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Preparing a Scientifically Responsible Submission

Many ethical issues arise during the different phases of the preparation of a scientific paper.

Ethics Resources for Investigators

Martin McKneally, MD

In clinical research, a conflict may arise between the best interest of the patient-subject and the scientific requirements of the study protocol. In clinical practice, patients' best interests are safeguarded by their physicians' fiduciary duty to choose tests and treatments that seem best for the individual patient. Physicians often modify techniques and adjust doses, appointments, and follow-up tests to fit a patient's particular needs or circumstances. In contrast, a mandated follow-up angiogram one month after surgery (irrespective of symptoms) is an example of the "tyranny of the protocol," overriding the convenience and comfort of the patient in order to serve the scientific interest of the investigator and society.

The career interests of the investigator, the financial interests of the sponsoring manufacturer, and the research agenda of the institution may also conflict or compete with the individual patient-subject's best interest. Payment of fees to patient-subjects or finders' fees to physicians may further distort the ideal physician-patient relationship.

The scientific requirement for data collection and storage introduces another risk. Researchers or reviewers who have no clinical responsibility for patient-subjects may gain access to private information in the chart—information that the patients gave to their caregivers, trusting it would be protected by the clinicians' duty to maintain confidentiality. For this reason, many institutions and publications require some form of institutional ethics review even for chart studies.

To safeguard patients, investigators, institutions, and the public, various research-related practices and regulations have been developed. Here are some publications that help us understand and work more effectively in the ethically interesting domain of clinical investigations conducted in human subjects.

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Annotated Bibliography

Clinical research

  • Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000;283:2701-2711.
    The single best paper on clinical research, in my view; this should be required reading for Research Ethics Board/IRB members and surgical researchers. Zeke Emanuel, Chairman of the Department of Clinical Bioethics at the U.S. National Institutes of Health, defines in detail the 7 essential requirements of ethical research: (1) value to society; (2) scientific validity; (3) fairness in selection of subjects; (4) favorable risk-benefit ratio; (5) independent scientific and ethics review; (6) informed consent for the research component; (7) respect and protection of subjects' rights (to confidentiality, withdrawal, welfare, information on newly discovered risks and benefits).
  • Levine RJ. Ethics and Regulation of Clinical Research. 2nd edition. New Haven; Yale University Press, 1986. The reference standard for clinical research—elegantly written by the leading scholar in this field over the past decades.
  • Zlotnik-Shaul R, McKneally MF. Ethical considerations for innovations and clinical trials. Sem Thorac Cardiovasc Surg 2003;15:380-385. A brief overview of the ethical and legal issues in clinical research. This paper explains terms such as the therapeutic misconception and clinical equipoise and outlines some of the important ethical distinctions between research and therapy.
  • Beauchamp TL.,Childress, JF. Principles of Biomedical Ethics, 5th edition. New York:Oxford Press; 2001. The leading American textbook of bioethics.
  • Sade RM, McKneally M. Responsibilities of investigators. J Thorac Cardiovasc Surg 2002;123:837-838 and Ann Thorac Surg 2002;73:1364-1365 . An explanation of the policy of JTCVS and ATS on financial conflicts of interest that should be reported at the time of manuscript submission. Authors are advised to disclose whether industrial or other sponsors have controlled the design, analysis, interpretation, or publication of their results. Restriction on "Freedom of Investigation" requires a letter of explanation and may lead to denial of publication.
  • Steinbrook R. Improving protection for research subjects. N Engl J Med 2002;346:1425-1430 .
    An explanation of the problems associated with the oversight of clinical research and some clear guidance toward their solution.
  • Freedman B. Equipoise and the ethics of clinical research. N Engl J Med 1987;317:141-145 .
    A classic paper, explaining how uncertainty in the informed medical community (about which treatment is best) can provide practitioners with an ethical justification for entering their patients into trials, though they themselves may have a strong prejudice in favor of one of the treatments.
  • Sade RM. Publication of unethical research studies: The importance of informed consent. Ann Thorac Surg 2003;75:325-328 . A clear review of the abuses of research subjects that led to the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report. These documents provide the basis for regulation of clinical research.
  • World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA 2000;284:3043-5 . The foundation document for governance of clinical research, and the reference standard for many journals, including our own.
  • Brody BA. The Ethics of Biomedical Research: an international perspective. New York: Oxford University Press;1998. A thoughtful text by a scholar in the field.

