragraph-hierarchy">FCOI report</em> means an Institution's report of a financial conflict of interest to a PHS Awarding Component.</p> </div> <div id="p-50.603(Financial%20interest)"> <p class="indent-1" data-title="50.603 “Financial interest”" data-term="true"><em class="paragraph-hierarchy">Financial interest</em> means anything of monetary value, whether or not the value is readily ascertainable.</p> </div> <div id="p-50.603(HHS)"> <p class="indent-1" data-title="50.603 “HHS”" data-term="true"><em class="paragraph-hierarchy">HHS</em> means the United States Department of Health and Human Services, and any components of the Department to which the authority involved may be delegated.</p> </div> <div id="p-50.603(Institution)"> <p class="indent-1" data-title="50.603 “Institution”" data-term="true"><em class="paragraph-hierarchy">Institution</em> means any domestic or foreign, public or private, entity or organization (excluding a Federal agency) that is applying for, or that receives, PHS research funding.</p> </div> <div id="p-50.603(Institutional%20responsibilities)"> <p class="indent-1" data-title="50.603 “Institutional responsibilities”" data-term="true"><em class="paragraph-hierarchy">Institutional responsibilities</em> means an Investigator's professional responsibilities on behalf of the Institution, and as defined by the Institution in its policy on financial conflicts of interest, which may include for example: activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.</p> </div> <div id="p-50.603(Investigator)"> <p class="indent-1" data-title="50.603 “Investigator”" data-term="true"><em class="paragraph-hierarchy">Investigator</em> means the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.</p> </div> <div id="p-50.603(Manage)"> <p class="indent-1" data-title="50.603 “Manage”" data-term="true"><em class="paragraph-hierarchy">Manage</em> means taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.</p> </div> <div id="p-50.603(PD%2FPI)"> <p class="indent-1" data-title="50.603 “PD/PI”" data-term="true"><em class="paragraph-hierarchy">PD/PI</em> means a project director or principal Investigator of a PHS-funded research project; the PD/PI is included in the definitions of senior/key personnel and Investigator under this subpart.</p> </div> <div id="p-50.603(PHS)"> <p class="indent-1" data-title="50.603 “PHS”" data-term="true"><em class="paragraph-hierarchy">PHS</em> means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).</p> </div> <div id="p-50.603(PHS%20Awarding%20Component)"> <p class="indent-1" data-title="50.603 “PHS Awarding Component”" data-term="true"><em class="paragraph-hierarchy">PHS Awarding Component</em> means the organizational unit of the PHS that funds the research that is subject to this subpart.</p> </div> <div id="p-50.603(Public%20Health%20Service%20Act)"> <p class="indent-1" data-title="50.603 “Public Health Service Act”" data-term="true"><em class="paragraph-hierarchy">Public Health Service Act</em> or PHS Act means the statute codified at <a href="https://www.govinfo.gov/link/uscode/42/201" class="usc external" target="_blank" rel="noopener noreferrer">42 U.S.C. 201</a> <em>et seq.</em></p> </div> <div id="p-50.603(Research)"> <p class="indent-1" data-title="50.603 “Research”" data-term="true"><em class="paragraph-hierarchy">Research</em> means a systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug). As used in this subpart, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant or cooperative agreement, whether authorized under the PHS Act or other statutory authority, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.</p> </div> <div id="p-50.603(Senior%2Fkey%20personnel)"> <p class="indent-1" data-title="50.603 “Senior/key personnel”" data-term="true"><em class="paragraph-hierarchy">Senior/key personnel</em> means the PD/PI and any other person identified as senior/key personnel by the Institution in the grant application, progress report, or any other report submitted to the PHS by the Institution under this subpart.</p> </div> <div id="p-50.603(Significant%20financial%20interest)"> <p class="indent-1" data-title="50.603 “Significant financial interest”" data-term="true"><em class="paragraph-hierarchy">Significant financial interest</em> means:</p> <div id="p-50.603(Significant%20financial%20interest)(1)"> <p class="indent-2" data-title="50.603 “Significant financial interest” (1)" data-disable="true"><span class="paragraph-hierarchy"><span class="paren">(</span>1<span class="paren">)</span></span> A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator's spouse and dependent children) that reasonably appears to be related to the Investigator's institutional responsibilities:</p> <div id="p-50.603(Significant%20financial%20interest)(1)(i)"> <p class="indent-3" data-title="50.603 “Significant financial interest” (1)(i)" data-disable="true"><span class="paragraph-hierarchy"><span class="paren">(</span>i<span class="paren">)</span></span> With regard to any publicly traded entity, a <em>significant financial interest</em> exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;</p> </div> <div id="p-50.603(Significant%20financial%20interest)(1)(ii)"> <p class="indent-3" data-title="50.603 “Significant financial interest” (1)(ii)" data-disable="true"><span class="paragraph-hierarchy"><span class="paren">(</span>ii<span class="paren">)</span></span> With regard to any non-publicly traded entity, a <em>significant financial interest</em> exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator's spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or</p> </div> <div id="p-50.603(Significant%20financial%20interest)(1)(iii)"> <p class="indent-3" data-title="50.603 “Significant financial interest” (1)(iii)" data-disable="true"><span class="paragraph-hierarchy"><span class="paren">(</span>iii<span class="paren">)</span></span> Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.</p> </div> </div> <div id="p-50.603(Significant%20financial%20interest)(2)"> <p class="indent-2" data-title="50.603 “Significant financial interest” (2)" data-disable="true"><span class="paragraph-hierarchy"><span class="paren">(</span>2<span class="paren">)</span></span> Investigators also must disclose the occurrence of any reimbursed or sponsored travel (<em>i.e.,</em> that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at <a href="https://www.govinfo.gov/link/uscode/20/1001" class="usc external" target="_blank" rel="noopener noreferrer">20 U.S.C. 1001(a)</a>, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. The Institution's FCOI policy will specify the details of this disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with the Institution's FCOI policy, the institutional official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.