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Documents Available
There are a number of documents available on this web site for browsing. Included are published papers, published guidelines and reports, and unpublished papers and policy statements. These are presented with the permission of the authors and publishers.
Some of these documents have been linked to the various situations you will encounter in this course. They may also be read in their entirety or browsed by clicking on the links below. An annotation has been provided to help in selecting what to browse.
Articles
| Bebeau, M.J. Developing a Well-Reasoned
Response to a Moral Problem in Scientific Research.
| This reference is must reading for all students. Dr. Bebeau outlines in clear and concise fashion how to form a response to an ethical dilemma. Please read this in its entirety!
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| Fields, K.L. and Price, A.R. Problems in Research
Integrity Arising from Misconceptions about the Ownership of Research
| This paper deals with the ownership of research data. It
discusses the NIH and ORI policies and includes a discussion of the
rights of scientists, their collaborators and their trainees to intellectual
property: ideas, materials and grants.
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| Fishbein, E.A. Ownership of Research Data
| This is another paper dealing with the ownership of research data, but this one
deals with the subject from a legal point of view. It points out that the research institution
has both ownership and responsibility for intellectual property under a "works-for-hire" principle,
but universities have chosen to release ownership to investigators for certain items.
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| Goodman, K. Intellectual Property and Control
| In this paper, Goodman argues that the issue in intellectual property disputes
is one of control of ideas. He argues that there must be a free exchange of ideas, at
the same time that universities' interests are protected. |
| Mann, M.D. Ethics of Collecting and
Processing Data and Publishing Results of Scientific Research
| This paper was developed for our original course in research ethics. It goes through many of the areas in which "unethical" practices occur with respect to designing experiments; collecting, processing and publishing data; and reviewing manuscripts and grant proposals. It deals not only with misconduct, but also with practices, which, although they may not be formally within the definition of misconduct, are nonetheless bad practices.
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| Mann, M.D., Crouse, D.A. and Prentice, E.D. Appropriate animal numbers in biomedical research in light of animal welfare considerations, Laboratory Animal Science 41:6-14, 1991.
| This paper deals with factors that determine the appropriate numbers of animals to use in an experiment. It points out that there are good "statistical" reasons for using a particular number of animals, but there are also some "non-statistical" factors that must be considered.
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| Murray, H., Gillese, E., Lennon, M., Mercer, P., and Robinson, M. Ethical principles for college and university teaching, AAHE Bulletin 49:3-6, 1996.
| In this paper, a group of Canadian professors defines its professional responsibilities as teachers. It considers competence, interactions with students, and respect for colleagues and the institution.
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| Prentice, E.D., Crouse, D.A. and Mann, M.D. Scientific merit review: The
role of the IACUC, ILAR News 34:15-19, 1992.
| These authors argue that review of scientific merit is legitimately a
function of an IACUC because [among other reasons] (a) some projects get no other
merit review and (b) the granting agencies expect that such merit review has been
done when approval is given. |
| Prentice, E.D., Gordon, B.G. and Lin, M.H. Determining when a clinical activity should be classified as research
requiring Institutional Review Board review, Journal of Extra-Corporial Technology 29:88-91, 1997.
| This article examines that nebulous boundary between
therapeutric treatments and clinical research, a boundary that becomes
more nebulous when treatments are new (experimental?).
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| Prentice, E.D. and Zetterman, R.K. Evolution, structure and function of the institutional review board, The Nebraska Medical Journal 68:293-295, 1983.
| After reviewing the reasons for formation of IRBs, the authors outline the responsibilities, structure and review procedures of IRBs. |
| Swazey, J.P., Anderson, M.S. and Lewis, K.S. Ethical problems in academic research, American Scientist 81:542-553, 1993.
| These authors used questionnaires to assess the rates of exposure of students and faculty to perceived misconduct. They were surprised (and so should we be) that such
problems are more pervasive than many insiders believe. They also found significant differences
among disciplines in the frequency and the types of questionable behavior observed.
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| Woodward, J. and Goodstein, D. Conduct, Misconduct and the Structure of Science, American Scientist 84:479-490, 1996.
| These authors, both professors at Caltech, discuss the rules that define ethical conduct, especially those that suggest that scientists must be objective in formulating
hypotheses and conducting experiments. You might be surprised at what they conclude.
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Government guidelines and regulations
 Department of Health and Human Services, Protection of Human Subjects. Code of Federal Regulations, 45 CFR 46 (Revised June 18, 1991)
| Basic federal policies for protection of human subjects, especially fetuses, pregnant women, prisoners and children
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 National Research Council, Guide for the Care and Use of Laboratory Animals. Washington, D.C.: National Academy Press, 1996
| Nearly everything you ever wanted to know about the care of animals used in research. |
 U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington DC: U.S. Government Printing Office, 1979
| Report of a commission formed to delineate "the basic ethical principles which should underlie the conduct of biomedical and behavioral research involving human subjects" and provide "guidelines that should be followed to assure that such research is conducted in accordance with those principles." In this report you will find an outline of use of informed consent as well as definitions of and distinctions between "clinical practice" and "clinical research." Finally, the report defines three fundamental principles to be applied in dealing with human subjects. |
 Commission of Research Integrity. Integrity and Misconduct in Research. Washington DC: U.S. Government Printing Office, 1995
| The report of a commission created by Congress in 1993 to advise the Secretary of HHS and Congress about ways to improve the PHS response to misconduct in research. Not all of this has been implemented, but it may be.
