Policies and Procedures
Basic Principles
Investigations conducted at The University of Toledo are expected to embody the following basic principles in agreement with The Belmont Report, The Declaration of Helsinki, The University of Toledo’s Federal wide Assurance for Protection of Human Subjects, the “Revised Common Rule” 45 CFR 46, Subpart A: and 45 CFR 46 Subparts B, C and D, as well as FDA 21 CFR 50 and 21 CFR 56.
1. Participation of human beings as subjects must be voluntary, i.e., must occur as a result of free choice, without compulsion or obligation, based upon disclosure of relevant information in a comprehensible way.
2. Adequate standards of informed consent must always be utilized.
3. Adequate provision must be made to protect the privacy of subjects and maintain the confidentiality of information.
4. The selection of subjects must be based upon fair procedures and not overburden, over-utilize, unfairly favor, or discriminate against any particular subject pool.
5. Any risks to the subject must be carefully minimized, and adequately balanced against potential benefits. Proper precaution should be taken and plans made to deal with emergencies that may develop in the course of even seemingly routine activities.
6. Approval for any human subject research must be obtained from one of the UToledo IRBs prior to the initiation of any research activities.