</p> </div> <div id="p-50.603(Significant%20financial%20interest)(3)"> <p class="indent-2" data-title="50.603 “Significant financial interest” (3)" data-disable="true"><span class="paragraph-hierarchy"><span class="paren">(</span>3<span class="paren">)</span></span> The term <em>significant financial interest</em> does not include the following types of financial interests: salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property rights assigned to the Institution and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the Investigator, if the Institution is a commercial or for-profit organization; income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles; income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at <a href="https://www.govinfo.gov/link/uscode/20/1001" class="usc external" target="_blank" rel="noopener noreferrer">20 U.S.C. 1001(a)</a>, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or income from service on advisory committees or review panels for a Federal, state, or local government agency, an Institution of higher education as defined at <a href="https://www.govinfo.gov/link/uscode/20/1001" class="usc external" target="_blank" rel="noopener noreferrer">20 U.S.C. 1001(a)</a>, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.</p> </div> </div> <div id="p-50.603(Small%20Business%20Innovation%20Research)"><p class="indent-1" data-title="50.603 “Small Business Innovation Research”" data-term="true"><em class="paragraph-hierarchy">Small Business Innovation Research</em> (SBIR) Program means the extramural research program for small businesses that is established by the Awarding Components of the Public Health Service and certain other Federal agencies under Public Law 97-219, the Small Business Innovation Development Act, as amended. For purposes of this subpart, the term SBIR Program also includes the Small Business Technology Transfer (STTR) Program, which was established by Public Law 102-564.</p></div> </div> <div class="section" id="50.604"> <h4 data-hierarchy-metadata='{"path":"/current/title-42/section-50.604","citation":"42 CFR 50.604"}'>§ 50.604 Responsibilities of Institutions regarding Investigator financial conflicts of interest.</h4> <div class="fr-cross-reference"><div class="box box-enhanced no-footer"> <div class="seal-block seal-block-header"><div class="seal-content"><h6>Cross Reference</h6></div></div> <div class="content-block ">Link to an amendment published at <a href="https://www.federalregister.gov/citation/89-FR-80064" class="fr-reference" data-reference="89 FR 80064">89 FR 80064</a>, Oct. 2, 2024.</div> </div></div> <p>Each Institution shall:</p> <div id="p-50.604(a)"> <p class="indent-1" data-title="50.604(a)"><span class="paragraph-hierarchy"><span class="paren">(</span>a<span class="paren">)</span></span> Maintain an up-to-date, written, enforced policy on financial conflicts of interest that complies with this subpart, and make such policy available via a publicly accessible Web site. If the Institution does not have any current presence on a publicly accessible Web site (and only in those cases), the Institution shall make its written policy available to any requestor within five business days of a request. If, however, the Institution acquires a presence on a publicly accessible Web site during the time of the PHS award, the requirement to post the information on that Web site will apply within 30 calendar days. If an Institution maintains a policy on financial conflicts of interest that includes standards that are more stringent than this subpart (e.g., that require a more extensive disclosure of financial interests), the Institution shall adhere to its policy and shall provide FCOI reports regarding identified financial conflicts of interest to the PHS Awarding Component in accordance with the Institution's own standards and within the timeframe prescribed by this subpart.</p> </div> <div id="p-50.604(b)"> <p class="indent-1" data-title="50.604(b)"><span class="paragraph-hierarchy"><span class="paren">(</span>b<span class="paren">)</span></span> Inform each Investigator of the Institution's policy on financial conflicts of interest, the Investigator's responsibilities regarding disclosure of significant financial interests, and of these regulations, and require each Investigator to complete training regarding the same prior to engaging in research related to any PHS-funded grant and at least every four years, and immediately when any of the following circumstances apply:</p> <div id="p-50.604(b)(1)"> <p class="indent-2" data-title="50.604(b)(1)"><span class="paragraph-hierarchy"><span class="paren">(</span>1<span class="paren">)</span></span> The Institution revises its financial conflict of interest policies or procedures in any manner that affects the requirements of Investigators;</p> </div> <div id="p-50.604(b)(2)"> <p class="indent-2" data-title="50.604(b)(2)"><span class="paragraph-hierarchy"><span class="paren">(</span>2<span class="paren">)</span></span> An Investigator is new to an Institution; or</p> </div> <div id="p-50.604(b)(3)"> <p class="indent-2" data-title="50.604(b)(3)"><span class="paragraph-hierarchy"><span class="paren">(</span>3<span class="paren">)</span></span> An Institution finds that an Investigator is not in compliance with the Institution's financial conflict of interest policy or management plan.</p> </div> </div> <div id="p-50.604(c)"> <p class="indent-1" data-title="50.604(c)"><span class="paragraph-hierarchy"><span class="paren">(</span>c<span class="paren">)</span></span> If the Institution carries out the PHS-funded research through a subrecipient (e.g., subcontractors or consortium members), the Institution (awardee Institution) must take reasonable steps to ensure that any subrecipient Investigator complies with this subpart by:</p> <div id="p-50.604(c)(1)"> <p class="indent-2" data-title="50.604(c)(1)"><span class="paragraph-hierarchy"><span class="paren">(</span>1<span class="paren">)</span></span> Incorporating as part of a written agreement with the subrecipient terms that establish whether the financial conflicts of interest policy of the awardee Institution or that of the subrecipient will apply to the subrecipient's Investigators.</p> <div id="p-50.604(c)(1)(i)"> <p class="indent-3" data-title="50.604(c)(1)(i)"><span class="paragraph-hierarchy"><span class="paren">(</span>i<span class="paren">)</span></span> If the subrecipient's Investigators must comply with the subrecipient's financial conflicts of interest policy, the subrecipient shall certify as part of the agreement referenced above that its policy complies with this subpart. If the subrecipient cannot provide such certification, the agreement shall state that subrecipient Investigators are subject to the financial conflicts of interest policy of the awardee Institution for disclosing significant financial interests that are directly related to the subrecipient's work for the awardee Institution;</p> </div> <div id="p-50.604(c)(1)(ii)"> <p class="indent-3" data-title="50.604(c)(1)(ii)"><span class="paragraph-hierarchy"><span class="paren">(</span>ii<span class="paren">)</span></span> Additionally, if the subrecipient's Investigators must comply with the subrecipient's financial conflicts of interest policy, the agreement referenced above shall specify time period(s) for the subrecipient to report all identified financial conflicts of interest to the awardee Institution. Such time period(s) shall be sufficient to enable the awardee Institution to provide timely FCOI reports, as necessary, to the PHS as required by this subpart;</p> </div> <div id="p-50.604(c)(1)(iii)"> <p class="indent-3" data-title="50.604(c)(1)(iii)"><span class="paragraph-hierarchy"><span class="paren">(</span>iii<span class="paren">)</span></span> Alternatively, if the subrecipient's Investigators must comply with the awardee Institution's financial conflicts of interest policy, the agreement referenced above shall specify time period(s) for the subrecipient to submit all Investigator disclosures of significant financial interests to the awardee Institution. Such time period(s) shall be sufficient to enable the awardee Institution to comply timely with its review, management, and reporting obligations under this subpart.