CURS 3

Etape ale dezvoltarii si normarii eticii cercetarii

stiintifice.
Declaratia de la Helsinki 1964-2013 si comparatia cu
alte documente normative ale eticii cercetarii pe
subiectul uman

Prof. GC Curca
 Etapa 1
NORMAREA ETICA A ACTULUI MEDICAL
TERAPEUTIC (etica medicala)

• Actiunea: practica medicala neunitara la patul

bolnavului, etic si profesional
• Masura: normarea etica a actului medical
terapeutic prin juramantul Hipocratic 450 i.H.,
Hisbah atestat in 931 d.H, juramantul
Maimonide 1170 d.H
Organizatie socio-profesionala Non-maleficenta
Beneficenta Juramantul Hipocratic Competenta, profesionalism
Egalitarism, Nondiscriminare
Independenta
Justitie
(400 iH) Fidelitate
Pro-viata: nu eutanasiei, avortului Responsabilitate
“Jur pe Apollo medicul, Asclepius, Hygeia si Panacea, si iau ca martori pe toti zeii si zeitele, ca voi pastra
dupa abilitatile si judecata mea urmatorul juramant si intelegere:
Sa il consider pe profesorul care m-a invatat aceasta arta egal cu parintii mei; sa impart cu el traiul meu,
si atunci cand va fi in datorie de plata, daca va fi nevoie, sa contribui pentru a-l ajuta; sa ii consider pe
copii sai ca pe fratii mei pe linie barbateasca si sa-i invat aceasta arta daca vor dori, fara taxe ori fara
vreun acord scris, si invatandu-i , sa impart cunoasterea acestei arte catre fii mei, catre fii profesorilor
mei si catre discipolii care au prestat un juramant dupa legile medicale, dar nu si catre altii.
Voi folosi prescriptii pentru a ajuta pe cel bolnav dupa abilitatile si cunostiintele mele; dar si ca sa tin
departe orice vatamare si injustitie.
De asemenea nu voi da nici o substanta letala chiar daca mi se cere si nici nu voi sfatui în această privință.
Tot așa nu voi da unei femei remedii pentru a induce avortul. Voi pastra in puritate si curatenie viata
si arta mea.
Nu voi folosi cutitul, nici chiar pentru cei cu pietre, dar voi permite sa o faca celor care practica aceasta
munca.
Si in oricate case as putea sa intru, voi intra spre binele bolnavului, tinandu-ma departe de orice injustitie
din vina mea ori prin inselaciune abtinandu-ma de la placerile iubirii cu femei sau barbati, fie ei liberi
sau sclavi.
Tot ceea ce voi vedea sau auzi in timpul tratamentului sau in afara lui in legatura cu viata aceluia si care
nu trebuie vorbit in nici un fel in afara, nu voi vorbi, cu privire la cele ce nu se pot spune.
Daca va fi sa tin acest juramant cu credinta, fie sa ma bucur de viata si practica artei mele respectat de
catre toti oamenii in toate timpurile; dar daca il voi incalca sau voi jura stramb, contrariul sa mi se intam"
 Juramantul Maimonide (1170 d.H)
In Europa mediteraneana si Asia
