CGU Policy and Procedures to Meet Requirements of the Public Health Service (including the National Institutes of Health) and the National Science Foundation
CGU is committed to promoting objectivity in research and compliance with National Science Foundation (NSF) and Public Health Services (PHS) regulations* regarding the disclosure of Significant Financial Interests and the management of Financial Conflicts of Interest affecting covered research activities.
CGU is implementing this policy and the corresponding procedures in order to provide a reasonable expectation that the design, conduct and reporting of research funded by the NSF or PHS, including the National Institutes of Health (NIH), will be free from bias resulting from Financial Conflicts of Interest as defined by the regulations. Compliance with these requirements shall be a condition for submitting proposals and accepting awards of Federal financial support from the NSF or PHS for all activities conducted under CGU auspices. This policy and the associated procedures are intended to supplement existing CGU policies on conflict of interest and conflict of commitment. This policy and these procedures apply to all individuals who meet the definition of Investigator as defined herein, including faculty, staff, postdoctoral scholars, students, external collaborators and co-investigators from other educational institutions or organizations.
* Investigator Financial Disclosure Policy -NSF -Federal Register, Vol 60, July 11, 1995, pp. 35820 to 35823. Objectivity in Research -DHHS -Federal Register, Vol. 76, August 25, 2011, pp. 53256 to 53293
The following procedures may change from time to time to ensure efficiency in administration and effective compliance.
"Investigator" is the project director or principal investigator, co-investigators, and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of the research funded by NSF or PHS, or proposed for such funding, which may include faculty, staff, postdoctoral scholars, students, external collaborators and co-investigators from other institutions or organizations.
"Institutional responsibilities" include an investigator's professional responsibilities on behalf of CGU, including activities such as teaching, research, committee or board membership and services and other administrative duties.
"Significant financial interest" (SFI): The term is defined differently for PHS and NSF. Please review the following carefully to understand the differences and to ensure accurate reporting.
SFI For purposes of PHS (NIH) funding:
SFI 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 relate to the Investigator's Institutional Responsibilities:
Included in the definition of SFI is the occurrence of any reimbursed or sponsored travel (i.e. "sponsored travel" is travel which is paid on behalf of the Investigator and not reimbursed directly to the Investigator so that the exact monetary value may not be readily available), related to the Investigator's institutional responsibilities.
The term SFI does not include the following:
SFI For purposes of NSF funding:
SFI means anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria4); equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights).
The term does not include:
Disclosure is the submission of the CGU Conflict of Interest Disclosure form (COID) by each CGU individual who meets the definition of Investigator. The Disclosure should include the details of the nature of any SFI for the applicable Federal agency (as defined by the agency), and which is held by the Investigator, his/her spouse and/or dependent children.
For NSF and PHS proposals or awards involving an external collaborator who meets the definition of Investigator and who has an SFI, Disclosure can take one of two forms:
Financial Conflict of Interest is an SFI held by an Investigator that could directly and significantly affect the design, conduct, or reporting of his/her PHS or NSF funded research. The determination as to whether an SFI constitutes a Financial Conflict of Interest is made by the Institutional Official, which is the Provost or the Provost's designee. For purposes of PHS and NSF, any ownership interests (whether SFI or not) in a business will not constitute a Financial Conflict of Interest if the business is an applicant under a Phase I Small Business Innovation Research Program (SBIR) or Small Business Technology Transfer (STTR) Program.
Manage taking action to address a financial conflict of interest, which may include reducing or eliminating the financial conflict of interest, to ensure to the extent possible, that the design, conduct and reporting of the research will be free from bias.
Senior/Key Personnel the Project Director or Principal Investigator and any other person identified as senior/key personnel in the grant application, progress report, or any other report submitted to PHS by CGU.
Institutional Official The Institutional Official is the Provost or the Provost's designee. The Provost's designee is the Vice Provost and Director of Research.
Investigators are required to identify and disclose, or identify and re-verify, if previously disclosed, SFIs before an application is submitted to either NSF or PHS, and thereafter within 30 days of discovering or acquiring a new SFI, employing Disclosure forms made available for this purpose by the Office of Research and Sponsored Programs. Disclosures must also be updated at least annually in connection with CGU's annual Financial Conflicts of Interest Disclosure process.
At the time a proposal is being prepared, the individual serving as Principal Investigator should alert any other individuals who may meet the definition of Investigator of the need to comply with these procedures. All individuals who are considered to be Investigators (including the principal investigator) are to determine and certify whether they have any SFIs and, if so, each must file Disclosure of the nature and magnitude of the financial interest, employing forms made available for this purpose by the Office of Research and Sponsored Programs. According to Federal requirements, all such Disclosures should be submitted to the appropriate Institutional Official before CGU forwards the proposal to the covered Federal funding agency. Proposals will only be processed by the Office of Research and Sponsored Programs if the appropriate Disclosures are on file.
