Course: Ethics of Human Subject Research

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Syllabus

Please note that this course does not fulfill the NIH or the JHSPH requirement for training in the responsible conduct of research.

Course Description

Ethics of Human Subject Research (2 credits) is offered by the Department of Health Policy and Management and the Distance Education Division, Johns Hopkins Bloomberg School of Public Health and The Phoebe R. Berman Bioethics Institute, Johns Hopkins University. The course introduces students to the ethics of human subject research. Ethical theory and principles are introduced, followed by a brief history of research ethics. Topics covered in lectures and moderated discussions include informed consent for research participation, role and function of institutional review boards, just selection of research subjects, ethical aspects of study design, and privacy and confidentiality. Student evaluation will be based on participation in moderated discussions, an informed consent exercise and written case analysis.

Course Objectives

After completion of this course, you will be able to:

  • Discuss the principles of bioethics and how these principles should be applied the ethical conduct of human subject research.
  • Identify, define, and analyze ethical issues in the context of human subject research.
  • Identify, through case studies, ethical issues that arise in different contexts and begin to reason through an appropriate course of action.
  • Draft informed consent forms.

Readings

Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary . Edited by: Ezekiel Emanuel, Robert Crouch, John Arras, Jonathan Moreno and Christine Grady. Johns Hopkins University Press 2003.

This text can be ordered through:

Matthews Johns Hopkins Medical Book Center
1830 East Monument Street
Baltimore, MD 21205 USA
410.955.3931
800.266.5725
410.955.0576 Fax
http://www.cbamatthews.com/jhmedbook/

Course Format

The first week of the course will focus on ethical theory and a review of historical and contemporary issues in research ethics. Weeks two through six will cover substantive issues relevant to the conduct of human subject research. During weeks seven and eight students will choose whether to be engaged in an in-depth exploration of research with children or ethical issues in genetics research.

Course Topics

  • Ethical theory and principles
  • History of research ethics
  • Contemporary issues in research ethics
  • Balancing the benefits and harms of participation in research
  • Ethical issues in study design
  • Informed consent in research
  • Institutional Review Boards
  • Selection of research participants
  • Ethical issues in vaccine research