Responsible Conduct of Research - Human Subjects Research

Howard Mann, M.D.,
Program Associate, Division of Medical Ethics and Humanities

The destination of research is essentially melioristic. It does not serve the preservation of the existing good from which I profit myself and to which I am obligated. Unless the present state is intolerable, the melioristic goal is in a sense gratuitous, and not only from the vantage point of the present. Our descendants have a right to be left an unplundered planet; they do not have a right to new miracle cures

Hans Jonas  (Philosophical reflections on experimenting with human subjects. Daedalus Spring, 1969.)

Education in the responsible conduct of research traditionally addresses the following areas of interest: the collection, analysis and management of data; mentoring and collaboration in the laboratory; responsible authorship, peer review and publication of research results; scientific misconduct; intellectual property and conflicts of interest; and the use of animals and human subjects in research.

This course will provide an overview of ethical, regulatory and scientific issues pertinent to the responsible conduct of clinical research involving human subjects.

This course will attend to the didactic and the practical: ethical principles and regulatory imperatives pertinent to human subjects research will be reviewed, and this will be supplemented by an opportunity for case discussions and explorations of contentious issues prevalent in the modern research environment. To facilitate the latter, each session will be associated with an actual or hypothetical clinical scenario(s), and pertinent articles. Selected online references and suggestions for additional reading are provided.

The course comprises the following sessions :

I. What makes clinical research ethical ?

II. What is research and when does it involve a human subject ?

III. Harm-benefit assessment in the design and review of clinical research protocols.

IV. A. Expectations and obligations in the relationship between the investigator and research   participant. 
      B. The ethics of research participant recruitment.

V. Ethical issues in community-based and international clinical research.

VI. Science in the public interest : intellectual property, conflicts of interest and publication ethics.

This course is catalogued as MDCRC 6430 (University of Utah), Bioethical Issues in Clinical Research, conducted as part of the Masters in Clinical Investigation Program, starting in July each year.

Participants may take the course for University credit or Sessions for audit purposes. If you are interested in the latter, please contact : Howard.Mann@hsc.utah.edu in advance, stating the nature of your interest.

Recommended book to supplement online material : Emanuel, Crouch, Arras, et al. Editors. Ethical and regulatory aspects of clinical research The Johns Hopkins University Press. 2004.

Recommended fiction book for Summer Reading : Intuition, by Allegra Goodman

Note concerning course articles provided online : This online course provides copyrighted material the use of which has not always been specifically authorized by the copyright owner. I am making this material available specifically and exclusively for non-profit educational purposes. I believe this constitutes "fair use" of any such copyrighted material as provided for in section 107 of the US Copyright Law. In accordance with Title 17 U.S.C. Section 107, the material on this site is distributed without profit to those who have expressed a prior interest in receiving the included material for educational purposes. For more information, go to: http://www.law.cornell.edu/uscode/17/107.shtml.

If you wish to use copyrighted material provided on this page for purposes of your own that go beyond "fair use," you must obtain permission from the copyright owner.

Return to Division Activities
Return to the Division's Home Page