Specific to Research-Funding Sponsored by the Public Health Service (PHS)
ARTICLE I - INTRODUCTION
This Policy governs the disclosure of significant financial interests (SFI)1 on the part of individuals at Stevens Institute of Technology (Stevens) involved with PHS-funded awards and the management and reporting of financial conflicts. It applies to research performed at Stevens Institute of Technology and at subrecipient institutions that cannot certify to the presence of their own Policy which complies with 42 CFR 50, Subpart F (this Final Rule was published in the Federal Register on 8.25.2011). It is a research-specific Policy implemented by the Office of Sponsored Programs and does not replace the Institutional Conflict of Interest Policy at 10.3
ARTICLE II - PURPOSE
The government's purpose is to promote "...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." (42 CFR 50.601)
The purpose of this Policy is to provide guidance on the disclosure of financial interests that comply with the disclosure requirements of federal regulations of the U.S. Department of Health and Human Services (DHHS) and the DHHS Public Health Service (PHS) as described at 42 CFR 50.601-607 (hereafter "the Regulation"). If a specific federal law, regulation or Stevens' Policy provides different requirements than this Policy, the more stringent requirement applies.
ARTICLE III -STEVENS' RESPONSIBILITIES REGARDING PHS FCOI
Stevens, by means of this Policy: a) maintains a current, written and enforced Policy; b) informs Investigators of the Policy and their responsibilities; c) manages subrecipients receiving PHS funding; d) designates an Institutional Official; e) manages the Investigator disclosure process; f) provides operational guidelines to the Institutional Official; g) manages financial conflicts of interest; h) provides FCOI reports to the PHS Award Component; i) develops and maintains a recordkeeping system; j) establishes adequate enforcement mechanisms; k) certifies institutional compliance with all elements of the Regulation in all PHS proposals. These broad categories are discussed with more specificity in the following sections; however, a complete and detailed description of the Institution's processes is contained in the companion document entitled "Administrative Guide for FCOI Management of PHS-funded Awards," hereafter referred to as the "OSP Guide."
Section III (a) - Maintain a Current, Written and Enforced Policy
Stevens, by means of this Policy maintains a current, written, enforced Policy on PHS FCOI that complies with the Regulation and makes the Policy available on the Office of Sponsored Programs' websites.
Section III (b) - Inform Investigators of the Policy and their Responsibilities
Stevens, by means of this Policy, informs each Investigator of the Institution's Policy entitled "Public Health Service (PHS) Financial Conflict of Interest (FCOI)" and their responsibilities regarding disclosure of significant financial interests. Stevens requires each Investigator to complete training prior to engaging in PHS-funded research and every four years thereafter. Investigators are required to engage, or re-engage in training immediately if: a) the Institution revises the Policy in a way that affects Investigator responsibilities; b) an Investigator is new to the Institution; or c) an Investigator is found to be non-compliant with the Institution's PHS FCOI Policy.
Section III (c) - Manage Subrecipients Receiving PHS Funding
If the Institution's PHS-funded research includes the presence of a subrecipient, the Institution must take reasonable steps to ensure that a subrecipient Investigator complies with the requirements of the Regulation. The Institution must provide FCOI reports to the PHS Awarding Component regarding all subrecipient FCOI.
Section III (d) - Designate an Institutional Official
The Provost is responsible for designating an Institutional Official who will solicit and review disclosures of significant financial interests from each Investigator who is planning to participate in, or is participating in, PHS-funded research.
Section III (e) - Manage the Investigator Disclosure Process
Stevens, by means of this Policy requires each Investigator who is planning to participate in PHS-funded research to disclose his/her significant financial interests (as well as those of the Investigator's spouse and dependent children) to the Institutional Official. A current disclosure must be on file at the time a proposal is submitted for PHS-funded research and annually during the Institutional cycle.
