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Nursing Ethics, Vol. 13, No. 6, 649-660 (2006)
DOI: 10.1177/0969733006069699

Inclusion Practice in Lung Cancer Trials

Patricia Jaspers

Maastricht University, The Netherlands

Arie van der Arend

Maastricht University, The Netherlands

Rinus Wanders

MAASTRO Clinic, Maastricht, The Netherlands

This article presents the results of a qualitative study on the ethical aspects of inclusion practice for radiotherapy patients taking part in clinical research. The study focused on the standards and values of this process. Patients and physicians were interviewed about their views and experiences. Analysis of these interviews showed that candidate research participants need better protection from unwanted factors that could influence their choice about participation. Researchers need proper education about regulation, codes and directives in the field of research ethics, and they should be aware of the underlying ethical concepts of these regulations. A sound institutional ethics policy is necessary in order to guide medical staff in decisions about the inclusion of patients in trials.

Key Words: inclusion • lung cancer trials • radiotherapy • research ethics

References

  • Strategisch plan.(Strategic plan.) Radiotherapeutic Institute Limburg (RTIL), Department of Radiotherapy, Academic Hospital of Maastricht, and Capacity Group Radiotherapy, University of Maastricht , 2001 (in Dutch).
  • Schäfer C, Herbst M. Ethical aspects of patient information in radiation oncology . Strahlenther Onkol 2003; 179: 431-440 .[ISI][Medline] [Order article via Infotrieve]
  • Gunderman RB. Why is ethics needed in the radiology curriculum? Acad Radiol 2001; 8: 82-85 .[CrossRef][ISI][Medline] [Order article via Infotrieve]
  • Kirkpatrick CT. Regulators and the good clinical practice. In: Kirkpatrick CT ed. Handbook for clinical investigators. Taylor & Francis , 1999: 11-24.
  • The Nuremberg Code. Trials of war criminals before the Nuremberg military tribunals under Control Council law no. 10, vol. 2. US Government Printing Office , 1949: 181-182.
  • Portney LG, Watkins MP. Ethical issues in clinical research. In: Portney LG, Watkins MP eds. Foundations of clinical research. Applications to practice. Prentice Hall Health , 2000: 33-46.
  • World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects. WMA , 2000.
  • The European Agency for the Evaluation of Medicinal Products (EMEA). Guideline for good clinical practice (GCP) -ICH harmonised tripartite guideline. EMEA , 2002.
  • European Parliament. Directive 2001/20/EC of the European Parliament and of the Council of Europe, 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use . Official Journal of the European Communities 2001; 121: 34-44 .
  • Wet medisch-wetenschappelijk onderzoek met mensen. (Dutch Law on Medical Scientific Research with Human Subjects.) Staatsblad 1999, 145: 1-1 .
  • Berg JW, Appelbaum PS, Lidz CW, Parker, LS. Informed consent. Legal theory and clinical practice, second edition. Oxford University Press , 2001.
  • Farndon JR. Patients’ understanding of clinical trials . Lancet 1998; 351: 1663-1663 .[ISI][Medline] [Order article via Infotrieve]
  • Dickert N, Grady C. What’s the price of a research subject? N Engl J Med 1999; 341: 198-203 .[Free Full Text]
  • Spece RG, Shimm DS, Buchanan AE. Conflicts of interest in clinical practice. Oxford University Press , 1996.
  • DeRenzo EG. Coercion in the recruitment and retention of human subjects, pharmaceutical industry payments to physician-investigators, and the moral courage of the IRB . IRB 2000; 22: 1-5 .[CrossRef][Medline] [Order article via Infotrieve]
  • Jonson AR, Siegler M, Winslade WJ. Clinical ethics: a practical approach to ethical decisions in clinical medicine. McGraw-Hill Medical , 2002.
  • Oberle K, Storch, JL. Nursing ethics and research. In: Storch JL, Rodney P, Starzornski R eds. Toward a moral horizon: nursing ethics for leadership and practice. Prentice Hall , 2003: 358-377.
  • Maso I, Smaling A. Kwalitatief onderzoek: praktijk en theorie. (Qualitative research: practice and theory.) Boom , 1998 (in Dutch).
  • ‘t Hart H, Van Dijk J, De Goede M, Jansen W, Teunissen J. Onderzoeksmethoden. (Research Methods.) Boom , 1998 (in Dutch).
  • Karnofsky DA, Abelman WH, Craner LF. The use of nitrogen mustards in palliative treatment of carcinoma . Cancer 1948; 1: 634-656 .[CrossRef]
  • Central Committee on Human Research (CCMO). Manual for ethical reviewing. CCMO , 2002.
  • Bjarnason NH, Kampmann, JP. Selection bias introduced by the informed consent process . Lancet 2003; 361: 1990-1990 .[ISI][Medline] [Order article via Infotrieve]
  • Helgesson G, Ludvigsson J, Gustafsson Stolt U. How to handle informed consent in longitudinal studies when participants have a limited understanding of the study . J Med Ethics 2005; 31: 670-673 .[Abstract/Free Full Text]
  • Kottow M. The battering of informed consent J Med Ethics 2004; 30: 565-569 .[Abstract/Free Full Text]
  • May T. Social restrictions on informed consent: research ethics and medical decision making . HEC Forum 2004; 16: 38-44 .[CrossRef][Medline] [Order article via Infotrieve]
  • O’Neill O. Some limits of informed consent . J Med Ethics 2003; 29: 4-7 .[Abstract/Free Full Text]
  • Paasche-Orlow MK, Taylor HA, Brancati FL. Readability standards for informed-consent forms as compared with actual readability . N Engl J Med 2003; 348: 721-726 .[Abstract/Free Full Text]
  • Picker Institute. Family and friends as partners in chronic illness care . New Visions for Health Care 2000; 22: 1-1 .
  • Ruhnke GW, Wilson SR, Akamatsu T. Ethical decision-making and patient autonomy: a comparison of physicians and patients in Japan and the United States . Chest 2000; 118: 1172-1182 .[Abstract/Free Full Text]
  • Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for biomedical research involving human subjects. CIOMS , 1993.
  • Comis, RL, Miller, JD, Aldige, CR, Linda K, Ellen S. Public attitudes toward participation in cancer clinical trials . J Clin Oncol 2001; 21: 830-835 .
  • Brasel KJ. Research ethics primer . J Surg Res 2005; 128: 221-225 .[CrossRef][ISI][Medline] [Order article via Infotrieve]

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This Article
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