VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004

many clinical trials focus primarily on white middle-class research subject groups, the results of some trials were of questionable value for members of other social, racial, sexual, and ethnic groups. As a result, both the National Institutes of Health and the Food and Drug Administration now require study designs to include as broad a range of research subjects as feasible and the data analyzed to uncover responses that differ between groups. 2.2. 45 CFR 46 This regulation, published by the Department of Health and Human Services, codifies basic human subjects protection measures. Because this subpart has been adopted for human subjects research by many federal agencies, it is known as the Common Rule. The Common Rule requires that every institution performing federally supported human subjects research file an assurance of protection for human subjects. 2.3. 21 CFR 50 and 21 CFR 56 These Federal Drug Administration (FDA) regulations define consent requirements for the use of certain types of drugs in human subjects research. DEFINITIONS VCOM has adopted the definitions included in federal regulations to guide researchers and others in the determination if human subjects are involved in a research project. Adverse Event: An undesirable and unintended, though not necessarily unanticipated, injury or physical or emotional consequence to a human subject. Assent: A child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent [45CFR46.402(b)]. Certification: The official notification by the institution to the supporting Federal department or agency component, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance [45CFR46.102(a)]. Children: Persons who have not attained the legal age for consent to treatments or procedures involved in the research, unless the applicable law of the jurisdiction in which the research will be conducted [45CFR46.402(a)]. In Virginia, the age of majority is 18 years. Clinical Research: NIH defines human clinical research as: (1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies. (2) Epidemiologic and behavioral studies. (3) Outcomes research and health services research. Clinical Trial: NIH defines clinical trial as: a research study in which one more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. 3.

VCOM Institutional Review Board Policies and Procedures

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