Opinion of the Bioethics Committee No. KB-141/2006

Opinion of the Bioethics Committee No. KB-141/2006 Opinion of the Bioethics Committee No. KB-141/2006

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Bioethics Committee of the Wrocław Medical University ul. Pasteura 1, 50-367 Wrocław fax: 071/784-10-13, tel. 071/784-10-14 email: bioetyka@am.wroc.pl http://www.bioetyka.am.wroc.pl Opinion of the Bioethics Committee No. KB-141/2006 The Bioethics Committee of the Wrocław Medical University, appointed by directive No. 4XIII R/99 of September 27, 1999, of the President of the Wrocław Medical University and acting in the manner foreseen by the directive of May 12, 1999, of the Minister of Health and Social Welfare (Law Gazette No. 47, pos. 480) on the basis of the law on the physician's profession of December 5, 1996 (Law Gazette No. 28 of 1997, pos. 152 and later amendments), composed of: Prof. Dr. Karol BAL, philosopher, full professor Director of the Institute of Philosophy, University of Wrocław Prof. Dr. Wiktor BENDARZ, surgeon, professor Department and Clinic of General, Gastroenterological, and Endocrinological Surgery, Wrocław Medical University Fr. Dr. Janusz CZARNY, theologian, assistant professor, Papal Faculty of Theology in Wrocław Dr. Henryk KACZKOWSKI, oral surgeon, dental surgeon assistant professor, Department and Clinic of Jaw and Face Surgery, Wrocław Medical University Irena KNABEL-KRZYSZOWSKA, MS, pharmaceutics, representative of the Lower Silesian Chamber of Pharmacists Prof. Dr. Jan KOLASA, lawyer, full professor of the University of Wrocław Prof. Dr. Krystyna ORZECHOWSKA-JUZWENK, clinical pharmacology, internal diseases professor emeritus of the Wrocław Medical University Prof. Dr. Janusz PATKOWSKI, allergology, internal diseases, full professor, Department and Clinic of Internal Diseases and Allergology, Wrocław Medical University Prof. Dr. Zbigniew RUDKOWSKI, pediatrics, infectious diseases, professor emeritus, Wrocław Medical University Dr. Sławomir SIDOROWICZ, psychiatry, Department of Psychiatry, Wrocław Medical University Danuta TARKOWSKA, midwife, retired Dr. Andrzej WOJNAR, pathomorphology, dermatology, representative of the Lower Silesian Chamber of Physicians chair: Prof. Dr. Jan KORNAFEL, gynecology and midwifery, oncology full professor, Department of Oncology and Clinic of Gynecological Oncology, Wrocław Medical University p. 2 acting in accordance with the principles of Good Clinical Practice and the principles of the Declaration of Helsinki, in its session of March 16, 2006, after becoming acquainted with the following submitted by Prof. Dr. Andrzej Górski: • amendment No. 1 to the project of a medical experiment of February 23, 2006.

<strong>Bioethics</strong> <strong>Committee</strong><br />

<strong>of</strong> <strong>the</strong> Wrocław Medical University<br />

ul. Pasteura 1, 50-367 Wrocław<br />

fax: 071/784-10-13, tel. 071/784-10-14<br />

email: bioetyka@am.wroc.pl<br />

http://www.bioetyka.am.wroc.pl<br />

<strong>Opinion</strong> <strong>of</strong> <strong>the</strong> <strong>Bioethics</strong> <strong>Committee</strong><br />

<strong>No</strong>. <strong>KB</strong>-<strong>141</strong>/<strong>2006</strong><br />

The <strong>Bioethics</strong> <strong>Committee</strong> <strong>of</strong> <strong>the</strong> Wrocław Medical University, appointed by directive <strong>No</strong>. 4XIII<br />

R/99 <strong>of</strong> September 27, 1999, <strong>of</strong> <strong>the</strong> President <strong>of</strong> <strong>the</strong> Wrocław Medical University and acting in <strong>the</strong><br />

manner foreseen by <strong>the</strong> directive <strong>of</strong> May 12, 1999, <strong>of</strong> <strong>the</strong> Minister <strong>of</strong> Health and Social Welfare<br />

(Law Gazette <strong>No</strong>. 47, pos. 480) on <strong>the</strong> basis <strong>of</strong> <strong>the</strong> law on <strong>the</strong> physician's pr<strong>of</strong>ession <strong>of</strong> December 5,<br />

1996 (Law Gazette <strong>No</strong>. 28 <strong>of</strong> 1997, pos. 152 and later amendments), composed <strong>of</strong>:<br />

Pr<strong>of</strong>. Dr. Karol BAL, philosopher, full pr<strong>of</strong>essor<br />

Director <strong>of</strong> <strong>the</strong> Institute <strong>of</strong> Philosophy, University <strong>of</strong> Wrocław<br />

