VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004

Administrator with additional information as requested in order to assure completion of the IRB review in a timely fashion. The Principal Investigator will not recruit or involve human subjects in the proposed research until the IRB has informed him or her of full approval for the use of human subjects in the research. The Principal Investigator must meet all stipulations resulting from review in order to receive full approval to implement the proposed research. By submitting an IRB application package, a VCOM researcher is attesting that that they will follow specific assurances related to ethical research conduct as a component of the application process: • Certify that the information provided in this application is complete and correct. • Describe the conduct of the study, the ethical performance of the project, and the protection of the rights and welfare of human subjects. • Comply with all VCOM IRB policies and procedures, as well as with all applicable Federal, State and local laws regarding the protection of human subjects in research. • Ensure that the study is performed by qualified personnel adhering to the VCOM IRB approved protocol. • Submit all proposed modifications to the approved protocol or consent materials to the VCOM IRB for review and approval prior to implementation of any change. • Obtain informed consent from the research participants as applicable to this research and as prescribed in the approved protocol. • Promptly report significant adverse events to the VCOM IRB in writing. • Adhere to all requirements for continuing review. • Advise the VCOM IRB of any change of address or contact information as long as the protocol remains active. 20.2. Following Approval The Principal Investigator will ensure that subject consent is documented in the manner prescribed by the IRB. Any modifications of the approved research protocol and/or consent document must be submitted to the IRB for review and approval before the change can be implemented. The Principal Investigator will maintain consent documents signed by subjects for not less than three years beyond closure of the protocol. The Principal Investigator will maintain the confidentiality of data obtained from subjects in the manner required by the IRB. The Principal Investigator will report the progress of the research to the IRB at the required intervals and in the manner prescribed by the IRB. The Principal Investigator will promptly report to the IRB any adverse events or injuries to human subjects resulting from the research. The Principal Investigator will also report any unanticipated problems that involve risks to the subjects or others. These reports must be in writing. The Principal Investigator will promptly report to the IRB any proposed changes in the research and will obtain the approval of the IRB prior to the changes being made, except where necessary to eliminate apparent immediate hazards to subjects. In this case, changes should be reported as soon as subjects have been removed from immediate danger/risk. The Principal Investigator will promptly report to the IRB any proposed involvement of human subjects in research which

VCOM Institutional Review Board Policies and Procedures

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