4.2 PHS and NSF Requirements Regarding Financial Disclosures and Agency Notifications
Establishes guidelines for implementation of agency requirements related to financial disclosures by faculty members and other key personnel involved with submitting proposals and notifications to agencies in the event a financial conflict of interest (FCOI) is identified.
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1. Introduction
Stanford's Faculty Policy on Conflict of Commitment and Interest establishes requirements for faculty disclosures (on both an annual and an ad hoc basic) of financial interests and professional relationships related to research projects, and for annual certifications of policy compliance. In addition, Stanford's policy requires that faculty members seeking funding from an external sponsor comply with the disclosure requirements of that sponsor.
In addition to requirements for an institutional policy on conflict of interest, several federal agencies have their own requirements for disclosures related to their sponsored research projects; these include the Public Health Service (PHS) and related components such as the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC), as well as the National Science Foundation (NSF). This policy provides specific guidance related to the requirements of those agencies.
2. PHS Investigator Disclosures [1]
PHS requires that, for each proposal submitted to that agency, the Principal Investigator (PI) and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research (Investigators) certify that he or she has appropriately disclosed any Significant Financial Interests (SFI) related to his or her institutional responsibilities to Stanford. These SFI disclosures must be updated at least annually and within thirty days of entering into a new relationship with a company/organization or discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new SFI. Before an award can be accepted, Stanford must determine:
- If the SFI is related to the Investigator's research responsibilities and to the specific research award in question
- If the SFI creates an FCOI
- If an FCOI is determined to exist, then a Management Plan detailing how the conflict will be managed, reduced, or eliminated must be developed and implemented.
At Stanford, each School will handle this responsibility for its own Investigators, relying on the annual (OPACS) and transactional/ad hoc disclosures submitted by faculty as required by Stanford's Faculty Policy on Conflict of Commitment and Interest in RPH.
PHS components including the NIH require that Investigators disclose to a designated representative of the institution all SFIs that would reasonably appear to be related to the Investigator's institutional responsibilities which include: research and other scholarly activities; clinical care activities; teaching or educational activities; and administrative activities.
SFI means a financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator's spouse/domestic partner or dependent children) that reasonably appear to be related to the Investigator's institutional 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
- 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
- Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests that is not paid through Stanford
An FCOI means an SFI that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
[1] The requirements regarding Investigator financial conflicts of interest in research funded under PHS grants or cooperative agreements can be found at http://grants.nih.gov/grants/FCOI_Final_Rule_inspection_Desk.pdf, pp 53283-53288.
A. Stanford University Implementation, PHS Requirements
PIs must complete a Proposal Development & Routing Form (PDRF) in order to document that all requirements related to the submission of a funded research proposal have been met. One requirement is for Stanford to ensure that if there are personal financial interests related to the funded research, these relationships are examined and dealt with according to institutional and funding agency policies on conflict of interest. A personal financial interest with an entity would be reasonably considered related to an investigator's research study in circumstances such as the following:
- Entity sponsors research at Stanford in which the investigator is directly involved
- Entity has financial interests that could reasonably be considered to have a potential influence on the design, conduct or reporting of investigator's research/scholarship
- Entity has a reasonable possibility of being financially affected by investigator's research/scholarship
- Entity makes gifts to Stanford that benefit investigator's research/scholarship (including equipment gifts or loans)
- Entity makes a product that is under study in research in which investigator is involved
- Entity licenses Stanford intellectual property in which investigator has a financial interest
- Entity has a Materials Transfer Agreement or Human Tissue Agreement (MTA/HTA) to provide materials used in investigator's research or for materials provided by investigator to the company/organization
- Entity sponsors or makes a product that is under study in human subjects in which investigator is directly or indirectly involved
If a related financial interest exists, the PDRF links to questions about personal financial interests that may reasonably appear to be related to the research project (see Attachment A - Evaluation of Financial Interests in Related Items below).
B. Agency Notifications, PHS Only
Upon receipt of an award from the Public Health Service and prior to the expenditure of any funds, as well as within 60 days for any interest that the Institution identifies as conflicting subsequent to the Institution's initial report under the award, Stanford is obligated to notify the sponsoring institute or agency of any FCOI associated with that award. In addition Stanford will provide annual updates on any previously-identified FCOI for the duration of the research project or until the FCOI ceases to exist. The annual FCOI report will address the status of the financial conflict of interest and changes to the management plan and is done at the same time as the Investigator’s submission of the annual progress report, multi-year progress report, or extension.