</p> </div> </div> <div id="p-50.604(c)(2)"> <p class="indent-2" data-title="50.604(c)(2)"><span class="paragraph-hierarchy"><span class="paren">(</span>2<span class="paren">)</span></span> Providing FCOI reports to the PHS Awarding Component regarding all financial conflicts of interest of all subrecipient Investigators consistent with this subpart, <em>i.e.,</em> prior to the expenditure of funds and within 60 days of any subsequently identified FCOI.</p> </div> </div> <div id="p-50.604(d)"> <p class="indent-1" data-title="50.604(d)"><span class="paragraph-hierarchy"><span class="paren">(</span>d<span class="paren">)</span></span> Designate an institutional official(s) to solicit and review disclosures of significant financial interests from each Investigator who is planning to participate in, or is participating in, the PHS-funded research.</p> </div> <div id="p-50.604(e)"> <p class="indent-1" data-title="50.604(e)"><span class="paragraph-hierarchy"><span class="paren">(</span>e<span class="paren">)</span></span> </p> <div id="p-50.604(e)(1)"> <p class="indent-2" data-title="50.604(e)(1)"><span class="paragraph-hierarchy"><span class="paren">(</span>1<span class="paren">)</span></span> Require that each Investigator who is planning to participate in the PHS-funded research disclose to the Institution's designated official(s) the Investigator's significant financial interests (and those of the Investigator's spouse and dependent children) no later than the time of application for PHS-funded research.</p> </div> <div id="p-50.604(e)(2)"> <p class="indent-2" data-title="50.604(e)(2)"><span class="paragraph-hierarchy"><span class="paren">(</span>2<span class="paren">)</span></span> Require each Investigator who is participating in the PHS-funded research to submit an updated disclosure of significant financial interests at least annually, in accordance with the specific time period prescribed by the Institution, during the period of the award. Such disclosure shall include any information that was not disclosed initially to the Institution pursuant to <a href="/current/title-42/section-50.604#p-50.604(e)(1)" class="cfr external">paragraph (e)(1)</a> of this section, or in a subsequent disclosure of significant financial interests (e.g., any financial conflict of interest identified on a PHS-funded project that was transferred from another Institution), and shall include updated information regarding any previously disclosed significant financial interest (e.g., the updated value of a previously disclosed equity interest).</p> </div> <div id="p-50.604(e)(3)"> <p class="indent-2" data-title="50.604(e)(3)"><span class="paragraph-hierarchy"><span class="paren">(</span>3<span class="paren">)</span></span> Require each Investigator who is participating in the PHS-funded research to submit an updated disclosure of significant financial interests within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new significant financial interest.</p> </div> </div> <div id="p-50.604(f)"> <p class="indent-1" data-title="50.604(f)"><span class="paragraph-hierarchy"><span class="paren">(</span>f<span class="paren">)</span></span> Provide guidelines consistent with this subpart for the designated institutional official(s) to determine whether an Investigator's significant financial interest is related to PHS-funded research and, if so related, whether the significant financial interest is a financial conflict of interest. An Investigator's significant financial interest is related to PHS-funded research when the Institution, through its designated official(s), reasonably determines that the significant financial interest: could be affected by the PHS-funded research; or is in an entity whose financial interest could be affected by the research. The Institution may involve the Investigator in the designated official(s)'s determination of whether a significant financial interest is related to the PHS-funded research. A financial conflict of interest exists when the Institution, through its designated official(s), reasonably determines that the significant financial interest could directly and significantly affect the design, conduct, or reporting of the PHS-funded research.</p> </div> <div id="p-50.604(g)"> <p class="indent-1" data-title="50.604(g)"><span class="paragraph-hierarchy"><span class="paren">(</span>g<span class="paren">)</span></span> Take such actions as necessary to manage financial conflicts of interest, including any financial conflicts of a subrecipient Investigator pursuant to <a href="/current/title-42/section-50.604#p-50.604(c)" class="cfr external">paragraph (c)</a> of this section. Management of an identified financial conflict of interest requires development and implementation of a management plan and, if necessary, a retrospective review and a mitigation report pursuant to <a href="/current/title-42/section-50.605#p-50.605(a)" class="cfr external">§ 50.605(a)</a>.</p> </div> <div id="p-50.604(h)"> <p class="indent-1" data-title="50.604(h)"><span class="paragraph-hierarchy"><span class="paren">(</span>h<span class="paren">)</span></span> Provide initial and ongoing FCOI reports to the PHS as required pursuant to <a href="/current/title-42/section-50.605#p-50.605(b)" class="cfr external">§ 50.605(b)</a>.</p> </div> <div id="p-50.604(i)"> <p class="indent-1" data-title="50.604(i)"><span class="paragraph-hierarchy"><span class="paren">(</span>i<span class="paren">)</span></span> Maintain records relating to all Investigator disclosures of financial interests and the Institution's review of, and response to, such disclosures (whether or not a disclosure resulted in the Institution's determination of a financial conflict of interest) and all actions under the Institution's policy or retrospective review, if applicable, for at least three years from the date the final expenditures report is submitted to the PHS or, where applicable, from other dates specified in <a href="/current/title-45/section-75.361" class="cfr external">45 CFR 75.361</a> for different situations.</p> </div> <div id="p-50.604(j)"> <p class="indent-1" data-title="50.604(j)"><span class="paragraph-hierarchy"><span class="paren">(</span>j<span class="paren">)</span></span> Establish adequate enforcement mechanisms and provide for employee sanctions or other administrative actions to ensure Investigator compliance as appropriate.