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About the IRB -- Statement of Authority and Purpose

A. Governing Principles

Institutional Review Boards (IRBs) are guided by the ethical principles applied to all research involving humans as subjects, as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, titled "The Belmont Report:  Ethical Principles and Guidelines for the Protection of Human Subjects of Research").  These principles are defined in the Belmont Report as summarized below:

  • Respect for Persons - Respect for persons involves recognition of the personal dignity and autonomy of individuals, and special protection of those persons with diminished autonomy.  Respect for persons is manifested in the informed consent process in which potential subjects are provided information about the study in a manner understandable to them and then allowed to choose whether or not they wish to participate.
  • Beneficence - Beneficence entails an obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm.  Beneficence requires that investigators and IRB members engage in an analysis of the risks and benefits to the subjects, making sure that the anticipated risks are relative to the potential benefits.  Risk should be minimized as much as possible.
  • Justice - Justice requires that the benefits and burdens of research be distributed without bias. The principle of justice directs us that subjects should not be chosen simply because they are available and easy to influence.  In addition, it requires that subjects who are likely to benefit from a study should not be excluded.

A. Governing Principles
B. Authority
C. Responsibility

1. IRB Review of Research
2. Failure to Submit a Project for IRB Review
3. Confidentiality