MCB293C: Responsible Conduct of Research

MCB293C - RESPONSIBLE CONDUCT OF RESEARCH

Instructor: Howard K. Schachman

231 Hildebrand Hall, Phone 642-7046 Fax 642-8699

Spring 2007

COURSE DESCRIPTION

Courses on the Responsible Conduct of Research generally focus primarily on the ethical transgressions of individual scientists with startling admonitions from the literature like "Stop Misbehaving". Often these courses deal with hypothetical cases posing dilemmas that research workers, and especially students, might face during their careers. Unfortunately there is no need to deal with fictionalized situations because, regrettably, there are too many examples of actual research misconduct. These are described with alarm in the press. Although detailed discussion of them is valuable and indeed essential, focusing on the fraudulent activities of scientists alone will not suffice if we are to attain our goal of achieving and maintaining highly ethical research practices.

In this course, mandated by the National Institutes of Health (NIH) for all graduate students and post-doctoral fellows supported by NIH Training Grants or Fellowships, we will consider not only the unethical behavior of scientists but also the roles of others who must be engaged in efforts aimed at enhancing scientific integrity. Hence we will inspect the actions and obligations of administrators in the universities where research is conducted, along with the requirements imposed by companies contributing funds for the support of research in these academic institutions. The policies of government agencies in fostering, sponsoring and regulating research and in investigating research misconduct will be analyzed. In addition we will examine the responsibilities of professional societies in developing ethical standards, the practices of editors of journals in which scientific findings are published, and the roles of journalists, newspapers, and authors of books in terms of their effect on the public perception of the ethics of scientific research. The obligations of these various groups differ, but all of them are implicated in this joint effort aimed at improving the integrity of scientific research and the public's perception of that research.

A brief history of government investigations of fraud in science will be presented along with subsequent actions over the following 20 years leading to the requirement of a course on Responsible Conduct of Research. The culture of science and misperceptions of the public will be discussed. Since the principal focus is on misconduct in research, we will deal with the definition of research misconduct and an analysis of some cases of horrible behavior by scientists that attracted widespread attention in the popular press and in the halls of the United States Congress. Discussions of government activity will also address the overreaching and unproven allegations that have damaged reputations and undermined scientific research. Some cases and their impact will be described. Issues of authorship and sharing data will be treated in conjunction with scrutiny of conflict of interest issues stemming from the different motivations of scientists, university administrators, and managers in industry.

Over the past few years there has been a striking increase in adverse publicity about the ethics of scientists resulting largely from notorious cases involving fabrication and falsification of important research findings. These cases involve scientists in diverse disciplines and different countries, and they have stimulated inquiries about the extent of such intolerable research along with proposals of remedies. This recent focus has expanded to encompass surveys and discussions of "misbehavior" and "questionable practice". Moreover, because so much scientific research in biology is now on the front pages of daily newspapers and reports on TV, the scrutiny is more intense. In some respects biology has replaced physics in the political discourse by the public, and questions have now arisen about the ethics of publishing "sensitive" findings in so-called "dual use" research. Deliberations in the general area of bio-terrorism are now generating new problems in defining Responsible Conduct of Research along with the potential imposition of new regulations. These issues will be examined and provocative papers will be assigned for student critiques.

Attempts to understand the dramatic changes in the conduct of biomedical research in academia and the radically altered position of universities toward patenting discoveries must deal with the impact of the Bayh-Dole Act of 1980 and the seminal paper in 1968 by the biologist, Garrett Hardin, entitled "The Tragedy of the Commons". This paper, which has had a tremendous impact on most areas of society, will be discussed along with the Bayh-Dole Act which, while fostering the development of the remarkable and highly productive biotechnology industry, has also had a marked effect on the research and openness in universities. Numerous papers and books by prominent biomedical scientists, administrators, editors and journalists have been devoted to the commercialization and changing culture of universities. Increasingly questions are being raised as to whether the change from publishing to patenting is actually inhibiting research progress. Examination of the legitimacy of patents of biological tools is now a contentious issue and a major focus of deliberations by those concerned about Responsible Conduct of Research.

The course composed of six 2-hour sessions covers many, but not all, of the areas of ethical concerns in biomedical research. In five sessions there will be lectures, and a sixth will be devoted to discussion of papers and issues raised by students. Students will be asked to analyze 10 case studies in the areas of Mentoring, Authorship, Conflict of Interest, Intellectual Property, and Record Keeping. The case studies were taken from the book, "Scientific Integrity" by Francis L. Macrina. About 6 different hypothetical situations for each area are provided, and students will select 2 cases in each of the 5 areas for analysis. Additional assignments requiring critical reading of selected articles will be given at each session. Even though the large enrollment is not conducive to discussion, students are invited to raise issues in class, after class, by e-mail or at my office.

The Berkeley Campus does not have a medical school, and there is comparatively little research involving human subjects. Nevertheless, this area is covered in terms of privacy, confidentiality, and risks to subjects through the use of one-hour videos on subjects entitled "Who Gets to Know? Genetics and Privacy"; and "Genes on Trial: Genetics, Behavior, and the Law". These Fred Friendly Seminars involving outstanding panelists are educational, stimulating and entertaining. They focus on basic ethical issues such as: When it comes to genetic testing, how much should a patient be told? Could or should privileged information be made available to employers and insurance companies? Could genetic research stigmatize people who carry a "bad" gene? Can behavior of individuals be determined by "bad" genes? Is there free will? Who should make such determinations? A Nova Film entitled "Secret of Photo 51; Meet the Unsung Heroine Beyond the Discovery of DNA's Double Helix" will be shown in order to deal with issues of confidentiality, priority and publication practices.