Juram Maimonide (cca. 1170 dH): umanism si competenta profesionala, a valorizat calitatile
medicului si nevoia lor de autodezvoltare, prin calitatile sale morale actul medical castiga in
moralitate, a sustinut valori prudentiale si toleranta fata de diversitate, nevoia de
colegialitate. A initiat modelul de tratament bio-psihologic.
• "Dumnezeul meu, pune in inima mea iubirea pentru arta si pentru toate creaturile.
• Sa nu accepti ca setea de castig si de glorie sa imi influenteze arta, pentru ca dusmanii adevarului si ai iubirii de
oameni sa nu ma poata abuza ori sa ma indeparteze de la datoria mea nobila de a face bine copiilor tai.
• Sustine forta inimii mele pentru ca sa pot fi intotdeauna gata sa servesc atat pe cel sarac cat si pe cel bogat, pe
prieten dar si pe dusman, pe cel bun cat si pe cel rau.
• Fă, Doamne, ca in cel atins de boală să nu văd altceva decît omul suferind.
• Fa astfel ca spiritul meu sa ramana liber si clar la patul bolnavului si sa nu se rataceasca inainte de a inregistra tot
ceea ce experienta si stiinta m-au invatat.
• Fa astfel ca bolnavii sa aiba incredere in mine si in arta mea pentru a urma sfaturile mele si prescriptiile mele.
Indeparteaza de patul lor pe sarlatanii inarmati cu miile lor de sfaturi sip e cei care stiu tot pentru ca vanitatea poate
esua cele mai bune intentii ale artei si conduce adesea spre moarte.
• Daca ignorantii ma blameaza fa astfel ca iubirea mea pentru arta sa imi fie aparatoare si sa ma faca invulnerabil
pentru ca sa pot continua fara sa tin seama de prestigiul, renumele si varsta dusmanilor mei. Da-mi Doamne,
indulgenta si rabdare pe langa bolnavii incapatanati si grosolani.
• Fa astfel ca sa fiu ponderat in toate, dara fara limita in iubirea pentru stiinta. Nu ma fa sa cred ca pot totul. Da-mi
forta, vointa si ocazia de a cunoaste mereu mai mult.
• As putea astazi afla lucruri nestiute ieri caci arta este mare dar spiritul omului este patrunzator si mereu mai in fata.
• Fă-mă să ţin seama, în faţa celor din breasla mea, de sfaturile celor cu adevărat ştiutori şi ale celor dornici să mă
înveţe să înţeleg, căci mare şi necuprinsa este întinderea ştiinţei!”
(traducere literara dupa Soulier, Du Serment d'Hippocrate à l'éthique médicale, Thèse médecine, Marseille, 1985
[http://wij.free.fr/maimonid.htm])
 ETAPA 2
Prima incercare de normare etica a cercetarii
stiintifice pe subiectul uman: definiri ale “experiment-
voluntariat-consimtamant”
VOINTA PACIENTULUI SI CONSIMTAMANTUL DUPA
CORECTA EXPLICARE SI PREALABILA INFORMARE
• Actiunea : cazul Neisser, 1897-1899
• Masura: Norme cu privire la cercetarea pe
subiectul uman in Germania 1900-1931
 Gerhard Armauer Hansen Albert Neisser

