CFR: The Code of Federal Regulations (CFR)is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. The CFR is divided into 50 titles which represent broad areas subject to Federal regulation. The VMI IRB Guidelines refers to CFR sections at times. The main page for the CFR online may be located at https://www.govinfo.gov/help/cfr.
Research means the systematic investigation designed to develop or contribute to generalizable knowledge. Under this definition, some demonstration, service and training projects may be considered to include research activities.
Human Subject is defined in 45CFR46 as a living individual about whom an investigator conducting research obtains (a) data through intervention or interaction with the individual or identifiable, private information. While the term "subject" has some negative connotations, it has been used in this document for purposes of consistency with federal regulations.
Private information includes information about behavior that typically occurs in a context in which an individual can expect that no research observation or recording is taking place and/or information which has been provided for specific purposes by an individual and which that individual can expect will not be made public, e.g., a medical record. If there are limitations on the degree to which privacy may be maintained, the limits of such protection will be made explicit during the informed consent process.
Minimal Risk means that the risks of harm anticipated in the proposed research are not greater in either probability or magnitude than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Informed consent means the knowing, legally effective consent of any individual or the individual's legally authorized representative. Such consent can be obtained only under circumstances that provide the prospective subject or representative sufficient opportunity to consider whether or not to participate without coercion or undue influence. The nature of the information presented and the means of securing consent must be clearly understood by the potential subject. Informed consent is a process. A written informed consent documents this process but cannot serve as a substitute for it.
Legally Authorized Representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the research procedure(s). Any legally authorized representative who is not the parent should indicate the decree number (that establishes the legal representation) on the consent form.
Review refers to the evaluation of a proposal by the IRB consistent with the policies established by appropriate federal agencies and the Belmont Report. The review (and subsequent approval) is required before the study may be initiated.
The Belmont Report. On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations. It has become a seminal document in establishing principles for research with human subjects. It may be accessed on-line at http://www.dhhs.gov/ohrp/humansubjects/guidance/belmont.html.
All systematic investigations involving human subjects that are performed to meet academic requirements (e.g., thesis, dissertation, etc.) or designed for public dissemination under the aegis of VMI require IRB approval.