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Instructor Class Description

Time Schedule:

Anna C. Mastroianni
LAW H 536
Seattle Campus

Research Ethics and Regulation

Explores the ethical foundations, principles and concepts, and U.S. laws related to the conduct of research with human subjects. Required for graduate students in the Department of Bioethics and Humanities, School of Medicine. Offered: jointly with B H 536; W.

Class description

This is a graduate-level seminar course designed to explore important history, relevant principles and regulations, and emerging issues in research ethics. Through a combination of lectures and small-group discussions, this course provides a historical perspective and presents the current ethical and legal issues and debates that arise in the following three areas: (1) research involving human participants; (2) the responsible conduct of research; and (3) research conducted with animals. Frameworks for ethical analysis will be introduced.

Grades in the course will be based on two analytic writing assignments and class participation, which will include weekly posts (for 6 designated weeks) on a class blog. There are no prerequisites. This course will provide critical knowledge to students who are pursuing the study of ethics and law in health-related fields or who plan to work in medical, public health, or biotechnology-related settings. This course fulfills a requirement for the health law concentration in the School of Law and is an elective for graduate students, including nursing and law students.

Student learning goals

Describe current debates in research ethics

Identify landmark cases in the history of ethical and legal debates related to the conduct of research;

Become familiar with relevant federal regulations and international guidelines;

Analyze implications of history for present research practices and policy; and

Learn a principle-based and a relationship-based approach to research ethics.

General method of instruction

Recommended preparation

Class assignments and grading


1. CLASS ATTENDANCE AND PARTICIPATION including close attention to the assigned readings and respectful discussion.


Each student is required to post comments and questions to the Course Blog for six designated assignments, as indicated on the Course Blog ( The purpose of the posts is to foster discussion and questions on the readings before class so that we can make the best use of our class time together. The instructor will share questions to guide the readings and foster discussion on the blog. Students will be required to submit at least two (2) questions or comments on the assigned readings. Postings will be due on the Friday before class by noon (12:00 pm) to give the instructor time to respond and incorporate the content into the plan for using class time. Questions and comments posted on the class blog will be used to organize and guide in-class discussions.


Two 4-5 page case analyses are required. For the first case analysis, bring a hard copy of your draft to class February 17, with the final paper due no later than February 18 at 4 pm (via email). For the second case analysis, bring a hard copy of your draft to class on March 10 with, with the final paper due no later than March 11 at 4 pm (via email). For each case analysis, you will be given a case raising an ethical issue in research, and will be asked to: (1) review the details of the case using a research ethics framework presented in the class; (2) identify relevant legal, regulatory and ethical considerations raised by the case; (3) provide a brief review of relevant literature and opinion on those issues; and (4) make and justify a resolution to the case. Papers are to be double-spaced, with one-inch margins all around, page numbers, and written in 11-point Times New Roman font.


Each student is required to write a 1-page statement of learning goals and expectations for the class. This learning contract is due at the start of class on January 13. At the end of the quarter, students will write an additional 1-page statement reflecting on personal lessons from the course. What are you taking away from this seminar? What helped your understanding the most? How were your learning goals met? Due March 15 at 4 pm, to be submitted via email to with a copy to to

Total 100% 400

Grading: The distribution of grade percentage and points is as follows:

Class attendance and participation 30% 120 Weekly postings to the course blog 30% 120 Short paper 1: Case analysis 20% 80 Short paper 2: Case analysis 20% 80 Learning contract & self evaluation C/NC C/NC

The information above is intended to be helpful in choosing courses. Because the instructor may further develop his/her plans for this course, its characteristics are subject to change without notice. In most cases, the official course syllabus will be distributed on the first day of class.
Additional Information
Last Update by Anna C. Mastroianni
Date: 01/05/2009