If an FCOI is identified at the time a proposal is submitted, and that proposal is subsequently awarded, or if an FCOI is identified subsequent to the award of the project, Stanford must prepare a notification to the eRA Commons FCOI Module. That notification is to consist of the following:
- Grant number
- PD/PI or contact PD/PI
- Name of Investigator with the FCOI
- Name of the entity with which the Investigator has an FCOI
- Nature of FCOI (e.g., equity, consulting fees, travel reimbursement, honoraria)
- Value of the financial interest (in pre-specified dollar ranges) or a statement that a value cannot be readily determined
- A description how the financial interest relates to NIH-funded research and the basis for the Institution’s determination that the financial interest conflicts with such research
- Key elements of the Institution’s management plan including:role and principal duties of the conflicted Investigator in the research project
- Conditions of the management plan
- How the management plan is designed to safeguard objectivity in the research project
- Confirmation of the Investigator's agreement to the management plan
- How the management plan will be monitored to ensure Investigator compliance. Stanford will monitor Investigator compliance until the completion of the PHS-funded research project.
- Other information as needed
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In the event that Stanford identifies a significant financial interest that was not disclosed in a timely fashion by the Investigator or previously reviewed by Stanford during an on-going PHS-funded research project, Stanford will, within 60 days, determine whether it is related to PHS-funded research and, if so, whether a financial conflict of interest exists. If an FCOI exists, Stanford will implement a management plan.
In addition, whenever a financial conflict of interest is not identified or managed in a timely manner, Stanford will, within 120 days of its determination of non-compliance, complete a retrospective review of the Investigator’s activities and the PHS-funded research project. The purpose of the review is to determine whether any PHS-research conducted during the period of non-compliance was biased in its design, conduct or reporting.
The documentation of the retrospective review will include these elements:
- Project number
- Project title
- PD/PI or contact PD/PI if a multiple PD/PI model is used
- Name of the Investigator with the FCOI
- Name of the entity with which the Investigator has a financial conflict of interest
- Reason(s) for the retrospective review and methodology used for the review
- Findings and conclusions of the review
Based on the the retrospective review, if appropriate, Stanford will update the previously submitted FCOI report, specifying the actions that will be taken to manage the FCOI
If bias is found, Stanford will notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component. The mitigation report will include the key elements documented in the retrospective review, the impact of the bias on the research project and Stanford’s plan of action or actions to eliminate or mitigate the effect of the bias.
In any case in which Health and Human Services (HHS) determines that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness or 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 as required by PHS regulations, Stanford will 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.
Stanford will maintain records relating to all Investigator disclosures of financial interests and Stanford’s review of and actions taken related to such disclosures for at least three years from the date of the final expenditures report is submitted to the PHS, or, where applicable, from other dates specified in PHS regulations.
C. Other PHS Requirements
1. Public Accessibility
Prior to the expenditure of funds, Stanford will make certain that information concerning FCOIs held by senior/key personnel is publicly accessible via a Web site or by a written response to any requester within five business days of a request or as required by law. This information will include: 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 (in pre-specified dollar ranges), or a statement that a value cannot be readily determined. This information will remain publicly accessible for at least three years from the date that it was most recently updated.
2. Investigator Training
Each Investigator must have completed the training class: Conflicts of Interest Certification: COI-PROG-0001 prior to engaging in research related to any PHS-funded grant. The training must be re-taken at least every four years. In addition, education is required immediately when:
- Financial conflict of interest policies are revised in a manner that changes researcher requirements.
- A researcher is new to the organization.
- A researcher is non-compliant with financial conflict of interest policies and procedures.
3. Subawards
If an institution carries out agency-funded research through subawardees, contractors, or collaborators, the institution must take reasonable steps to ensure that the collaborating entity has its own policies in place that meet the requirements of the PHS policy or that investigators working for such entities follow the policies of the primary institution.
4. Travel
Investigators who are planning to participate in PHS-funded research must disclose their reimbursed or sponsored travel related to their institutional responsibilities over the previous twelve-month period to their Institution no later than the time of application for PHS-funded research. They must also submit an updated disclosure of reimbursed or sponsored travel within 30 days of each occurrence.
3. NSF Investigator Disclosures [2]
NSF requires Stanford to maintain an appropriate written and enforced policy on conflict of interest and that all conflicts of interest for each award be managed, reduced or eliminated prior to the expenditure of the award funds. If an institution carries out agency-funded research through subawardees, contractors, or collaborators, the institution must take reasonable steps to ensure that the collaborating entity has its own policies in place that meet the requirements of this policy or that investigators working for such entities follow the policies of the primary institution.
