Designated Official Responsibilities
The Designated Official or his/her designee shall be responsible for the following:
- Informing Applikate Investigators of their obligations under this policy and any related regulations.
- Reviewing disclosures of significant financial interest to determine whether they are related to the subject research and, if so, whether they constitute financial conflicts of interest.
- Screening and managing potential financial conflicts of interest.
- Maintaining all records relating to disclosures of financial interests, Applikate’s review of and response to such disclosures, and any related actions under this policy.
- Ensuring inclusion of any required certifications in applications for funding or contract proposals.
- Reporting and disclosure as required under this policy and applicable regulations.
For PHS-funded research, the Designated Official shall also have the following responsibility:
Taking reasonable steps to ensure that Investigators for subrecipients (e.g., subgrantees, subcontractors, or collaborators) fully comply with this policy or provide Applikate with sufficient assurances to enable Applikate’s compliance with all applicable laws or regulations. To this end, the written agreement between Applikate and the subrecipient will specify whether Applikate’s or the subrecipient’s financial conflicts of interest policy will apply to the subrecipient’s Investigators and, if the subrecipient’s policy will apply, the Designated Official will:
- Obtain certification from the subrecipient that its policy complies with Applikate’s policy and the applicable regulations (absent such certification, Applikate’s policy will apply to the subrecipient’s Investigators.
- Establish time periods for subrecipient reporting of financial conflicts of interest to Applikate that enable Applikate to report such conflicts in a timely manner, as required under its policy and the applicable regulations.
If Applikate’s policy will apply to the subrecipient Investigators, Applikate will be responsible for meeting the requirements of this policy and the reporting obligations reflected in the applicable regulations.
Internal Reporting Requirements
For PHS-funded research in particular, as part of the funding application or proposal and prior to performing any work on the research, each Investigator who is planning to participate in the research is required by regulation to disclose to Applikate’s Designated Official an up-to-date listing of their SFIs (and those of their spouse and dependent children), as defined above. This requirement also applies to Investigators who are or who work for subgrantees, subcontractors, or collaborators on PHS-funded research. The information reported to the Designated Official includes a listing of the Investigator’s known SFIs and those of his/her immediate family that reasonably appear to be related to the research or that are in entities whose financial interests could be affected by the research.
Applikate Investigators in non-PHS-funded research who have any SFI that may reasonably appear to be affected by the research are also expected to submit disclosures to Applikate’s Designated Official.
Investigators are expected to submit an updated SFI disclosure during the period of the award as necessary (at least annually for PHS-funded research). Such disclosures shall include any information that was not previously disclosed; any change in information regarding any previously disclosed significant financial interest; or, within 30 days of discovery or acquisition, any new significant financial interest (e.g., an interest acquired through purchase, marriage, or inheritance).
For Investigators who are senior officers within Applikate (e.g. CEO, co-CEO, CSO, CTO, CMO, the Designated Official, etc.), review of SFI will be conducted by the Applikate Board of Directors.
Determination and Management of Financial Conflicts of Interest
Upon receipt of a SFI disclosure, the Designated Official shall determine whether an Investigator’s SFI is related to the subject research and, if so, whether the interest constitutes a FCOI under this policy and any applicable regulations. The Investigator may be required to submit additional information as part of the process. A disclosed interest may be related to the subject research either because the interest could be affected by the research or because it is in an entity whose financial interest could be affected by the research. A FCOI exists if the significant financial interest could directly and significantly affect the design, conduct, or reporting of the research.
If Applikate determines that a FCOI exists, a FCOI management plan will be implemented and monitored on an ongoing basis. The management plan will include appropriate steps to manage, reduce, or eliminate the conflict. The following are examples of conditions or restrictions that might be imposed:
- Disclosure to research participants or the public of SFIs (e.g., when presenting or publishing the research).
- Monitoring of research by independent reviewers.
- Modification of the research plan.
- Disqualification of staff from participation in all or a portion of the research.
- Reduction or divestiture of a financial interest.
- Severance of relationships that create actual or potential conflicts.
In addition to the conditions or restrictions described above, Applikate may require the management of conflicting financial interests in other ways as it deems appropriate.
