University of Texas, MD Anderson Cancer Center, Houston, TX.
Submitted by: Kristin Bialobok, RN, Manager, Research Administration.

The following information was submitted by the applicant for the award. The Institute may have edited the text for presentation purposes. Health Improvement Institute has not verified, and does not guarantee, the completeness or accuracy of the information for any purpose. Institutions interested in adopting or adapting the practice would be well advised to contact the person who submitted the application and to evaluate this and any additional information for their purposes.

Description: Clinical Research Training Program was developed by and facilitated through the University’s Office of Protocol Research Quality Assurance (OPRQA). In June 2002, the University of Texas M.D. Anderson Cancer Center (UTMDACC) approved the implementation of the Clinical Research Training Program for all faculty and fellows performing clinical research at the institution. The course provides detailed information regarding research ethics, informed consent process, rights of human subjects’ etc. The course focuses on the history and ethics of clinical research, federal regulations, good clinical practice guidelines, and institutional policies for research involving human subjects. The specific references addressed in the course include, for example, titles 21 and 45 of the Code of Federal Regulations. The President of the institution mandated that the faculty comply with this new requirement within one year. Any faculty member not fulfilling his/her obligation by the established deadline has had clinical research privileges revoked until successful completion of the competency tests.

Genesis: The curriculum for the Faculty Research Training Course was developed to address the most common deficiencies identified in audits conducted by the Clinical Trials Auditors in OPRQA during the years 2001 and 2002. The course was developed to improve the conduct of clinical trials, and result in increased data integrity and protection of human research subjects by overcoming the faculty’s lack of knowledge of federal regulations, good clinical practice, and local IRB policies and procedures.

Experience: The Faculty Research Training Course was launched on September 1, 2002. To date approximately 832 faculty and fellows have successfully completed the course.

Compliance: The need for this course was due to the increasingly complex regulatory environment for clinical research and the responsibility the institution has to educate researchers about proper conduct of clinical research.

Protection of human subjects: The presentations for this course were designed to assure and to improve human subject protection.

Monitoring and evaluation/outcomes: OPRQA conducted audits in 2001and 2002 and developed the faculty research-training program based audit results. Pre-and-post-course completion audits will be compared to determine the improvement in quality of clinical research.

Innovation: UTMDACC has a more comprehensive and in-depth training program when compared to some other institutions which allow computer-based self-learning activities to complete IRB and NIH mandated human subject protection education.

Replicability: This program could be adopted by any institution that conducts clinical research.

Applicant’s justification for award: UTMDACC is one of the only institutions in the country that provide a comprehensive clinical research-training program.

For additional information: Kristin Bialobok
Tel: 713-745-3421
Fax: 713-794-4589
Email: kmbialobo@mdanderson.org