Rationale

With some exceptions, key documents in the ethics of clinical research such as the Nuremberg Code, Declaration of Helsinki, or the Federal Common Rule tend to define standards and almost universally accepted view that human research should always be conducted according to a specific set of ethical standards that differ in important ways from the standards of patient care. These standards have been almost universally adopted across the world. Because clinical research often grows out of patient care and is responsive to patient care problems and opportunities, the boundary between the domains of clinical practice and research is actually indefinite in individual cases. Relying on the Belmont report, however, it has been commonplace to assume that novel medical treatments or innovations in patient care should be formally evaluated in protocols that meet the ethical standards and procedures for protecting subjects of research.

It is commonly assumed among bioethicists that the only ethically sound process for legitimating innovation in medicine is through the application of the ethical standards for research. In this course, we will critically explore this belief and examine the conceptual, ethical, and policy foundations upon which it rests. We will explore this boundary within which medical innovations reside and address the ethical challenges and policy implications associated with deciding which standards should govern innovations in medical and healthcare. We will explore the ethical standards and conceptual boundaries of clinical practice and research and consider the goals of clinical practice and clinical research in relation to patient care. The persistence of the common belief that innovation is and should be evaluated in formal clinical research protocols has imposed a burden of high administrative costs in reviewing low risk studies and modifications designed to improve the quality of health care delivery that needs to be addressed.

We will review the basic ethical principles and procedures governing research with human subjects and discuss their application in specific examples of innovation in medicine. We will also discuss the basic concepts of risk-benefit identification, definition of what constitutes research or experimentation in the care of patients, informed consent standards and requirements, and ethical issues in study design, e.g., use of blinding, randomization, and placebos. By discussing illustrative case studies, we will also discuss common ethical problems in the design and conduct of clinical trials and, hopefully, develop an ethic of innovation that combines ethical standards and values implicit in clinical care and research.