• n. 1855, 1877 absolvent in Breslau

• n. 1841; 1866 absolvent Oslo
• 1879 descopera gonococul (Neisseria ghonorhoae)
• 1868 incepe studiul leprei cu Danielssen
• 1880 anunta descoperirea etiologica a leprei
• 1872-73 descopera bacteria si anunta ca a identificat cauza
• 1882 numit profesor extraordinar
(un germen) dar nu a putut lega etiologic bacilul de boala
• 1898 publica date despre seroterapia sa contra
• 1979 il roaga pe Albert Neisser sa il ajute in histopatologia
sifilisului; pentru baza de cercetare si-a ales ca
produselor biologice
subiecti umani prostituate: unele se imbolnavesc
• 1880 Neisser anunta singur descoperirea leprei prin
• Este acuzat de incalcarea bunei conduite in
identificarea bacilului in produsele recoltate de Hansen
cercetare dar ordinul medicilor il absolva de
• Sub presiunea de a putea macar lega bacilul de boala
acuzatie, pacientele neputand aduce dovezi ca s-
clinica, dupa 1880 Hansen contamineaza intentionat cativa
au imbolnavit din seroterapia lui Neisser iar nu de
subiecti umani, femei, in speranta ca va demonstra
pe urma meseriei lor
legatura cauzala: acestea insa nu fac boala si astfel nu
• Contribuie la diagnosticul sifilisului (lucreaza cu
obtine demonstratia.
Wasserman), la tratamentul sifilisului (Salvarsan,
• Este acuzat de incalcarea bunei conduite in cercetare.
Paul Ehrlich) si la profilaxia sifilisului
Ordinul medicilor il condamna la ridicarea dreptului de
• Moare in 1916 de septicemie la 61 de ani dupa 37
libera practica
de practica
• Ramane in organizarea sistemului medical ca expert in
• Unul dintre cei mai mari bacteriologi inscris in
lepra, implementeaza primele masuri epidemiologice,
panteonul medical al Germaniei
promoveaza legea cu privire la lepra si reduce nr. de leprosi
cu 2/3, Norvegia fiind tara cu cel mai bun control al leprei:
profilaxia norvegiana este preluata in toate tarile
• Moare in 1912 la 71 de ani de inima desi suferea de sifilis
de 50 de ani si devine o legenda a medicinii norvegiene.
• Se manifesta ingrijorari cu privire la
cercetarea si experimentarea pe subiect
uman (in ecoul cazului Neisser)
• Emil Adolf von Behring (n. 15 martie 1854,
Hansdorf - d. 31 martie 1917, Marburg) a
fost un bacteriolog și serolog german, care a
descoperit împreună cu japonezul Kitasato
Shibasaburo serul antitetanic.
• În anul 1890, împreună cu Paul Ehrlich, a
descoperit antitoxina difterică. Pentru
meritele sale a primit în anul 1901 premiul
Nobel pentru medicină.

• [http://ro.wikipedia.org/wiki/Emil_Adolf_von_Behring]

• Intr-un raport olograf, Emil von Behring

argumenta in 1900 in referire la cazul Neisser
ca autoexperimentarea trebuie intotdeauna
sa preceada experimentul pe pacienti.
• Emil von Behring aprecia de asemenea ca
experimentarea pe subiectul uman este
neetica daca se efectueaza fara
consimtamantul voluntar la subiectului.
 1900 in Germania
• In 1891 ministerul Prusac al interiorului a emis o PRIMA DIRECTIVA a Sanatatii, religiei si
educatiei privind Autonomia, 1891 si in care se transmitea catre toate inchisorile ca testul la
tuberculina utlizat in tratamentul tuberculozei sa “nu fie folosit in nici un caz impotriva
vointei pacientului” si de asemenea importanta “vointei pacientului “. “Orice testare nu
trebuie in nici un caz sa fie folosita impotirva vointei pacientului”

• A DOUA DIRECTIVA A MINISTERULUI PRUSAC al Sanatatii, religiei si educatiei, cu privire la

Interventiile non-terapeutice, 1900) constituie PRIMELE REGULAMENTE SI NORME despre
cercetarea stiintifica in Europa si au fost emise de catre Ministerul Prusac pentru afaceri
medicale, religioase si educatie in 1900.

