FCOI GUIDELINES

This process covers SIBCR administered research sponsored by Public Health Service (PHS) grants and contracts and any subawards and subcontracts issued by SIBCR in support of PHS-funded research projects. These requirements are effective as of August 24, 2012 and are promulgated by the 2011 revised Financial Conflict of Interest (FCOI) regulation, Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 CFR Part 50, Subpart F) and Responsible Prospective Contractors (45 CFR Part 94).

Principal Investigators and other key personnel who meet the definition of “Investigator” must complete the training and meet the disclosure requirements by the timelines indicated below.

It is the responsibility of the Principal Investigator to identify Investigators for each PHS award.

Definitions may be found in the beginning of SIBCR’s FCOI Policy.

SIBCR is available to provide personalized guidance for any questions Investigators may have on the FCOI guidelines.

 

TRAINING

For ongoing projects, training must be completed by the issue date of the first Notice of Award after August 23, 2012. Thereafter, the requirements listed below apply.

Prior to engaging in PHS-funded research and no less often than every four years, all PHS-funded Investigators must complete training with respect to the SIBCR FCOI policy and the current PHS FCOI rules and regulations. Additionally, PHS Investigators shall complete training whenever:

  • SIBCR revises its FCOI policies or procedures in any manner that affects the requirements of Investigators;
  • An Investigator is new to SIBCR; or
  • SIBCR finds that an Investigator is not in compliance with SIBCR’s FCOI policy or management plan.

The training may be completed at any time, but must be completed in accordance with the deadlines indicated above. Investigators must certify that they have completed the training by signing a certification page and sending it back to SIBCR via email to spo@sibcr.org.

 

DISCLOSURE, REVIEW AND MONITORING

SIBCR’s Significant Financial Interest (SFI) Disclosure Form is found here. An Investigator should email the completed form to their grant administrator or to spo@sibcr.org. For confidential information, the form may be sent in an envelope marked ‘Confidential’ to the SIBCR Executive Director.

In accordance with the regulation, disclosures are required at the following times:

  • At the time of application for PHS-funding;
  • At least annually during the period of award;
  • Within 30 days of acquiring or learning of a newly acquired significant financial interest; and
  • Within 30 days of an Investigator newly participating in the project.

Acknowledging that Investigators often participate in multiple projects or applications, once an Investigator has completed and signed a disclosure, SIBCR will accept an email confirmation that the prior disclosure is accurate and remains in effect to meet subsequent disclosure requirements for the next 12 months.  Beyond 12 months or if a new disclosure must be filed for any reason (e.g., a change in institutional responsibilities or Investigator SFIs) the above guidelines apply.

The existence of an SFI related to an Investigator’s institutional responsibilities does not automatically create an FCOI. Whenever there is a significant financial interest, disclosures must be submitted by Investigators to SIBCR. SIBCR will refer disclosures that meet the definition of significant financial interests and are related to institutional duties to the Conflict of Interest Subcommittee for review.

The COI Subcommittee consists of five voting and one non-voting member:

  • A representative of the management of SIBCR;
  • An attorney of the VA Office of General Counsel;
  • A representative of the UW’s Office of the Associate Vice Provost for Research; and
  • Two experienced clinical or biomedical research scientists not currently serving on the R&D Committee; and
  • The Associate Chief of Staff for R&D is an ex officio/non-voting member.

The COI Subcommittee reviews related SFI disclosures, determines if an SFI constitutes an FCOI and recommends management plans in accordance with the federal regulations.  For VA Investigators, the COI Subcommittee relies on, among other rules, federal guidelines contained in 5 CFR Part 2635 and 18 USC §208.

All SFI Disclosures must include sufficient information to enable the COI Subcommittee to understand the nature and extent of the SFI and to assess the appropriateness of a management plan.

Further information may be required to assess the disclosure or report any conflict. The following information will be required for review:

  • Project number;
  • PD/PI or Contact PD/PI if a multiple PD/PI model is used;
  • Name of the Investigator with the SFI;
  • Name of the entity with which the Investigator has an SFI;
  • Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium);
  • 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; and
  • A description of how the financial interest relates to institutional responsibilities.

All records relating to the disclosure of financial interests and any action taken with respect thereto will be maintained for at least three years or as required by applicable government regulations, whichever is longer.

In accordance with PHS policy, SIBCR makes identified FCOIs held by Investigators available to requesters within five calendar days of the receipt date of written requests.  Please review the FCOI policy in its entirety.

 

TRAVEL DISCLOSURES

All sponsored and reimbursed travel for PHS-funded Investigators must be disclosed using the SFI Disclosure Form.

The timing of travel disclosures shall be as follows:

  • At the time of application for PHS-funded research, all sponsored travel and reimbursed travel occurring in the preceding months shall be disclosed; and
  • Thereafter, during the course of the Investigator’s participation in PHS-funded research:
    • No more than 30 days after the occurrence of any sponsored or reimbursed travel; and
    • Annually as part of the SFI disclosure process.

Travel disclosures may be completed prior to the trip.

