Law and Ethics in Biomedical Research: Regulation, Conflict of Interest, and Liability

Alan Belk, Ph.D., is a sessional instructor in the Philosophy Department
at the University of Guelph.

This collection of 10 papers about research involving human subjects
addresses a number of important questions. How much influence should the
sponsor of a research project have on the project’s methodology and
outcome? How much information should be given to a person who volunteers
to become a research subject? Is there any way to resolve the various
conflicts of interest that emerge when the results of a research project
give rise to some marketable product? What compensation should medical
practitioners receive when they encourage their patients to become
research subjects?

Questions such as these arise in part because of the way in which
research in North America is funded. Typically, universities serve as
“partners” of sponsors. The person who pays the piper feels entitled
to call the tune. Drug manufacturers, for example, have no interest in
publishing results that will not help them to market a new product.
University researchers are often encouraged to start spin-off companies
to market the fruits of their research.

If people volunteer to become experimental subjects in gene
manipulation research, then they agree to undertake a risk, but what
sort of risk? In this kind of setup, conflict of interest is inevitable.
Ethics provides researchers with some guidance, but ethics itself exerts
only moral suasion. Apart from a professional or statutory obligation to
adhere to a code of ethics, researchers are not bound by a standard
ethical protocol. The only recourse left to injured subjects (or their
survivors) is the law.

If you are interested in these issues, you should read this book.