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Proiect cofinanat din Fondul Social European prin Programul Operaional Sectorial Dezvoltarea Resurselor Umane 2007

2013
Investete n oameni!
FONDUL SOCIAL EUROPEAN
Axa prioritar 1: Educaia i formarea n sprijinul creterii economice i dezvoltrii societii bazate pe cunoatere
Domeniul major de intervenie 1.2: Programe de studii mai bune pentru studen i i pia a muncii
Titlul proiectului: Aplicarea metodologiilor de cercetare tiin ific n domeniul tiin elor medicale i promovarea culturii
antreprenoriale pentru facilitarea inseriei pe piaa muncii a studenilor mediciniti din ciclul de studii universitare de licen
Numrul de identificare al contractului: POSDRU/156/1.2/G/141745
Beneficiar: Universitatea de Medicin i Farmacie Carol Davila din Bucureti

SYLLABUSUL MODULULUI DE FORMARE


Introducere n bioetic

Titularul modulului: Dr. Cristian Ducu

Activitatea: A1.2. Dezvoltarea i furnizarea sistemului gradual de coordonare al modulelor


de formare la nivelul studenilor mediciniti n metodologiile de cercetare tiinific specifice
domeniului tiinelor medicale i celor conexe acestora.
Modulul se adreseaz: studenilor mediciniti din ciclul de licen, anii I-VI.
Numr de ore/Verificarea/Credite
Formare face-to-face
Studiu Individual
9
41

Examinare

Credite
2

A. OBIECTIVELE DISCIPLINEI
Cursul de Introducere n Bioetic i propune s familiarizeze studenii cu limbajul tehnic i
problematica specifice eticii n cercetarea biomedical astfel nct s neleag dificultile,
limitele i implicaiile problemelor reale cu care s-ar putea ntlni n domeniul cercetrii.
B. COMPETENE SPECIFICE
La finalul celor trei cursuri i studiului individual, cursanii vor putea:
1. s identifice o problem de natur moral din domeniul cercetrii biomedicale;
2. s evalueze din punct de vedere moral o situaie de natur profesional;
3. s opereze cu terminologia specific eticii aplicate i n mod special eticii n cercetarea
biomedical;
4. s recunoasc responsabilitile i drepturile cercettorilor din domeniul biomedical.
1

C. CONINUTUL DISCIPLINEI
Tema
1. CONCEPTE,
DISTINCII I
ABORDRI

Coninuturi
1.01. Ce este etica?
1.02. Etic/moral neetic/immoral non-etic/amoral

Nr. ore alocate


(formare face to face
si studiu individual)
Formare face-to-face: 3
Studiu individual: 17

1.03. Etic, moralitate, deontologie i deontologism


1.04. Falsa distincie ntre morala individual i
morala colectiv
1.05. Valori, principii, reguli
1.06. Reguli morale reguli juridice reguli
profesionale
1.07. Reflecia moral judecata moral deciziile
etice
1.08. Sunt teoriile etice relevante pentru practica
medical i domeniul cercetrii medicale?
1.09. Aristotel i caracterul moral al individului
1.10. Immanuel Kant, demnitatea uman i
autonomia
1.11. John Stuart Mill i binele general
1.12. Metode de decizie etic
1.12.1. Evaluarea consecinionist
1.12.2. Principiismul i Metoda celor 4
Cadrane

2. ETICA I
CERCETAREA PE
SUBIECI UMANI

2.1. Istoria problemei proteciei subiecilor umani n


cercetarea biomedical

Formare face-to-face: 3
Studiu individual: 12

2.2. Consimmntul informat


2.3. Protejarea grupurilor vulnerabile n studiile
clinice
2.4. Protecia datelor n cercetarea biomedical cu
subieci umani
2.5. Rolul Comisiilor de etic n aprobarea studiilor
cu subieci umani

3. ETICA I
CERCETAREA PE
ANIMALE

5.1. Drepturile animalelor vs. obligaii morale


fa de animale
5.2. Bunstarea animalelor n laborator
5.3. Constrngeri morale privind testarea de
medicamente pe animale
5.4. Constrngeri morale privind
dezvoltarea/nvarea de procedee medicale pe
animale
5.5. Eutanasierea animalelor folosite n cercetarea
biomedical
2

Formare face-to-face: 3
Studiu individual: 12

Total ore:

50

D. EVALUARE (Se precizeaz metodele, formele de evaluare i ponderea acestora n stabilirea notei
finale. Se indic standardele minime de performan, raportate la competenele definite la punctul A.
Obiectivele disciplinei).

1. Forme de evaluare si pondere:


Evaluarea se va face n mod permanent pe parcursul celor 9 ore de formare fa-n-fa, prin
notarea contribuiilor fiecrui participant la discuiile din cadrul cursului, i la finalul
programului de formare, prin intermediul unui test gril.
2. Standarde de performan raportate la competene:
Tip standard
Minim (media 5)

Descriere standard
Este capabil s identifice o problem moral i s se foloseasc de cel puin o
metod de evaluare etic n analiza situaiei date.

Folosete n mod corect termenii tehnici specifici eticii n cercetare.


