The University is committed to ensuring that research activities involving human participants are in compliance with applicable laws and ethical principles and that the rights and welfare of human participants involved in that research are protected. The applicable laws include what is known as The Common Rule (codified at various locations, including 45 C.F.R. Part 46) and the FDA regulations (codified at 21 C.F.R. Parts 50 and 56). In addition, several state laws may be applicable, depending upon the specifics of the research project. The relevant ethical principles are set forth in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Those ethical principles are respect for persons (recognition of personal dignity and autonomy of individuals, and special protection of those persons with diminished autonomy), beneficence (obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm), and justice (the benefits and burdens of research be distributed fairly). In addition, international organizations have developed ethical guidance documents, with which the University will comply when applicable. Two such organizations (and their guidance document names) are the following:
In furtherance of these commitments, the University has a Human Research Protection Program consisting of policies, procedures, and practices, all of which are designed to protect the rights and welfare of the human participants and to promote a culture of compliance with the law and ethics. The Vice President for Research is the University official responsible for implementation and oversight of the Human Research Protection Program. If you are an investigator and want to contact Dr. Michael P. Sarras, Jr., Vice-President for Research, regarding questions, concerns, and/or suggestions, please call (847) 578-3251. All University employees and others who act on behalf of or under the auspices of the University must comply with all applicable laws, ethical principles, and the policies and procedures established by the Human Research Protection Program. Furthermore, all committees, boards, and individuals involved in the conduct or review of human research activities must cooperate, coordinating activities in such a way as to protect the rights and welfare of human participants. Michael Zdon, M.D. – IRB Chair Nancy Bryant – IRB Administrator (847) 578-8713 If you are a research participant or potential participant and have questions, please contact Nancy Bryant in the IRB Office.