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


The Standard Conflict of Interest (COI) Management Plan for Human Subject Research (SMP) is generally invoked when an investigator reports a significant financial interest (as defined in the Conflict of Interest Committee (COIC) COIC’s Working COI Policy for Human Subject Research) in either the sponsor of a human subject research study, or in the technology being evaluated. Positive responses to questions 1-3 in section 7.3 of an OSIRIS protocol automatically invoke the Principal Investigator (PI) exclusion rule and the Standard Management Plan.

Please review the instructions below and complete the SMP as directed. All requests for exceptions should first be communicated to the director of the COI Office (David T. Wehrle; 412-383-1774; wehrledt@upmc.edu; Suite 206, Hieber Building). 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, the vice chancellor for research conduct and compliance (Dr. Randy Juhl). All other exceptions to the standard COI management plan (e.g., adding/removing elements to/from the standard plan) must be approved by a subcommittee of the COI Committee.

 

Completing the Standard Conflict of Interest Management Plan for Human Subject Research:

In the introductory paragraph:

  1. Specify the name of the research sponsor and/or the technology being evaluated in which you have an SFI.
  2. Provide the Institutional Review Board (IRB) protocol number.

Item 1:

Indicate your responsibilities as a co-investigator in the study.

Item 7:

The Informed Consent Form must include the paragraph provided here, customized as follows:

  1. Add study-specific information;
  2. Provide the name and telephone number of the PI of the research study. Do not include the name of the person with the financial relationship;
  3. Upload the modified informed consent document into Section 4.9 of your OSIRIS protocol.

Item 8:

Record your name at the top of the Notification of Significant Financial Interest Form (link to form provided within the SMP document) and distribute it to other individuals (such as students, staff, or other faculty members) involved in the research project for their signatures. Signed forms should be returned to the COI Office (206 Hieber Building) for its files.

Item 10:

If this study is funded by a federal research grant, you must provide the grant number(s) and title(s) to the Chair of the COIC (Dr. Jerome Rosenberg; 412-624-3007; jrosenb@pitt.edu). The University is mandated to disclose in a general manner to the federal funding agency that a COI has been identified and managed in accordance with federal regulations.

Signatures:

  1. You and the IRB-approved PI must sign the Standard Management Plan.
  2. Upload a signed copy of the SMP into Section 7.3.3 of OSIRIS.

Please contact the COI Office (Ms. Khrys Myrddin; 412-383-2828, myrddink@upmc.edu) if you have any questions. Thank you.