Guiding Principles

The Institutional Review Board (IRB) has been constituted primarily to ensure that the University of San Diego remains in compliance with federal regulations on the use of human subjects in research. The University believes that the work of the IRB also reflects the Catholicity of the University and supports the basic principles of interpersonal relations that are to characterize our work together.

Catholicity of the University of San Diego

The University of San Diego is a university committed to its Catholic identity. As such, all research is bound by this Catholic identity and is rooted in the Mission and Core Values of the University. Some of the guiding principles are summarized in this Statement of Catholicity.

• The University of San Diego is a Roman Catholic institution, committed to belief in God and to the recognition of the dignity of each individual. The University welcomes and respects those whose lives are formed by different traditions.
• The University is committed to its Catholic identity as intended by its founders and mandated by its corporate declaration and the Board of Trustees. It will communicate this identity, and the activities this identity inspires, to its various constituencies.
• The University believes its commitment to the Roman Catholic tradition in American higher education is not only consistent with, but also supports, the other goals it has set for its foreseeable future and the spirit of ecumenism and tolerance of other religious beliefs those goals imply.

The Belmont Report

The basic ethical principles and guidelines for the protection of human subjects of research are defined in the Belmont Report. All other rules stem from three core principles defined in this document. All research at the University of San Diego is governed by these rules.

Respect for Persons

• Individuals treated as autonomous agents — as capable of deliberation about personal goals;
• Persons with diminished capacity afforded additional protections.

Beneficence

• Individuals understand the nature and scope of the research with full written disclosure of the risks and benefits;
• This can be summarized under two rules (1) do no harm; (2) maximize benefits while minimizing possible harms.
• Justice
• Fairness in distribution of benefits and burdens of research; burdens not placed on social, ethnic, or otherwise vulnerable population.

The Belmont Report is applied in three aspects of research:

Informed Consent

• Information — research procedure, purposes, risks, benefits, alternative procedures, opportunity to withdraw without penalty and ability to ask questions at any time;
• Comprehension — the manner and context of information must be appropriate;
• Voluntarism — consent is free of coercion or undue influence.

Assessment of Risks and Benefits

• Risk refers to any possibility of harm;
• Benefit refers to something of positive value related to health or welfare — either to the individual or to society as a whole;
• These must be balanced in a favorable ratio.

Selection of Participants

• Social Justice — takes account of protected populations, such as children;
• Individual Justice — takes unbiased selection.