All KUMC research personnel who are engaged in projects sponsored by an agency of the PHS or by an entity that has adopted PHS rules regarding Financial Conflict of Interest must complete training in Conflicts of Interest. Training is an additional requirement to your disclosure of financial interest and time commitment certifications.

WHEN DO YOU NEED TO COMPLETE COI TRAINING?

Prior to engaging in research when:

1. The sponsor is the Public Health Service or a PHS-compliant entity.³ AND
2. The individual is responsible for the design, conduct, or reporting of research.*

     In addition to the preceding conditions, Investigators are required to take COI training when:

• Institutional Financial Conflict of Interest policies change in a manner that affects Investigator requirements
• An Investigator is new to an Institution
• An Institution finds that an Investigator is not in compliance with the Institution's Financial Conflict of Interest policy or management plan.

HOW DO YOU ACCESS THE TRAINING?

If you are a KUMC faculty, staff, or employee

• Visit CITI Program and Log in through my Organization. Select the COI course to enroll.

If you are a volunteer faculty member, affiliate, or collaborator, alternative arrangements may be made. See below

HOW MUCH TIME SHOULD YOU ALLOT?

Allow approximately 30 minutes to complete the module and quiz

IS YOUR TRAINING CURRENT?

COI Training is generally effective for four (4) years barring certain qualifying events (see above).

AFFILIATES OR COLLABORATORS:

The requirement to maintain current training may also apply to collaborators from other institutions who are working on KUMC projects. If the subrecipient or subcontractor is not a PHS compliant institution and has not signed a subaward accepting responsibility for oversight of COI requirements, then collaborators must demonstrate completion of COI training and disclosure through KUMC. Collaborators will either complete training by accessing CITI should they have a KUMC network affiliate account, or they will be asked to review the information provided here and attest to its review on a "paper" disclosure reporting form which will be provided to collaborator by regulatory staff.

*"Investigator" means the project director or principal investigator and another person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS (e.g., NIH), or proposed for such funding, which may include, for example, collaborators or consultants.¹

In a further elaboration on the role of Investigator, NIH states:

Institutions should consider the role, rather than the title, of those involved in research and the degree of independence with which those individuals work. When the definition of investigator is limited to titles or designations (e.g., to principal investigators, key personnel, faculty) the risk is that an unidentified FCOI may compromise the research enterprise increases.

³"PHS Compliant" describes funding agencies that have adopted or sponsor projects, proposed or funded, that are bound by the PHS regulations on Promoting Objectivity in Research, 42 CFR 50 subpart F and 45 CFR 94

 List of Agencies using the PHS FCOI Regulations: http://thefdp.org/default/fcoi-clearinghouse/