VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004

Policy, the Department of Research will obtain and retain an Individual Investigator Agreement (IIA) to document the investigator's commitment to abide by the same requirement for the protection of human subjects as does the College and the determinations of the VCOM IRB. • The Department of Research is responsible for reporting to the Provost any noncompliance with the requirements and determinations of the VCOM IRB. The Department of Research is further responsible for reporting to the OHRP any serious or continuing noncompliance. • The Department of Research will be responsible for procedural and recordkeeping inspections at least once a year for the purpose of detecting, correcting, and reporting (as required) administrative and/or material breaches in protecting the rights and welfare of human subjects. • The Department of Research will ensure compliance with the requirements set forth 45 CFR 46 Section 114 regarding cooperative research projects. In particular, where the IRB of another institution with an OHRP FWA is relied upon, the Department of Research will ensure documentation of this reliance will be in writing, approved and signed by the Vice Provost for Research, approved and signed by the correlative official of the other cooperating institution, and retained by the Department of Research for at least three years past completion of the related research project. 20. RESPONSIBILITIES OF THE PRINCIPAL INVESTIGATOR When research involving human subjects is to be performed by any VCOM Principal Investigator, he or she is responsible for meeting the requirements outlined below. The Principal Investigator will notify the VCOM IRB of the proposed research by submitting a completed IRB Application package. The IRB must have sufficient information to determine that risks associated with the research are reasonable in relation to anticipated benefits. This should include a description of the: • Research purpose/objectives • Research design (study population, description of instruments/testing protocols, data collection methods and procedures, data analysis) • Procedures to protect confidentiality • Risks/benefits of participation In addition, all other materials are required at the time of submission. Where applicable, this will include: • The proposed informed consent documents • The Principal Investigator's brochure for an investigational drug/device and instrument manuals • Data collection forms and survey instruments • Proposed advertisements to recruit research subjects • Approval/support letters from remote sites (i.e., school districts, IRB approval letters from other institutions, industry sites, etc.) 20.1. Application Process Before a research protocol involving human subjects is reviewed (whether exempt, expedited, or full), the Principal Investigator must complete and submit the IRB application package including all relevant materials to the IRB via IRBNet. The Principal Investigator will provide the IRB

VCOM Institutional Review Board Policies and Procedures

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