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Course Catalog

390.673.81 Ethical and Regulatory Issues in Clinical Research

Department:
Clinical Investigation
Term:
2nd term
Credits:
3 credits
Academic Year:
2017 - 2018
Location:
Internet
Auditors Allowed:
Yes, with instructor consent
Grading Restriction:
Letter Grade or Pass/Fail
Contact:
Franklin Adkinson
Course Instructors:
  • Franklin Adkinson
  • Norman Fost
  • Jennifer L. Dodson
Resources:
Prerequisite:

Introduction to Online Learning is required prior to participating in any of the School's Internet-based courses.

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.

Learning Objectives:

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

  1. Observe the ethical underpinnings of human subjects research
  2. Identify good clinical practices for clinical trials, including the use of standard operating procedures
  3. Identify the requirements and procedures for IRB approval of human subject research, including recent HIPAA regulations
  4. Integrate modern ethical standards and regulatory requirements into design of a clinical investigation
Methods of Assessment:

Student evaluation based on written homework assignments and a final paper

Instructor Consent:

Consent required for some students

Consent Note:

This course is geared toward GTPCI and SOCI students, however it is open to other scientists or clinicians.

For consent, contact:

fadkinso@jhsph.edu