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Session 6

Session 6

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

Scientific research is conducted to answer questions that are intended to promote the public's well-being. Scientific knowledge enables the development of valuable therapeutic, diagnostic, and prophylactic interventions. Knowledge about both the efficacy and harms of medical interventions is necessary to judge the utility of interventions. The successful development of one research procedure may enable the pursuit of scientific questions not previously possible or feasible.

Developments in our modern medical research environment threaten the pursuit of these objectives. They include deleterious influences of financial conflicts of research on the conduct of clinical research, the sharing of knowledge and research techniques, and the analysis and reporting of the results of research.

Objectives

1. To understand different types of intellectual property and explore the implications of the Bayh-Dole Act that permits the acquisition of patents by Universities whose faculty conducts research with public funds.
2. To understand the notion of a conflict of interest (individual and institutional).
3. To explore notions of secrecy in medical research.
4. To understand the many ways (overt and subtle) in which violations of publication ethics may occur.

Required reading for this session

• Secrecy in Medical Research, by Steven Rosenberg.
• Can Patents Deter Innovation? The Anticommons in Biomedical Research, by Michael A. Heller and Rebecca S. Eisenberg, published in Science.
• Understanding Financial Conflicts of Interest, from the NEJM.
• Institutional Conflict of Interest, from the NEJM.
• What is Research Misconduct?, a very informative discussion by Dr. Richard Smith, former Editor of the British Medical Journal. It includes definitions of research misconduct, including examples pertinent to the publication of research results.

Case for Discussion

An investigator has conducted genetic research for a number of years, having obtained IRB approval for several active protocols. Each involves the acquisition of human biological material and certain personally-identifiable information from individuals invited to participate in the research.

One of the protocols has been particularly fruitful, yielding information that may permit the development of a screening test for a gene associated with a particular form of cancer. Aware of the potential commercial value of such a test, he and several individuals create a start-up company after receiving pertinent advice from the University's Office of Technology Transfer. The latter Office and the Company execute a contractual agreement that involves a licensing arrangement whereby the Company is granted "access" to the tissue samples, and the University will receive license fees and also a share of potential profits in the form of royalty payments.

The previously collected samples are transferred to the Company's newly constructed, off-campus facility and the Company starts to solicit venture capital by, in part, advertising its possession of the tissue samples and associated "demographic and clinical data." It is anticipated that the investigator will apply for approval of additional research protocols involving human biological material in the future.

Questions

1. What concerns arise from the facts of this case with respect to the process whereby informed consent for the research was acquired from previously enrolled research subjects ? What are the implications for consent from potential participants in the ongoing research?
2. What individual and institutional conflicts of interest are derivative of the arrangement?
3. Should such conflicts of interest be prohibited by University policy ? Or, should identifiable conflicts of interest be "managed," and disclosed ? If so, how and to whom?

Additional resources

• The Bayh-Dole Act.
• Investigator-Industry Relationships by Dr. Thomas Bodenheimer, published in the NEJM.
• Washburn J. Hired education. American Prospect. January 2005.
• Keselheim AS, Avorn J. University-based Science and Technology Products. Defining the boundaries of intellectual property. JAMA. 2005; 293: 850
• Guidelines on Good Publication Practice, from the Committee on Publication Ethics.
• Responsible Conduct Regarding Scientific Communication, another informative guidance document, published by the Society for Neuroscience.

Let us not forget that progress is an optional goal, not an unconditional commitment, and that its tempo in particular, compulsive as it may become, has nothing sacred about it. Let us also remember that a slower progress in the conquest of disease would not threaten society, grievous as it is to those who have to deplore that their particular disease be not yet conquered, but that society would indeed be threatened by the erosion of those moral values whose loss, possibly caused by too ruthless a pursuit of scientific progress, would make its most dazzling triumphs not worth having.

Hans Jonas (1)

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