</p> </div> <div id="p-50.604(k)"> <p class="indent-1" data-title="50.604(k)"><span class="paragraph-hierarchy"><span class="paren">(</span>k<span class="paren">)</span></span> Certify, in each application for funding to which this subpart applies, that the Institution:</p> <div id="p-50.604(k)(1)"> <p class="indent-2" data-title="50.604(k)(1)"><span class="paragraph-hierarchy"><span class="paren">(</span>1<span class="paren">)</span></span> Has in effect at that Institution an up-to-date, written, and enforced administrative process to identify and manage financial conflicts of interest with respect to all research projects for which funding is sought or received from the PHS;</p> </div> <div id="p-50.604(k)(2)"> <p class="indent-2" data-title="50.604(k)(2)"><span class="paragraph-hierarchy"><span class="paren">(</span>2<span class="paren">)</span></span> Shall promote and enforce Investigator compliance with this subpart's requirements including those pertaining to disclosure of significant financial interests;</p> </div> <div id="p-50.604(k)(3)"> <p class="indent-2" data-title="50.604(k)(3)"><span class="paragraph-hierarchy"><span class="paren">(</span>3<span class="paren">)</span></span> Shall manage financial conflicts of interest and provide initial and ongoing FCOI reports to the PHS Awarding Component consistent with this subpart;</p> </div> <div id="p-50.604(k)(4)"> <p class="indent-2" data-title="50.604(k)(4)"><span class="paragraph-hierarchy"><span class="paren">(</span>4<span class="paren">)</span></span> Agrees to make information available, promptly upon request, to the HHS relating to any Investigator disclosure of financial interests and the Institution's review of, and response to, such disclosure, whether or not the disclosure resulted in the Institution's determination of a financial conflict of interest; and</p> </div> <div id="p-50.604(k)(5)"><p class="indent-2" data-title="50.604(k)(5)"><span class="paragraph-hierarchy"><span class="paren">(</span>5<span class="paren">)</span></span> Shall fully comply with the requirements of this subpart.</p></div> </div> <p class="citation">[<a href="https://www.federalregister.gov/citation/76-FR-53283" class="fr-reference" data-reference="76 FR 53283">76 FR 53283</a>, August 25, 2011, as amended at <a href="https://www.federalregister.gov/citation/81-FR-3006" class="fr-reference" data-reference="81 FR 3006">81 FR 3006</a>, Jan. 20, 2016] </p> </div> <div class="section" id="50.605"> <h4 data-hierarchy-metadata='{"path":"/current/title-42/section-50.605","citation":"42 CFR 50.605"}'>§ 50.605 Management and reporting of financial conflicts of interest.</h4> <div id="p-50.605(a)"> <p class="indent-1" data-title="50.605(a)"><span class="paragraph-hierarchy"><span class="paren">(</span>a<span class="paren">)</span></span> Management of financial conflicts of interest.</p> <div id="p-50.605(a)(1)"> <p class="indent-2" data-title="50.605(a)(1)"><span class="paragraph-hierarchy"><span class="paren">(</span>1<span class="paren">)</span></span> Prior to the Institution's expenditure of any funds under a PHS-funded research project, the designated official(s) of an Institution shall, consistent with <a href="/current/title-42/section-50.604#p-50.604(f)" class="cfr external">§ 50.604(f)</a>: review all Investigator disclosures of significant financial interests; determine whether any significant financial interests relate to PHS-funded research; determine whether a financial conflict of interest exists; and, if so, develop and implement a management plan that shall specify the actions that have been, and shall be, taken to manage such financial conflict of interest. Examples of conditions or restrictions that might be imposed to manage a financial conflict of interest include, but are not limited to:</p> <div id="p-50.605(a)(1)(i)"> <p class="indent-3" data-title="50.605(a)(1)(i)"><span class="paragraph-hierarchy"><span class="paren">(</span>i<span class="paren">)</span></span> Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research);</p> </div> <div id="p-50.605(a)(1)(ii)"> <p class="indent-3" data-title="50.605(a)(1)(ii)"><span class="paragraph-hierarchy"><span class="paren">(</span>ii<span class="paren">)</span></span> For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants;</p> </div> <div id="p-50.605(a)(1)(iii)"> <p class="indent-3" data-title="50.605(a)(1)(iii)"><span class="paragraph-hierarchy"><span class="paren">(</span>iii<span class="paren">)</span></span> Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the financial conflict of interest;</p> </div> <div id="p-50.605(a)(1)(iv)"> <p class="indent-3" data-title="50.605(a)(1)(iv)"><span class="paragraph-hierarchy"><span class="paren">(</span>iv<span class="paren">)</span></span> Modification of the research plan;</p> </div> <div id="p-50.605(a)(1)(v)"> <p class="indent-3" data-title="50.605(a)(1)(v)"><span class="paragraph-hierarchy"><span class="paren">(</span>v<span class="paren">)</span></span> Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;</p> </div> <div id="p-50.605(a)(1)(vi)"> <p class="indent-3" data-title="50.605(a)(1)(vi)"><span class="paragraph-hierarchy"><span class="paren">(</span>vi<span class="paren">)</span></span> Reduction or elimination of the financial interest (e.g., sale of an equity interest); or</p> </div> <div id="p-50.605(a)(1)(vii)"> <p class="indent-3" data-title="50.605(a)(1)(vii)"><span class="paragraph-hierarchy"><span class="paren">(</span>vii<span class="paren">)</span></span> Severance of relationships that create financial conflicts.</p> </div> </div> <div id="p-50.605(a)(2)"> <p class="indent-2" data-title="50.605(a)(2)"><span class="paragraph-hierarchy"><span class="paren">(</span>2<span class="paren">)</span></span> Whenever, in the course of an ongoing PHS-funded research project, an Investigator who is new to participating in the research project discloses a significant financial interest or an existing Investigator discloses a new significant financial interest to the Institution, the designated official(s) of the Institution shall, within sixty days: review the disclosure of the significant financial interest; determine whether it is related to PHS-funded research; determine whether a financial conflict of interest exists; and, if so, implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such financial conflict of interest. Depending on the nature of the significant financial interest, an Institution may determine that additional interim measures are necessary with regard to the Investigator's participation in the PHS-funded research project between the date of disclosure and the completion of the Institution's review.</p> </div> <div id="p-50.605(a)(3)"> <p class="indent-2" data-title="50.605(a)(3)"><span class="paragraph-hierarchy"><span class="paren">(</span>3<span class="paren">)</span></span> Whenever an Institution identifies a significant financial interest that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed by the Institution during an ongoing PHS-funded research project (e.g., was not timely reviewed or reported by a subrecipient), the designated official(s) shall, within sixty days: review the significant financial interest; determine whether it is related to PHS-funded research; determine whether a financial conflict of interest exists; and, if so:</p> <div id="p-50.605(a)(3)(i)"> <p class="indent-3" data-title="50.605(a)(3)(i)"><span class="paragraph-hierarchy"><span class="paren">(</span>i<span class="paren">)</span></span> Implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such financial conflict of interest going forward;</p> </div> <div id="p-50.605(a)(3)(ii)"> <p class="indent-3" data-title="50.605(a)(3)(ii)"><span class="paragraph-hierarchy"><span class="paren">(</span>ii<span class="paren">)</span></span> </p> <div id="p-50.605(a)(3)(ii)(A)"> <p class="indent-4" data-title="50.605(a)(3)(ii)(A)"><span class="paragraph-hierarchy"><span class="paren">(</span>A<span class="paren">)</span></span> In addition, whenever a financial conflict of interest is not identified or managed in a timely manner including failure by the Investigator to disclose a significant financial interest that is determined by the Institution to constitute a financial conflict of interest; failure by the Institution to review or manage such a financial conflict of interest; or failure by the Investigator to comply with a financial conflict of interest management plan, the Institution shall, within 120 days of the Institution's determination of noncompliance, complete a retrospective review of the Investigator's activities and the PHS-funded research project to determine whether any PHS-funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such research.