Mission & Purpose
The Franciscan Children’s Institutional Review Board (IRB) is responsible for protecting the rights and welfare of human subjects participating in research conducted at or under the auspices of Franciscan Children’s.
The IRB reviews all research involving human subjects to ensure ethical conduct, regulatory compliance, and participant safety.
The IRB is guided by the ethical principles of the Belmont Report: Respect for Persons, Beneficence, and Justice.
IRB Authority & Regulatory Framework
The Franciscan Children’s IRB reviews research involving human subjects in accordance with applicable federal and state regulations.
The IRB operates under 45 CFR 46 (HHS regulations for protection of human subjects), 21 CFR Parts 50 and 56 (FDA regulations), and other applicable federal and Massachusetts state laws.
The institution maintains a Federalwide Assurance (FWA) with the U.S. Department of Health & Human Services Office for Human Research Protections (OHRP), when applicable.
The IRB has the authority to:
- Approve research
- Require modifications prior to approval
- Defer or disapprove research
- Suspend or terminate approved research when necessary
IRB Structure & Governance
The IRB functions as an independent review committee established under Franciscan Children’s governance.
The IRB includes members with diverse backgrounds, including clinical expertise, scientific research experience, and at least one unaffiliated (community) member, as required by federal regulations.
The IRB Chair presides over convened meetings and oversees regulatory determinations.
Leadership & Staff Contacts / Roles
The IRB administrative office manages submission intake, regulatory review coordination, meeting scheduling, and investigator support.
Roles may include:
- IRB Chair
- IRB Administrator
- Research Compliance Officer ?