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Commitment

University's Statement of Institutional Commitment

Regulatory Requirements

Loyola University Chicago recognizes its ethical, legal and federally mandated responsibilities to safeguard the rights and welfare of human subjects in all research conducted under its sponsorship or on its premises. Its ethical responsibilities are guided by the principles outlined in the Belmont Report of respect for persons, beneficence, and justice. Loyola's federally mandated responsibilities come from the Department of Health and Human Services (DHHS), and are outlined in Title 45, Part 46 of the Code of Federal Regulations (45 CFR 46). These regulations mandate that all institutions engaged in research with human subjects provide the dual protections of Institutional Review Board for the Protection of Human Subjects (IRB) review and informed consent.

Federalwide Assurance (FWA)

The ethical and federally-mandated responsibilities mentioned above serve as the foundation for an agreement between Loyola University Chicago and the Office of Human Research Protections (OHRP), in DHHS, called a "Federalwide Assurance," (FWA). Loyola University Chicago has filed and received approval of its FWA from OHRP. This assurance (FWA #00000104) covers research conducted by Loyola University Chicago affiliated faculty members, students, and staff at the campuses in Chicago, Rome, and Ho Chi Minh City.

Institutional Responsibilities

The IRB for the Lakeside Campus is sponsored by the Office of Research Services. Members of the IRB, appointed by the Vice Provost for Research, represent the interests of the University and the broader community. They possess varied backgrounds and expertise and include at least one member not affiliated with the University.

It is the responsibility of deans, department chairpersons, program directors and individual investigators to familiarize themselves with the policies and procedures of the University. The University regards any infringement of these policies and procedures as a serious breach of professional standards. The University's willingness to defend researchers in litigation depends on strict adherence to policies and procedures regarding IRB approval. Interpretation of applicability of IRB rules and regulations are solely the legal right and responsibility of the IRB.

Regulatory Requirements

Loyola University Chicago recognizes its ethical, legal and federally mandated responsibilities to safeguard the rights and welfare of human subjects in all research conducted under its sponsorship or on its premises. Its ethical responsibilities are guided by the principles outlined in the Belmont Report of respect for persons, beneficence, and justice. Loyola's federally mandated responsibilities come from the Department of Health and Human Services (DHHS), and are outlined in Title 45, Part 46 of the Code of Federal Regulations (45 CFR 46). These regulations mandate that all institutions engaged in research with human subjects provide the dual protections of Institutional Review Board for the Protection of Human Subjects (IRB) review and informed consent.

Federalwide Assurance (FWA)

The ethical and federally-mandated responsibilities mentioned above serve as the foundation for an agreement between Loyola University Chicago and the Office of Human Research Protections (OHRP), in DHHS, called a "Federalwide Assurance," (FWA). Loyola University Chicago has filed and received approval of its FWA from OHRP. This assurance (FWA #00000104) covers research conducted by Loyola University Chicago affiliated faculty members, students, and staff at the campuses in Chicago, Rome, and Ho Chi Minh City.

Institutional Responsibilities

The IRB for the Lakeside Campus is sponsored by the Office of Research Services. Members of the IRB, appointed by the Vice Provost for Research, represent the interests of the University and the broader community. They possess varied backgrounds and expertise and include at least one member not affiliated with the University.

It is the responsibility of deans, department chairpersons, program directors and individual investigators to familiarize themselves with the policies and procedures of the University. The University regards any infringement of these policies and procedures as a serious breach of professional standards. The University's willingness to defend researchers in litigation depends on strict adherence to policies and procedures regarding IRB approval. Interpretation of applicability of IRB rules and regulations are solely the legal right and responsibility of the IRB.