David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Jack Alan Reynolds
Learn more about PhilPapers
Science and Engineering Ethics 13 (3):337-350 (2007)
Although Directive 2001/20/EC of the European Parliament and of 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 does not contain an exception for emergency situations, and requires the informed consent of a legal representative in all cases where research is conducted on legally competent individuals who are unable to give informed consent, in Poland, emergency research can be conducted without consent. Polish regulations on emergency research can hardly be treated as a result of intentional legislative policy. Our provisions arise from multiple and sophisticated interpretations of different regulations that govern medical experiments on human subjects and clinical trials. These interpretations can be summarized as follows: (1) There are two categories of medical experiments: therapeutic and non-therapeutic experiments. Emergency research without consent may be conducted in the category of therapeutic experiment only (therapeutic experiment consists of the introduction by the physician of new or only partially proven diagnostic, therapeutic or preventive methods in order to achieve direct benefit to the health of the patients, and it can be carried out when hitherto applied methods were ineffective or their effectiveness was insufficient). (2). Emergency research may be conducted without consent if there is a situation of great urgency in which the research subject’s life is in danger and there is no possibility of obtaining immediate consent from the research subject him or herself, or from his or her legal representative or guardianship court, and the research subject has not refused to give consent for the participation in an emergency therapeutic experiment. The legal representative or guardianship court shall be provided with all the relevant information concerning subject’s participation in an experiment as soon as possible. All projects of emergency research with intent to be done without the research subject’s consent must be approved by an independent bioethics committee. Because these five requirements seem to provide insufficient protection for a subject’s autonomy and rights it is necessary to add to them two other conditions: (1) the emergency research could not be conducted using other research participants capable of giving informed consent; and (2) informed consent for continued participation in the emergency research shall be obtained from either the participant him or herself or the legally authorized representative as soon as possible (requirement of obtaining deferred consent). A consolidated single Act that will govern all aspects of medical experiments on human subjects, including emergency research, should be prepared and enacted as soon as possible.
|Keywords||Emergency research Polish law Medical experiments Informed consent Waiver of consent|
|Categories||categorize this paper)|
Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
|Through your library|
References found in this work BETA
C. E. Blixen (2005). Stroke Patients' Preferences and Values About Emergency Research. Journal of Medical Ethics 31 (10):608-611.
Council of Europe (2005). Additional Protocol to the Convention on Human Rights and Biomedicine, Concerning Biomedical Research. Jahrbuch für Wissenschaft Und Ethik 10 (1).
S. Lotjonen (2002). Medical Research in Clinical Emergency Settings in Europe. Journal of Medical Ethics 28 (3):183-187.
Citations of this work BETA
Marcin Waligora (2013). A European Consistency for Functioning of RECs? We Just Lost Our Chance. Journal of Medical Ethics 39 (6):408-409.
Similar books and articles
Oonagh Corrigan (ed.) (2009). The Limits of Consent: A Socio-Ethical Approach to Human Subject Research in Medicine. Oxford University Press.
Andrew D. McRae, Stacy Ackroyd-Stolarz & Charles Weijer, Risk in Emergency Research Using a Waiver of/Exception From Consent: Implications of a Structured Approach for Institutional Review Board Review.
Agata Wnukiewicz-Kozłowska (2007). The Admissibility of Research in Emergency Medicine. Science and Engineering Ethics 13 (3):315-332.
Erwin J. O. Kompanje (2007). No Time to Be Lost! Science and Engineering Ethics 13 (3):371-381.
Andrew D. McRae & Charles Weijer, Lessons From Everyday Lives: A Moral Justification for Acute Care Research.
Andrew McRae & Charles Weijer, U.S. Federal Regulations for Emergency Research: A Practical Guide and Commentary.
Ritva Halila (2007). Assessing the Ethics of Medical Research in Emergency Settings: How Do International Regulations Work in Practice? Science and Engineering Ethics 13 (3):305-313.
Malcolm G. Booth (2007). Informed Consent in Emergency Research: A Contradiction in Terms. Science and Engineering Ethics 13 (3):351-359.
Michelle H. Biros (2007). Research Without Consent: Exception From and Waiver of Informed Consent in Resuscitation Research. Science and Engineering Ethics 13 (3):361-369.
Piotr S. Iwanowski (2007). Informed Consent Procedure for Clinical Trials in Emergency Settings: The Polish Perspective. Science and Engineering Ethics 13 (3):333-336.
Added to index2009-01-28
Total downloads8 ( #160,007 of 1,096,394 )
Recent downloads (6 months)2 ( #134,922 of 1,096,394 )
How can I increase my downloads?