Conflict of Interest Policy Scientific Analysis Corporation:The Public Health Service (PHS) requires disclosure of significant financial interests by investigators who participate in PHS-funded research either directly or by subaward. Other agencies (FCOI Agencies Using the PHS FCOI Regulations – The Federal Demonstration Partnership (thefdp.org)), have adopted the PHS requirements. All required forms can be accessed through the links below or by emailing or calling the administrative office at (415) 777-2352.
At the proposal stage the Principal Investigator (PI) must fill out the Conflict of Interest screening questions (see link below) on behalf of all investigators that will be involved in the project. For this purpose, an “investigator” is defined as: the Principal Investigator (PI) and any other person/s (regardless of title or position) that the PI identifies as independently responsible for the design, conduct, or reporting of the research.
If disclosure is required PI will need to complete the PHS Financial Interest Financial Interest Screening Questions Form (see link below) on behalf of all investigators involved in the project and email it to the COI Office at email@example.com.
Note: If any investigator prompts the PI to respond “yes” to any of the screening questions, the investigator will be required to complete and submit the PHS Financial Disclosure Form (see link below) to the COI Office at firstname.lastname@example.org for review prior to the award being released.
Subawards: If subawards are included in the proposal, the authorized official of each subaward recipient will need to complete the most current Subrecipient Commitment Form and answer financial interest questions on behalf of all subrecipient investigators named in the Scientific Analysis Corporation proposal. Note: A subaward cannot be issued to a subrecipient that does not have a PHS compliant COI policy in place.
If any investigator prompted the PI to answer “yes” to any of the screening questions at the proposal stage, the investigator will be required to complete and submit the PHS Financial Disclosure Form (see link below) to the COI Office at email@example.com prior to the award being released.
If the PI responded, “no,” to all the screening questions at the proposal stage then nothing more is required unless the PI’s responses to the screening questions were obtained more than 12 months prior to award receipt. If the questions were answered more than 12 months earlier, the PI will need to submit an updated PHS Financial Interest Financial Interest Screening Questions Form (see link below) on behalf of all investigators currently involved in the project.
Training: All Investigators are required to take PHS Compliant Training — FINANCIAL CONFLICT OF INTEREST – NEWEST (nih.gov) prior to engaging in PHS-funded research. During Life of Award
The PI is required to complete the PHS Financial Disclosure Form (see link below) at least annually on behalf of all investigators involved in the project when the PI:
• Submits the progress report/non-competing continuation (RPPR),
• Requests a no-cost time extension,
• Adds new investigators to the project, and/or
• Becomes aware that an investigator that is involved in the project has acquired or discovered a new significant financial interest. (This must be reported within 30 days.)
If the PHS Financial Interest Screening Questions Form provided by the PI at any point listed above includes a “yes” response, then the investigator that prompted the “yes” response will be required to complete the Financial Disclosure Form (see link below) and email it to the administrator at Scientific Analysis Corporation.
Investigators must disclose new Significant Financial Interests within 30 days of acquiring the new interest by submitting a Financial Disclosure Form (see link below) by email to the administrator at Scientific Analysis Corporation.
Training — All Investigators are required to take PHS Compliant Training: FINANCIAL CONFLICT OF INTEREST – NEWEST (nih.gov) while engaging in PHS-funded research.
NOTE: Please use Adobe Acrobat or Reader to fill out PDF forms. (If you have difficulty filling out a form, please download the form to a local computer before filling it out.)
• PHS Financial Interest Screening Questions Form (at proposal stage, and annually or at the Progress Report stage)
• PHS Financial Disclosure Form (if yes to any screening questions)
• PHS Financial Disclosure: Significant Financial Interests-Entity (optional attachment to PHS Financial Disclosure Form)
Review and Management
Scientific Analysis Corporation’s (SAC) Conflict of Interest Officer will review all positive financial disclosures and take the necessary steps to manage, reduce, or eliminate any conflicts of interest before approval is granted. Approval of the financial disclosure by the COI Committee is required prior to any awards being released and accepted. Below is an overview of the review process for positive disclosures and what happens when the committee finds a conflict of interest.Review Timeline
• Positive disclosure received
• COI Officer reviews disclosure to determine if expedited or full review is needed
• COI Committee review
- Expedited review (1-2 weeks)
- Full review (monthly)
• Results emailed to Investigators and staff (5-10 business days after review)Overview
A positive disclosure is a Significant Financial Interest (SFI), i.e. a disclosable financial interest.
