VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004

This policy statement supersedes all previous policy statements for the VCOM IRB regarding the protection of human subjects.

2.

STATEMENT OF PRINCIPLES Human subjects research is a privilege, not a right. Consistent with that philosophy, it is the mission of the Edward Via College of Osteopathic Medicine (VCOM) IRB to provide that: • The rights and welfare of human subjects are paramount in the research progress; • The highest standards of ethical conduct are employed in all human subjects research; • Research investigators are properly trained in the ethical and regulatory aspects of research with human subjects; • Research investigators deal honestly and fairly with human subjects, informing them fully of procedures to be followed and the risks and benefits of participating in research; and • Research using human subjects at VCOM conforms with all applicable local, state and federal laws and regulations and the officially adopted policies of the College. VCOM is committed to protecting the rights and ensuring the safety of human subjects participating in research at the College. This commitment is guided by the ethical principles described in the Protection of Human Subjects of Biomedical and Behavioral Research entitled: Ethical Principles and Guidelines for the Protection of Human Subjects of Research , often referred to as the Belmont Report (National Commissions for the Protection of Human Subjects of Biomedical and Behavioral Research, April 1979). Furthermore, VCOM’s commitment is also guided by the federal regulations 45 CFR 46 (the “Common Rule”), 21 CFR 50, and 21 CFR 56. For operational purposes, this commitment is vested in the VCOM IRB for Research Involving Human Subjects, which operates under a Federalwide Assurance (FWA #00004592) on file with the OHRP, a subdivision of the DHHS. All research at the College involving human subjects, regardless of funding source, is under the authority of the VCOM IRB. VCOM’s IRB is also registered at OHRP (IRB00003389). 2.1. The Belmont Report It is the duty of VCOM IRB to review and make decisions on all protocols for research involving human subjects. The primary responsibility of the IRB is the protection of research subjects from undue risk and from deprivation of personal rights and dignity. This protection is best assured by consideration of three principles, which are the touchstones of ethical research: • Voluntary participation by the subjects, indicated by free and informed consent, is assured. • An appropriate balance exists between the potential benefits of the research to the subject or to society and the risks assumed by the subject. • There are fair procedures and outcomes in the selection of research subjects. These principles are summarized as respect for persons, beneficence, and justice . Respect for Persons: Voluntary Participation and Informed Consent One of the most important elements in any research involving human research subjects is the assurance of voluntary informed consent. Any person who is to be a research subject must

VCOM Institutional Review Board Policies and Procedures

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