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Conflict of Interest

  • Lemmens T, Singer PA. Bioethics for Clinicians: 17. Conflict of interest in research, education and patient care. CMAJ 1998;159-960-965 . A short, clear explanation of the conflict of interest problem.
  • Khushf G, Gifford R. Understanding, assessing, and managing conflicts of interest. In: McCullough LB, Jones JW, Brody BA. Surgical Ethics. New York; Oxford University Press, 1998:342-366 (Chapter 18). A detailed, elegantly explained analysis of the problem of conflicts of interest.
  • Spece RG Jr, Shimm DS, Buchanan AE, editors. Conflicts of Interest in Clinical Practice and Research. New York; Oxford University Press, 1996. A comprehensive and critical collection of essays on conflict of interest. See especially Part IV Clinical Research, pp 361-436.
  • Levinsky NG. Nonfinancial conflicts of interest in research. N Engl J Med 2002;347:759-761 .
    A clear exposition of the academic and other interests that may distort the fiduciary relationship between patient-subjects and their caregivers.

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Innovation

  • Margo CE. When is surgery research? Towards an operational definition of human research. J Med Ethics 2001;27:40-43 . A clear exposition of how improvements or innovations in practice morph into research.
  • McKneally MF. Ethical problems in surgery: Innovation leading to unforeseen complications. World J Surg 1999;23:786-788 . An exploration of the ethical challenges in the borderland between research and practice, wherein Dr. Innovatore leads his partners, his patient and himself into dangerous territory.
  • McKneally MF, Daar AS. Introducing new technologies: Protecting subjects of surgical innovation and research. World J Surg 2003;27:930-935 . A challenge to surgeons to take responsibility for the oversight of innovation.
  • Frader JE, Caniano DA. Research and innovation in surgery. In: McCullough LB, Jones JW, Brody BA. Surgical Ethics. New York; Oxford University Press, 1998:216-241 (Chapter 12).
    A very readable exposition of the ethical issues in innovation and research, with pediatric surgical examples.
  • McCullough LB, Jones JW, Brody BA. Surgical Ethics. New York; Oxford University Press, 1998. Straight talk. Every chapter is coauthored by a bioethicist and a surgeon. Cardiothoracic surgeon Jim Jones is one of the editors of this very solid textbook.
  • Jones JW. Ethics of rapid surgical technological advancement (Editorial). Ann Thorac Surg 2000;69:676-677 ; Colvin B, Grossi EA, Galloway AC. Regarding ethics of rapid surgical technological advancement. Ann. Thorac. Surg. 2000 70: 1758 (LE)

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Scientific Fraud

  • Lock S, Wells F, Farthing M. (editors) Fraud and Misconduct in Biomedical Research. 3rd edition. London, BMJ Books, 2001. A superbly written and fascinating compendium on fraudsters.
  • Weijer C. The breast cancer research scandal: Addressing the issues. CMAJ 1995;152:1195-1197 .
  • Angell M, Kassirer JP. Setting the record straight in the breast-cancer trials. New Engl J Med 1994;330:1448-1449 . A classic case of an investigator's misconduct, violating the protocol "on behalf of his patients," and undermining an important clinical trial.

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Authorship

  • Riesenberg D, Lundberg GD. The order of authorship: Who's on first? JAMA 1990;264:1857 .
  • Rennie D, Flanagin A, Yank V. The contributions of authors. JAMA 2000;284:89-91 .
  • Davidoff F, DeAngelis CS, Drazen JM, et al. Sponsorship, authorship, and accountability. N Engl J Med 2001;345:825-826 .
  • International Committee of Medical Journal Editors: Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication. The Uniform Requirements state the ethical principles in the conduct and reporting of research and provide recommendations relating to specific elements of editing and writing. http://www.icmje.org/

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Copyright

It is the author’s responsibility to know and follow international and United States intellectual property law and the copyright policies of the journal to which the manuscript is submitted. Many journals ask authors to transfer copyright to the journal; other journals have an open access policy and do not require copyright transfer.

Copyright issues also come into play when an author wishes to reproduce illustrations or graphs from sources that have already been published. Most journals require that the author him- or herself obtain permission from the original source.

Check information for authors for the journal of interest to you.

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Duplicate (redundant) publication

All journal editors consider duplicate publication a serious problem and will go so far as to refuse publication for up to several years to authors who knowingly engage in this practice.

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Conflict of interest

Most journals require authors to declare any commercial or other relationships they have that could compromise the integrity of their work. Check the information for authors of the journal to which you are planning to submit.

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Publication Date: 23-Aug-2004
Last Modified: 20-Jan-2005
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