• For PHS, a Financial Conflict of Interest (FCOI) is defined under the regulation as an SFI that is related to the PHS-funded research activity and that could directly and significantly affect the design, conduct or reporting of that activity.
• For NSF and other federal non-PHS agencies, a Related Financial Interest is an SFI 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.
• For State disclosures, a positive disclosure signals the existence of a potential conflict of interest, a situation in which financial or other personal considerations may bias, or have the appearance of biasing, an investigator’s professional judgment in conducting or reporting research funded by the non-governmental agency. The SAC Conflict of Interest Committee is a panel of staff and board members appointed by the director. They review positive disclosures of financial interests to determine whether these interests constitute significant conflicts of interest that must be eliminated, reduced or managed before research support can be accepted. If they determine that the research support may be accepted, the Committee then also determines an appropriate strategy for management of any significant conflict before approval is granted.
Approval of the COI Committee is required before any awards are accepted and set up at SAC. Conflict of Interest Committee Determination
In general, the Committee asks: are the research interests and the private interests kept separate and have licensing agreements been appropriately reviewed.
The Committee then determines whether the financial interest represents a real or perceived conflict of interest, and if so, whether any action should be undertaken to eliminate, reduce, or otherwise manage the conflict. The Committee applies standards that have evolved over time, based on their prior experience, the appearance of new types of conflicts, and input from the local and national research community. Managing Related Significant Financial Interest
If the Committee determines that the disclosed financial interests constitute a real or perceived conflict of interest, they will recommend actions designed to eliminate, reduce, or manage the conflict. In some instances, the Committee may simply recommend disclosing the interest in all publications and presentations. Depending on the facts, the Committee may also recommend other measures such as divestiture of all equity interest in the sponsor or elimination of any consulting arrangement with the sponsor. Management or elimination of conflicts of interest may include but are not limited to:
• Withdrawal of proposal
• Non-acceptance of the gift or grant
• Notice to students and other project personnel of Investigator’s conflicting interests
• Appointment of additional, non-conflicted student advisors
• Public disclosure of the related financial interest
• Monitoring of the project by independent reviewers
• Modification of the research or project plan
• Disqualification from participation in all or a portion of the project
• Divestiture of the related financial interest(s)
• Severance of relationships that create actual or potential conflicts Confidentiality
The details of personal financial interests reported to SAC are treated sensitively and shared only on a need to know basis within the Institute. The decision of the Conflict of Interest Committee may be shared with board members and management staff as deemed necessary. In cases relating to projects involving human subjects, the recommendation will be shared with the IRB. It may also be shared with the research sponsor if requested. Other than these mandated disclosures or limited internal disclosures, the information is treated as confidential. However, under California law and PHS regulations, information disclosed to SAC must be made available to the public upon request. Public Access to Information
The institution must make certain FCOI information for senior/key personnel available within five business days of the request. The response must be postmarked or dated (if replying by electronic means) within five days of receipt of a written request. All written requests must be sent to the COI Office at firstname.lastname@example.org.
All information provided as a result of such requests will be current as of the date of the correspondence to the requester and will be updated at least annually and within 60 days of any subsequent request. Any information in such requests which falls outside of the 2011 regulations will be responded to in accordance with the requirements of the California Public Records Act. Maintenance of Records
SAC will maintain all FCOI-related 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, for at least three (3) years from the date the final expenditures report is submitted to the PHS (NIH), or where applicable, from other dates specified in 45 CFR 75.361 for different situations.
PHS OnlyInstitutional Reporting to NIH
The institution must determine if any disclosed SFI is related to the PHS-funded research and, if so, whether that SFI rises to the level of a Financial Conflict of Interest (FCOI). If such a determination is made, the institution must report the FCOI to NIH, along with details about the SFI and its management. The regulation also now requires that the public be provided, upon request, certain details of the SFI as reported to NIH. Retrospective Review
In cases of non-compliance, a retrospective review is required for later determined financial conflicts of interest. The review is not required to be submitted to the PHS Awarding Component unless bias is found.