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Research Ethics Committees

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Part of the Ius Gentium: Comparative Perspectives on Law and Justice book series (IUSGENT,volume 92)

Abstract

Ethics committees represent a “way of doing bioethics” that is useful in plural and democratic societies. Although there are different types of ethics committees, clinical ethics committees, national ethics committees or ad hoc committees, I will focus my analysis on research ethics committees in biomedicine. I will examine their international legal framework in order to define them, identify their functions and analyse their possible instrumentalisation. Lastly, I will provide some practical information as a member of two research ethics committees in Spain, the Bioethics Committee at the University of Barcelona and the Research Ethics Committee at Hospital Clínic de Barcelona, to draw some conclusions and make proposals.

Keywords

  • Research Ethics Committees
  • Bioethics
  • Human rights
  • Ethics in research with human beings
  • Human biological samples and personal data
  • Human rights

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Notes

  1. 1.

    Article 12. Universal Declaration on Bioethics and Human Rights, UNESCO (2005).

  2. 2.

    Rodotà (2009).

  3. 3.

    Beecher (1966).

  4. 4.

    De Lecuona (2011).

  5. 5.

    “The Belmont Report” Office of the Secretary Ethical Principles and Guidelines for the Protection of Human Subjects of Research The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research U.S.A, April 18, 1979.

  6. 6.

    The 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, Council of Europe (1997a).

  7. 7.

    Casado and López Baroni (2018).

  8. 8.

    Hottois (1990).

  9. 9.

    Article 2. Convention on Biomedicine and Human Rights, Council of Europe (1997b).

  10. 10.

    Annas (1991).

  11. 11.

    Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects, World Medical Association (1964).

  12. 12.

    Brody (1998).

  13. 13.

    Research Ethics Committees: 23 Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects, World Medical Association (WMA) 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, Republic of South Africa, October 1996 52nd WMA General Assembly, Edinburgh, Scotland, October 2000 53rd WMA General Assembly, Washington DC, USA, October 2002 (Note of Clarification added) 55th WMA General Assembly, Tokyo, Japan, October 2004 (Note of Clarification added) 59th WMA General Assembly, Seoul, Republic of Korea, October 2008 64th WMA General Assembly, Fortaleza, Brazil, October 2013.

  14. 14.

    The Council for International Organizations of Medical Sciences CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects (2016) Preamble “The term “research” refers to a class of activity designed to develop or contribute to generalizable knowledge. Generalizable knowledge consists of theories, principles or relationships, or the accumulation of information on which they are based, that can be corroborated by accepted scientific methods of observation and inference. “Research” includes both medical and behavioural studies pertaining to human health. Usually “research” is modified by the adjective “biomedical” to indicate its relation to health.

  15. 15.

    Sandel (2013).

  16. 16.

    The 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 and The Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research.

  17. 17.

    Explanatory Report to Additional Protocol on Biomedical Research of 2005 Available. http://www.coe.int/en/web/conventions/full-list/-/conventions/treaty/195.

  18. 18.

    Casado and López Baroni (2021).

  19. 19.

    Baron (2006).

  20. 20.

    Lysaught (2009).

  21. 21.

    European Group on Ethics in Science and New Technologies, “Statement on Clinical Trials”, 2013.

  22. 22.

    Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC.

  23. 23.

    Directive 2001/20/EC of the European Parliament and of the Council 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.

  24. 24.

    Evans (2002).

  25. 25.

    Annas (1991).

  26. 26.

    Casado et al. (2016).

  27. 27.

    Guide for research ethics committees members (Council of Europe 2011).

  28. 28.

    Mittelstadt and Floridi (2016).

  29. 29.

    The Network of ethics committees of the public universities and other research bodies http://www.ub.edu/rceue/ accessed Aug 2019

  30. 30.

    See The European Code of Conduct for Research Integrity (ALLEA, 2017).

  31. 31.

    Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation).

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de Lecuona, I. (2021). Research Ethics Committees. In: Busatta, L., Casonato, C. (eds) Axiological Pluralism. Ius Gentium: Comparative Perspectives on Law and Justice, vol 92. Springer, Cham. https://doi.org/10.1007/978-3-030-78475-1_4

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  • DOI: https://doi.org/10.1007/978-3-030-78475-1_4

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