VCOM Institutional Policy and Procedure Manual

a. Personnel: the number and qualifications of collaborating investigators and other members of the research team. b. Performance sites or cooperating institutions requiring separate or additional IRB review or Assurance of Compliance. c. Purpose of Project and anticipated contributions of the findings. d. Methods: describing the selection of subject pool and number of subjects to be recruited; expectations of subject time commitment and involvement; cost and logistics of proposed subject protection measures, as to safety and confidentiality; targeting of vulnerable populations. e. Other categories as applicable: e.g. differing drug dosages, additional treatment arms. 2. The designated IRB member will certify, after review, if the grant proposal is entirely consistent with any corresponding IRB protocol(s), or determine that the investigator must submit protocol amendments to reconcile any discrepancies. 3. The designated IRB member will submit written notice of his/her findings to the IRB Chair Person and/or coordinator. 4. All IRB members will refer to and abide by the terms of the VCOM IRB Confidentiality Agreement. D URATION OF P OLICY The VCOM Procedure on IRB Review of Applications for HHS Support established by the Institutional Review Board is effective as of the date above and shall remain effective until amended or terminated by the President and the Dean. 6.