Informed consent procedure for clinical trials in emergency settings: The Polish perspective

Science and Engineering Ethics

Volumn 13, Issue 3, 2007, Pages 333-336

  Iwanowski, Piotr S ^a  

^a Association for Good Clinical Practice in Poland   (Poland)

Author keywords

Clinical trials; Emergency medicine; Informed consent

Indexed keywords

ARTICLE; CLINICAL TRIAL; EMERGENCY MEDICINE; ETHICS; EUROPE; HUMAN; INFORMED CONSENT; INTERNATIONAL COOPERATION; LEGAL ASPECT; POLAND; RESEARCH ETHICS;

CLINICAL TRIALS AS TOPIC; EMERGENCY MEDICINE; ETHICS, RESEARCH; EUROPE; HUMANS; INFORMED CONSENT; INTERNATIONAL COOPERATION; POLAND;

EID: 38349104568     PISSN: 13533452     EISSN: 16605454     Source Type: Journal    
DOI: 10.1007/s11948-007-9030-9     Document Type: Article

References (14)

1. Guideline for Good Clinical Practice. (1996). International Conference on Harmonisation, Topic E6, http://www.emea.europa.eu
2. World Medical Association Declaration of Helsinki. (1964). Adopted by the 18th WMA General Assembly, Helsinki, Finland, last amended in 2004, http://www.wma.net
3. 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, http://www.conventions.coe.int
4. Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research. Council of Europe, http://www.conventions.coe. int
5. Agard, A., Herlitz, J., & Hermeren, G. (2004). Obtaining informed consent from patients in the early phase of acute myocardial infarction: Physicians' experiences and attitudes. Heart, 90, 208-210.
6. Smithline, H. A., Mader, T. J., & Crenshaw, B. J. (1999). Do patients with acute medical conditions have the capacity to give informed consent for emergency medicine research? Academic Emergency Medicine, 6, 776-780.
7. Agard, A., Hermeren, G., & Herlitz, J. (2001). Patients' experiences of intervention trials on the treatment of myocardial infarction: Is it time to adjust the informed consent procedure to the patient's capacity? Heart, 86, 632-637.
8. Williams, B. F., French, J. K., & White, H. D., HERO-2 consent substudy investigators (2003). Informed consent during the clinical emergency of acute myocardial infarction (HERO-2 consent substudy): A prospective observational study. Lancet, 361, 918-922.
9. Demarquay, G., Derex, L., Nighoghossian, N., Adeleine, P., Philippeau, F., Honnorat, J., & Trouillas, P. (2005). Ethical issues of informed consent in acute stroke. Analysis of the modalities of consent in 56 patients enrolled in urgent therapeutic trials. Cerebrovascular Diseases, 19, 65-68.
10. Gammelgaard, A., Mortensen, O. S., Rossel, P., DANAMI-2 Investigators (2004). Patients' perceptions of informed consent in acute myocardial infarction research: A questionnaire based survey of the consent process in the DANAMI-2 trial. Heart, 90, 1124-1128.
11. Stocchetti, N., Dearden, M., Karimi, A., Lapierre, F., Maas, A., Murray, G. D., Ohman, J., Persson, L., Sahuquillo, J., Servadei, F., Teasdale, G., Trojanowski, T., & Unterberg, A. (2003). New European directive on clinical trials. Lancet, 361, 1473.
12. Lotjonen, S. (2002). Medical research in clinical emergency settings in Europe. Journal of Medical Ethics, 28, 183-187.
13. Biros, M. H. (2003). Research without consent: Current status, 2003. Annals of Emergency Medicine, 42, 550-564.
14. Liddell, K., Chamberlain, D., Menon, D. K., Bion, J., Kompanje, E. J., Lemaire, F., Druml, C., Vrhovac, B., Wiedermann, C. J., & Sterz, F. (2006). The European clinical trials directive revisited: The VISEAR recommendations. Resuscitation, 69, 9-14.