Financial Conflict of Interest in Research Policy

Purpose:

InnoTech and all Investigators1 employed at or with sponsorship by InnoTech must conduct their business free of inappropriate influence from outside institutional financial relationships, and conserve the integrity of research free of bias. The purpose of this Financial Conflict of Interest (FCOI)2, 3 in Research is to identify, manage, mitigate and resolve conflicts of interest that have the potential to directly and significantly compromise an Investigator’s objectivity and judgement in the design, execution, or reporting of research.
InnoTech Investigators who engage in research and development projects that are funded by the Public Health Services (PHS) must comply with applicable FCOI regulations policies 42 CFR Part 50 Subpart F and NIH’s Office of Extramural Research (OER), Financial Conflict of Interest guidelines.

  1. Training:
    1. InnoTech maintains an up-to-date, written and enforced policy of financial conflicts of interest that complies with Public Health Service (PHS) policies 42 CFR Part 50 Subpart F and based on NIH’s Office of Extramural Research (OER), Financial Conflict of Interest
    2. InnoTech from time to time, will revise its financial conflict of interest policies or procedures as per any new rules and regulations that will be implemented by the HHS.
    3. All InnoTech’s new employees will be provided with an electronic copy of InnoTech’s policy on FCOI. They are required to:
      1. Review the InnoTech’s FCOI policy;
      2. Take the CTI course entitled NIH/PHS Conflict of Interest Course;
      3. Provide certificate of completion as part of their onboarding to InnoTech’s designated institutional official.
    4. All Investigators who participate or plan to participate in PHS-funded research are required
      to complete conflict of interest training that is mandatory by the awarding agency and
      provide documentation of the successful completion of the training:

      1. Prior to engaging in PHS-funded research;
      2. At least every four years following the initial training;
      3. At any time that there is a change in policy;
      4. When the institution finds an Investigator is not in compliance with the policy or a
        management plan.

2. Disclosure, Review and Monitoring

  1. InnoTech’s Chief Technology Officer is the designated institutional official to solicit and review disclosures of FCOI and SFI from each Investigator and those of their spouse and dependent children that is related to an Investigator’s responsibilities at InnoTech and PHS-funded programs.
  2. InnoTech’s Chief Technology officer with the Investigator will review and determine if the Investigator’s SFI is reasonably related to PHS-funded research and if it is related, whether it is FCOI.
  3. Each Investigator who is planning to participate in the PHS-funded research is required to disclose to the InnoTech’s designated official any significant financial interests (SFI)4 that the Investigator, her/his/its spouse and dependent children have:
    1. Prior to the time of application for funding;
    2. At least annually during the award period for updating the initial SFI, including updated value, or any FCOI that was not originally reported or was transferred from another institution;
    3. Within 30 days of discovering or acquiring (i.e., through purchase, marriage, or inheritance);
    4. Any sponsored travel within the previous 12 months.
  4. Prior to expenditure of any PHS funds, InnoTech in consultation with the Investigator will determine:
    1. Whether any SFI disclosure is related to the research funded by PHS;
    2. If the SFI is related to the research funded by PHS, InnoTech will determine whether it constitutes a FCOI.
    3. In case of an FCOI, InnoTech will determine how to manage and resolve the FCOI within sixty days of the identification of an SFI that was not disclosed timely, or was not reviewed by the institution previously.
    4. Such management plan of FCOI could include:
      1. Public disclosure of FCOI when presenting or publishing the research;
      2. Appointment of an independent monitor who can protect the design, execution and reporting of the research against potential bias that could result from the FCOI;
      3. Modification of research plan;
      4. Creation of a firewall between the Investigator and the PHS-funded research through change of Investigator’s responsibilities, or change of Investigator;
      5. Elimination or reduction in the financial interest (i.e., sale of equity);
      6. InnoTech’s designated financial officer will Monitor the Investigator’s compliance with the management plans until completion of the project.
  5. For any FCOI that is identified during a PHS-funded research program, InnoTech will:
    1. Within 60 days from the date of the disclosure, determine if the disclosure is related to the Investigator’s PHS-funded research;
    2. If it is related, then InnoTech will determine if it is an FCOI;
    3. If it is an FCOI, InnoTech will implement a formal management plan same as 2c(iv) above for the duration of the PHS funding.
  6. For any FCOI that is identified late, due to failure of Investigator to timely disclose the SFI that is then determined to be FCOI, failure of InnoTech to review and manage such FCOI, or non-compliance of a management plan for an FCOI by an Investigator:
  7. InnoTech will review and make its determination of noncompliance within 120 days
  8. Complete a retrospective review of the activities of the Investigator on the PHS-funded research
  9. Determine whether there was a bias in design, execution or reporting of PHS-funded research during the non-compliance time
  10. InnoTech will document the retrospective review with the following information included:
    1. Project number and title;
    2. Principal Investigator or Project Directors;
    3. Investigator resulting in the FCOI and their affiliation(s);
    4. Reason for conducting the retrospective review;
    5. Detailed description of how the retrospective review was conducted;
    6. Findings and conclusions of the retrospective review.
  11. In case of finding of a bias, InnoTech will promptly inform the PHS awarding agency and promptly develop and implement a mitigation plan and report such plan to PHS. The report will include:
    1. Key points documented in the retrospective review;
    2. Description of the bias and its impact on the PHS-funded project;
    3. Corrective action plan taken to mitigate or eliminate the effect of the bias.