</p> </div> <div id="p-50.605(a)(3)(ii)(B)"> <p class="indent-4" data-title="50.605(a)(3)(ii)(B)"><span class="paragraph-hierarchy"><span class="paren">(</span>B<span class="paren">)</span></span> The Institution is required to document the retrospective review; such documentation shall include, but not necessarily be limited to, all of the following key elements:</p> <div id="p-50.605(a)(3)(ii)(B)(1)"> <p class="indent-5" data-title="50.605(a)(3)(ii)(B)(<em>1</em>)"><span class="paragraph-hierarchy"><span class="paren">(</span><em>1</em><span class="paren">)</span></span> Project number;</p> </div> <div id="p-50.605(a)(3)(ii)(B)(2)"> <p class="indent-5" data-title="50.605(a)(3)(ii)(B)(<em>2</em>)"><span class="paragraph-hierarchy"><span class="paren">(</span><em>2</em><span class="paren">)</span></span> Project title;</p> </div> <div id="p-50.605(a)(3)(ii)(B)(3)"> <p class="indent-5" data-title="50.605(a)(3)(ii)(B)(<em>3</em>)"><span class="paragraph-hierarchy"><span class="paren">(</span><em>3</em><span class="paren">)</span></span> PD/PI or contact PD/PI if a multiple PD/PI model is used;</p> </div> <div id="p-50.605(a)(3)(ii)(B)(4)"> <p class="indent-5" data-title="50.605(a)(3)(ii)(B)(<em>4</em>)"><span class="paragraph-hierarchy"><span class="paren">(</span><em>4</em><span class="paren">)</span></span> Name of the Investigator with the FCOI;</p> </div> <div id="p-50.605(a)(3)(ii)(B)(5)"> <p class="indent-5" data-title="50.605(a)(3)(ii)(B)(<em>5</em>)"><span class="paragraph-hierarchy"><span class="paren">(</span><em>5</em><span class="paren">)</span></span> Name of the entity with which the Investigator has a financial conflict of interest;</p> </div> <div id="p-50.605(a)(3)(ii)(B)(6)"> <p class="indent-5" data-title="50.605(a)(3)(ii)(B)(<em>6</em>)"><span class="paragraph-hierarchy"><span class="paren">(</span><em>6</em><span class="paren">)</span></span> Reason(s) for the retrospective review;</p> </div> <div id="p-50.605(a)(3)(ii)(B)(7)"> <p class="indent-5" data-title="50.605(a)(3)(ii)(B)(<em>7</em>)"><span class="paragraph-hierarchy"><span class="paren">(</span><em>7</em><span class="paren">)</span></span> Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed);</p> </div> <div id="p-50.605(a)(3)(ii)(B)(8)"> <p class="indent-5" data-title="50.605(a)(3)(ii)(B)(<em>8</em>)"><span class="paragraph-hierarchy"><span class="paren">(</span><em>8</em><span class="paren">)</span></span> Findings of the review; and</p> </div> <div id="p-50.605(a)(3)(ii)(B)(9)"> <p class="indent-5" data-title="50.605(a)(3)(ii)(B)(<em>9</em>)"><span class="paragraph-hierarchy"><span class="paren">(</span><em>9</em><span class="paren">)</span></span> Conclusions of the review.</p> </div> </div> </div> <div id="p-50.605(a)(3)(iii)"> <p class="indent-3" data-title="50.605(a)(3)(iii)"><span class="paragraph-hierarchy"><span class="paren">(</span>iii<span class="paren">)</span></span> Based on the results of the retrospective review, if appropriate, the Institution shall update the previously submitted FCOI report, specifying the actions that will be taken to manage the financial conflict of interest going forward. If bias is found, the Institution is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and the Institution's plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). Thereafter, the Institution will submit FCOI reports annually, as specified elsewhere in this subpart. Depending on the nature of the financial conflict of interest, an Institution may determine that additional interim measures are necessary with regard to the Investigator's participation in the PHS-funded research project between the date that the financial conflict of interest or the Investigator's noncompliance is determined and the completion of the Institution's retrospective review.</p> </div> </div> <div id="p-50.605(a)(4)"> <p class="indent-2" data-title="50.605(a)(4)"><span class="paragraph-hierarchy"><span class="paren">(</span>4<span class="paren">)</span></span> Whenever an Institution implements a management plan pursuant to this subpart, the Institution shall monitor Investigator compliance with the management plan on an ongoing basis until the completion of the PHS-funded research project.</p> </div> <div id="p-50.605(a)(5)"> <p class="indent-2" data-title="50.605(a)(5)"><span class="paragraph-hierarchy"><span class="paren">(</span>5<span class="paren">)</span></span> </p> <div id="p-50.605(a)(5)(i)"> <p class="indent-3" data-title="50.605(a)(5)(i)"><span class="paragraph-hierarchy"><span class="paren">(</span>i<span class="paren">)</span></span> Prior to the Institution's expenditure of any funds under a PHS-funded research project, the Institution shall ensure public accessibility, via a publicly accessible Web site or written response to any requestor within five business days of a request, of information concerning any significant financial interest disclosed to the Institution that meets the following three criteria:</p> <div id="p-50.605(a)(5)(i)(A)"> <p class="indent-4" data-title="50.605(a)(5)(i)(A)"><span class="paragraph-hierarchy"><span class="paren">(</span>A<span class="paren">)</span></span> The significant financial interest was disclosed and is still held by the senior/key personnel as defined by this subpart;</p> </div> <div id="p-50.605(a)(5)(i)(B)"> <p class="indent-4" data-title="50.605(a)(5)(i)(B)"><span class="paragraph-hierarchy"><span class="paren">(</span>B<span class="paren">)</span></span> The Institution determines that the significant financial interest is related to the PHS-funded research; and</p> </div> <div id="p-50.605(a)(5)(i)(C)"> <p class="indent-4" data-title="50.605(a)(5)(i)(C)"><span class="paragraph-hierarchy"><span class="paren">(</span>C<span class="paren">)</span></span> The Institution determines that the significant financial interest is a financial conflict of interest.</p> </div> </div> <div id="p-50.605(a)(5)(ii)"> <p class="indent-3" data-title="50.605(a)(5)(ii)"><span class="paragraph-hierarchy"><span class="paren">(</span>ii<span class="paren">)</span></span> The information that the Institution makes available via a publicly accessible Web site or written response to any requestor within five business days of a request, shall include, at a minimum, the following: the Investigator's name; the Investigator's title and role with respect to the research project; the name of the entity in which the significant financial interest is held; the nature of the significant financial interest; and the approximate dollar value of the significant financial interest (dollar ranges are permissible: $0-$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.