Maxim (media 10) Este capabil s identifice o problem moral i s se foloseasc de toate
metodele de evaluare etic prezentate de formator n analiza situaiei date.
Folosete n mod corect limbajul tehnici, avnd capacitatea de a dezvolta
argumente complexe n favoarea unui punct de vedere sau altul.
Identific n mod facil obligaiile morale i profesionale pe care un cercettor
trebuie s le respecte ntr-o situaie dat.
E. BIBLIOGRAFIE MINIMALA
1. Legislaie
Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research;
Council of Europe, Strasbourg, Ianuarie 2005. Ultima accesare: 2015-02-10, URL:
http://conventions.coe.int/Treaty/EN/Treaties/html/195.htm.
Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for
Health Purposes; Council of Europe, Strasbourg, Noiembrie 2008. Ultima accesare: 2015-02-10, URL:
http://conventions.coe.int/Treaty/EN/Treaties/html/203.htm.
Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of
Organs and Tissues of Human Origin; Council of Europe, Strasbourg, Ianuarie 2002. Ultima accesare:
2015-02-10, URL: http://conventions.coe.int/Treaty/EN/Treaties/html/186.htm.
Code of Federal Regulations, Title 21 Food and Drugs, Chapter I Food and Drug Administration,
Department of Health and Human Services, Part 50 Protection of Human Subjects; U.S. Food and
Drug
Administration,
Aprilie
2014.
Ultima
accesare:
2015-02-10,
URL:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50&showFR=1.
Code of Federal Regulations, Title 45 Public Welfare, Department of Health and Human Services, Part 46
Protection of Human Subjects; U.S. Department of Health and Human Services, Ianuarie 2009. Ultima
accesare: 2015-02-10, URL: http://www.hhs.gov/ohrp/policy/ohrpregulations.pdf.

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,
Oviedo,
Aprilie
1997.
Ultima
accesare:
2015-02-10,
URL:
http://conventions.coe.int/Treaty/EN/Treaties/html/164.htm.
Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects; World Medical
Association,
Octombrie
2013.
Ultima
accesare:
2015-02-10,
URL:
http://www.wma.net/en/30publications/10policies/b3/.
Recommendation Rec(2004)10 of the Committee of Ministers to member States concerning the protection of
the human rights and dignity of persons with mental disorder and its Explanatory Memorandum;
Council of Europe, Committee of Ministers, Septembrie 2004. Ultima accesare: 2015-02-10, URL:
http://www.coe.int/t/dg3/healthbioethic/Activities/08_Psychiatry_and_human_rights_en/Rec
%282004%2910%20EM%20E.pdf.
Recommendation Rec(2006)4 of the Committee of Ministers to member states on research on biological
materials of human origin; Council of Europe, Committee of Ministers, Martie 2006. Ultima accesare:
2015-02-10, URL: https://wcd.coe.int/ViewDoc.jsp?id=977859.
2. Raporte, studii, ghiduri
International Ethical Guidelines for Biomedical Research Involving Human Subjects; Council for
International Organizations of Medical Sciences, Geneva, 2002. Ultima accesare: 2015-02-10, URL:
http://www.cioms.ch/publications/layout_guide2002.pdf.
Standards and Operational Guidance for Etics Review of Health-Related Research with Human Participants;
World
Health
Organization,
2011.
Ultima
accesare:
2015-02-10,
URL:
http://whqlibdoc.who.int/publications/2011/9789241502948_eng.pdf?ua=1.
Moral Science. Protecting Participants in Human Subjects Research; Presidential Commission for the Study
of Bioethical Issues, Washington D.C., Decembrie 2011. Ultima accesare 2015-02-10, URL:
http://bioethics.gov/sites/default/files/Moral%20Science%20June%202012.pdf.
3. Literatur academic
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New York.
BIELBY, Philip (2008) Competence and Vulnerability in Biomedical Research; Springer, Dordrecht.
BONACCHI, Gabriella (ed.)(2003) Dialoghi di bioetica; Carocci, Roma.
BRODY, Howard (1994) The Four Principles and Narrative Ethics; n Principles of Health Care Ethics,
pp. 207-215.
CALLAHAN, Joan C. (ed.)(1988) Ethical Issues in Professional Life; Oxford University Press, New York.
COHEN, Perrin & Melissa McDaniels & Donna M. Qualters (2005) AIR Model. A Teaching Tool for
Cultivating Reflective Ethical Inquiry; n College Teaching, vol. 53(3), pp. 120-127.
EMANUEL, Ezekiel J. & Christine Grady & Robert A. Crouch & Reidar Lie & Franklin Miller & David
Wendler (eds.)(2008) The Oxford Textbook of Clinical Research Ethics; Oxford University Press,
Oxford.
FINEGOLD, David & Allison Moser (2006) Ethical Decision-Making in Bioscience Firms; n Nature
Biotechnology, vol. 24(3), pp. 283-290.
FINEGOLD, David L. & Ccile M. Bensimon & Abdallah S. Daar & Margaret Eaton & Batrice Godard &
Bartha Maria Knoppers & Jocelyn E. Mackie & Peter A. Singer (2005), Bioindustry Ethics; Elsevier,
Amsterdam.
FISCHER, Johannes (2014) What Kind of Ethics? How Understanding the Field Affects the Role of
Empirical Research in Morality for Ethics; n CHRISTEN, Markus & Carel van Schaik & Johannes
Fischer & Markus Huppenbauer & Carmen Tanner (eds.)(2014) Empirically Informed Ethics: Morality
between Facts and Norms; Springer, Dordrecht, pp. 29-44.

GRACIA, Diego (2001) Moral Deliberation: The Role of Methodologies in Clinical Ethics; n Medicine,
Health Care and Philosophy, vol. 4, pp. 223-232.
HARRIS, John (1995) The Elimination of Morality; n Journal of Medical Ethics, vol. 21, pp. 220-224.
HAWKINS, Jennifer S. & Ezekiel J. Emanuel (eds.)(2008) Exploitation and Developing Countries: the
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JONES, James W. & Laurence B. McCullough & Bruce W. Richman (2008) The Ethics of Surgical Practice.
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Titularul modulului:
Dr. CRISTIAN DUCU
Expert elaborare i susinere module de formare pentru studen i pt. activitatea A1(S)