Major in Clinical Research Regulation & Ethics - Beginning Fall 2008

Beginning in the fall of 2008, the University of Florida offers a part-time online major in Clinical Research Regulation and Ethics (CRRE) within the Master of Science in Pharmacy program.  This major provides students with the opportunity to better understand regulatory and ethical aspects of experimentation with human subjects.  Courses in the program are taught by national content experts.  Courses are taught using a distance-learning format, thus students do not need to relocate to earn this degree.

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Background

The CRRE major was developed as a response to student demand based on a survey of University of Florida students and graduates.  These prospective students aspire to be clinical investigators, Institutional Review Board members or staff, government agency employees, pharmaceutical industry research liaisons, and study coordinators.  The program takes two years for students to complete.  All online courses are 7 weeks in length and are taken sequentially; two courses per semester.  Online courses use Electronic Learning System (a University of Florida adaptation of WebCT Vista) as the learning platform and Elluminate for live online classes.  Individual courses are available to those who wish to acquire limited specialized knowledge without making a commitment to the complete program.  All students must attend three weekend seminars in Gainesville during the course of their two years of study.

Program Goals

Regulatory and ethical barriers exist to the application of scientific knowledge in the clinical care of patients, and appropriately so.  A shameful history of human beings using other human beings as objects in unnecessary studies masquerading as science has let the human community to adopt specific regulatory and ethical standards that control what can be done by investigators who use human subjects in their research.  Some of the regulations and ethical standards are daunting and they may thwart the conduct of appropriate research by those who do not understand them.  The CRRE program is committed to providing education for all those involved in the transfer of knowledge from bench science to the clinical setting, and from the clinic to the laboratory, to assure that all necessary safeguards for human subjects are observed, and that no research is stifled by misunderstandings of the applicable regulatory and ethical criteria.

Courses in the curriculum:

• Structure, Process & Outcomes of Regulation
  
  
• Federal Regulation of Drugs & Pharmacy
  
  
• The Use & Abuse of Statistics
  
  
• Research Methods
  
  
• Ethics of Drug Production, Distribution & Use
  
  
• Regulation of Clinical Research
  
  
• Research Ethics
  
  
• Pharmaceutical Products & Public Policy
  
  
• Practices & Procedures of the IRB
  
  
• Pharmaceutical Outcomes & Policy Seminar

Schedule