3. Reporting Requirements to PHS-funding agency:

  1. InnoTech’s designated institutional official will send initial, annual, and revised FCOI reports for InnoTech and subrecipients, if applicable, to the NIH via ecommons. These reports will be sent to PHS-funding agency/NIH
    1. Prior to the expenditure of funds;
    2. Within 60 days of identification of FCOI for a new participant in the project;
    3. Within 60 days of identification of a new FCOI for existing Investigators;
    4. An update of FCOIs, at the time of submission of annual progress report, multiyear progress report or at time of extension of the project;
    5. After completion of a retrospective review;
    6. In case of identification of a bias, InnoTech will promptly inform the PHS funding agency as described in 2.K. above. InnoTech will include the mitigation report;
    7. In case the Investigator fails to comply with InnoTech’s FCOI management plan;
    8. In case where a FCOI management plan seems to have biased the design, execution, or reporting of the PHS-funded research.

4. Maintenance of Records:

  1. InnoTech will maintain all FCOI-related records pertaining Investigator trainings, disclosures of financial interests, the institution’s review and response to each disclosure and all management and mitigation actions, any retrospective review and mitigation actions for three years from the date of the submission of final expenditure report to PHS/NIH.
  2. In case of any claim, financial management review, audit or litigation that is initiated prior to the expiration of the three-year period, the records will be retained until all such actions have been resolved and final action taken.

5. Enforcement Mechanisms and Remedies for Noncompliance:

  1. In the event of a non-compliance with the financial conflict of interest, the management plan, or corrective actions by the Investigator, InnoTech will take disciplinary actions/sanctions, including, but not limited to, a reprimand; a period of suspension with or without pay; a salary reduction.
  2. InnoTech will complete, document and report retrospective reviews and any corrective actions within 120 days of:
    1. To disclose the FCOI in each public presentation and publication of the results of the research;
    2. To amend any previously presentations and publications with the disclosure of FCOI.
    3. determination of non-compliance for SFIs that have not been disclosed in a timely manner;
    4. have not been previously reviewed;
    5. or in case of an FCOI that is not identified or managed on time.
  3. In the event that Department of Health and Human Services determines establishes that a PHS-funded research project involving evaluation of safety and/or effectiveness of a drug, treatment or a medical device has been conducted in the absence of a managed and reported FCOI, InnoTech will require the involved Investigator:

6. Subrecipient Requirements:

  1. InnoTech will incorporate as part of a written agreement with any subrecipient, subcontractor, or consortium members that the FCOI policy of InnoTech or that of the subrecipient will apply to their Investigators.
    1. In the event that the subrecipient’s Investigator must comply with the subrecipient’s FCOI policy, InnoTech will require the subrecipient to certify that as part of the agreement the policy complies with 42 CFR Part 50 Subpart F.
    2. In the event that the subrecipient’s Investigator are subject to the financial conflicts of interest of InnoTech, the agreement will specify the time period(s) for subrecipient to report all identified financial conflicts of interest to InnoTech. The time period needs to provide sufficient time for InnoTech to report financial conflict
      of interest to PHS.
    3. If applicable, the written agreement will include a requirement to solicit and review subrecipient Investigator’s disclosures by InnoTech so that InnoTech can identify, manage and report identification of FCOI to PHS.
    4. In case of the determination of a financial conflict of interest by any InnoTech Investigator or that of a subrecipient Investigator, InnoTech will develop and implement a management plan. If needed, a review of the financial conflicts of interest will be done retrospectively and a mitigation report will be provided.

7. Public Accessibility Requirements:

  1. InnoTech maintains an up-to-date, written and enforced policy of financial conflicts of interest that complies with Public Health Service (PHS) policies 42 CFR Part 50 Subpart F and based on NIH’s Office of Extramural Research (OER), Financial Conflict of Interest guidelines.
  2. In the event of the request for InnoTech’s policy on financial conflict of interest, InnoTech will make its written policy available within 5 days to the requestor.
  3. InnoTech will make its FCOI policy available on its website within 30 calendar days of its presence on a publicly available web site.
  4. In the case of the identification of FCOIs held by senior or key personnel, such FCOI will be publicly accessible prior to the expenditure of the funds. The information will
    1. Become available within 5 calendar days of a written request with any initial and updated information;
    2. Posted publicly, when InnoTech launches its website
    3. Be updated, on the website, at least annually
    4. Be updated within 60 days of the identification of any new FCOI on the website.
      For the written request, such information will be provided within 5 days of the written request.
    5. Be available for three years from the date that the FCOI was last updated.