External Reporting Requirements
Applikate will disclose FCOI as required by applicable laws or regulations. Before expending any funds under a PHS award, Applikate will ensure public accessibility by posting FCOI information on a publicly available web site or by responding in a timely manner to written requests as required under the regulations. The Designated Official will also report to the PHS Awarding Component, as detailed in the regulations, the existence of any FCOI that has not been eliminated and will ensure that Applikate has implemented a plan to manage the conflict.
If a FCOI is identified after its initial reporting and during ongoing research (e.g., through participation of a new Investigator) and has not been eliminated, Applikate will provide the PHS Awarding Component with an update within 60 days and ensure that it has implemented a plan to manage the conflict.
Upon request Applikate will provide HHS with information relating to any Investigator disclosure of SFI; Applikate’s review of, and response to, such disclosure; and whether the disclosure resulted in Applikate’s determination of a FCOI.
The information that Applikate will make available in a written response to any requestor within five days of request will include, at a minimum, the following:
- The Investigator’s name.
- The Investigator’s title and role with respect to the research project.
- The name of the entity in which the SFI is held.
- The nature of the SFI.
- The approximate dollar value of the SFI in the following ranges: $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.
If the FCOI report involves a SFI that was not disclosed by an Investigator or not previously reviewed or managed by Applikate (e.g., not reviewed or reported by a subrecipient in a timely manner), Applikate will undertake a retrospective review. Such retrospective review will determine whether there was bias in the design, conduct, or reporting of the PHS-funded research, or portion thereof, conducted prior to the identification and management of the conflict. If bias is found, Applikate will promptly notify the PHS Awarding Component and submit a mitigation report. The retrospective review will include:
- Project Number
- Project Title
- Primary Investigator(s)
- Name of Investigator with the FCOI
- Name of the entity with which the Investigator has an FCOI
- Reasons for the retrospective review
- Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documentation reviewed)
- Finding for the review
- Conclusions of the review
Confidentiality
Applikate will, to the extent possible, protect the confidentiality of disclosures. In every instance, Applikate will endeavor to balance the privacy interests of individuals with its responsibility and obligation to identify and manage conflicts of interest. Disclosures will be available to Applikate staff only on a need-to-know basis and will not be disclosed outside of Applikate unless necessary to comply with contractual, legal, or regulatory requirements.
Investigator Noncompliance
If an Investigator knowingly fails to comply with this policy (e.g., fails to identify an actual or potential FCOI), Applikate may take appropriate disciplinary action, which may include, without limitation, termination of the Investigator’s participation in the research. In addition, for PHS-funded research, failure to comply with this policy or the applicable regulations shall result in the following:
- If the Investigator’s failure to comply with this policy or a FCOI management plan has biased the design, conduct, or reporting of the PHS-funded research, Applikate shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken.
- Applikate will make available to HHS all records pertinent to financial conflicts of interest and the management of those conflicts.
- If HHS determines that a clinical PHS-funded research project whose purpose is to evaluate the safety or effectiveness of a medical device has been designed, conducted, or reported by an Investigator with a FCOI that was neither disclosed nor managed, Applikate shall require disclosure of the conflicting interest in each public presentation of the results of the research and shall request an addendum to previously published presentations, if necessary.
Training and Education
Investigators receive training to promote objectivity in research and to ensure Investigator compliance with regard to the applicable regulations and SFI disclosure obligations. The training module and other resources developed by NIH will be updated as appropriate and can be accessed through the NIH Web site (https://grants.nih.gov/grants/policy/coi/fcoi-training.htm). Investigators are required to submit an electronic copy of the certificate of completion of training from the NIH web site to the Designated Official.
Applikate requires Investigators to complete such training at least once every 4 years, and when any of the following occurs:
- Applikate revises its financial conflicts of interest policy or procedures in any manner that affects the Investigator’s obligations.
- An Investigator is new to Applikate.
- Applikate finds that an Investigator is not in compliance with this policy or a financial conflicts of interest management plan.
Retention of Records
The Designated Official will retain financial conflicts of interest disclosure forms and other supporting information consistent with Applikate’s Record Retention policy. For PHS-funded research, records of all financial disclosures, whether or not they result in a reporting obligation, and all actions taken by Applikate with respect to each FCOI will be retained for at least 3 years from the date of submission of the final expenditures report or final payment on the contract or, where applicable, from other dates specified in 45 CFR 74.53(b) or 48 CFR Part 4, Subpart 4.7.