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| Nuremberg Code: Directives for Human
Experimentation from Trials of War Criminals
before the Nuremberg Military Tribunals under Control Council Law No. 10,
Vol. 2, pp. 181-182. Washington, D.C.: U.S. Government Printing Office,
1949.
| The Nuremberg Military Tribunal's decision in the case of the United States v. Karl Brandt et al. includes what is now called the Nuremberg Code, a ten-point statement delimiting permissible medical experimentation on human subjects. According to this statement, humane experimentation is justified only if its results benefit society and it is carried out in accord with basic principles that "satisfy moral, ethical, and legal concepts." To some extent, the Nuremberg Code has been superseded by the Declaration of Helsinki as a guide for human experimentation.
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| Helsinki Declaration, Adopted by the 18th World
Medical Assembly, Helsinki, Finland, June 1964 and amended by the 29th World Medical
Assembly, Tokyo, Japan, October, 1975, 35th World Medical Assembly, Venice, Italy,
October 1983 and the 41st World Medical Assembly, Hong Kong, September 1989
| Sets the current international standards for experimentation
using human subjects. Largely supercedes the Nuremberg Code.
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Scientific and professional society reports/guidelines
 National Academy of Science, On Being a Scientist. 2nd Edition. Washington, D.C.: National Academy Press, 1995.
| This booklet, published by the National Academy of Science, is an introduction for developing scientists to scientific methods and "rules" of behavior. Topics include the obligations of the scientist functioning within society, problems of credit and responsibility, the nature of the scientific method and the nature and causes of scientific misconduct. Because of its readability, it is a good place to start in exploring this area of inquiry.
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University guidelines and regulations
| Institution Review Board, University of Nebraska Medical Center. IRB Guidelines for the Protection of Human Subjects in Research 2000.
| This official document of the Institution Review Board provides investigators with a resource to be used in preparation and submission of research proposals involving human subjects, including informed consent forms, for review by the IRB. It provides information on the ethical and legal duties of investigators during the conduct of research using human subjects.
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| Institution Animal Care and Use Committee, University of Nebraska Medical Center. IACUC Guidelines for the Care and Use of Live Vertebrate Animals 1998.
| This official document of the Institution Animal Care and Use Committee provides investigators with a resource to be used in preparation and submission of research proposals involving animal subjects for review by the IACUC. It provides information on the ethical and legal duties of investigators during the conduct of research using animal subjects. It also provides useful information about drugs used in anethesia and analgesia.
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| Office of Graduate Studies and Research, UNMC. Guidelines for Good Practice in Graduate Education 1996.
| This official document of the Office of Graduate Studies and Research outlines some rules or guidelines for conduct of graduate students with respect to their participation in graduate education. It also outlines expectations they should have of the educational process and the faculty. In addition, it outlines rules or guidelines for conduct by faculty in their interactions with graduate students.
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| Division of Student Services, UNMC, POLICIES from 1996-97 Student Handbook.
| This section of the official Student Handbook for UNMC gives policies regarding academic activities (appeals, residency, standards of performance); conduct and health (communicable diseases, cheating) and administrative/financial policies (mailboxes, adequate academic performance for financial aid).
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| Office of the Dean for Graduate Studies and Research, UNMC, Regulatory Issues--Research Integrity in Research Support Services of the University of Nebraska Medical Center, 1996.
| Policies regarding use of animal and human subjects in research are detailed here, including the role of the IACUC and IRB. In addition, this document discusses issues of environmental safety. The second section of the document concentrates on Medical Center policies with respect to scientific integrity, i.e., data management, authorship, University-industry relations and conflicts-of-interest.
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| University of Nebraska Medical Center, Professional Conduct Committee, Rules of Procedure
| This official document describes the rules of procedure of the Professional Conduct Committee, which is formed to investigate allegations of misconduct by faculty. Its purview includes all professional activities, including research. It can concern itself not only with the actions of faculty, but also the actions of anyone working in a research lab, for whom the faculty bears responsibility. The document outlines the methods of procedure in investigations of allegations of misconduct and specifies the nature of actions the committee may take depending upon the outcome of the investigations.
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| University of Nebraska Medical Center, Department of Technology Development, Intellectual Property Protection and Technology Transfer
| This document sets forward the guidelines for protection of new ideas and conceptual designs of faculty and students. It outlines the procedures for obtaining patents on such designs, procedures or devices.
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