Financial Conflicts of Interest
The procedures described in this policy were created and designed primarily to comply with the specific regulatory requirements for U.S. Public Health Service (PHS)-sponsored research but are also intended to provide a basic framework and standards for identifying, evaluating, and managing potential financial conflicts of interest relating to CairnSurgical’s other research activities. For non-PHS research, the specific steps, timing, determinations, documentation, and notifications may be tailored as appropriate but will remain focused on maintaining CairnSurgical high standards for research integrity and effectively eliminating or managing actual or potential financial conflicts of interest.
These regulations do not cover Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) Program Phase 1 applications or awards but do apply to applicants and recipients under the SBIR/STTR Program Phase II. SBIR is the extramural research program for small business that was established by the Awarding Components of PHS and certain other Federal agencies under Pub. L. 97-219, the Small Business Innovation Development Act, as amended. The term SBIR Program includes the STTR Program, which was established by Pub. L. 102-564.
- With regard to interests in any publicly traded entity, a financial interest consisting of any remuneration received from the entity in the 12 months preceding the disclosure and any equity interest (e.g., stock, stock option, or other ownership interest) in the entity as of the date of disclosure, in which the value when aggregated exceeds $5,000;
- With regard to interests in any non-publicly traded entity, a financial interest consisting of any remuneration received from the entity in the 12 months preceding the disclosure, in which the value when aggregated exceeds $5,000, or when the Investigator or his/her immediate family holds any equity interest (e.g., stock, stock option, or other ownership interest); or
- Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
- Salary, royalties, or other remuneration paid by CairnSurgical (or a subrecipient as applicable) to the Investigator if the Investigator is currently employed or otherwise appointed by CairnSurgical including that paid for intellectual property rights assigned or licensed to CairnSurgical and agreements to share in royalties related to such rights;
- Any ownership interest in CairnSurgical (or a subrecipient as applicable) held by the Investigator (e.g., Employee Stock Ownership Plan);
- Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;
- Income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency; an institution of higher education as defined at 20 U.S.C. 1001(a); an academic teaching hospital; a medical center; or a research institute that is affiliated with an institution of higher education; or
- Income from service on advisory committees or review panels for a Federal, state, or local government agency; an institution of higher education as defined at 20 U.S.C. 1001(a); an academic teaching hospital; a medical center; or a research institute that is affiliated with an institution of higher education.
- Informing CairnSurgical Investigators of their obligations under this policy and any related regulations;
- Reviewing disclosures of significant financial interest with CairnSurgical’s Administrator 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, CairnSurgical’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; and
- Reporting and disclosure as required under this policy and applicable regulations.
- Taking reasonable steps to ensure that Investigators for subrecipients (e.g., subgrantees, subcontractors, or collaborators) fully comply with this policy or provide CairnSurgical with sufficient assurances to enable CairnSurgical’s compliance with all applicable laws or regulations. To this end, the written agreement between CairnSurgical and the subrecipient will specify whether CairnSurgical 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 CairnSurgical s policy and the applicable regulations (absent such certification, CairnSurgical’s policy will apply to the subrecipient’s Investigators, and
- Establish time periods for subrecipient reporting of financial conflicts of interest to CairnSurgical that enable CairnSurgical to report such conflicts in a timely manner, as required under its policy and the applicable regulations.
If CairnSurgical’s policy will apply to the subrecipient Investigators, CairnSurgical will be responsible for meeting the requirements of this policy and the reporting obligations reflected in the applicable regulations.
Investigators are expected to submit an updated SFID Form during the period of the award as necessary (at least annually for PHS-funded research). The annual update will typically be done in conjunction with completion of the annual training. 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).
- Disclosure to research participants or the public of significant financial interests (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; or
- Severance of relationships that create actual or potential conflicts.
In addition to the conditions or restrictions described above, CairnSurgical may require the management of conflicting financial interests in other ways as it deems appropriate.
If a financial conflict of interest is identified after its initial reporting and during ongoing research (e.g., through participation of a new Investigator) and has not been eliminated, CairnSurgical will provide the PHS Awarding Component with an update within 60 days and ensure that it has implemented a plan to manage the conflict. If the financial conflicts of interest report involves a significant financial interest that was not disclosed by an Investigator or not previously reviewed or managed by CairnSurgical (e.g., not reviewed or reported by a subrecipient in a timely manner), CairnSurgical 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, CairnSurgical will promptly notify the PHS Awarding Component and submit a mitigation report. Upon request, CairnSurgical will provide HHS with information relating to any Investigator disclosure of significant financial interests; CairnSurgical
CairnSurgical will, to the extent possible, protect the confidentiality of disclosures. In every instance, CairnSurgical 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 CairnSurgical staff only on a need-to-know basis and will not be disclosed outside of CairnSurgical unless necessary to comply with contractual, legal, or regulatory requirements.
- If the Investigator’s failure to comply with this policy or a financial conflicts of interest management plan has biased the design, conduct, or reporting of the PHS-funded research, CairnSurgical shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken;
- CairnSurgical will make available to HHS all records pertinent to financial conflicts of interest and the management of those conflicts; and
- If HHS determines that a clinical PHS-funded research project whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a financial conflict of interest that was neither disclosed nor managed, CairnSurgical 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.
- CairnSurgical revises its financial conflicts of interest policy or procedures in any manner that affects the Investigator’s obligations;
- An Investigator is new to CairnSurgical; or
- CairnSurgical finds that an Investigator is not in compliance with this policy or a financial conflicts of interest management plan.
The Designated Official will retain financial conflicts of interest disclosure forms and other supporting information consistent with CairnSurgical 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 CairnSurgical with respect to each financial conflict of interest 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.