VCOM Institutional Policy and Procedure Manual

V COM Policy and Procedure

Policy # R 013

4.

RESPONSIBILITIES AND D UTIES 4.1. Responsibilities of the College The College will:

a. Mai ntain an up - to - date, written, enforced policy that complies with 42.CFR.50.601 - 607 , and make this policy available via a publically accessible web site; b. Inform each Investigator of this policy, the Investigator ’s responsibilities and require each Investigator to complete training prior to engaging in research ; c. Ensure any subcontractors and their Investigators comply with 42.CFR.50.601 - 607 ; d. Designate an Institutional Integrity Officer to review disclosures from each Investigator , and p rovide guidelines for the Institutional Integrity Officer to determine financial conflict of interest; e. Take actions as n ecessary to manage financial conflicts of interest; f. Provide reports to any Public Health Services agencies sponsoring research; g. Maintain records relating to all Investigator disclosures, reviews of and responses to such disclosures; and h. Establish adequate enforcement mechanisms and provide for sanctions or other administrative actions to ensure compliance. a. Submit, at least annually, to the College a disclosure of significant financial interests (and those of spouse/domestic partner and dependent children); b. Update disclos ur e to the College prior to submission of a grant application or proposal, regardless of sponsor, or prior to be added to an ongoi ng research project ; c. Update, within 30 days, disclosure upon discovering or acquiring a new significant financial interest ; and d. Disclose the occurrence of any reimbursed or sponsored travel related to the Investigator’s institutional responsibilities duri ng the previous 12 months (other than travel reimbursed or sponsored by an excluded payer). All Investigators are required to complete the Research Financial Conflict of Interest Disclosure Form each time they are involved with a n extramurally funded research project as defined in Section 3 of this policy. In the ca se of PHS - funded research, the f orm must be submitted no later than at the time of application for the research. The Research Financial Conflict of Interest Disclosure Form is required to be completed when an Investigator submits an application to the Office of Research Administration (ORA) for all research funded or supported by external grants or entities as well as all industr y - sponsored clinical trials. It is also required when externally funded projects are submitted to the VCOM Institutional Review Board (IRB) for continuing review or changes to the research staff. The College ORA and IRB will not approve externally funded research projects until appropriate assurance forms have been submitted and reviewed. The form shall be available on the Research Department web site; both on the ORA site and the IRB site. The form shall include a statement which affirms that such pers on: a. Has read and is aware of the requirements of the Policy, b. Agrees to comply with the Policy and c. Has provided true and accurate information in the Research Financial Conflict of Interest Disclosure Form . 5. REPORTING FINANCIAL I NFORMATION TO THE C OLLEGE 4.2. Responsibilities of the Investigators Each Investigator who is planning to participate in research will:

Financial Conflicts of Interest in Research Policy

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