Instructions for Completing Standard Conflict of Interest Management Plan for Human Subject Research

Overview

The COI Management Plan for Human Subject Research – for SFIs Triggering the PI-Exclusion Rule is invoked when an investigator has certain significant financial interests in either the sponsor of a human subject research study or in the technology being evaluated.

Completing the Management Plan

The management plan is completed and signed electronically through DocuSign. All parties including the COI Office are notified by email when the plan is reviewed and signed.

Use of the DocuSign version of the management plan will expedite processing by COI Office staff and is strongly preferred. A fillable PDF version of the management plan is available for manual completion, but will result in additional processing time. All form content must be typed.

Complete electronically via DocuSign – preferred method
Download Fillable PDF

Requesting Exceptions

All requests for exceptions to elements included in the COI Management Plan for Human Subject Research – for SFIs Triggering the PI-Exclusion Rule should first be communicated to the director of the COI Office:

David T. Wehrle, CPA, CIA, CFE
Email
(412) 383-1774

Your request will then be forwarded to the appropriate party for deliberation. You will be informed of the results of these deliberations within two weeks of making such request.

Exceptions to the PI exclusion rule must be approved by the authorized institutional official for human subject research, Professor George A. Huber, Vice Chancellor for Research Conduct and Compliance. Please note that the only justification for such an exception is for the protection of human subjects. All other exceptions to the management plan (e.g., adding/removing elements to/from the plan) must be approved by a subcommittee of the COI Committee.