Section III (f) - Provide Operational Guidelines to Institutional Official
Operating guidelines have been developed and provided to the Institutional Official in order to determine whether an Investigator's significant financial interest is related to PHS-funded research and, if related, whether the significant financial interest is a FCOI.
Section III (g) - Manage Financial Conflicts of Interest
Stevens, by means of this Policy, requires such actions as necessary to manage FCOI, including those of a subrecipient Investigator. Management of an identified PHS FCOI will include development and implementation of a Management Plan and a retrospective review and mitigation report pursuant to the requirements of the Regulation.
Section III (h) - Provide FCOI Reports to PHS
Stevens, by means of this Policy, provides FCOI reports to PHS prior to expenditure of any funds under a PHS-funded research project regarding any Investigator's significant financial interest found to be conflicting, as required by the Regulation and as more fully described in ARTICLE IV, Section IV (b) of this Policy.
Section III (i) - Develop and Maintain Recordkeeping System
Stevens, by means of this Policy has developed processes in order to maintain records relating to all Investigator disclosures of financial interests, including the Institution's review and assessment of such disclosures and all actions resulting from the disclosure and resulting assessment. Records must be maintained for at least three years from the date the final expenditure report is submitted to PHS.
Section III (j) - Establish Adequate Enforcement Mechanisms
Compliance with this Policy is a condition of employment at Stevens and requires the timely, complete, and accurate disclosure of activities and financial interests consistent with this Policy. An Investigator who does not comply will be subject to discipline, including termination of employment. An Investigator who is not an employee of Stevens, i.e., the employee of a subrecipient institution, a consultant or collaborator, must comply with the requirements of the Regulation as implemented by their institution, or the Stevens' Policy, whichever is deemed appropriate by either the Institutional Official or the OSP Director of Research Data, Audit and Compliance prior to award. Failure to comply could result in suspension or termination of the PHS funded project.
Section III (k) - Certify Institutional Compliance in all PHS Proposals
Stevens, by means of electronic submission through eraCommons, certifies compliance with all elements of the Regulation at the time a PHS proposal is submitted.
ARTICLE IV - MANAGEMENT AND REPORTING OF PHS FCOI
Substantive elements of the Institution's management and reporting responsibilities are broadly categorized as follows:
Section IV (a) - Management of PHS FCOI
The Institutional Official, required by means of this Policy:
- Review of disclosures prior to the Institution's expenditure of any funds under a PHS-funded research project
- Review new Investigator or amendments to existing disclosures
- Review delinquent or previously unreviewed disclosure(s)
- Monitor Investigator compliance with an established Management Plan
- Ensure public accessibility of information
Section IV (b) - Reporting of PHS FCOI
The Institutional Official, by means of this Policy:
- Provide an FCOI report to the PHS Awarding Component prior to the Institution's expenditure of any funds under a PHS-funded research project
- Provide amended FCOI reports to PHS Awarding Component within sixty (60) days
- Complete and submit results of a retrospective review where such subsequent reporting involves a significant financial interest that was not disclosed in a timely way by an Investigator, or, for whatever reason was not previously reviewed or managed by the Institution
- Provide sufficient information on PHS FCOI reports to enable PHS assessment
- Provide annual updates to PHS on previously submitted FCOI reports
ARTICLE V - INVESTIGATOR RESPONSIBILITIES PHS FCOI
Each Investigator by means of this Policy:
- Files an initial disclosure within thirty (30) days of the Institution's initial implementation of the Regulation on 8.25.2012, prior to submission of a PHS-funded proposal, and by July 1 every year thereafter
- Files an amended disclosure within thirty (30) days of discovering or acquiring a new, or previously unreported, significant financial interest
- Completes required training within thirty (30) days of the institutional implementation of the Regulation on 8.25.2012 and every four (4) years thereafter
- Acknowledges by signature his/her understanding of and obligation to comply with the SIT FCOI Advisory Committee's recommended Management Plan in the event a FCOI is determined
ARTICLE VI - REMEDIES AND CORRECTIVE ACTIONS
The substantive elements of PHS' rights and the Institution's responsibilities pertaining to remedies and corrective actions are broadly categorized to include requirements relevant to: a) an Investigator's failure to comply; b) PHS' rights of inquiry; and c) an Investigator's duty to publicly disclose.
