Result card

  • LEG4: Does the use of Genetic Tests for breast cancer produce some additional (i.e. diagnostically or therapeutically irrelevant) information on the patient?
Prognostic tests for breast cancer recurrence (uPA/PAI-1 [FEMTELLE], MammaPrint, Oncotype DX )
I0007
English
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Does the use of Genetic Tests for breast cancer produce some additional (i.e. diagnostically or therapeutically irrelevant) information on the patient?

Authors: Marina Casini, Emanuela Midolo, Marco Marchetti

Internal reviewers: Judite Neves, Ana Bação, Vesna Kovač

The domain methodology used for this question has been collection, selection and analysis of European norms and sentences.

If additional information from prognostic testing is irrelevant to the current state of health of the patient the physician has an obligation to inform the patient and to report exactly any data of which the doctor is aware. This obligation of the physician is less strong when the patient expresses a desire not to be informed. The European normative documents relevant here are the same as those cited in the result card RC-LEG1. {1},{2},{3},{4},{5},{6}

Important
Completely
Casini M et al. Result Card LEG4 In: Casini M et al. Legal aspects In: Jefferson T, Vicari N, Raatz H [eds.]. Prognostic tests for breast cancer recurrence (uPA/PAI-1 [FEMTELLE], MammaPrint, Oncotype DX ) [Core HTA], Agenzia nationale per i servizi sanitari regionali (age.na.s), Italy ; 2013. [cited 7 February 2023]. Available from: http://corehta.info/ViewCover.aspx?id=113

References

  • {1}   COUNCIL OF EUROPE, Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, Oviedo, 4-IV-1997.
  • {2}  COUNCIL OF EUROPE, Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes, Strasbourg, 27-XI-2008.
  • {3}  COUNCIL OF EUROPE, Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research, Strasbourg, 25-I-2005.
  • {4}  WORLD MEDICAL ASSOCIATION, Declaration of Helsinki, Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964 and amended by the: 29th WMA General Assembly, Tokyo, Japan, October 1975; 35th WMA General Assembly, Venice, Italy, October 1983; 41st WMA General Assembly, Hong Kong, September 1989; 48th WMA General Assembly, Somerset West, South Africa, October 1996; 52nd WMA General Assembly, Edinburgh, Scotland, October 2000; 53rd WMA General Assembly, Washington, DC, USA, October 2002 (Note of Clarification on paragraph 29 added); 55th WMA General Assembly, Tokyo, Japan, October 2004 (Note of Clarification on Paragraph 30 added); 59th WMA General Assembly, Seoul, Korea, October 2008.
  • {5}  EUROPEAN PARLIAMENT AND COUNCIL, Directive 2001/20/EC of 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.
  • {6}  UNESCO, Universal Declaration on the Human Genome and Human Rights, 11 November 1997.