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Graduate Course Proposal Form Submission Detail - GMS6805
Tracking Number - 1738

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Current Status: Approved, Permanent Archive - 2006-12-05
Submission Type:
Course Change Information (for course changes only):

Detail Information

  1. Date & Time Submitted: 2006-10-17
  2. Department: USF Health Office of Research
  3. College: MD
  4. Budget Account Number: 600105
  5. Contact Person: Sandra Anderson
  6. Phone: 45566
  7. Email:
  8. Prefix: GMS
  9. Number: 6805
  10. Full Title: Ethical and Regulatory Aspects of Clinical Research
  11. Credit Hours: 3
  12. Section Type: C - Class Lecture (Primarily)
  13. Is the course title variable?: N
  14. Is a permit required for registration?: N
  15. Are the credit hours variable?: N
  16. Is this course repeatable?:
  17. If repeatable, how many times?: 0
  18. Abbreviated Title (30 characters maximum): Ethics in Clinical Research
  19. Course Online?: -
  20. Percentage Online:
  21. Grading Option: R - Regular
  22. Prerequisites: Postdoctoral Status
  23. Corequisites: Permission of Instructor
  24. Course Description: This course addresses ethical and regulatory aspects of clinical research, specifically in relation to biomedical research that is patient-oriented. Instructor permission is required. The course is 3 credits and is not repeatable.

  25. Please briefly explain why it is necessary and/or desirable to add this course: This course has been developed to meet the requirements of a National Institutes of Health-sponsored program for training health professionals with the knowledge and skills necessary to conduct academic patient-oriented research. The course is required t
  26. What is the need or demand for this course? (Indicate if this course is part of a required sequence in the major.) What other programs would this course service? No course currently exists that comprehensively covers these topics for patient-oriented researchers. It is part of a required sequence to meet a concentration in Clinical and Translational Research in the Master of Science in Medical Sciences degree program in the College of Medicine. The course would only be available to other programs after consultation with the course director.
  27. Has this course been offered as Selected Topics/Experimental Topics course? If yes, how many times? Yes. One time.
  28. What qualifications for training and/or experience are necessary to teach this course? (List minimum qualifications for the instructor.) Minimum qualifications include either a PhD or an MD and experience in research, including certification in Research Ethics by USF.
  29. Objectives: Objectives: 1) discuss various biomedical topics and issues related to research integrity and ethics, 2) explain the regulatory and standard of care bases for past and current structure regarding the conduct of clinical research, 3) address teh importance of an individual's commitment to intellectual honesty and personal responsibility regarding biomedical research, 4) review the importance of moral character and experience to the conduct of human subjects research, 5) describe the expectation of one's institution to create an environment that promotes responsible conduct by embracing standards of excellence, trustworthiness, and lawfulness, 6) discuss the need for research integrity to include the traditional ideals of honesty, fairness and compliance with research guidelines and policies, as well as the goal of integrating one's work as a researcher with one's broader life experiences and values, and 7) provide numerous case studies in the biomedical literature that help to reinforce the practice of highly ethical and compliant research.
  30. Learning Outcomes: Students will be prepared to meet certification requirements for knowledge and attitudes in the ethical conduct of clinical research. They will be aware of the regulatory requirements and expectations for designing, carrying out and reporting clinical research studies.
  31. Major Topics: History of international agreements on ethics of human research; data acquition, management, sharing and ownership; mentor/trainee responsibilities; publication practices and responsible authorship; peer review; collaborative science; human subjects; studies involving genetic information or gene therapy; use of human tissues and samples in research; stem cell research; research involving animals; research misconduct; conflicts (real and apparent) of interest; confidentiality and HIPAA requirements.
  32. Textbooks: EJ Emanuel, RA Crouch, JD Arras, JD Moreno, & C Grady (eds). Ethical and Regulatory Aspects of Clinical Research, The Johns Hopkins University Press, Baltimore, 2003.

    RL Penslar (ed)., Research Ethics: Cases and Materials, Indiana Univ Press, Bloomington, 1995.

  33. Course Readings, Online Resources, and Other Purchases:
  34. Student Expectations/Requirements and Grading Policy:
  35. Assignments, Exams and Tests:
  36. Attendance Policy:
  37. Policy on Make-up Work:
  38. Program This Course Supports:
  39. Course Concurrence Information:

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