Below is the standard process followed by the COI Office to manage conflicts with animal and human subject research projects.
1. Submission to IRB or IACUC
The study team submits a protocol or modification in the ARO, OSIRIS, or PittPRO systems for review by the Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC). If affirmative responses are entered under the protocol or modification's Conflict of Interest (COI) section, an ancillary review will be triggered.
2. COI Office Receives Ancillary Review
The COI Office automatically receives the ancillary review request from the ARO, OSIRIS, or PittPRO systems. A COI Office staff member is assigned to complete the review.
3. Development of CMP
The COI Office staff member will work with department chairpersons, deans, Human Research Protection Office (HRPO) staff, IACUC staff, and/or the COI Committee (COIC) to select and develop the appropriate COI Management Plan (CMP) to address the investigator's disclosed conflict.
Depending on the nature of financial interest disclosed, further supervisory approvals may be required. Additional CMP terms may be required and subsequently added to the plan, including but not limited to data steward oversight.
4. Contact with Conflicted Investigator
The COI Office staff member will contact the conflicted investigator and provide a copy of the final CMP for his or her review and agreement.
Investigators requiring a management plan for human subject research receive CMPs through DocuSign for review and signature. Animal research-related CMPs are sent via standard email.
5A. CMP Uploaded to PittPRO or OSIRIS
Applicable to human subject research protocols only; does not apply to animal research.
The study team must upload the final signed CMP to the "Local Supporting Documents" section of the protocol in PittPRO. In the legacy OSIRIS system, the CMP must be uploaded to Section 7.3 of the protocol form in the designated area.
5B. COI Declaration Added to Informed Consent
Applicable to any human subject research protocol subject to a CMP requiring this disclosure.
If not previously completed, the study team must edit the protocol's informed consent form and add the COI declaration language as required by the CMP. The study team must re-upload the informed consent form to OSIRIS or PittPRO for review once changes are made.
6. COI Office Issues Approval
Once a CMP is in place, the COI Office will issue ancillary approvals in ARO, OSIRIS, or PittPRO. The IRB or IACUC will then proceed with the remainder of the overall review process.