Section VI (a) - Investigator Failure to Comply
If an Investigator fails to comply with this Policy or a FCOI Management Plan or if a FCOI appears to have biased the design, conduct, or reporting of any PHS-funded research, the Institution will promptly (within ten  working days) notify the PHS Awarding Component of the corrective action taken, or to be taken.
Section VI (b) - PHS Rights of Inquiry
Stevens, by means of this Policy responds to any PHS request for information at any time before, during, or after award about Investigator disclosure(s) of financial interest and the Institution's review (including any retrospective review) of, and response to, such disclosure. The University shall submit, or permit, on-site review of, all records pertinent to compliance with this Policy. The University, by means of this Policy, is required to comply with a PHS determination that the imposition of special award conditions or suspension of funding or other enforcement action is necessary until the matter is resolved.
Section VI (c) - Investigator's Duty to Publicly Disclose
Stevens, by means of this Policy, requires an Investigator to disclose identified FCOI in each public presentation of the result of the research and to request an addendum to previously published presentations in the following circumstances:
- PHS determines that PHS-funded project of clinical research whose purpose is to evaluate the safety of effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a FCOI and was not managed or reported by the Institution as required by this Policy
ARTICLE VII - REFERENCE MATERIAL
1 This term, as much of the verbiage in this Policy, mirrors the Regulation. A dictionary is included as Appendix A in this document. Significant financial interest as it pertains to the disclosure of any reimbursed or sponsored travel will specify, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. The Institutional Official will determine if further information is needed. Disclosure of all SFI will be done through the OSP Coeus COI module.
Disclosure of significant financial interests means an Investigator's disclosure of significant financial interest to an Institution.
Entity (as used in the FCOI regulation means any domestic or foreign, public or private, organization (excluding a Federal agency) from which an Investigator (and spouse and dependent children) receives remuneration or in which any person has an ownership or equity interest.
Financial conflict of Interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
FCOI report means the Institution's report of a financial conflict of interest to a PHS Awarding Component.
Financial interest means anything of monetary value, whether or not the value is readily ascertainable.
Institution 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.
Institutional responsibilities means an Investigator's professional responsibilities on behalf of the Institution, and as defined by the Institution in this Policy, which may include for example: activities such as research, research consultation, teaching, institutional committee memberships, and service on panels such as Institutional Review Boards (IRB), Institutional Animal Care and Use Committee (IACUC), and Institutional Biosafety Committee (IBC).
Investigator 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.
Manage 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 report of research will be free from bias.
New Significant Financial Interest means a different type or nature of SFI (e.g., royalty payment versus consulting fees) than what had previously been disclosed from the same source that meets or exceeds the threshold. In addition, a "new" SFI is also considered to be the same type or nature of SFI (e.g., royalty payment) from a different source (e.g., company A versus company B).
PD/PI means a project director of principal Investigator of a PHS-funded research project; the PI/PI is included in the definition of senior/key personnel and Investor under Subpart F.
PHS Awarding Component means the organizational unit of the PHS that funds the research that is subject to this subpart.
Research 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, drug or product). As used in Subpart F, the term includes activity for which research funding is available such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, research resource awards, conference grants, and Minority Biomedical Research Support award, and Minority Biomedical Research Support.
Research 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 Subpart F, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant or cooperative agreement, research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, research resources award, conference grant
Senior/key personnel 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 Policy and Subpart F
Significant financial interest means:
- 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 institution responsibilities:
- With regard to any publicly traded entity, a significant financial interest 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;
- With regard to any non-publicly traded entity, a significant financial interest 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
- Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
- Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., 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 , 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 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.
- The term significant financial interest 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, 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, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.