Travel that is sponsored or reimbursed by the following types of domestic U.S. entities is exempt from disclosure:

  • 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.

SIBCR will perform an internal review of travel disclosures upon submission of the SFI Disclosure Form. If recommended for further review, travel disclosure(s) will be sent to the COI Subcommittee.

Travel disclosures by PHS-funded Investigators must include the following information:

  • The purpose of the trip;
  • The identity of the sponsor/organizer;
  • The destination;
  • The duration;
  • The inclusion of a spouse or dependent child; and
  • An estimate of the approximate value of the travel.

 

REPORTING

SIBCR is responsible for reporting FCOIs in accordance with applicable federal requirements. Reports must include an assurance to the PHS agency that SIBCR has implemented an appropriate Conflict Management Plan. If requested, SIBCR may also report the details of the Plan.

SIBCR submits FCOI reports to the PHS awarding component at the following times:

  • Prior to expending funds on a newly awarded PHS-research project;
  • Within 60 days of identification of the FCOI for ongoing studies; and
  • Annually for any previously reported FCOIs.

If SIBCR identifies a previously unreported SFI and it is determined that an FCOI related to an ongoing PHS-funded research project exists, SIBCR and the COI Subcommittee are required to implement an appropriate Conflict Management Plan within 60 days of identifying this interest and provide the PHS awarding component with an FCOI report.

FCOI reports must include sufficient information to enable the PHS awarding component to understand the nature and extent of the FCOI and to assess the appropriateness of the Conflict Management Plan. As required by the regulation, the FCOI report must include at a minimum the following information:

  • Project number;
  • Principal Investigator;
  • Name of the Investigator with the FCOI;
  • Name of the entity with which the Investigator has an FCOI;
  • Nature of the Financial Interest (e.g., Compensation, Equity, Intellectual Property, Consulting Fees, Sponsored or Reimbursed Travel);
  • Value of the Financial Interest (dollar ranges are acceptable);
  • Description of how the FCOI relates to the PHS-Funded Research and the basis for SIBCR’s determination that it is an FCOI; and
  • Description of the key elements of SIBCR’s Conflict Management Plan, including:
    • Role and principal duties of the conflicted Investigator;
    • Conditions of the Conflict Management Plan;
    • How the Conflict Management Plan is designed to safeguard objectivity in the research project; and
    • How the Conflict Management Plan will be monitored to ensure Investigator compliance; and
    • Other information as needed, including information regarding the FCOIs of all subrecipient Investigators.

In cases in which SIBCR and the COI Subcommittee identify a financial conflict of interest and eliminate it prior to the expenditure of PHS-awarded funds, SIBCR is not required to submit an FCOI report to the PHS awarding component under the federal regulation.

 

RETROSPECTIVE REVIEWS AND MITIGATION PLANS

If an FCOI is not identified or managed in a timely manner due to non-compliance by the Investigator or SIBCR, SIBCR and the COI Subcommittee are required to, within 120 days from the date the non-compliance was identified, complete a retrospective review of the Investigator’s activities and the research project and make a reasonable determination whether there was any bias in the design, conduct or reporting of the research resulting from the FCOI.

In accordance with the regulation, the COI Subcommittee and SIBCR shall document all retrospective reviews, including:

  • PHS project number;
  • Project title;
  • Principal Investigator;
  • Name of the Investigator with the FCOI;
  • Name of the entity in which the Investigator has an FCOI;
  • The reasons for the retrospective review;
  • A detailed description of the methodology used for the retrospective review; and
  • The findings and conclusions of the review.

After the retrospective review, if necessary, an SIBCR Institutional Official is required to report the actions that will be taken to manage the FCOI going forward. If bias in PHS-funded research is identified in the course of a retrospective review, the SIBCR Institutional Official is required to submit a mitigation plan to the PHS funding agency.

In accordance with the regulation, the mitigation plan must include, at a minimum, the following items:

  • Key elements documented in the retrospective review;
  • A description of any impact of the bias on the research; and
  • A plan to mitigate the effect of the bias.

With respect to PHS-funded research for which a mitigation plan has been submitted, SIBCR will provide annual FCOI reports addressing the status of the identified FCOI and any changes to the Conflict Management Plan for the duration of the PHS-funded research.

 

SUBRECIPIENTS

SIBCR subrecipients funded from PHS agency awards shall provide appropriate assurances to SIBCR that policies and procedures no less stringent than the 2011 DHHS regulation exist and are enforced prior to submission of research proposals and execution of subawards.

SIBCR takes reasonable steps to confirm that all Investigators employed by subrecipients, contractors, subcontractors and other collaborators participating in research as investigators are subject to conflict of interest rules and procedures that are no less stringent than these regulations.

If SIBCR allows subrecipient researchers to comply with SIBCR’s FCOI policy or the Federal Demonstration Partnership Model Policy (www.thefdp.org), SIBCR will specify the time period by which subrecipients must submit subrecipient Investigator SFI disclosures. The time period will be sufficient to enable SIBCR and the COI Subcommittee to perform the review, management and reporting required by these regulations.