Zusammenfassung
Obwohl man seit langem erkannt hat, daß für jegliche Art der medizinischen Behandlung die Einwilligung des Patienten eingeholt werden sollte, sei es zur Therapie oder für die Forschung, gibt es viele Beispiele, wo dieses Dictum nicht erfüllt wurde. In Amerika hat die Sorge um den Schutz der Versuchspersonen in der klinischen Forschung eine Reihe von Bundesvorschriften hervorgebracht. Eine der wichtigsten dieser Vorschriften, vom „Department of Health, Education, and Weifare” von 1966 (1), fordert die Einrichtung von lokalen Gutachter-Kommissionen, um die Rechte und die Gesundheit der Versuchspersonen zu schützen, die an öffentlich unterstützten Forschungsaktivitäten der jeweüigen Institutionen (wie z.B. Krankenhäuser oder Kliniken) teilnehmen. Das Ziel der folgenden Ausführungen ist es, die allgemeine Bedeutung der neuesten Bundesvorschriften sowie die Rolle der lokalen Gutachterkommissionen für den Schutz von Versuchspersonen, die an klinischer Forschung teilnehmen, darzustellen.
Übersetzung aus dem Englischen: B. Müller-Oerlinghausen.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
Literatur
U.S. Public Health Service: Policy and Procedure Order No. 129, July 1, 1966
Taylor, W.J.R.: Introduction. In: Peer Review in Human Research, F.G. McMahon (ed.). Mount Kisco, N.Y.: Futura Publishing, in press
Hodges, R.M.: Ethical Considerations in Clinical Research. In: Principles and Techniques of Human Research and Therapeutics. Volume 1: General Considerations and Principles. McMahon, F.G. (ed.). Mount Kisco, N.Y.: Futura Publishing 1974
Percival, Sir Thomas: Medical Ethics. Manchester, England: J. Johnson 1803
Office of the Adjutant General of the United States: Trials of War Criminals. U.S. Government Printing Office, Washington, D.C., Vol. 2, pp. 181–183, 1947
World Medical Assembly: Declaration of Helsinki. Helsinki 1964
World Health Assembly: Declaration of Tokyo. Tokyo 1975
World Psychiatric Association: Declaration of Hawaii. Hawaii 1977
Kefauver-Harris Amendments of October 10, 1962 to the Food, Drugs and Cosmetic Act; Code of Federal Regulations; U.S. Government Printing Office, Washington, D.C., 1962
National Academy of Sciences/National Research Council: Final Report, Drug Efficacy Study. U.S. Government Printing Office, Food and Drug Administration Publication. Washington, D.C., July 9, 1969
Smith, Kline and French Laboratories: A Chronology and Review of the National Academy of Sciences/National Research Council Drug Efficacy Study: A Monograph. Smith, Kline and French Laboratories; Philadelphia, Pa., March 1971
Fortner vs. Koch: Northwestern Reports, 261, 762 (1935)
Chalkley, D.T.: The NIH Role in the Support and Regulation of Clinical Research. In: Principles and Techniques of Human Research and Therapeutics, Volume 1: General Considerations and Principles, McMahon, F.G. (ed.). Mount Kisco, N.Y.: Futura Publishing 1974
Beecher, H.K.: Research and the Individual. Boston, Mass.: Little, Brown and Co. 1970
The National Research, Training and Protection of Human Research Subjects Act, Public Law 93–348. (CR 120, H5727–32, June 28, 1974)
Federal Register, May 30, 1974 (39 FR 18914)
Survey Research Center, Institute for Social Research, University of Michigan: Research Involving Human Subjects: A Report to the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. University of Michigan; Ann Arbor, Mich., October 2, 1976
CFR 310.102
Lisook, A.B.: Responsibilities of Clinical Investigators — FDA Viewpoint. In: Principles and Techniques of Human Research and Therapeutics, Volume 1: General Considerations and Principles, McMahon, F.G. (ed.). Mpunt Kisco, N.Y.: Futura Publishing 1974
Federal Register, April 17, 1971
Department of Health, Education and Welfare: The Institutional Guide to DHEW Policy on Protection of Human Rights. U.S. Government Printing Office, DHEW Publication 72–102; Washington, D.C., 1971
Department of Health, Education and Welfare; DHEW Grants Administration Manual, Chapter 1–40. U.S. Government Printing Office, DHEW Publication; Washington, D.C.
