VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004

• constitute serious or continuing noncompliance with IRB determinations or federal regulations. In such cases, the Chair shall suspend the study procedures pending a timely investigation and institutional review, and shall immediately notify the Provost, Dean of the Respective Campus and the relevant Associate Dean(s). Investigations by the IRB focus on the protection of study subjects. In cases that involve allegations of scientific misconduct, the Chair shall contact the Institutional Integrity Officer for further action. Inquiries or investigations into scientific misconduct do not preclude IRB review and actions. The following chronological sequence is recommended for resolving alleged noncompliance: • When made aware of a potential problem, IRB Administration will compile file information and present concerns to the IRB Leadership. • The Chair determines whether to pursue the matter with the PI via telephone call, e-mail, paper memo, in person, or video conference. The purpose of such contact is fact-finding (i.e., to determine whether a problem exists and if so, its magnitude and significance relative to the rights and welfare of human subjects). • When the initial inquiry does not result in resolution of the matter, a meeting with the PI is scheduled as soon as possible. The Provost, Dean of the Respective Campus and the relevant Associate Dean(s) are notified of the status of the inquiry. • The IRB has the authority to suspend or terminate IRB approval of protocols that are found to be non-compliant with institutional policies and procedures, state laws, and/or federal laws or regulations. Other sanctions imposed by the IRB may include but are not limited to compliance audits, letters of reprimand, and restrictions on serving as an investigator on human subjects protocols. • If the IRB acts regarding the noncompliance, the IRB sends written notification of these actions to the Principal Investigator, the Provost, the Dean of the Respective Campus and the relevant Associate Dean(s). To the extent that any action includes suspension or termination in cases of externally funded programs, notice shall be sent to the Office of Research Administration when the project is externally funded. • Under certain circumstances requiring prompt action, the IRB Chair or a designated IRB Co-Chair, has the authority to immediately suspend or terminate IRB approval of protocols that are found to have unacceptable risk and/or be non-compliant with institutional policies and procedures, state laws, and/or federal laws or regulations. • The IRB Chair and Director of Research Administration are responsible for all required reporting of noncompliance and the resulting IRB actions to the appropriate federal agencies. Care should be taken to maintain confidentiality when leaving messages for the PI via voice mail or with secretarial and support staff. The IRB Administration should document in writing for the IRB files the outcome of any and all communications and discussions. Such documentation should be factual and objective and should include timelines for resolution (e.g., meeting dates, response deadlines, etc.).

VCOM Institutional Review Board Policies and Procedures

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