VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004

9.6. Review by Institution Research covered by this policy that has been approved by the IRB may be subject to further appropriate review and approval or disapproval by the Provost and/or Dean(s) of College or other Officers. However, those officials may not approve or disapprove any research if it has not been approved by the IRB. 9.7. Outside IRB Authorization When a VCOM employee is engaged in multi-center research that involves human subjects, the VCOM employee must contact the VCOM IRB to determine if an institutional authorization agreement is in place or if additional agreements and/or additional IRB review is required. If the research has been reviewed by an outside IRB, the investigator must submit to VCOM IRB administration the other IRB determination letter and other documents as requested. In the case of an approval with no changes, the research may proceed once the PI receives written documentation of IRB approval. Unless otherwise specified, the approval period for research approved without changes is one year from the date of the meeting at which approval was granted. 10.2. Minor Modifications or Clarifications Required The IRB may determine that a study may be approved with minor modifications or clarifications. Minor changes are those changes that do not involve potential for increased risk or decreased benefit to the human subjects. Examples of minor changes are changes in contact information or identity of non-key research personnel, changes in the study title, and changes in the consent form that reflect the minor changes listed earlier. For minor changes, the IRB Chair, IRB Administration or a voting IRB member(s) designated by the Chair must ensure that the PI makes the appropriate changes to the research protocol. Such changes must be clearly delineated at the convened meeting so that subsequent review requires simple verification of concurrence. The research may proceed after the required changes are verified and the designated reviewer approves the protocol. The Chair, the primary reviewers, or a subcommittee may be assigned responsibility for reviewing the changes to ensure that the stipulated changes are appropriately addressed. The application receives final approval when all required changes have been submitted and approved. Unless otherwise specified, the approval period for research for which minor changes were stipulated is one year from the date of the last convened meeting at which the protocol was reviewed. 10.3. Deferral The term “deferral” (or “tabling”) is used to describe the situation in which the IRB determines that substantive modifications must be made before approval may be granted. The PI’s response, including any amended materials, must be reviewed by the convened IRB. Subject to IRB discretion, a protocol may be withdrawn if the PI does not respond to a deferral within a reasonable amount of time. If the PI wishes to conduct a study that has been withdrawn, he/she must submit a new application, incorporating comments from the prior IRB review. 10. ACTIONS FOLLOWING REVIEW 10.1. Approval of Research

VCOM Institutional Review Board Policies and Procedures

Page 20 of 40