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.

 

Bluebonnet Ethical Review Board operates under comprehensive written standard operating procedures that govern the initial and continuing review, including full board, expedited and exempt determinations, for clinical, and social-behavioral research studies. Bluebonnet Ethical Review Board is in full compliance with applicable regulations, including:

 

• U.S. Food and Drug Administration (FDA) regulations: 21 CFR Parts 50, 56, 312 and 812

 

• U.S. Department of Health and Human Services (DHHS) regulations: 45 CFR Part 46

 

• The 2018 Common Rule

 

• International Conference on Harmonisation (ICH) Guidelines for Good Clinical Practices (ICH E6[R3]

 

• Other applicable federal agency requirements, as well as local and state laws

 

Bluebonnet Ethical Review Board adheres to the principles outlined in ICH E6(R3) to ensure ethical conduct, data integrity, and participant safety across all phases of research oversight.