COURSE DESCRIPTION 2012 2013

Medical Research Ethics and Law

Ms. Nancy R. Rice,

2 credits day; 2 credits evening.

Medical research is an exciting, fast-moving scientific and business activity, with competing interests that require legal protection and public policy consideration. This course will look at the legal and ethical issues affecting those who sponsor and conduct medical research and those who volunteer as research subjects. How do law and public policy prevent fraud in research and manage conflicts of interest to protect patients? Who is responsible for the quality and safety of the clinical trials? Should research subjects be paid to participate in trials? How should wealthy nations conduct human trials in underdeveloped countries? Who can legally consent to participating in research? The course looks at the role of the federal and state agencies in promoting and protecting the quality of research and the role of the Food and Drug Administration in the development of new drugs, biologics and medical devices. Course requirements include participation in a mock ethics research review meeting, two short oral research reports, and a final examination. This course should be particularly useful for students interested in health law, life sciences, medical-legal ethics, administrative law and public policy. There are no prerequisites. Course Introduction Medical research is a growth industry, involving the development and testing of new drugs and other therapies in human volunteers. Medical research is also a very active field for lawyers, whose services are required to resolve disputes, advise on the ethics and regulations affecting clinical trials, develop licensing and other agreements that support the clinical trial activities, secure government approvals of new therapies, and to prosecute and defend clients in various law enforcement initiatives.

This course examines the legal interests and ethical challenges that surround this industry. The course begins with the legal issues involved in protecting the quality of scientific discoveries, and then moves from the laboratory to the health care arena, where the new therapies are tested in highly regulated clinical trials, involving both healthy and sick children and adults. The course will examine legal and ethical issues involved in clinical trials, including limitations on clinical study design, the protection of privacy, the recruitment of subjects with significant educational or cultural differences, the requirements of informed consent in the research setting, the management of financial conflicts of interest that could infect research results, and the role of state and federal agencies in regulating new therapies. In this field there are often several valid competing interests, which give students the opportunity to consider problem-solving alternatives and techniques.

Although this course uses a single business activity as a basis for developing legal talents, it is in many respects a survey course, involving a wide variety of legal themes. Students will have an opportunity to examine topics of particular interest in more detail and share their findings and observations in two short oral reports.

Elective Course

Meets Health/Biomedical Concentration Requirements

Take Home Exam Required