The major issues on Responsible Conduct of Research are summarized here, but it should be emphasized that not all of them will be considered.

Research Misconduct

Fabrication

Falsification

Plagiarism

Publication Practices

Authorship

Citing Previous Work

Access to Data

Sharing of Data

Retention of Data

Ownership of Data

Collaborative Research

Mentor – Trainee Relationships

Peer Review

Scientific papers

Grant Applications

Confidentiality of Proprietary Information

Treatment of Human Subjects

Conflict of Interest and Commitment

Publishing versus Patenting

Privatization of Academic Institutions

Addressing Suspected Misconduct or Errors

Protection of Whistleblowers

Humane Care and Use of Laboratory Animals

Use and Disposal of Hazardous Materials

Bibliography

Watson, James D (1968) The Double Helix, Atheneum

Broad, William and Wade, Nicholas (1982) Betrayers of the Truth: Fraud and Deceit in the Halls of Science, Simon & Schuster, Inc.

Kohn, Alexander (1986) False Prophets: Fraud and Error in Science and Medicine, Basil Blackwell Ltd.

Klotz, Irving (1986) Diamond Dealers and Feather Merchants: Tales from the Sciences, Birkhauser

Djerassi, Carl (1991) Cantor's Dilemma: A Novel, Penguin Books

Grinnell, Frederick (1992) The Scientific Attitude (2nd ed.), The Guilford Press

LaFollette, Marcel C (1992) Stealing into Print: Fraud, Plagiarism, and Misconduct in Scientific Publishing, University of California Press, Los Angeles

Committee on Science, Engineering, and Public Policy (U.S.), Panel on Scientific Responsibility and the Conduct of Research, National Academy of Sciences, National Academy of Engineering, Institute of Medicine, Responsible Science, Volume I: Ensuring the Integrity of the Research Process (1992), Responsible Science, Volume II: Background Papers and Resource Documents (1993), National Academy Press

Sarasohn, Judy (1993) Science on Trial: The Whistle-blower, the Accused, and the Nobel Laureate (1st ed.), St. Martin's Press

Korenman, Stanley G. and Shipp, Allan C. (1994) Teaching the Responsible Conduct of Research through a Case Study Approach, Association of American Medical Colleges

Penslar, Robin Levin, ed. (1995) Research Ethics: Cases & Materials, Indiana University Press

Kevles, Daniel J. (1998) The Baltimore Case: A Trial of Politics, Science, and Character, W. W. Norton & Company

Macrina, Francis L.(2000) Scientific Integrity. An Introductory Text with Cases (2nd ed.), American Society for Microbiology Press

Sabbagh, Karl (2001) A Rum Affair: A True Story of Botanical Fraud, De Capo Press

Institute of Medicine, National Research Council, (2002) Integrity in Scientific Research. Creating Environment That Promotes Responsible Conduct, The National Academies Press

Bok, Derek, (2003) Universities in the Marketplace, Princeton University Press

Judson, Horace Freeland, (2004), the Great Betrayal: Fraud in Science, Harcourt, Inc.

Steneck, Nicholas H (2004) ORI; Introduction to the Responsible Conduct of research, US Government Printing Office

Shuchman, Miriam, (2005) The Drug Trial: Nancy Olivieri and the Science Scandal that Rocked the Hospital for Sick Children, Random House Canada

Kassirer, Jerome P. (2005) On the Take: How Medicine's Complicity with Big Business Can Endanger Your Health, Oxford University Press

Washburn, Jennifer, (2005) University, Inc. The Corporate Corruption of American Higher Education, Basic Books

Goodman, Allegra, (2006) Intuition, Dell Press

Crichton, Michael, (2006) Next, Harper Collins

Recent Ethical Crisis at NIH

• The Los Angeles Times (December 7, 2003) Drug Companies and Government Medical Research; Some of the National Institutes of Health's top scientists are also collecting paychecks and stock options from biomedical firms

• The Washington Post (January 19, 2004) Critics of NIH Studies Prompt Senate Hearing

• The Los Angeles Times (January 23, 2004) NIH Directors No Longer Drug Firm Consultants

• The Washington Post (May 13, 2004) House Panel Scolds NIH Chief, HHS

• The Chronicle of High Educatio (May 13, 2004) Department of Health and Human Services Publishes Final Guide on Financial Conflicts of Interest

• The Washington Post (May 19, 2004) Probe Targets Government Scientists¹ Consulting

• The Los Angeles Times (December 22, 2004) The National Institutes of Health: Public Servant or Private Marketer? Doctors have long relied on the NIH to set medical standards. But with its researchers accepting fees and stock from drug companies, will that change? A continuing examination by the times shows an unabashed mingling of science and commerce

• The New York Times (February 1, 2005) Ban on Federal Scientists¹ Consulting Nears

• The Washington Post (February 2, 2005) NIH Will Restrict Outside Income

• The Washington Post (February 3, 2005) NIH Workers Angered by New Ethics Rules

• Science ( February 11, 2005) NIH Chief Clamps Down on Consulting and Stock Ownership

• The Washington Post (February 23, 2005) NIH Clears Most Researchers in Conflict of Interest Probe

Online Materials

• Scientific Integrity -- Virginia Commonwealth University; Macrina

• "What is Misconduct in Science?"; Howard K. Schachman, 1993

• "Scientific Misconduct"; David Goodstein, 2002

• "On Being a Scientist: Responsible Conduct in Research"; National Academic of Sciences,1995

• "Advisor, Teacher, Role Model, Friend"; National Academic of Sciences,1997

• "A Stampede of Zebras" by Robert G. Martin, 1991