REVIEW PAPER
Patient’s informed consent in clinical trials
1
Clinical Research Organization – Worldwide Clinical Trials, Warsaw, Poland
2
Department of Gastroenterology, Provincial Hospital No. 2, Rzeszow, Poland
3
Faculty of Human Nutrition and Consumer Sciences, Warsaw University of Life Sciences
4
Department of Endoscopy, Institute of Rural Health, Lublin, Poland
Corresponding author
Joanna Polanin-Huk
Clinical Research Organization – Worldwide Clinical Trials, Jana Pawła II 23, 00-854 Warsaw, Poland.
Clinical Research Organization – Worldwide Clinical Trials, Jana Pawła II 23, 00-854 Warsaw, Poland.
J Pre Clin Clin Res. 2010;4(2):161-164
KEYWORDS
ABSTRACT
The doctrine of informed consent is fundamental to all medical personnel involved in investigational research. Informed consent arose from the Helsinki Declaration that stated, ‘concern for the interests of the subject must always prevail over the interests of science and society’. As clinical research is a part of medical practice, it is reasonable to assume that exceptions to fully informed consent that are defendable in medical practice can also be applied to clinical research. The exceptions to fully informed consent are waiver, incompetence, therapeutic privilege, emergency, or proxy.
REFERENCES (16)
1.
Kuczewski MG, Marshall P: The decision dynamics of clinical research: the context and process of informed consent. Med Care 2002, 40, 45- 54.
2.
Raich PC, Plomer KD, Coyne CA: Literacy, Comprehension, and informed consent in clinical research. Cancer Investig 2001, 19, 437- 445.
3.
Sankar P: Communication and miscommunication in informed consent to research. Med Antropol Quart 2004, 18, 429-446.
4.
John M, LuceKarbwang J et al.: Informed Consent for Clinical Research Involving Patients With Chest Disease in the United States, Ethical review and the globalization of clinical trials. App Clin Trials 2002, 90-94.
5.
Annas G, Grodin M: The Nazi doctors and the Nuremberg code. Oxford University Press, New York 1992.
6.
Beyrer C, Kass NE: Human rights, politics and reviews of research ethics. Lancet 2002, 360, 246-251.
7.
Cola P: Institutional review boards and local context review, Clin Res 2003, 3, 15-21.
8.
Fitzmaurice DA, Adams JL: A systematic review of patient information leaflets for hypertension. J Hum Hypertens 2000, 14, 259-62.
9.
Anngell M: Investigators’ responsibilities for human subjects in developing countries. New Eng J Med 2000, 342, 96796.
10.
Andrus MR, Roth MT: Health literacy: a review. Pharmacotherapy 2002, 22, 282-302.
11.
The history and importance of Informed Consent in Clinical Trials – Jessica Kiefer-Biology 1979, 103-2001.
12.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission). Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. US Government Printing Office, Washington DC 2007, 501-502.
13.
Karbwang J et al.: Ethical review and the globalization of clinical trials. App Clin Trials 2002, 90-94.
14.
Marshall PA, Koenig B: Accounting for culture in a globalized bioethics. J Low Med and Eth 2004, 32, 255-266.
15.
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. Off J Eur Commun L 2001, 121, 33-44.
16.
Druml Ch: Informed consent of incapable (ICU) patients in Europe: existing laws and the EU Directive Opinion in Critical Care 2004, 10, 570-573.
| eISSN: | 1898-7516 |
| ISSN: | 1898-2395 |
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