</p> </div> <div id="p-50.605(a)(5)(iii)"> <p class="indent-3" data-title="50.605(a)(5)(iii)"><span class="paragraph-hierarchy"><span class="paren">(</span>iii<span class="paren">)</span></span> If the Institution uses a publicly accessible Web site for the purposes of this subsection, the information that the Institution posts shall be updated at least annually. In addition, the Institution shall update the Web site within sixty days of the Institution's receipt or identification of information concerning any additional significant financial interest of the senior/key personnel for the PHS-funded research project that was not previously disclosed, or upon the disclosure of a significant financial interest of senior/key personnel new to the PHS-funded research project, if the Institution determines that the significant financial interest is related to the PHS-funded research and is a financial conflict of interest. The Web site shall note that the information provided is current as of the date listed and is subject to updates, on at least an annual basis and within 60 days of the Institution's identification of a new financial conflict of interest. If the Institution responds to written requests for the purposes of this subsection, the Institution will note in its written response that the information provided is current as of the date of the correspondence and is subject to updates, on at least an annual basis and within 60 days of the Institution's identification of a new financial conflict of interest, which should be requested subsequently by the requestor.</p> </div> <div id="p-50.605(a)(5)(iv)"> <p class="indent-3" data-title="50.605(a)(5)(iv)"><span class="paragraph-hierarchy"><span class="paren">(</span>iv<span class="paren">)</span></span> Information concerning the significant financial interests of an individual subject to <a href="/current/title-42/section-50.605#p-50.605(a)(5)" class="cfr external">paragraph (a)(5)</a> of this section shall remain available, for responses to written requests or for posting via the Institution's publicly accessible Web site for at least three years from the date that the information was most recently updated.</p> </div> </div> <div id="p-50.605(a)(6)"> <p class="indent-2" data-title="50.605(a)(6)"><span class="paragraph-hierarchy"><span class="paren">(</span>6<span class="paren">)</span></span> In addition to the types of financial conflicts of interest as defined in this subpart that must be managed pursuant to this section, an Institution may require the management of other financial conflicts of interest in its policy on financial conflicts of interest, as the Institution deems appropriate.</p> </div> </div> <div id="p-50.605(b)"> <p class="indent-1" data-title="50.605(b)"><span class="paragraph-hierarchy"><span class="paren">(</span>b<span class="paren">)</span></span> Reporting of financial conflicts of interest.</p> <div id="p-50.605(b)(1)"> <p class="indent-2" data-title="50.605(b)(1)"><span class="paragraph-hierarchy"><span class="paren">(</span>1<span class="paren">)</span></span> Prior to the Institution's expenditure of any funds under a PHS-funded research project, the Institution shall provide to the PHS Awarding Component an FCOI report regarding any Investigator's significant financial interest found by the Institution to be conflicting and ensure that the Institution has implemented a management plan in accordance with this subpart. In cases in which the Institution identifies a financial conflict of interest and eliminates it prior to the expenditure of PHS-awarded funds, the Institution shall not submit an FCOI report to the PHS Awarding Component.</p> </div> <div id="p-50.605(b)(2)"> <p class="indent-2" data-title="50.605(b)(2)"><span class="paragraph-hierarchy"><span class="paren">(</span>2<span class="paren">)</span></span> For any significant financial interest that the Institution identifies as conflicting subsequent to the Institution's initial FCOI report during an ongoing PHS-funded research project (e.g., upon the participation of an Investigator who is new to the research project), the Institution shall provide to the PHS Awarding Component, within sixty days, an FCOI report regarding the financial conflict of interest and ensure that the Institution has implemented a management plan in accordance with this subpart. Pursuant to <a href="/current/title-42/section-50.605#p-50.605(a)(3)(ii)" class="cfr external">paragraph (a)(3)(ii)</a> of this section, where such FCOI report involves a significant financial interest that was not disclosed timely by an Investigator or, for whatever reason, was not previously reviewed or managed by the Institution (e.g., was not timely reviewed or reported by a subrecipient), the Institution also is required to complete a retrospective review to determine whether any PHS-funded research, or portion thereof, conducted prior to the identification and management of the financial conflict of interest was biased in the design, conduct, or reporting of such research. Additionally, pursuant to <a href="/current/title-42/section-50.605#p-50.605(a)(3)(iii)" class="cfr external">paragraph (a)(3)(iii)</a> of this section, if bias is found, the Institution is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component.</p> </div> <div id="p-50.605(b)(3)"> <p class="indent-2" data-title="50.605(b)(3)"><span class="paragraph-hierarchy"><span class="paren">(</span>3<span class="paren">)</span></span> Any FCOI report required under <a href="/current/title-42/section-50.605#p-50.605(b)(1)" class="cfr external">paragraphs (b)(1)</a> or <a href="/current/title-42/section-50.605#p-50.605(b)(2)" class="cfr external">(b)(2)</a> of this section shall include sufficient information to enable the PHS Awarding Component to understand the nature and extent of the financial conflict, and to assess the appropriateness of the Institution's management plan. Elements of the FCOI report shall include, but are not necessarily limited to the following:</p> <div id="p-50.605(b)(3)(i)"> <p class="indent-3" data-title="50.605(b)(3)(i)"><span class="paragraph-hierarchy"><span class="paren">(</span>i<span class="paren">)</span></span> Project number;</p> </div> <div id="p-50.605(b)(3)(ii)"> <p class="indent-3" data-title="50.605(b)(3)(ii)"><span class="paragraph-hierarchy"><span class="paren">(</span>ii<span class="paren">)</span></span> PD/PI or Contact PD/PI if a multiple PD/PI model is used;</p> </div> <div id="p-50.605(b)(3)(iii)"> <p class="indent-3" data-title="50.605(b)(3)(iii)"><span class="paragraph-hierarchy"><span class="paren">(</span>iii<span class="paren">)</span></span> Name of the Investigator with the financial conflict of interest;</p> </div> <div id="p-50.605(b)(3)(iv)"> <p class="indent-3" data-title="50.605(b)(3)(iv)"><span class="paragraph-hierarchy"><span class="paren">(</span>iv<span class="paren">)</span></span> Name of the entity with which the Investigator has a financial conflict of interest;</p> </div> <div id="p-50.605(b)(3)(v)"> <p class="indent-3" data-title="50.605(b)(3)(v)"><span