ETHICAL AND REGULATORY ISSUES IN CLINICAL RESEARCH Syllabus

390.673.01 | AY 2013-2014 - 1st Term | 3 Credit(s)
M 5:30:00 PM
  • Contact Information
    Faculty
    Franklin Adkinson
  • Course Learning Objectives

    Upon successfully completing this course, students will be able to:

    • Observe the ethical underpinnings of human subjects research
    • Identify good clinical practices for clinical trails, including the use of standard operating procedures
    • Identify the requirements and procedures for IRB approval of human subject research, including recent HPPA regulations
    • Integrate modern ethical standards and regulatory requirements into design of a clinical investigation
  • Course Description
    Explores and examines the ethical issues central to clinical research, reviews current regulations for clinical investigation, promotes understanding of the function and procedures of Institutional Review Boards, and better appreciation of the role of good clinical practices for clinical trials.

    Additional Faculty Notes:

    Once again we are fortunate to have as a Visiting Professor for this course,  Norman Fost, M.D., MPH.  Dr. Fost is Professor of Pediatrics at the University of Wisconsin, Director of the Program in Medical Ethics there, and longstanding Chair of both the Hospital Ethics Committee and the School of Medicine IRB.   Dr. Fost's extensive experience in ethical and regulatory issues in human subject research is combined with  provocative teaching dialogues to stimulate much thoughtful class discussion on the ethical underpinnings of the modern regulation of clinical reearch.  Dr. Fost will travel to Baltimore to participate personally in 6 of the 8 course sessions. 

     

     

  • Intended Audience
    Scientists, clinicians, or support personnel fully engaged in clinical investigation

    Additional Faculty Notes:

    This course is offered as part of the Science of Clinical Investigation (SOCI) Training Program.  These courses are suitable for any participants in the clinical research enterprise, including clinical coordinators, research nurses and technicians, regulatory personnnel and IRB members, clinical trainees and physician-investigators.  Some ongoing experience with clinical research will be helpful.

    In additional the course is a core curriculum requirement for the GTPCI graduate programs, both MHS and PhD.  Only graduate students in these programs can take this course for academic credit. 

  • Methods of Assessment
    Student evaluation based on written homework assignments and a final paper
  • Prerequisites

    Additional Faculty Notes:
    No course pre-requisites.  Some knowledge of or experience with clinical invesgigation will be an asset.

  • Course Schedule

    Please see the course Session for a full list of dates and items for this course.

  • Files from the Online Library
  • Academic Ethics Code

    Students enrolled in the Bloomberg School of Public Health of The Johns Hopkins University assume an obligation to conduct themselves in a manner appropriate to the University's mission as an institution of higher education. A student is obligated to refrain from acts which he or she knows, or under the circumstances has reason to know, impair the academic integrity of the University. Violations of academic integrity include, but are not limited to: cheating; plagiarism; knowingly furnishing false information to any agent of the University for inclusion in the academic record; violation of the rights and welfare of animal or human subjects in research; and misconduct as a member of either School or University committees or recognized groups or organizations.

  • Course topics
    Please consult the course syllabus for topic listings and schedule.
  • Contact Information(from old syllabus)

    Norman Fost, M.D., M.P.H
    Email: ncfost@wisc.edu
    Tel: 608-263-8562

    Fred Luthardt, MA
    Email: fluthard@jhmi.edu
    Office: 4940 Eastern Ave 310 B
    Tel: (410) 550-1850

  • Course Objectives(from old syllabus)

     To familiarize students with the basic ethical and regulatory principles that guide research involving human subjectsThis will be accomplished primarily through the assigned readings; reading of the Common Rule (45 CFR 46); and the homework assignments. Additional material is available as “Supplementary Readings,” identified in the syllabus, and in designated chapters of the Levine book.

    To develop critical thinking skills addressing the problems and limits of the standard ethical principles and regulations.   This will be accomplished primarily through the class discussions. These discussions will generally not review the readings. The discussions are intended to raise doubts and uncertainty about the conventional wisdom on current ethical and regulatory issues.

  • Disability Support Services
    If you are a student with a documented disability who requires an academic accommodation, please contact the Office of Student Life Services at 410-955-3034 or via email at dss@jhsph.edu.