Conflict of Interest Policy

OVERVIEW

To set forth policy and procedure to identify, assess and address actual and potential conflicts of interest (COI) relating to research studies conducted and monitored by the St. John Health System (SJHS).

POLICY

A. To promote objectivity in research performed, reviewed and monitored by SJHS, the IRB will review and address any conflicts of interest that could reasonably be expected to cause bias in the approval, review, design, conduct or reporting of a research study.

1. IRB members are to appropriately and completely notify the Board at any IRB meeting in which the member has or may have a potential COI involving a study at issue.

a) The Board Member may be required to recuse themselves from voting on any matter involving that study, unless the Board approves a remedial action plan to manage, reduce or eliminate the conflict as further defined below.

(1) Upon satisfying the remedial action plan, the Board may allow the Member to vote on the underlying matter. 

b) The Board member acknowledging a COI will be included when determining the presence of a quorum.

2. As part of an initial application to conduct research, and on an annual basis thereafter until an approved study has been completed and closed, any individual who intends to serve or will serve as an Investigator will be required to complete a certification identifying the existence or absence of a COI, for themselves, their Sub-Investigators, and their immediate family members.

a) The certification will be provided to the Investigator and other responsible parties as appropriate by the Institutional Review Board (IRB) Administrator or his/her designee.

b) (1) The submitting individual is responsible for updating the certification within thirty (30) days of identifying a previously unreported or acquiring an actual or potential COI or upon the addition of a sub-investigator to the study. 

c) An initial application to conduct research may be considered, but will not be approved by the IRB until such time as the above requirements have been fulfilled.

d) Reviews of all certifications are to be completed within ninety (90) days of receipt.

e) If a required certification is not completed as part of the annual review process, the IRB Administrator or his/her designee shall provide notice to the responsible parties.

(1) If a completed certification is not provided within 60 days thereafter, then the IRB Administrator will notify the Board of the failure and of any corrective action to be taken by the IRB.

(a) Corrective action may include termination or suspension of the research study.

3. The IRB will review all Board Member acknowledgements and notices, as well as completed certifications to determine if a COI exists which could directly and significantly affect the approval, review, design, conduct or reporting of the research.

a) If an actual or potential COI is identified, the Board may impose remedial actions. i.e. a management plan, to manage, reduce or eliminate the conflict, including but not limited to:

(1) Public disclosure of the financial interests;

(2) Monitoring of the research by independent reviewers;

(3) Modification of the research plan;

(4) Disqualifying from participation any or all participants;

(5) Divestiture of the conflicting financial interests;

(6) Severance of relationships that create the actual or potential conflicts; or

(7) Independent management of the conflicting financial interests by 
third parties. 

(a) The IRB may provide oversight and monitoring regarding the remedial action and take any action warranted to resolve the underlying COI in support of the related study. 

4. The information provided via the certifications will be used in support of any federal, state or other similar COI reporting requirements associated with human research studies.

a) For any COI identified by the IRB as having the potential to affect the approval, review, design, conduct or reporting of research and meeting the applicable monetary thresholds as determined by federal regulations, the IRB Administrator will report the matter in accordance with applicable standards as determined by the Department of Health and Human Services (DHHS, Public Health Service (PHS) and/or National Institute of Health (NIH). 

5. In the event the DHHS determines a PHS funded clinical research project involving the safety or effectiveness of a drug, medical device, or treatment has been designed, managed or reported on by an Investigator who has not disclosed a COI as required by regulation and which was not reviewed and addressed by the IRB, the Investigator will be required to:

a) Comply with any remedial action issued by the DHHS;

b) Disclose the COI during each public presentation of the results of the research; and 

c) Issue an appropriate addendum to previously published presentations. 


6. Investigators are required to complete the on-line training course provided by the DHHS, entitled “Conflict of Interest Mini Course,” prior to engaging in research and at least every four (4) years thereafter.

a) The above course will be required as a “refresher” whenever the following occur:

(1) This policy is revised in such a manner as to affect the reporting requirements and/or obligations of Investigators; 

(2) The Investigator is new to St. John Health System and seeks to participate in research; or

(3) An Investigator has not complied with the policy or remedial action imposed by the IRB.

7. This policy and any revisions may be made public via the St. John Health System website.

a) Public requests for information regarding actual COI involving senior and/or key personnel, as identified by and meeting applicable federal regulations, may be directed by letter to St. John Medical Center, 1923 South Utica, Tulsa, Oklahoma 74133: Attention : IRB Administrator.

(1) Requests must specifically identify a research study or protocol. 

(2) Responses to such written inquiries will be provided within five (5) business days. 

8. All actions taken regarding the review or management of conflicts of interest by the IRB will be documented in the minutes of the Board’s meetings. 

a) Records relating to this policy will be retained for a minimum of three (3) years.

DEFINITION

B. Association – includes friendships, relationships, commitments and/or obligations involving or relating to third parties. 

C. Business arrangement – includes employment, contractual obligations, ownership, partnership, or investment in any private or public entity that provides health care and/or health care related services or products.

D. Conflict of Interest – means a financial or other interest, association or gift that could directly affect or improperly influence the review, approval, design, conduct, or reporting of any matter relating to a research study.

E. Family member – includes immediate family and household, parents, children, step-children, grandchildren and step-grandchildren.

F. Financial Interest – means anything of monetary value, whether or not the value is readily ascertainable, but excludes funds or shares in jointly held funds, such as mutual funds, which are not controlled or directed by the investor(s).

G. Gift – includes any gratuity, honorarium, trip or similar item of value, excluding items of de minimus value of $50.00 or less per occasion. For St. John associates, gift also includes any items or favors valued over $10.00 from any sales representative or vendor who conducts business with or is a competitor of the Health System.

H. Investigator – means the project director or principle investigator who is directly involved in the treatment or evaluation of research subjects, their immediate family members.Research – means a systematic investigation, study or experiment designed to develop or contribute to the generalized knowledge relating broadly to public health, including behavioral and social-sciences research, which involves human subjects.

I. Sub-Investigator – means any individual member of the clinical trial team designated and supervised by the primary investigator at a trail site their immediate family members, and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research related information 

REFERENCES

J. Title 42, Code of Federal Regulations (C.F.R.), Section 50.601 et. seq.