Uslovi za punovažnost pristanka na klinička ispitivanja

Shuster E. Fifty years later: the significance of the Nuremberg Code. N Engl J Med 1997; 337(20): 1436−40.

Živojinović D. The historical development and international reg-ulations of clinical research involving human subjects. In: Mićović M , editor. The collection of papers from the Interna-tional scientists’ gathering under the topic Law and Service; Kragujevac: Faculty of Law; 2012. p. 677−97.

Radišić J. Professional responsibility of medical staff. Belgrade: Institute for Social Sciences; 1986. (Serbian)

Ivović N. Saglasnost za eksperimentalne medicinske tretmane. Pravni život 2004; 53(9): 339−51. (Serbian)

Živojinović D. Requirements of ethical justification of clinical re-search. Novi Sad: Collection of papers of the Law Faculty; 2012; 46(1): 331−47. (Serbian)

Official Gazette of RS 107/05, 72/09, 88/10, 99/10, 57/11. (Serbian)

Official Gazette of RS 30/10, 107/2012. (Serbian)

Official Gazette of RS 18/05, 72/11. (Serbian)

„Official Gazette of SFRY“ 29/78, 39/85, 45/89; „Official Gazette of SRY“ 31/93; „Official Gazette of SM“ 1/03. (Ser-bian)

Official Gazette of RS 2008 28/08. (Serbian)

The Nuremberg Code. Trials of War Criminals Before the Nuremberg Military Tribunals Under Control. Washington, DC: US Government Printing Office. 1949.

Vodinelić V. Civil law - Introduction to the civil law and its general part. Belgrade: Union University - Law School, Public Company Official Gazette; 2012. (Serbian)

Stojanović D, Antić O. Introduction to the Civil Law. Belgrade: Belgrade; Faculty of Law; 2004.

Appelbaum PS, Grisso T. Assessing patients' capacities to con-sent to treatment. N Engl J Med 1988; 319(25): 1635−8.

Radišić J. Medical Law. Belgrade: Nomos; 2004.

Tatić-Klajn V. Children as subjects of biomedical researches or experiments from the perspective of of medical, ethical and le-gal considerations. Pravni život 2009; 529(9): 837−54.

Official Gazette of RS 2009 72/09.

Planojević N. The property law in practice. Kragujevac: Faculty of Law, Institute for Legal and Social Sciences; 2012.

Coots TJ, Shakur H. Consent in emergency research: new regu-lations. Emerg Med J 2005; 22(10): 683−5.

Simar R, Johnson VA. Pediatric informed consent. Challenges for investigators. Appl Clin Trial 2002; 7: 3−10.

Wirgley A. Proxy consent: moral authority misconceived. J Med Ethics 2007;33: 527−31.

Mason S, Barrow H, Phillips A, Eddison G, Nelson A, Cullum N, et al. Brief report on the experience of using proxy consent for incapacitated adults. J Med Ethics 2006; 32:61−2.

A Guides of the British Medical Association (BMA). Online Application System. Available from: http://www.bma.org.uk/

World Medical Association. World Medical Association Declara-tion of Helsinki: ethical principles for medical research involv-ing human subjects. J Postgrad Med 2002; 48(3): 206−8.

Council for International Organizations of Medical Sciences. Interna-tional ethical guidelines for biomedical research involving hu-man subjects. Geneva, Switzerland: World Health Organiza-tion; 2002.

UN General Assembly. International Covenant on Civil and Political Rights; 16 December 1966, United Nations, Treaty Series. Available from: http://www.unhcr.org/refworld/docid/3ae6b3aa0.html [ac-cessed 20 February 2013].

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: Council of Europe; 1997.

General Conference of United Nations Educational, Scientific and Cultural Organizations. Universal Declaration on Bioeth-ics and Human Rights. Paris: UNESCO; 2005.

Childress JF. The Place of Autonomy in Bioethics. Hastings Center Report 1990; 20(1): 12−7.

Živojinović D. Consent on clinical research: notion and grounds for the consent, and content of subject intended information. Kragujevac: Faculty of Low; 2012. (Serbian)

Official Gazette of RS 2006 98/06.

Grady C. Vulnerability in Research: Individuals with Limited Financial and/or Social Resources. J Law Med Ethics 2009; 37(1): 19−27.

Živojinović D. Ethical dilemma of globalization of clinical re-search. Pravni život 2012; 555(9): 537−52. (Serbian)

Del CMG. Informed Consent for Medical Treatment and Re-search: A Review. Oncologist 2005; 10(8): 636−41.

Directive 2001/20/EC of the European Parliament and of the Council. Luxembourg: Official Jurnal of the European Com-munities; 1.5.2001; 1996.

European Medicines Agency. ICH Topic E 6 (R1). Guidelines for Good Clinical Practice, CPMP/ICH/135/95. London: European Medicines Agency; 2002.

Joffe S, Cook E, Cleary PD, Clark JW, Weeks JC. Quality of in-formed consent in cancer clinical trials: a cross-sectional sur-vey. Lancet 2001; 358(9295): 1772−7.

Lynöe N, Sandlund M, Dahlqvist G, Jacobsson L. Informed con-sent: study of quality of information given to participants in a clinical trial. BMJ 1991; 303(6803): 610−3.

Zhang D, Yin P, Freemantle N, Jordan R, Zhong N, Cheng KK. An assessment of the quality of randomised controlled trials con-ducted in China. Trials 2008; 9: 22.

Flory J. Interventions to Improve Research Participants' Un-derstanding in Informed Consent for Research. J Am Med Assoc 2004; 292(13): 1593−1601.

Mujović-Zornić H, Petrović Z. Responsibility of Health Institutions for Harms as Consequences of Treatment. Vojnosanit Pregl 2012; 69(8): 692−9. (Serbian)

Official Gazette of RS 85/05, 88/05, 107/05, 72/09, 111/09.

Stojanović Z. Comment of the Penal Code. Belgrade: Savremena administracija; 2009. (Serbian)