Bridging the Gap Between Human Research Participants, Investigators & Research Sponsors.
Statement of Compliance
Opus Institutional Review Board, LLC provides ethical review and services to institutions,
principal investigators, sponsors, and contract research organizations, is organized and
operates in compliance with the U.S. Department of Health and Human Services and
U.S. Food and Drug Administration regulations for the protection of human subjects as
described in 45 CFR Part 46, 160, 164 and 21 CFR Parts 50, 56, 312 and 812 and adheres
to the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP)
guidelines for all international research or as requested by the sponsor, researcher
and/or the funding agency. In accordance with Federal regulations, Opus Institutional Review Board, LLC
has written standard operating procedures for the operation of the IRB as described in 45
CFR 46.103(b) (4) and (5), and the FDA guidance for IRBs and Clinical Investigators 1998,
Appendix H. In accordance with 21 CFR 56.106 and 45 CFR 46.106, Opus Institutional
Review Board, LLC is registered with the Office of Human Research Protection (OHRP)
and Food and Drug Administration (FDA) as IORG0005982 (IRB00007215). The Opus IRB
expiration date occurs on 08/18/2012.