Pr<strong>of</strong>. Dr. Wiktor BENDARZ, surgeon, pr<strong>of</strong>essor<br />

Department and Clinic <strong>of</strong> General, Gastroenterological, and Endocrinological Surgery,<br />

Wrocław Medical University<br />

Fr. Dr. Janusz CZARNY, <strong>the</strong>ologian, assistant pr<strong>of</strong>essor, Papal Faculty <strong>of</strong> Theology in Wrocław<br />

Dr. Henryk KACZKOWSKI, oral surgeon, dental surgeon<br />

assistant pr<strong>of</strong>essor, Department and Clinic <strong>of</strong> Jaw and Face Surgery,<br />

Wrocław Medical University<br />

Irena KNABEL-KRZYSZOWSKA, MS, pharmaceutics, representative <strong>of</strong> <strong>the</strong><br />

Lower Silesian Chamber <strong>of</strong> Pharmacists<br />

Pr<strong>of</strong>. Dr. Jan KOLASA, lawyer, full pr<strong>of</strong>essor <strong>of</strong> <strong>the</strong> University <strong>of</strong> Wrocław<br />

Pr<strong>of</strong>. Dr. Krystyna ORZECHOWSKA-JUZWENK, clinical pharmacology, internal diseases<br />

pr<strong>of</strong>essor emeritus <strong>of</strong> <strong>the</strong> Wrocław Medical University<br />

Pr<strong>of</strong>. Dr. Janusz PATKOWSKI, allergology, internal diseases, full pr<strong>of</strong>essor,<br />

Department and Clinic <strong>of</strong> Internal Diseases and Allergology, Wrocław Medical University<br />

Pr<strong>of</strong>. Dr. Zbigniew RUDKOWSKI, pediatrics, infectious diseases,<br />

pr<strong>of</strong>essor emeritus, Wrocław Medical University<br />

Dr. Sławomir SIDOROWICZ, psychiatry, Department <strong>of</strong> Psychiatry, Wrocław Medical University<br />

Danuta TARKOWSKA, midwife, retired<br />

Dr. Andrzej WOJNAR, pathomorphology, dermatology, representative <strong>of</strong> <strong>the</strong><br />

Lower Silesian Chamber <strong>of</strong> Physicians<br />

chair:<br />

Pr<strong>of</strong>. Dr. Jan KORNAFEL, gynecology and midwifery, oncology<br />

full pr<strong>of</strong>essor, Department <strong>of</strong> Oncology and Clinic <strong>of</strong> Gynecological Oncology,<br />

Wrocław Medical University<br />

p. 2<br />

acting in accordance with <strong>the</strong> principles <strong>of</strong> Good Clinical Practice and <strong>the</strong> principles <strong>of</strong> <strong>the</strong><br />

Declaration <strong>of</strong> Helsinki, in its session <strong>of</strong> March 16, <strong>2006</strong>, after becoming acquainted with <strong>the</strong><br />

following submitted by Pr<strong>of</strong>. Dr. Andrzej Górski:<br />

• amendment <strong>No</strong>. 1 to <strong>the</strong> project <strong>of</strong> a medical experiment <strong>of</strong> February 23, <strong>2006</strong>.


• patient information and patient consent form for participation in a medical experiment, version 2<br />

<strong>of</strong> February 23, <strong>2006</strong>,<br />

• a copy <strong>of</strong> civil insurance policy <strong>No</strong>. 000-06-447-05844559, TU Allianz Polska Spółka S.A.,<br />

term <strong>of</strong> insurance: April 25, <strong>2006</strong> to April 24, 2009,<br />

• annex 1 to <strong>the</strong> policy <strong>No</strong>. 000-06-447-05844559 <strong>of</strong> insurance <strong>of</strong> civil responsibility <strong>of</strong> March 6,<br />

<strong>2006</strong>,<br />

to <strong>the</strong> research project "Experimental phage <strong>the</strong>rapy <strong>of</strong> infections by antibiotic-resistant bacteria,<br />

including MRSA"<br />

approved by <strong>Committee</strong> opinion <strong>No</strong>. <strong>KB</strong>-349/2005 <strong>of</strong> June 15, 2005,<br />

has decided:<br />

• to approve <strong>of</strong> fur<strong>the</strong>r conducting <strong>the</strong> research<br />

Instruction: The applicant has <strong>the</strong> right to appeal this opinion to <strong>the</strong> Appeals Commission through<br />

<strong>the</strong> agency <strong>of</strong> <strong>the</strong> <strong>Bioethics</strong> <strong>Committee</strong> <strong>of</strong> <strong>the</strong> Wrocław Medical University within 14 days <strong>of</strong> its<br />

receipt.<br />

Chair <strong>of</strong> <strong>the</strong> <strong>Committee</strong><br />

Pr<strong>of</strong>. Dr. Jan Kornafel<br />

Wrocław, March 23, <strong>2006</strong>

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