class="paragraph-hierarchy"><span class="paren">(</span>v<span class="paren">)</span></span> Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium);</p> </div> <div id="p-50.605(b)(3)(vi)"> <p class="indent-3" data-title="50.605(b)(3)(vi)"><span class="paragraph-hierarchy"><span class="paren">(</span>vi<span class="paren">)</span></span> Value of the financial interest (dollar ranges are permissible: $0-$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value;</p> </div> <div id="p-50.605(b)(3)(vii)"> <p class="indent-3" data-title="50.605(b)(3)(vii)"><span class="paragraph-hierarchy"><span class="paren">(</span>vii<span class="paren">)</span></span> A description of how the financial interest relates to the PHS-funded research and the basis for the Institution's determination that the financial interest conflicts with such research; and</p> </div> <div id="p-50.605(b)(3)(viii)"> <p class="indent-3" data-title="50.605(b)(3)(viii)"><span class="paragraph-hierarchy"><span class="paren">(</span>viii<span class="paren">)</span></span> A description of the key elements of the Institution's management plan, including:</p> <div id="p-50.605(b)(3)(viii)(A)"> <p class="indent-4" data-title="50.605(b)(3)(viii)(A)"><span class="paragraph-hierarchy"><span class="paren">(</span>A<span class="paren">)</span></span> Role and principal duties of the conflicted Investigator in the research project;</p> </div> <div id="p-50.605(b)(3)(viii)(B)"> <p class="indent-4" data-title="50.605(b)(3)(viii)(B)"><span class="paragraph-hierarchy"><span class="paren">(</span>B<span class="paren">)</span></span> Conditions of the management plan;</p> </div> <div id="p-50.605(b)(3)(viii)(C)"> <p class="indent-4" data-title="50.605(b)(3)(viii)(C)"><span class="paragraph-hierarchy"><span class="paren">(</span>C<span class="paren">)</span></span> How the management plan is designed to safeguard objectivity in the research project;</p> </div> <div id="p-50.605(b)(3)(viii)(D)"> <p class="indent-4" data-title="50.605(b)(3)(viii)(D)"><span class="paragraph-hierarchy"><span class="paren">(</span>D<span class="paren">)</span></span> Confirmation of the Investigator's agreement to the management plan;</p> </div> <div id="p-50.605(b)(3)(viii)(E)"> <p class="indent-4" data-title="50.605(b)(3)(viii)(E)"><span class="paragraph-hierarchy"><span class="paren">(</span>E<span class="paren">)</span></span> How the management plan will be monitored to ensure Investigator compliance; and</p> </div> <div id="p-50.605(b)(3)(viii)(F)"> <p class="indent-4" data-title="50.605(b)(3)(viii)(F)"><span class="paragraph-hierarchy"><span class="paren">(</span>F<span class="paren">)</span></span> Other information as needed.</p> </div> </div> </div> <div id="p-50.605(b)(4)"> <p class="indent-2" data-title="50.605(b)(4)"><span class="paragraph-hierarchy"><span class="paren">(</span>4<span class="paren">)</span></span> For any financial conflict of interest previously reported by the Institution with regard to an ongoing PHS-funded research project, the Institution shall provide to the PHS Awarding Component an annual FCOI report that addresses the status of the financial conflict of interest and any changes to the management plan for the duration of the PHS-funded research project. The annual FCOI report shall specify whether the financial conflict is still being managed or explain why the financial conflict of interest no longer exists. The Institution shall provide annual FCOI reports to the PHS Awarding Component for the duration of the project period (including extensions with or without funds) in the time and manner specified by the PHS Awarding Component.</p> </div> <div id="p-50.605(b)(5)"><p class="indent-2" data-title="50.605(b)(5)"><span class="paragraph-hierarchy"><span class="paren">(</span>5<span class="paren">)</span></span> In addition to the types of financial conflicts of interest as defined in this subpart that must be reported pursuant to this section, an Institution may require the reporting of other financial conflicts of interest in its policy on financial conflicts of interest, as the Institution deems appropriate.</p></div> </div> </div> <div class="section" id="50.606"> <h4 data-hierarchy-metadata='{"path":"/current/title-42/section-50.606","citation":"42 CFR 50.606"}'>§ 50.606 Remedies.</h4> <div class="fr-cross-reference"><div class="box box-enhanced no-footer"> <div class="seal-block seal-block-header"><div class="seal-content"><h6>Cross Reference</h6></div></div> <div class="content-block ">Link to an amendment published at <a href="https://www.federalregister.gov/citation/89-FR-80064" class="fr-reference" data-reference="89 FR 80064">89 FR 80064</a>, Oct. 2, 2024.</div> </div></div> <div id="p-50.606(a)"> <p class="indent-1" data-title="50.606(a)"><span class="paragraph-hierarchy"><span class="paren">(</span>a<span class="paren">)</span></span> If the failure of an Investigator to comply with an Institution's financial conflicts of interest policy or a financial conflict of interest management plan appears to have biased the design, conduct, or reporting of the PHS-funded research, the Institution shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken. The PHS Awarding Component will consider the situation and, as necessary, take appropriate action, or refer the matter to the Institution for further action, which may include directions to the Institution on how to maintain appropriate objectivity in the PHS-funded research project. PHS may, for example, require Institutions employing such an Investigator to enforce any applicable corrective actions prior to a PHS award or when the transfer of a PHS grant(s) involves such an Investigator.</p> </div> <div id="p-50.606(b)"> <p class="indent-1" data-title="50.606(b)"><span class="paragraph-hierarchy"><span class="paren">(</span>b<span class="paren">)</span></span> The PHS Awarding Component and/or HHS may inquire at any time before, during, or after award into any Investigator disclosure of financial interests and the Institution's review (including any retrospective review) of, and response to, such disclosure, regardless of whether the disclosure resulted in the Institution's determination of a financial conflict of interest. An Institution is required to submit, or permit on site review of, all records pertinent to compliance with this subpart. To the extent permitted by law, HHS will maintain the confidentiality of all records of financial interests. On the basis of its review of records or other information that may be available, the PHS Awarding Component may decide that a particular financial conflict of interest will bias the objectivity of the PHS-funded research to such an extent that further corrective action is needed or that the Institution has not managed the financial conflict of interest in accordance with this subpart. The PHS Awarding Component may determine that imposition of specific award conditions under <a href="/current/title-45/section-75.207" class="cfr external">45 CFR 75.207</a>, or suspension of funding or other enforcement action under <a href="/current/title-45/section-75.371" class="cfr external">45 CFR 75.371</a>, is necessary until the matter is resolved.