Acestea au fost ocazionate de catre cazul Neisser care a ajuns sa fie discutat si in
Parlamentul Germaniei unde s-a intrunit consensul cu privire la introducerea bazei legale a
“consimtamantului dupa examinarea posibilelor consecinte negative” si a deschiderii
secretului profesional: “Directorii medicali sunt atentionati ca orice interventie medicala alta
decat diagnosticul, ingrijirea, imunizarea sunt excluse cat timp subiectul uman e minor ori
lipsit de competenta din orice ratiuni” sau daca subiectul nu si-a dat consimtamantul intr-o
forma lipsita de ambiguitate dupa o examinare corespunzatoare a posibilelor consecinte
negative ale interventiei. Orice cercetare ori interventie trebuie implinite numai de catre
directorul medical sau cu autorizatia lui ori a ei.“
[http://web.archive.org/web/20080304153538/http://www.bmj.com/archive/7070nd1.htm]
 1931 in Germania
• “In 1931 Reich-ul german a emis un regulament detaliat cu privire la “Ghiduri
pentru noi terapii si experimentarea umana”.
• Ghidul distinge clar intre cercetarea terapeutica (“noi terapii”) si cercetarea
non-terapeutica (“experimentarea umana”) si stabileste un set de precautii
stricte.“Noile terapii pot fi aplicate numai daca exista consimtamantul sau proxi
consimtamantul a fost dat in clar si indiscutabil dupa o prealabila informare.
Noi terapii pot fi introduse fara consimtamant numai daca sunt urgent cerute
si nu pot fi amanate datorita nevoii de a salva viata sau a preveni deteriorarea
sanatatii….”In aceste cazuri un raport va documenta clar aceste preconditii.
• Cercetarea non-terapeutica “nu este permisa fara consimtamant”.
• “Cercetarea exprimentala pe pacientii muribunzi este interzisa.
• Publicarea rezultatelor noii terapii trebuie sa respecte demnitatea pacientului
si mandatul umanitatii.
• Invatamantul trebuie sa sustina cu fiecare ocazie responsabilitatile medicului
in trialurile clinice.
• Orice exploatare a nevoilor sociale ori economice in noile terapii este
respinsa.”
• [http://web.archive.org/web/20080304153538/http://www.bmj.com/archive/7070nd1.htm]
 ETAPA 3
A 2-a incercare de normare etica a cercetarii stiintifice
pe subiect uman. Recunoasterea drepturilor
universale ale omului. Codul de la Nuremberg

-Actiunea: Eugenia 1870-1945, experimentele

din cel de-al doilea razboi mondial, 1939-
1942-1945
-Masuri: Tribunalul de la Nuremberg 1947,
Codul de la Nuremberg, 1947.
1939 in Germania

• In 1939 este emis decretul de “Eutanasie” ce marcheaza inceperea

actiunii T4 menita sa elimine persoanele cu handicap, deficiente
mintale ori fizice, etc. oprit oficial prin aceeasi sursa de autoritate in
1942.

• Decretul de “eutanasie” al deficientilor: “Reich Leader Bouhler and Dr.

Brandt are charged with the responsibility for expanding the authority
of physicians, to be designated by name, to the end that patients
considered incurable according to the best available human judgment
[menschlichem Ermessen] of their state of health, can be granted a
mercy death [Gnadentod]”. A. Hitler, 1939
(Traducere in engleza, citat de Robert Jay Lifton, The Nazi Doctors: Medical Killing and the Psychology of
Genocide, Basic Books 1986, 64, http://en.wikipedia.org/wiki/Action_T4)
Experimente desfasurate pe subiecti umani in lagare de concentrare
naziste in al doilea RM
1. gemeni (Auschwitz),
1939-1945
2. transplant de muschi/oase/nervi (Dachau)
3. traumatisme cranio-cerebrale operate fara anestezie (Dachau)
Al doilea RM
4. hipotermie (Dachau)
5. malarie (Dachau), Experimente desfasurate asupra
6. altitudine inalta (Dachau) prizonierilor, Shirō Ishii, unitatea 731
7. gaze iritante (1935-1945): arme biologice si toxice de
8. sulfonamida (in trat. Streptocociilor) lupta
9. tetanos, gangrena gazoasa http://en.wikipedia.org/wiki/Unit_731
10. apa de mare (exper. pe romi),
11. sterilizare (Auschwitz, Ravensbrück)
12. eugenie, igiena rasiala (Ravensbrück)
13. otravuri (Buchenwald)
14. bombe incendiare cu fosfor
http://en.wikipedia.org/wiki/Nazi_human_experimentation Profesionisti
Posedand cunoastere, independenti,
Clasa care munceste abilitati sporite, expertiza antreprenori, persoane
Persoane limitate in si isi aduce onorabil ridicata, capabili ce creaza locuri de
Indezirabili, raufacatori, cunoastere si abilitati: aportul la bunul mers sa-I invete pe altii, etc.: munca, capital:
neasimilati, marginalizati, prost platiti, saraci al societatii: bine platiti foarte
care franeaza dezvoltarea echitabil platiti bine platiti
sociala generand prejudicii
si cheltuieli ce depasesc
beneficiile comunitare: fara plata

