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Financial Disclosures Saint Luke’s Health System Financial Conflict of Interest in Research Policy

Financial Disclosures Saint Luke’s Health System Financial Conflict of Interest in Research Policy. Changes in Reporting. Mandatory COI training Lower threshold for disclosure Required annual disclosure (and amended disclosure if changes occur) Mandatory disclosure of funded travel.

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Financial Disclosures Saint Luke’s Health System Financial Conflict of Interest in Research Policy

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  1. Financial DisclosuresSaint Luke’s Health System Financial Conflict of Interest in Research Policy

  2. Changes in Reporting • Mandatory COI training • Lower threshold for disclosure • Required annual disclosure (and amended disclosure if changes occur) • Mandatory disclosure of funded travel

  3. Mandatory COI Training • All investigators must complete conflict of interest course at www.citiprogram.org • Other CITI courses (research with human subjects, GCP) are different from the COI course.

  4. Lower Threshold for Disclosure Aggregate income or holdings in excess of $5,000 from a publicly-traded or non-publicly traded entity paid to the investigator, his/her spouse or dependent children must be disclosed.

  5. Travel Disclosure • Reimbursed or sponsored travel must be promptly disclosed (even if the $$ amount is unknown). • Exceptions are made for reimbursement by a government agency, a U.S. institution of higher education or an affiliated research institute.

  6. To whom does the new FCOI policy apply? Principal Investigators, sub-Investigators and other key individuals engaged in the design, conduct or reporting of research. This includes study coordinators.

  7. Recipients of PHS funding for research must report financial interests regardless of whether their research involves human subjects.

  8. How do I report financial interests? • Go to the Saint Luke’s Health System website: www.saintlukeshealthsystem.org • Click on ‘My Saint Luke’s’ (top of page) • Create an account by registering under ‘Sign up now to get started.’ (Your username is your e-mail address.)

  9. On the left-hand side, under SLHS Researchers, click on ‘SLHS Financial Conflict of Interest in Research Policy’ • Read the policy • Once you have read the policy, hit the ‘Back’ arrow to return to your ‘My Saint Luke’s’ page. • Click on Financial Disclosure Form

  10. Follow the instructions at the beginning for completing the form. A drop-down list is provided under ‘Company’. Select one. A separate form must be completed for each entity in which you hold financial interest. • Click on ‘Submit’ at the bottom of the page. • A new form will then appear for disclosing interest in another company.

  11. If you have no financial interests, check the box, ‘I do not have any financial interests to disclose.’ • Click on ‘Submit’ at the bottom of the page.

  12. What if the company with which I have financial interest is not on the list of choices? • To add a company name to the list, email webmaster@saint-lukes.org • Once the company name is added, you can go back in and complete the disclosure for that company.

  13. What if I acquire financial interest after completing the disclosure? You are required to update your financial disclosure information yearly or sooner if you have any change in financial holdings or fiduciary interest in a company. To make a change, login using the same process and complete a new form.

  14. Will the disclosed information be made public in any way? There is no plan to make disclosures public. The FCOI Committee and any other employees who might have access to the information will keep your information confidential.

  15. Am I required to report funds received that are deposited to a SLH Foundation research account? Disclosure of payments made to SLH or a SLH Foundation account do not have to be reported. However, payments made directly to an investigator and then turned over to SLH or SLH Foundation to support future research activities must be reported.

  16. Do I need to complete a disclosure form for each IRB submission? No. The new policy requires investigators to complete financial disclosure(s) once per year. If your Financial Interest changes during the year, you are required to update your disclosure form within 30 days of acquiring new financial interests.

  17. Disclosing financial interest does not necessarily preclude investigators from participating in research or receiving research funding. • Not disclosing financial interest can have serious consequences for both the investigator and Saint Luke’s research program.

  18. If you have questions, you may contact: Ellen McDowell, Central Office for Research Administration, emcdowell@saint-lukes.org 816-932-2288 or Marilyn Horn, Institutional Review Board Office, mhorn@saint-lukes.org 816-932-3661

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