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St. Joseph Medical Center seeks to uphold the integrity of clinical research conducted by its staffs. This policy ensures that individuals responsible for the design, conduct, or reporting of clinical research results are not biased by any external commitments and financial interests related to Public Health Service funding.

This SJMC Financial Conflict of Interest in Research (FCOI) policy complements any existing SJMC Conflict of Interest policy or policies and does not intend to supersede those policies.

Study Oversight

The principal investigator (PI) assumes full responsibility for the conduct of her or his WIRB-approved clinical research study. She/he must be a member of the medical or management-level nursing staffs from the study department or a full-time employee at St. Joseph Medical Center in order to perform a clinical study at this Institution.* This is stipulated to assure compliance under the Institution’s Federal-Wide Assurance for the Protection of Human Subjects (FWA). Staffs are required to know the policies of St. Joseph Medical Center, including the Standards of Conduct and Ethical and Religious Directives.

* Non-clinical staff, non-affiliated physicians or other non-St. Joseph Medical Center employed clinical individuals interested in conducting clinical research will be expected to have a member of the medical or management-level or nursing staffs from the study department named as sub investigator to the study for all patient-related clinical research conducted at St. Joseph Medical Center.

Study approval process for investigators

The OCR staff assists investigators in reviewing clinical trial agreements (CTA) and negotiating appropriate study budgets as part of the study approval process. A legal representative of the Institution will also review all CTAs for soundness. Researchers may begin the process by submitting an electronic copy of the CTA, protocol, lay summary of the protocol, informed consent form(s), proposed budget and all supporting study documents as well as a staff name with their contact information to ocr@umm.edu

An approved budget and a finalized clinical trial agreement signed by the investigator, sponsor and the St. Joseph Medical Center Chief Financial Officer must be completed and filed with the Office of Clinical Research prior to the study being submitted to the Western Institutional Review Board (WIRB).

A review and approval of the protocol will be also conducted by the internal Scientific Review Committee prior to submitting the study to the WIRB.

Please note that the WIRB requires the signature of the Office of Clinical Research’s IRB coordinator or director to be on each application submitted for IRB approval.

Regulations and Forms