Bluebonnet Ethical Review Board, an independent IRB located in Lockhart, Texas, established in 2021. Bluebonnet Ethical Review Board is committed to meeting rigorous standards for quality and maintaining sound policies and procedures involved in the protection of human research participants. Designed to accelerate the IRB process without compromising accuracy or the protection of human subjects, Bluebonnet Ethical Review Board delivers study documents to the Investigator, Sponsor and/or CRO in an efficient and timely manner.

 

Written standard operating procedures govern Bluebonnet Ethical Review Board for initial, continuing, full board, expedited and exempt review of clinical, and social-behavioral research studies. Bluebonnet Ethical Review Board complies with the regulations as defined in the United States Food and Drug Administration (FDA), Code of Federal Regulations, Title 21, Parts 50, 56, 312 and 812, International Conference on Harmonization (ICH) Guidelines for Good Clinical Practices, E6, the Department of Health and Human Services (DHHS) regulations as identified in the Code of Federal Regulations, Title 45, Part 46, the 2018 Common Rule, other federal agencies and regulations as applicable, as well as local and state laws.