IRB
Franciscan Children’s Institutional Review Board (IRB)
Purpose
• To evaluate all research proposals for benefits and risks to human subjects.
• To recommend modification or approval of research applications as they relate to the benefits and risks to human subjects and the mission of Franciscan Children’s.
• To conduct periodic ongoing review of approved research at Franciscan, at a frequency not less than once per year.
Authority
The Franciscan IRB shall approve or disapprove research proposals submitted based on the benefits and risks to the human subjects. The IRB is authorized to suspend or terminate any approval as a result of adverse events or adverse findings resulting from continuing review of the existing research projects.
Composition
The committee members and committee chairperson are appointed by the Franciscan Medical Director and are responsible to the Medical Executive Committee. Tenure is self-limited.
In keeping with federal regulations (2018 Requirements [2018 Common Rule] | HHS.gov), the Franciscan IRB membership shall have at least 5 members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members (professional competence), and the diversity of its members, including race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. The IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments (including policies and resources) and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas and shall consist of:
a. At least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.
b. At least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.
The Franciscan IRB may not have a member participate in the IRB’s initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
The Franciscan IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.
Questions?
IRB Committee; IRB@franciscanchildrens.org
Download documents below.
2024 Institutional Review Board (IRB) Meeting Dates and Submission Deadlines
Instructions for IRB Application Submission
Franciscan IRB Progress Report
Franciscan Children’s IRB Application
Research compliance
Download Financial Conflict of Interest documents below.
PHS Financial Conflict of Interest (FCOI) Policy
PHS Financial Conflict of Interest (FCOI) Disclosure Statement