CGU will review Disclosures of SFIs in accordance with these procedures to determine whether an actual or potential Financial Conflict of Interest exists. CGU's Institutional Official will review and work with the Investigator(s) to develop a management plan for any such conflicts before awarded funds are expended. Compliance with CGU's governing policies and these procedures is an ongoing requirement that CGU must fulfill in order to be eligible to receive funding from NSF and PHS.
Institutional Officials and the Office of the Provost are designated by CGU as responsible for reviewing Disclosures of SFIs and determining whether a Financial Conflict of Interest exists for purposes of covered Federal funding. When a Financial Conflict of Interest is identified, these individuals also are responsible for determining what steps need to be taken to manage the conflict prior to the expenditure of covered funding.
The Institutional Official receiving a Disclosure will: review the disclosure to determine if the disclosed SFI constitutes a Financial Conflict of Interest for purposes of the award. If any actual or potential Financial Conflict of Interest is identified, the Institutional Official will work with the Investigator to determine the steps that should be taken to manage the conflict and will prepare a proposed written management plan. The proposed management plan will be forwarded to the Provost along with the Disclosure form.
The Provost will review the Disclosure in the context of the proposed activity along with the management plan proposed by the Investigator and Institutional Official. Before permitting any expenditure of funds from the Federal sponsor, the Provost, in collaboration with the Institutional Official, will approve the management plan describing the conditions and possible restrictions that CGU believes are necessary to manage the actual or potential Financial Conflict of Interest. The following are examples of conditions or restrictions that may be included in a management plan:
Copies of the approved management plan will made available to the Investigator and the plan must be implemented before the expenditure of funds.
For PHS-funded activities, all SFI must be reviewed by the Institutional Official and all potential Financial Conflicts of Interest completely addressed prior to expenditure of funds. Should an SFI arise during the term of the award, the Investigator must file a Disclosure within 30 days and the SFI must be reviewed by the Institutional Official and all potential Financial Conflicts of Interest completely addressed within 60 days of the Disclosure. If an Investigator does not file his/her Disclosure in a timely manner, additional compliance action by the Institutional Official and CGU will be required pursuant to 42 CFR 50.605.
The Office of Research and Sponsored Programs will make any required reports to PHS and NSF. In the case of PHS, the PHS will review the reported Financial Conflict of Interests to determine if additional information is needed. PHS may decide that further action is needed to ensure the objectivity of the research or that the Financial Conflict of Interest has not been appropriately managed, reduced or eliminated. PHS may also require suspension of funding until the matter is resolved.
For PHS funded or proposing Investigators, CGU requires Investigators to be familiar with this document and to receive training via the NIH tutorial or an acceptable equivalent:
The Principal Investigator will be responsible for identifying all investigators who should have undergone the required training prior to their engagement in the covered research.
NSF funded or proposing Investigators should familiarize themselves with this document relative to obligations required by NSF.
CGU will maintain required records of all Disclosures and of all actions taken to manage actual or potential conflicts of interest for at least three (3) years from the date the final expenditure or project report is submitted to PHS or NSF or until the resolution of any legal or government action involving these records, whichever is later.
CGU will include provisions in all covered subawards requiring subrecipients to comply with NSF and PHS rules related to the disclosure of SFIs and management of Financial Conflict of Interests consistent with Federal requirements for covered awards.
Upon written request to the Office of Research and Sponsored Programs, CGU is required to provide, within 5 business days, a written disclosure of Financial Conflicts of Interest held by Investigators proposing for funding or funded by PHS, including:
CGU requires that the designated Principal Investigator for an activity that is proposed to be, or actually is, funded by a covered Federal sponsor is required to:
CGU will post these procedures and the governing policy for financial conflicts of interest on the website. All current and future CGU personnel receiving or proposing to receive funds from the covered federal sponsors are required to become familiar with these procedures and the governing policy.
Failure to comply in a timely manner with disclosure requirements for PHS-funded awards may result in delays in accessing funds or suspension of expenditures on PHS-funded activities.
Individuals who persistently or purposefully fail to adhere to these procedures and the governing policy may be subject to suspension of funds, removal from participation in the covered award and other disciplinary action as determined by the provost, subject to CGU due process for disciplinary procedures.
The vice provost and director of research, and the staff of the Office of Research and Sponsored Programs, are available to provide advice and assistance to any individual on the interpretation of these requirements and the applicability to a specific situation.