Valoare sociala si genetica redusa Valoare sociala si genetica ridicata

Francis Galton, 1883: introduce termenul de eugenie (http://en.wikipedia.org/wiki/Eugenics)

 Tribunalul de la Nuremberg, 1947

• In 1947 in fata Tribunalulului de la Nuremberg au fost adusi in judecata 23 de medici care au fost
banuiti ca:
– au desfasurat ori comandat experimente pe om
– ori ca au condus destinele sistemului medical in perioada Germaniei naziste in care s-au
constatat atrocitati la adresa libertatii si demnitatii umane
• Au fost acuzati de:
1. Crime de razboi = experimente medicale pe om fara consimtamantul subiectului pe
prizonieri de razboi si civi din tarile ocupate, crime, brutalitati, cruzimi, torturi, atrocitati si
alte acte inumane savarsite asupra prizonierilor. Uciderea in masa a prizonierilor de razboi si
a civililor din tarile ocupate, stigmatizarea lor pe motive de varsta, tulburare psihica, boala
incurabila, handicap fizic, si uciderea lor prin administrarea de gaz, injectie letala si alte
metode in case de ingrijire, aziluri, sau camp concentrational.
2. Crime impotriva umanitatii. Crime indreptate impotriva civililor, a bunurilor culturale ale
umanitatii, a valorilor individuale si nationale, fara a fi ocazionate de actiuni de lupta sau
decurgand din actiuni de lupta, cu scopul explicit de a anihila, a distruge, a inlatura, grupuri
umane, populatii, natiuni, adresand actiuni fizic precum si catre valorile si cultura lor.
3. Participare si apartenenta de membru intr-o organizatie criminala
http://en.wikipedia.org/wiki/Doctors'_Trial
1947 in Germania
CODUL DE LA NUREMBERG (1947)

