VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R003

• The allegations be proven by a preponderance of the evidence.

4.3. Confidentiality To the extent permitted by law and a fair process, VCOM must protect the confidentiality of respondents and research subjects. Disclosure of a respondent’s identity is limited to those who need to know. 4.4. Research Conducted at a Former Institution For allegations involving research conducted at a previous institution by an individual prior to their appointment at VCOM, VCOM will cooperate with the previous institution’s proceedings as required by federal regulations (42 CFR § 93.400; § 93.411(e)). This cooperation primarily includes the prompt sequestration of any relevant research records or evidence currently in the employee’s possession. VCOM will review the final findings of the previous institution to determine if any administrative actions are necessary to protect the integrity of the employee’s current activities or to comply with federal sanctions. 4.5. Research Transferred to VCOM For allegations involving research studies transferred to VCOM by a new or current employee, VCOM will coordinate with the previous institution to ensure a thorough review, which may include designating a lead institution for a joint proceeding. VCOM will take necessary steps to promptly sequestrate all transferred data and records in the employee’s possession. VCOM may share relevant information with the prior institution to protect the ongoing research record and fulfill its affirmative duty to safeguard any PHS funds currently managed by VCOM. Should the previous institution conduct the review, VCOM will review the final findings of the previous institution to determine if any administrative actions are necessary to protect the integrity of the employee’s current activities or to comply with federal sanctions. The Associate Dean for Biomedical Affairs and Research on each campus serves as the Institutional Integrity Officer (IIO) for that campus. If an allegation of misconduct involves the Associate Dean for Biomedical Affairs, the President will appoint an alternate IIO to oversee that particular case. The IIO has primary responsibility for: • Initial assessment of allegations to determine if they meet the definition of research misconduct. • Appointing and overseeing Inquiry and Investigation Committees. • Ensuring all proceedings adhere to the timeframes mandated by 42 CFR Part 93. • Serving as the primary liaison between VCOM and the ORI, including promptly notifying ORI of a decision to initiate an investigation or if HHS interests are threatened (§ 93.309; § 93.317). • Preparing both the inquiry report and investigation report and providing both to the ORI and appropriate individuals as needed. 5.2. Institutional IDO The Vice President of Research serves as the Institutional Deciding Official (IDO). The IDO serves on the three-personal panel that receives the final investigation report and determines whether to accept the findings and what institutional administrative actions, disciplinary or corrective, shall be taken. The IDO shall ensure VCOM compliance with ORI requirements. 5. ROLES AND RESPONSIBILITIES 5.1. Institutional Integrity Officer

VCOM Policy on Research Misconduct

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