Research Committee Organization, the Proposal Review Process and Adverse Event Reporting: An Informative Report on Research within a VA Medical Center

The recent integration of chiropractic services into the Veterans Health Administration has provided the opportunity for doctors of chiropractic to contribute to scientific advancement in the role of principle investigator in both funded and non-funded VA sponsored research. Further, doctors of chiropractic have had the privilege of contributing to the oversight and shaping of the research process as a whole through local research committee involvement. The purpose of this informative report is to provide an understanding of the research infrastructure at a VA Medical Center regarding both the Research and Development Committee (R&D) and the Institutional Review Board (IRB) and the standard operating procedures for human subject research of these respective committees. The steps followed in the research proposal review process for both local and multi-site studies will be discussed covering the roles and responsibilities of both the R&D Committee and the IRB. Consistent with the annual meeting topics of interest, emphasis will be placed on descriptions of adverse events (AE's), unexpected/unanticipated adverse events (UAE's), serious adverse events (SAE's), and the current requirements for documenting and reporting AE's within VA research studies.