Changes in Reporting

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 Conflict of Interest Training • All investigators must complete the Conflict of Interest (COI) course at www.citiprogram.org • Other CITI courses (Human Subject Research, Good Clinical Practice) 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.’ (username is e-mail address.)

9. Click on the Clinical Research tab • On the left hand side, click on ‘Resources for Investigators – Forms & Documents • Scroll to the bottom of the page and click on ‘SLHS Financial Conflict of Interest Form’ • Before completing the form: In the first paragraph, click on SLHS Financial Conflict of Interest in Research Policy ADM 015’ to read the policy • Hit the ‘Back’ arrow to return to the Financial Disclosure Form

10. 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.

11. If you have financial interest to disclose: • 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.

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, click on ‘Add Company’ or email webmaster@saint-lukes.org

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, the Central Office for Research Administration and the IRB 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. Financial disclosure is not study specific. 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