1. Consimţământul voluntar al participanţilor într-un experiment este esenţial.

2. Rezultatele care urmează să fie obţinute din experiment trebuie să fie benefice pentru
societate, iar aceste rezultate nu pot fi obţinute prin alte mijloace.
3. Studiul trebuie să fie fundamentat pe rezultatele obţinute din experimente pe animale şi
cunoştinţe privind istoria naturală a bolii, astfel încât rezultatele anticipate să justifice
desfăşurarea experimentului.
4. Orice suferinţă sau lezare fizică sau psihică inutile trebuiesc evitate în timpul desfăşurării
experimentului.
5. Nici un experiment nu trebuie efectuat dacă există indicii că acesta ar putea duce la decesul
sau lezarea participanţilor, cu excepţia situaţiilor în care cercetătorul participă el însuşi ca subiect
în experiment.
6. Gradul de risc asupra subiecţilor nu trebuie să depăşească importanţa umanitară a problemei
cercetate în experiment.
7.Trebuie luate măsuri adecvate pentru a evita lezarea sau decesul participanţilor.
8. Experimentele trebuiesc conduse numai de către persoane cu calificare ştiinţifică.
9. Participanţii au dreptul de a decide terminarea participării într-o cercetare la orice moment
dacă ei consideră că participarea nu mai poate fi continuată.
10. Cercetătorul care conduce experimentul trebuie să fie pregătit să-l încheie dacă el consideră
că continuarea experimentului va duce la producerea de leziuni, dizabilităţi sau decesul
participanţilor.
 Declaratia de la Geneva AMM 1948,
Codul International al Eticii Medicale 1949
Textul Declaratiei de la Geneva (actualizat)
• “Pe timpul admiterii mele ca membru al profesiei medicale:
• Jur sa-mi consacru viata in serviciul umanitatii.
• Voi datora profesorilor mei respect si gratitudine.
• Voi practica profesiunea cu constiinta si demnitate.
• Sanatatea pacientilor mei va fi prima mea consideratie.
• Voi respecta secretele care imi sunt incredintate chiar si dupa ce pacientul a murit.
• Voi mentine prin toate fortele mele onoarea si traditiile nobile ale profesiunii medicale.
• Colegii mei vor fi surorile si fratii mei.
• Nu voi permite consideratiilor de varsta, boala, dizabilitati, credinta, origine etnica, sex,
nationalitate, afiliere politica, rasa, orientare sexuala, statut social sau oricarui alt factor sa
intervina intre datoria mea si pacientul meu.
• Voi mentine cel mai inalt respect pentru viata umana.
• Nu imi voi folosi cunostiintele medicale pentru a viola drepturile omului si libertatile sale civile,
nici chiar sub amenintare.
• Fac aceste promisiuni solemn, liber si pe cuvantul meu de onoare »
Declaratia de la Geneva este documentul initiatic de intrare in practica medicala, noul Juramant al
medicilor in dorinta de modernizare a J. Hipocratic, ca Juramant al organizatiei profesionale mondiale
(World Medical Association) care normeaza astfel inca o data moralitatea practicii medicale la scurt timp
dupa tribunalul medicilor de la Nuremberg. Cu rosu singura modificare principiala fata de J. Hipocratic.
Codul de la Nuremberg, 1947
1. Consimtamantul voluntar al
pacientului participant la expriment
2. Rezultate benefice si numai daca nu
pot fi obtinute altfel.
3. Evaluarea cost/beneficiu
4. un plan detaliat de cercetare de catre
persoane calificate
5. cercetare prealabila pe animal
6. cercetarea numai in interesul binelui
pacientului si cu riscuri minime si fara
risc de deces
7. doar atunci cand nu exista alte resurse
terapeutice
8. rezultatele justifica riscul
9. pacientul poate intreupe participarea
Declaratia de la Geneva, 1948
• Pe timpul admiterii mele ca membru al
profesiei medicale:
• Jur sa-mi consacru viata in serviciul umanitatii.
• Voi datora profesorilor mei respect si
gratitudine.
• Voi practica profesiunea cu constiinta si
demnitate.
• Sanatatea pacientilor mei va fi prima mea
preocupare.
• Voi respecta secretele care imi sunt
incredintate chiar si dupa ce pacientul a murit.
• Voi mentine prin toate fortele mele onoarea si
traditiile nobile ale profesiunii medicale.
• Colegii mei vor fi surorile si fratii mei.
• Nu voi permite consideratiilor de varsta, boala,
dizabilitati, credinta, origine etnica, sex,
nationalitate, afiliere politica, rasa, orientare
sexuala, statut social sau oricarui alt factor sa
intervina intre datoria mea si pacientul meu.
• Voi mentine cel mai inalt respect pentru viata
umana.
• Nu imi voi folosi cunostiintele medicale pentru
a viola drepturile omului si libertatile sale
civile, nici chiar sub amenintare.
• Fac aceste promisiuni solemn, liber si pe
cuvantul meu de onoare »
 DECLARATIA UNIVERSALA A DREPTURILOR
OMULUI, Adunarea Generala a Organizatiei
Natiunilor Unite la 10 de septembrie 1948
• „Articolul 1
Toate fiintele umane se nasc libere si egale in demnitate si in
drepturi. Ele inzestrate cu ratiune si constiinta si trebuie sa se
comporte unii fata de altele in spiritul fraternitatii.”
• Articolul 3
Orice fiinta umana are dreptul la viata, la libertate si la securitatea
persoanei sale.
• Articolul 5
Nimeni nu va fi supus torturii, nici la pedepse sau tratamente crude,
inumane sau degradante.
• Articolul 7
Toti oamenii sunt egali in fata legii si au, fara nici o deosebire,
dreptul la o egala protectie a legii. [7]
 Etapa 4
A 3-a incercare de normare etica a cercetarii stiintifice
pe subiect uman. Declaratia de la Helsinki
PRINCIPIILE CERCETARII
• Actiunea: incalcari repetate ale eticii cercetarii
stiintifice pe subiect uman in multe tari, 1950-
1964
• Masura : Declaratia de la Helsinki , 1964
 Dupa cel de al II-lea Razboi Mondial
1950 in Suedia
1.Experimentel Vipeholm, Suedia, 1950: zahar pentru copii handicapati mental pentru a
cerceta progresia cariei dentare

