VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004

If an SAE or UP poses serious risk to subject safety, the chair or designated subcommittee may immediately suspend the study before presenting the report to the convened meeting. If the IRB suspends or terminates a study due to an SAE or UP, it must notify the Provost and the appropriate campus Dean, who, along with the IRB Chair and the Director of Research Administration, is responsible for making any required reports to the appropriate federal regulatory agencies. 13. CONFIDENTIALITY The VCOM IRB is aware that it may be necessary to review sensitive or confidential material when considering proposed research. Consequently, the following steps will be taken to ensure confidentiality of the subjects: • Confidentiality agreements will be signed by IRB members annually. • IRB members will sign agreements of confidentiality if requested by the sponsor. • Disposition of protocols and related documents other than those required for IRB files will be made according to the sponsor and/or PI’s instructions. • The distribution of the meeting minutes will be controlled. Minutes sent to individuals will be edited to delete sensitive information not related to the research. • All discussions and actions by the Board will be kept confidential by IRB members. 14. INFORMED CONSENT As stated in the Code of Federal Regulations (45 CFR 46.116), no PI may involve a human being as a subject in research (covered under this policy) unless the PI has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. The VCOM IRB and the PI must ensure that informed consent is written and given in a legal and effective manner to the prospective subject. The prospective subject will be given sufficient opportunity to exercise free power of choice without any form of coercion or constraint. The consent form will contain all required information presented in a language understandable to the subject. The consent form will not contain any exculpatory language that causes the subject to waive or appear to waive any of his or her legal rights, or release VCOM or its agents from liability for negligence. If minors are involved in a research project, the permission of the parent(s) or guardian is needed. Assent will be required of all children mature enough to understand the research and what they are required to do. 14.1. General Requirements The consent form and the consent process must provide potential subjects with information needed to make an informed decision about whether to participate. The informed consent must give prospective participants the information that a reasonable person would want to have in order to make an informed decision about whether to participate. This information needs to be presented in sufficient detail and organized in a way that facilitates understanding. Key information about the research must be provided at the beginning of the informed consent document (purpose, risks, benefits and alternatives). The following information must be provided to each subject and must appear in the consent form (as described in 45CFR46.116 (b) (c): • A concise statement about the research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures that are experimental. • A description of any reasonably foreseeable risks or discomforts to the subject.

VCOM Institutional Review Board Policies and Procedures

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