VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004

5.1. Authorities of Review As explicitly stated in 45 CFR 46.109, the IRB has the authority to: • Approve as submitted.

• Approve with changes or require amendments to the protocol and/or consent form to better ensure the safety and protection of subjects. • Disapprove if any condition is not met. In such cases, the Principal Investigator (PI) will be notified in writing of the reasons for disapproval and provided an opportunity to respond in person or in writing. • Following review, continue, suspend, or terminate any study that fails to comply with protocol specifications, IRB directives, or has resulted in the unexpected harm or risk to participating subjects. Any suspension or termination will be promptly reported to the PI, department chair, sponsor, and appropriate regulatory agencies. • Defer actions or final consideration of a protocol in order to seek information or opinions from consultants and/or the PI. • Require documentation of informed consent or waive documentation as deemed necessary (see Section 14. Informed Consent ). • Require that information additional to the informed consent be given to subjects if the IRB judges that the additional information would add to the protection of the rights and welfare of subjects. • Require third-party representation at the giving of informed consent. This requirement may be waived by the IRB on a proposal receiving full board review or by the IRB Chair for expedited or exempt proposals. • If deemed necessary for the protection of subjects, inspect the facilities and investigators’ records of the subjects. In this event, the Chair will designate an IRB member to conduct such an inspection and pose questions in order to obtain information for the IRB. • Conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk.

6.

RESPONSIBILITIES OF THE IRB 6.1. Duties of the Members to the IRB Each member of the IRB will acknowledge and abide by the following responsibilities: • Attend each meeting. • Be prepared to discuss each agenda item.

• Consider the approval criteria offered in the Federal Regulations and the Belmont Report. • Maintain confidentiality regarding any information contained in any review. • Reveal any potential conflict of interest. • Provide the longest possible notice of inability to attend a meeting. • Be familiar with the IRB’s operating procedures.

VCOM Institutional Review Board Policies and Procedures

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