As provided by Stanford’s Faculty Policy on Conflict of Commitment and Interest in RPH, NSF requires that each investigator disclose to a responsible representative of the institution all significant financial interests of the investigator (including those of the investigator’s spouse and dependent children) that would reasonably appear to be affected by the research or educational activities funded or proposed for funding by NSF or in entities whose financial interests would reasonably appear to be affected by such activities.
The term “investigator” means the principal investigator, co-principal investigators/co-project directors, and any other person at the institution who is responsible for the design, conduct, or reporting of research or educational activities funded or proposed for funding by NSF.
As specified by NSF, the term “significant financial interest” (SFI) means anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interest (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:
- salary, royalties, or other remuneration from the applicant institution
- income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities
- income from service on advisory committees or review panels for public or nonprofit entities
- an equity interest that, when aggregated for the investigator and the investigator’s spouse and dependent children, meets both of the following tests: does not exceed $5,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a 5% ownership interest in any single entity
- salary, royalties or other payments that, when aggregated for the investigator and the investigator’s spouse and dependent children, are not expected to exceed $5,000 during the twelve month period
NOTE: Although current NSF regulations specify a higher threshold for SFI than PHS (NIH), Stanford policy identifies $5,000 as the monetary threshold. Similarly, in non-publicly traded companies, PHS and Stanford policy identify any equity amount as the threshold.
NSF requires Stanford to ensure that investigators have provided all required financial disclosures at the time the proposal is submitted to NSF. Stanford must also ensure that those financial disclosures are updated during the period of the award, either on an annual basis, or as new reportable significant financial interests are obtained.
Stanford designates individuals to review financial disclosures, determine whether a conflict of interest exists, and determine what conditions or restrictions, if any, should be imposed by the institution to manage, reduce or eliminate such conflict of interest. A conflict of interest exists when the reviewer(s) reasonably determines that a significant financial interest could directly and significantly affect the design, conduct, or reporting of NSF-funded research or educational activities.
Examples of conditions or restrictions that might be imposed to manage, reduce or eliminate conflicts of interest include, but are not limited to:
- public disclosure of significant financial interests
- monitoring of research by independent reviewers
- modification of the research plan
- disqualification from participation in the portion of the NSF-funded research that would be affected by significant financial interests
- divestiture of significant financial interests
- severance of relationships that create conflicts
Stanford must have adequate enforcement mechanisms, provide for sanctions where appropriate and must keep NSF’s Office of the General Counsel appropriately informed if the institution finds that it is unable to satisfactorily manage a conflict of interest. Grantee notifications of conflict of interest that cannot be managed, reduced, or eliminated must be submitted electronically via the NSF FastLane system by the Dean of Research Office.
Stanford must maintain records of all financial disclosures and of all actions taken to resolve conflicts of interest for at least three years beyond the termination or completion of the grant to which they relate, or until the resolution of any NSF action involving those records, whichever is longer.
[2] The conflict of interest policies of the NSF can be found at: http://www.nsf.gov/pubs/policydocs/pappguide/nsf08_1/aag_4.jsp
4. Attachment A: Evaluation of Financial Interests
Date: August 22, 2012
Principal Investigators must complete a Proposal Development & Routing Form (PDRF) in order to document that all requirements related to the submission of a funded research proposal have been met. If the PI indicates the existence of a related financial interest, the PDRF links to questions about those financial interests that may reasonably appear to be related to the research project, including:
1. Name of company/organization (foundation, society, other)
2. What is the nature of your activity/financial interest with the company/organization? (check all that apply)
__ Board of Directors membership
__ Advisory Board membership
__ Consultant (other than Advisory Board or Board of Directors membership)
__ Licensing of your Stanford or non-Stanford intellectual property
__ Ownership of stock or stock options or other ownership interests
(excluding investments for which you do not directly control investment
decisions, such as mutual funds)
__ Payment for royalties for inventions (not paid through Stanford)
__ Payment for lectures
__ Payment for preparation of papers or reports
__ Payment for product evaluation
__ Legal consultant or expert witness
__ Executive or other employee position with company/organization
__ This is a financial interest/activity of my spouse/domestic partner or dependent child
3. What is the total amount of your financial interest (or that of your spouse/domestic partner or dependent children) in this company/organization?
__ $1 - 4,999
__ $5K - $9,999K
__ $10K - 19,999K
__ $25 - 49,999K
__ $50K - 99,999K
__ $100 - 199,999K
__ greater then $200,000
4. If this entity is a company, is it
__ Publicly traded or
__ Privately held or Start Up
