VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R006

3. A DMINISTRATIVE R EVIEW AND S PECIAL C LEARANCES 3.1. Project Participants

Each participant in the project must devote the effort indicated, each participant must personally agree to participate, each must disclose any potential conflicts of interest and adequate salaries must be requested. Effort greater than 1% from an investigator with a primary appointment in another division of VCOM requires approval from the investigator's primary division. 3.2. Conflicts of Interest As cited in the VCOM Faculty Handbook, the arrangements within the conflict of interest clearance must be reviewed at the proposal stage by the PI’s Research Dean, who will then make recommendations to the Provost, Dean and Executive Vice President for final action. Situations that require written disclosure and review are listed below. Please refer to the VCOM Financial Conflicts of Interest in Research Policy for additional guidance:  Royalties and equity  Aggregate time for outside commitments  Written agreements relating to outside activities  Special circumstances (promotions, appointments, assignments, etc)  Use of VCOM name for outside activities 3.3. Human Subjects Federal law (45 CFR 46 and 21 CFR 50) and institutional policy require assurance that the rights and welfare of human subjects of research are protected. The VCOM Institutional Review Board provides assurance on behalf of VCOM. Regardless of sponsorship, no research involving human subjects may be performed by VCOM without IRB approval. 3.4. Animal Subjects Federal law and institutional policy require humane care and use of all vertebrate animals. As of this date, VCOM does not have animal laboratories; therefore, all projects involving the use of animals must be submitted through Virginia Tech. VCOM activities that use live vertebrate animals require prior protocol review and approval by Virginia Tech’s Intitutional Animal Care and Use Committee. Once the appropriate preceding clearances have been obtained, the PI must sign the Proposal Approval Form. The Proposal Approval Form should accompany all applications for funding (other than gifts), letters requesting budget revisions and other correspondence to sponsor agencies (see below). The Proposal Approval Form must be fully completed and all necessary signatures obtained. It is the responsibility of the PI to thoroughly answer the yes/no questions on the Proposal Approval Form. By signing the Proposal Approval Form, the PI is certifying the accuracy of the question responses and the corresponding details relating to the questions. The PI is also certifying that he/she understands and accepts the responsibilities of the project if awarded. The Proposal Approval Form questions highlight relevant project issues that require compliance with other formal institutional review mechanisms, as well as VCOM and governmental policies and regulations. Accurate responses enable VCOM, the ORA and division administration to advise the PI regarding compliance with institutional, 4. S UBMITTING P ROJECT D OCUMENTS FOR I NSTITUTIONAL S IGNATURES  Use of VCOM facilities and resources by outside entities  Intellectual/tangible property related to an outside commitment  Restrictive agreements with outside entities  Potential Influence  Remuneration for clinical practice

Office of Research Administration Grants Administration Policies and Procedures

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