University of Pennsylvania Office of Research Administration: Human Beings in Research, a Manual Describing Policies and Procedures. University of Pennsylvania; Philadelphia, Pa., 1974
Public Responsibility in Medicine and Research Conference on the Protection of Human Subjects and the Role of Institutional Review Boards. Held in Boston, Mass.: April 16–17, 1977
Melmon, K.L.: The clinical pharmacologist and scientifically unsound regulations for drug development. Clin. Pharmacol, and Therapeutics 20 (2), 125–129 (1976)
Robins, L.N.: Problems in follow-up studies. Am. J. Psychiatry 134, 8 (1977)
American Public Health Association Conference on Ethical Issues in Adolescent Health. Held in Washington, D.C.: December 6–7, 1976
Hirsch, B.D.: Hie medico-legal framework for clinical research in medicine. Ann. N.Y. Acad, of Science 169, 308 (1970)
Mahoney, M.J.: Ethical considerations in fetal research. Conn. Medicine 41 (2), 85–89 (1977)
Pilon, J.G.: Cost-benefit ethics and fetal research. Human Life Review 3 (1), 63–70 (1977)
Roth, L.H., et al.: Tests of competency to consent to treatment. Am. J. Psychiatry 134, 3 (1977)
McGough, L.S., Carmichael, W.C.: The right to treatment and the right to refuse treatment. Am. J. Orthopsychiatry 47 (2), 307–320 (1977)
Robitscher, J.: The right to psychiatric treatment: a socio-legal approach to the plight of the state hospital patient. Villanova Law Rev. 18, 11–36 (1972)
Helmchen, H., Müller-Oerlinghausen, B.: The inherent paradox of clinical trials in psychiatry. J. Med. Ethics. 1, 168–173 (1975)
Helmchen, H., Müller, Oerlinghausen, B.: Ethische und juristische Schwierigkeiten bei der Effizienzprüfung psychiatrischer Therapieverfahren. Nervenarzt 46, 397–403
Varley, A.B.: The Legal Environment and Clinical Research. In: Principles and Techniques of Human Research and Therapeutics, Volume 1: General Considerations and Principles, McMahon, F.G. (ed.). Mount Kisco, N.Y.: Futura Publishing 1974
Frank, J.: Courts on Trial. Princeton, N.J.: Princeton University Press 1950
Cole, J.O.: Research barriers in psychopharmacology. Am. J. Psychiatry 134, 8 (1977)
Barber, B., et al.: Research on Human Subjects: Problems of Social Control in Medical Experimentation. Russell Sage Foundation, New York, 1973
Gray, B.H.: An assessment of institutional review committees in human experimentation. Medical Care 13 (4), 318–328 (1975)
Gray, B.H.: The functions of human subjects review committees. Am. J. Psychiatry 134, 8 (1977)
Hassar, M., Weintraub, M.: „Uninformed” consent and the healthy volunteer: An analysis of patient volunteers in a clinical trial of a new anti-inflammatory drug. Clin. Pharmacol, and Therapeutics 20 (4), 379–386 (1976)
Ingelfinger, F.J.: Informed (but uneducated) consent. New Engl. J. Med. 287, 465–466(1972)
Laforet, E.G.: The fiction of informed consent. J. Am. Med. Ass. 235, 1579–1585
Sackler, A.M.: Informed consent. Medical tribune 15, 23 (1974)
Rickeis, K. (ed.): Non-Specific Factors in Drug Therapy. Springfield, I11.: Charles C Thomas 1968
Chalkley, D.T.: Federal constraints: Earned or unearned? Am. J. Psychiatry 134, 911–913 (1977)
Laves, B.S.: Legal aspects of experimentation with institutionalized mentally disabled subjects. J. of Clin. Pharmacology 16, 592–599 (1976)
Orne, M.T., Evans, F.J.: Social control in the psychological experiment: Antisocial behavior and hypnosis. J. of Personality and Social Psychology 1, 189–200 (1965)
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 1978 Springer-Verlag Berlin · Heidelberg
About this chapter
Cite this chapter
Rickels, K. (1978). Die Bedeutung von lokalen Gutachterkommissionen (Institutional Review Boards) für den Schutz der Versuchsperson. In: Helmchen, H., Müller-Oerlinghausen, B. (eds) Psychiatrische Therapie-Forschung. Monographien aus dem Gesamtgebiete der Psychiatrie, vol 19. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-87982-1_9
Download citation
DOI: https://doi.org/10.1007/978-3-642-87982-1_9
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-642-87983-8
Online ISBN: 978-3-642-87982-1
eBook Packages: Springer Book Archive