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Graduate Course Proposal Form Submission Detail - GMS6875
Tracking Number - 2466

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Current Status: Approved, Permanent Archive - 2011-06-30
Campus: Tampa
Submission Type: Change
Course Change Information (for course changes only): GMS 6875 is currently a 3-credit course which is being reduced to 2 credits to bring it more in line with the new NIH/NSF guidelines for instruction in Ethics and Responsible Conduct of Research on federally-funded research projects. This change will also reduce the number of credits required for the concentration in Clinical and Translational Research in the MSMS degree program.
Comments: recd 3/11/11- returned to faculty column for editing. Re-submitted for review 3/17/11; Apprved 4/18/11. to USF System for concurrence 5/3/11; ready for SCNS 5/11/11; SCNS approved the course changes for GMS 6875, effective 8/1/2011. banner updated

Detail Information

  1. Date & Time Submitted: 2011-02-17
  2. Department: Medical Sciences
  3. College: MD
  4. Budget Account Number: 600105
  5. Contact Person: Sandra Anderson
  6. Phone: 8139745566
  7. Email:
  8. Prefix: GMS
  9. Number: 6875
  10. Full Title: Ethical and Regulatory Aspects of Clinical Research
  11. Credit Hours: 2
  12. Section Type: C - Class Lecture (Primarily)
  13. Is the course title variable?: N
  14. Is a permit required for registration?: Y
  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?: C - Face-to-face (0% online)
  20. Percentage Online: 0
  21. Grading Option: R - Regular
  22. Prerequisites: None
  23. Corequisites: None
  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 in required. The course is 2 credits and is not repeatable.

  25. Please briefly explain why it is necessary and/or desirable to add this course: Needed for program/concentration/certificate change
  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? This course serves as the required training in ethical conduct of research as designated by the National Institutes of Health for the USF Health Scholars in Patient-Oriented Research program. USF Health graduate students and/or postdoctoral fellows may request permission to enroll based on availability after Scholar enrollment.
  27. Has this course been offered as Selected Topics/Experimental Topics course? If yes, how many times? Yes, 1 time
  28. What qualifications for training and/or experience are necessary to teach this course? (List minimum qualifications for the instructor.) In addition to a doctorate degree, qualifications for teaching this course include experience in research and 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 the importance of an individual's commmitment 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 tha promotes responsible conduct by embracing standards of excellence, trustworthiness, and lawfulness, 6) discuss the need for research integrity to include the traditional ideals of honest, 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 acquisition, 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: Recommended 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: Suggested readings from the recommended texts will be assigned, in addition to class handouts and referrals to websites for resource materials relevant to course topics.
  34. Student Expectations/Requirements and Grading Policy: 1. Participation: Attend and participate at each class meeting (5 %)

    2. Reading Review and Analysis: Be prepared to lead one assignment and discuss accordingly (20 %)

    3. Presentations: Each student will research a case of scientific misconduct identified on the NIH website, present the case in class and turn in a 3-5 page write-up of the case (15 %)

    4. An Institutional Review Board visit and write-up: A scheduled visit will be required to the campus regulatory committee responsible for human biomedical research. One page review is required (10 %)

    5. Final Exam: A final examination on course material will be required at the end of the course and will be essay format (50 %)

  35. Assignments, Exams and Tests: Assignments consist of suggested readings from the recommended text.

    Videos provided by the Office on Human Research Protections are shown in class and discussed. Faculty present materials on the following topics which are covered on the final exam: (1) Scandals and Tragedies of Research with Human Participants: Nuremberg, the Jewish Chronic Disease Hospital, Beecher, and Tuskegee, (2) Ethical and Regulatory Guidance for Research with Humans, (3) The Ethics of Clinical Trial Design, (4) The Ethics of Research Participant Recruitment, (5) Informed Consent in Research, (6) Clinical Research with Special Populations, (7) Special Topics in Research Ethics such as genetic and stem cell research studies, (8) Research with Communities (9) The Behavior of Clinical Investigators: keeping research separate from routine care and conflicts of interest, (10) Challenges to the Institutional Review Board System.

    Case studies are presented and all students must attend and prepare a report on a USF IRB meeting. Students also present a summary on a reading assignment on research ethics and also a summary on a case report on research ethics.

    A written final exam is taken at the end of the course.

  36. Attendance Policy: Course Attendance at First Class Meeting is required unless student contacts Course Director prior to the first day and is given permission to be absent.

    Attendance Policy for the Observance of Religious Days by Students: In accordance with Sections 1006.53 and 1001.74(10)(g) Florida Statutes and Board of Governors Regulation 6C-6.0115, the University of South Florida (University/USF) has established the following policy regarding religious observances: (

    In the event of an emergency, it may be necessary for USF to suspend normal operations. During this time, USF may opt to continue delivery of instruction through methods that include but are not limited to: Blackboard, Elluminate, Skype, and email messaging and/or an alternate schedule. Itís the responsibility of the student to monitor Blackboard site for each class for course specific communication, and the main USF, College, and department websites, emails, and MoBull messages for important general information.

  37. Policy on Make-up Work: The student will contact the Course Director for instructions on any make-up work that is needed for the course. In addition, the following policy on Academic Integrity of Students Reference USF Regulation 3.027 from the following weblink applies as it pertains to graduate students:
  38. Program This Course Supports: MSMS and PhD with a concentration in Clinical and Translational Research
  39. Course Concurrence Information: Graduate students and postdoctoral fellows at USF Health, by course director permission.

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