</p> </div> <div id="p-50.606(c)"><p class="indent-1" data-title="50.606(c)"><span class="paragraph-hierarchy"><span class="paren">(</span>c<span class="paren">)</span></span> In any case in which the HHS determines that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a financial conflict of interest that was not managed or reported by the Institution as required by this subpart, the Institution shall require the Investigator involved to disclose the financial conflict of interest in each public presentation of the results of the research and to request an addendum to previously published presentations .</p></div> <p class="citation">[<a href="https://www.federalregister.gov/citation/76-FR-53283" class="fr-reference" data-reference="76 FR 53283">76 FR 53283</a>, August 25, 2011, as amended at <a href="https://www.federalregister.gov/citation/81-FR-3006" class="fr-reference" data-reference="81 FR 3006">81 FR 3006</a>, Jan. 20, 2016] </p> </div> <div class="section" id="50.607"> <h4 data-hierarchy-metadata='{"path":"/current/title-42/section-50.607","citation":"42 CFR 50.607"}'>§ 50.607 Other HHS regulations that apply.</h4> <div class="fr-cross-reference"><div class="box box-enhanced no-footer"> <div class="seal-block seal-block-header"><div class="seal-content"><h6>Cross Reference</h6></div></div> <div class="content-block ">Link to an amendment published at <a href="https://www.federalregister.gov/citation/89-FR-80064" class="fr-reference" data-reference="89 FR 80064">89 FR 80064</a>, Oct. 2, 2024.</div> </div></div> <p>Several other regulations and policies apply to this subpart. They include, but are not necessarily limited to:</p> <div class="extract"> <p class="flush-paragraph-2"><a href="/current/title-2/part-376" class="cfr external">2 CFR part 376</a>—Nonprocurement debarment and suspension (HHS) </p> <p class="flush-paragraph-2"><a href="/current/title-42/part-50/subpart-D" class="cfr external">42 CFR part 50, subpart D</a>—Public Health Service grant appeals procedure </p> <p class="flush-paragraph-2"><a href="/current/title-45/part-16" class="cfr external">45 CFR part 16</a>—Procedures of the Departmental Grant Appeals Board </p> <p class="flush-paragraph-2"><a href="/current/title-45/part-75" class="cfr external">45 CFR part 75</a>—Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards </p> <p class="flush-paragraph-2"><a href="/current/title-45/part-79" class="cfr external">45 CFR part 79</a>—Program fraud civil remedies</p> </div> <p class="citation">[<a href="https://www.federalregister.gov/citation/76-FR-53283" class="fr-reference" data-reference="76 FR 53283">76 FR 53283</a>, August 25, 2011, as amended at <a href="https://www.federalregister.gov/citation/81-FR-3006" class="fr-reference" data-reference="81 FR 3006">81 FR 3006</a>, Jan. 20, 2016] </p> </div> </div><script type="application/json" id="source-and-authority-data">{"origins":[{"level":"part","identifier":"50","label_level":"Part 50","hierarchy":{"title":"42","chapter":"I","subchapter":"D","part":"50"},"current":false,"authority":["Sec. 215, Public Health Service Act, 58 Stat. 690 (\u003ca href=\"https://www.govinfo.gov/link/uscode/42/216\" class=\"usc external\" target=\"_blank\" rel=\"noopener noreferrer\"\u003e42 U.S.C. 216\u003c/a\u003e); Sec. 1006, Public Health Service Act, 84 Stat. 1507 (\u003ca href=\"https://www.govinfo.gov/link/uscode/42/300a-4\" class=\"usc external\" target=\"_blank\" rel=\"noopener noreferrer\"\u003e42 U.S.C. 300a-4\u003c/a\u003e), unless otherwise noted.\n"],"source":["\u003ca href=\"https://www.federalregister.gov/citation/43-FR-52165\" class=\"fr-reference\" data-reference=\"43 FR 52165\"\u003e43 FR 52165\u003c/a\u003e, Nov. 8, 1978, unless otherwise noted.\n"],"link":"/current/title-42/part-50","title":"Part 50"},{"level":"subpart","identifier":"F","label_level":"Subpart F","hierarchy":{"title":"42","chapter":"I","subchapter":"D","part":"50","subpart":"F"},"current":true,"authority":["\u003ca href=\"https://www.govinfo.gov/link/uscode/42/216\" class=\"usc external\" target=\"_blank\" rel=\"noopener noreferrer\"\u003e42 U.S.C. 216\u003c/a\u003e, \u003ca href=\"https://www.govinfo.gov/link/uscode/42/289b-1\" class=\"usc external\" target=\"_blank\" rel=\"noopener noreferrer\"\u003e289b-1\u003c/a\u003e, \u003ca href=\"https://www.govinfo.gov/link/uscode/42/299c-4\" class=\"usc external\" target=\"_blank\" rel=\"noopener noreferrer\"\u003e299c-4\u003c/a\u003e; Sec. 219, Tit. II, Div. D, \u003ca href=\"https://www.govinfo.gov/link/plaw/111/public/117\" class=\"publ external\" target=\"_blank\" rel=\"noopener noreferrer\"\u003ePub. L. 111-117\u003c/a\u003e, 123 Stat. 3034.\n"],"source":["\u003ca href=\"https://www.federalregister.gov/citation/76-FR-53283\" class=\"fr-reference\" data-reference=\"76 FR 53283\"\u003e76 FR 53283\u003c/a\u003e, August 25, 2011, unless otherwise noted.\n"],"link":"/current/title-42/part-50/subpart-F","title":"Subpart F of Part 50"}]}</script> </div><div class="seal-block seal-block-footer"><h6>eCFR Content</h6></div></div> </div> </div> </div> </div> </div> </div> </div> <div class="site-footer container-fluid" id="footer"> <div class="container"> <div class="col-xs-12 col-md-12"> <div class="row"> <div class="col-xs-3 col-md-3"> <h2>Pages</h2> <ul class="list with-bullets"> <li><a href="/">Home</a></li> <li><a href="/">Titles</a></li> <li><a href="/search">Search</a></li> <li><a href="/recent-changes">Recent Changes</a></li> <li><a href="/corrections">Corrections</a></li> </ul> </div> <div class="col-xs-3 col-md-3"> <h2>Reader Aids</h2> <ul class="list with-bullets"> <li> <a href="https://www.ecfr.gov/reader-aids/using-ecfr">Using the eCFR Point-in-Time System</a> </li> <li> <a href="https://www.ecfr.gov/reader-aids/understanding-the-ecfr">Understanding the eCFR</a> </li> <li> <a href="https://www.ecfr.gov/reader-aids/government-policy-and-ofr-procedures">Government Policy and OFR Procedures</a> </li> <li> <a href="https://www.ecfr.gov/reader-aids/ecfr-developer-resources">Developer Resources</a> </li> </ul> </div> <div class="col-xs-3 col-md-3"> <h2>Information</h2> <ul class="list with-bullets"> <li><a href="/reader-aids/government-policy-and-ofr-procedures/about-this-site">About This Site</a></li> <li><a href="/reader-aids/government-policy-and-ofr-procedures/about-this-site#legal-status">Legal Status</a></li> <li><a href="/reader-aids/government-policy-and-ofr-procedures/privacy">Privacy</a></li> <li><a href="/reader-aids/government-policy-and-ofr-procedures/accessibility">Accessibility</a></li> <li><a href="/reader-aids/government-policy-and-ofr-procedures/foia">FOIA</a></li> <li><a href="https://www.archives.gov/eeo/policy/no-fear-notice.html">No Fear Act</a></li> <li><a href="https://www.archives.gov/federal-register/contact.html#coop">Continuity Information</a></li> </ul> </div> <div class="col-xs-3 col-md-3"> <h2>My eCFR</h2> <ul class="list with-bullets"> <li> <a href="/my/subscriptions">My Subscriptions</a> </li> <li> <a data-turbo="false" href="https://www.ecfr.gov/auth/sign_in?jwt=eyJhbGciOiJIUzI1NiJ9.eyJub3RpZmljYXRpb25zIjp7ImluZm8iOiJZb3Ugd2lsbCBiZSByZWRpcmVjdGVkIGJhY2sgdG8gdGhlIGVDRlIgYWZ0ZXIgeW91IGhhdmUgc2lnbmVkIGluIG9yIGNyZWF0ZWQgYW4gYWNjb3VudC4ifX0.-sYkHWfC02yb0CpuUqmPkxxnF0yzlNHaS5520hYIUy8&redirect_to=https://www.ecfr.gov/current/title-42/chapter-I/subchapter-D/part-50/subpart-F">Sign In / Sign Up</a> </li> </ul> </div> </div> </div> </div> </div> </body></html>