In September 2012, the United States Department of Health and Human Services Food and Drug Administration's (FDA) Office of Counterterrorism and Emerging Threats (OCET) and the University of Texas Medical Branch at Galveston entered into a collaborative
educational partnership for the academic development of a robust training program for good laboratory practices in high-biocontainment environments. The implementation of problem-based learning techniques encouraged researchers and regulators to cross-educate
each other on the challenges related to the conduct of regulated studies in biological safety level 4 (BSL-4) laboratories and identified solutions that were acceptable from scientific and regulatory perspectives. The result was the development of
a face-to-face course entitled Achieving Data Quality and Integrity in Maximum Containment Laboratories and an additional online companion course covering the FDA regulation, Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR Part 58). The course offers a unique opportunity for members of the regulatory and scientific communities to solve complex issues in an interactive educational environment, especially for the advancement of medical countermeasures (MCMs) via
the FDA Animal Rule (21 CFR Parts 314 and 601 (2002)).
In 2017, the collaborative educational program expanded by developing a partnering course entitled Achieving Data Quality and Integrity in Clinical Trials Involving High Consequence Pathogens and in 2021 an online companion course
covering Good Clinical Practices.
The overall goal of this unique educational program is to provide a learning environment that promotes collaboration of ideas, provides tools for clinical study conduct, enhances mutual understanding of clinical, scientific and regulatory complexities,
and promotes the data quality and integrity derived from these regulated studies. The result is a better prepared, cohesive community of clinical, scientific and regulatory
experts mutually engaged in, and committed to, the research, development, and regulatory evaluation and approval of medical countermeasures for high consequence pathogens.