The eMedicus Institutional Review Board is organized and operates in compliance with FDA regulations 21 CFR Parts 50, 56, 312 and 812, DHHS regulations 45 CFR 46, the International Conference on Harmonization (ICH) E6 and Good Clinical Practice (GCP), as applicable.
The eMedicus Institutional Review Board is duly constituted, has written policies and procedures for the operation, conduct of clinical trials, and initial and continuing review, prepares written minutes of convened meetings, and retains records pertaining to the review and approval process.
The eMedicus Institutional Review Board reviews research in compliance with other federal and state laws and regulations governing institutional review boards and research with human subjects.
In addition, the eMedicus Institutional Review Board operates in compliance with portions of the Health Insurance Portability and Accountability Act of 1996 that apply to research, as described in 45 CFR Parts 160 and 164.
The eMedicus Institutional Review Board has a Federal Wide Assurance (FWA) #00010908. The eMedicus Institutional Review Board is registered with OHRP/FDA; our IRB Registration numbers are IRB00005758 (IRB #1-FWA), IRB00007808 (IRB #2-FDA) and the parent organization number is IORG0004831.
If you have any questions or require additional information, please contact the eMedicus Institutional Review Board at 781-275-3403.
Click here to download our Statement of Compliance pdf.
