Core Documentation for the Web-based Assessment:
Belmont Report
45CFR46 Protection of Human Subjects
UTMB IRB Policies and Procedures Manual
FDA/International Conference on Harmonization - Good Clinical Practice standards
Optional Educational Opportunities:
Regulations & Ethics in Clinical Research Module within the course "Clinical Research: Tools and Techniques". For course registration or videos, contact the Clinical Research Education Office at creo.utmb@utmb.edu or extension x21484.
Why Research Became Regulated, Dr. Harold Vanderpool,
AUGUST 28, 2000.
[Discusses the historical evolution of current standards for ethical conduct of human subject research.]
Connecting Federal Regulations to Conducting Your Research, Dr. Cheryl Chanaud,
SEPTEMBER 11, 2000.
[Discusses the Federal regulations governing clinical research, including regulatory application forms, study subject protection, and study data documentation, and relates these to "real world" clinical research practice.]
Monitoring and Oversight at the Federal Level, Dr. Cheryl Chanaud,
SEPTEMBER 18, 2000.
[Discusses regulations governing oversight and monitoring of FDA and NIH studies; serious adverse event reporting; and case studies of common violations found during inspections or audits.]
Roles and Responsibilities of Institutional Review Boards, Dr. Frank Schmalstieg,
OCTOBER 2, 2000.
[Briefly traces the origin and ethical basis of IRBs and discusses the initial institutional review process for research protocols, along with the process for continuing review, adverse events, and amendments to protocols.]
The Belmont Report: Ethical Principles and Their Applications, Dr. Ronald Carson,
SEPTEMBER 25, 2000.
[Discusses current standards for ethical conduct of human subject research and outlines the basic principles of the Belmont Report.]
Sound Clinical Trial Practices in the Era of Gene Therapy, Satellite/Video Conference sponsored by the Center for Biologics Evaluation and Research of the FDA and the Drug Information Association. [Discusses why sound clinical trial practices are important, not only in gene therapy, but in all clinical trials; overall requirements for good clinical trial practices; and the FDA and NIH roles, perspectives and requirements.]
This 2.5 hour video is available for individual use via the Research Resource Library, Room 3.112 Administration Building, or Extension 23087.
Continuing IRB workshops presented by Dr. Wayne Patterson of the Office of Institutional Review Coordination.
Attendance at Clinical Research Skills Workshops for Investigators, as offered.
Attendance at professional meeting session, workshop, seminar, etc. where the educational topic of discussion is the ethical care and treatment of human subjects in research.
Principal Investigators are strongly encouraged to read UTMB's Multiple Project Assurance and the IRB Policies and Procedures Manual at http://www2.utmb.edu/irb/files-irb.htm .