GREATER BALTIMORE MEDICAL CENTER Institutional Review Board Standard Operating Policies and Procedures (SOP)

Name of SOP: Ethical Principles of the IRB Section Number: 1.1 Effective Date: January 1, 2005 Last Revision: May 21, 2012 Replaced SOP Revised On:

In the United States, regulations protecting human subjects first became effective on May 30, 1974. Promulgated by the Department of Health, Education and Welfare (DHEW), those regulations raised to regulatory status policies for the protection of human subjects. The regulations established the Institutional Review Board (IRB) as one mechanism through which human subjects would be protected.

GBMC encourages the conduct of research in and among its facilities, and in collaboration with other educational institutions, agencies, and organizations. While respecting the right of the researcher to full academic freedom in research, GBMC is firmly committed to adhering to the basic ethical principles underlying the acceptable conduct of research involving human subjects, as set forth in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research.

The Belmont report sets forth the basic ethical principles underlying the acceptable conduct of research involving human subjects. These principles are now accepted as the three quintessential requirements for the ethical conduct of research involving human subjects:

Respect for persons involves recognition of the personal dignity and autonomy of individuals, and special protection of persons with diminished autonomy.

Beneficence entails an obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks.

Justice requires that the benefits and burdens of research be distributed fairly.

The report also describes how these principles apply to the conduct of research. Specifically, the principle of respect for persons underlies the need to obtain informed consent; the principle of beneficence underlies the need to engage in a risk/benefit analysis and to minimize risks; and the principle of justice requires that subjects be fairly selected.

GBMC has set standards for the conduct of research which mandate well-conceived and well- conducted research. Research must also be in keeping with the GBMC Mission. The IRB is charged with assisting in maintaining both these standards, and the GBMC mission.

The mission of GBMC is to provide medical care and service of the highest quality to each patient leading to health, healing and hope with a vision phrase of “To every patient, every time, we will provide the care that we would want for our own loved ones” and dedicated to the Greater Values of Respect, Excellence, Accountability, Teamwork, Ethical Behavior and Results.