VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004

Full Board Review: The proposed research is reviewed at a convened meeting of the IRB at which a majority of the membership is present, including at least one member whose primary concerns are in nonscientific areas. For the research to be approved, it must receive the approval of a majority of those members present at the meeting. Guardian: An individual who is authorized under applicable state or local law to consent on behalf of a child to general medical care [45CFR46.402(e)]. Human Subject: A living individual about whom an investigator (whether professional or student) conducting research (i) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. Identifiable Biospecimen : A biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen. Intervention: Both physical procedures by which information or biospecimens are gathered (for example, venipuncture) and manipulation of the subject or the subject's environment that are performed for research purposes. Interaction: Communication or interpersonal contact between investigator and subject. Investigator: An individual performing various tasks related to the conduct of human subjects research activities, such as obtaining information about living individuals by intervening or interacting with them for research purposes: obtaining identifiable private information about living individuals for research purposes; obtaining the voluntary informed consent of individuals to be subjects in research; and studying, interpreting, or analyzing identifiable private information or biospecimens for research purposes. Legally Authorized Representative: 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 procedures involved in the research [45CFR46.102(i)]. If there is no applicable law addressing this issue, legally authorized representative means an individual recognized by institutional policy as acceptable for providing consent in the non-research context on behalf of the prospective subject to the subject’s participation in the procedure(s) involved in the research. Minimal Risk: The probability and magnitude of harm and discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Principal Investigator: The designated faculty or staff member who shall have the overall responsibility for ensuring that a project is carried out in compliance with the terms, conditions and policies of both the sponsor and the College, including monitoring of project expenses and submission of all required narrative and technical reports. Most important, the Principal Investigator is responsible for controlling the academic quality of the activities they supervise. Private Information: Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual who reasonably expects it will not be made public (e.g., a medical

VCOM Institutional Review Board Policies and Procedures

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