VCOM Institutional Policy and Procedure Manual

V COM Policy and Procedure

Policy # R 013

Furthermore, the annual reports must also include the status of the financial conflict of interest and any changes to the management plan. The annual report must also specify whether the financial conflict of interest is still being managed or, if not, ex plain why it no longer exists.

8.2. Mitigation Reports For those financial conflicts of interest discovered during a retrospective review that involve PHS funded research, federal regulations as defined in 42.CFR.50.605(a) require additional reporting . If bias is found in a retrospective review, the College shall notify the PHS agency promptly and submit a mitigation report to the PHS agency that is funding the research. The mitigation report shall include, at a minimum, the key elements documented in the retrospective review above, as well as a thorough description of the impact of the bias on the research project and the College’s plan of action, or actions taken, to eliminate or mitigate the effect of the bias (e.g., qualitative and quantitative data to support extent of harm done or future harm, analysis of whether or not the research project is salvageable, etc.). The College must then submit such reports annually to the PHS agency, as described in subsection 8.1 above . V IOLATIONS AND ENFORCEMENT If a Financially Interested Individual fails to comply with this policy or with the management p lan, the College will take immediate corrective action via the Conflict of Interest Committee. The Committee will notify the Financially Interested Individual, inform that individual of the basis of the belief and allow that individual an opportunity to e xplain the alleged failure at a convened meeting of the Committee. After hearing the response from the Financially Interested Individual and gathering additional information as necessary, the Committee may determine that the individual has, in fact, faile d to disclose an actual or possible conflict of interest or has failed to comply with a management plan and that the non - compliance appears to have biased the design, conduct or reporting of the research . In such a case, the Committee will recommend the appropriate disciplinary and corrective action. This will include immediate notification of the sponsor, as required by law or agreement or as otherwise appropriate of the corrective action taken or to be taken. S uch actions may include the initiation of proceedings under College policies, including the College’s Faculty Handbook : Information on Misconduct and Disciplinary Procedures as well as relevant human resources department policies. If failure to comply to this policy or failure to follow a management plan occurs on a clinical research project and/or a project involving human subjects research with the purpose of evaluating the safety or effectiveness of a drug, medical device or treatment, the College, as required by federal regulations, shall require the Financially Interested Individual to disclose the financial conflict of interest in each public presentation of the results of the research and to request an addendum to previo usly published presentations. For those research projects sponsored by a PHS agency, the PHS awarding agency has the authority to inquire at any time into an Investigator’s disclosure of financial interests and the College’s review and response. Should the PHS awarding agency decide that further corrective action is needed or that the College has not managed the conflict in accordance to regulations, the imposition of special award conditions, suspension of funding or other enforcement actions may result until the matter is resolved. 9.

Financial Conflicts of Interest in Research Policy

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