Authority of the IRB

 

eMedicus, Inc. established the eMedicus Institutional Review Board in 2001. 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 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 an appropriately constituted group that has been formally designated to review and monitor research involving human subjects. The IRB has statutory authority to take any action necessary to protect the rights and welfare of human subjects participating in research. In accordance with the FDA regulations, the IRB has the authority to approve research, require modifications to research (in order to secure approval), or disapprove research.

The IRB has the authority to suspend or terminate the enrollment and/or ongoing involvement of human subjects in research as it determines necessary for the protection of those subjects. The IRB has the authority to observe and/or monitor the human subject research to whatever extent it considers necessary to protect human subjects (21 CFR 56.109(a)).

The primary purpose of the review by the eMedicus Institutional Review Board is to ensure that the rights and welfare of subjects are protected. In doing so, the IRB must ensure that the human subject research is conducted ethically and is in compliance with the applicable regulations of the U.S. Food and Drug Administration (FDA) and the requirements of applicable state laws. To accomplish this, the IRB performs prospective and continuing reviews of the human subject research including reviews of the protocol, the informed consent, the informed consent process, and the procedures used to enroll subjects.

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