1950-1960 in SUA
Thalidomida
In ultimii ani ai decadei 1950 talidomida a fost aprobata ca sedativ in Europa dar nu si in
SUA. Cu toate acestea medicamentul a fost folosit pentru a controla greata si insomnia pe
timpul sarcinii. S-a descoperit ca produce malformatii la fetus. Cele mai multe paciente nu
stiau ca medicamentul era in uz fara a fi aprobat; de asemenea nu li s-a cerut nici un
consimtamant medical pentru ca se realiza o cercetare asupra lor.
12,000 de copii s-au nascut cu malformatii. [http://www.cgu.edu/pages/1722.asp]
1950-1972 in SUA
Willowbrook hs.(1963-1966): hep. B, Gamma-globulina
Intre anii 1950-1972 numerosi copii cu handicap mental au fost infectati intentionat cu
virusuri hepatitice in spitalul Willowbrook State School, Staten Island, New York in scopul de
a dezvolta un vaccin antihepatitic. Intre 1963 - 1966, parintilor li se spunea ca vor fi ingrijiti
in spital si vor fi vaccinati: in acest scop li se cerea sa semneze un consimtamant. In realitate
se efectuau cercetari cu privire la vaccin care le punea in pericol sanatatea: copiii erau
hraniti ori injectati cu extracte de fecale provenit din fecalele pacientilor infectati.
[http://en.wikipedia.org/wiki/Unethical_human_experimentation_in_the_United_States]
 DECLARATIA DE LA HELSINKI
Asociatia Medicala Mondiala, 1964
Recomandari pentru medici in cercetarea clinica (iunie 1964, amendata
de 9 ori, ultima oara in 2013)
Devine manifestul international al cercetarii stiintifice biomedicale pe subiect uman care a influentat
normarea etica si legala in toata lumea:

• A.Introducere
• 1.WMA (Asociatia Medicala Mondiala) a emis Declaratia de la Helsinki ca pe o seama de
principii etice pentru cercetarea medicala in care sunt implicati subiecti umani,incluzand
materiale si date umane identificabile. Declaratia se doreste a fi privita ca un intreg si
fiecare din paragrafele sale nu trebuie sa fie aplicate in afara celorlalte paragrafe
relevante.

• 2.Desi Declaratia se adreseaza in primul rand medicilor WMA incurajeaza si pe alti

participanti la cercetarea medicala sa adopte aceste principii.

• 3.Este de datoria medicului de a promova si a avea grija de sanatatea pacientilor, inclusiv a

celor care sunt implicati in cercetare medicala. Cunostintele medicului si constiinta sa sunt
dedicate atingerii acestui scop.

• 4.Declaratia de la Geneva a Asociatiei Medicale Mondiale leaga medicul de cuvintele «

Sanatatea pacientului meu va fi principala mea preocupare» iar Codul International al
Eticii Medicale declara ca « Un medic trebuie sa actioneze pentru binele si in interesul
pacientului sau atunci cand furnizeaza ingrijire medicala»
• Sectiunea A prioritizeaza sanatatea subiectului
cercetarii. Aduce aminte despre populatiile vulnerabile
(economic, etc.)
• Sectiunea B principiile de baza ale cercetarii pe subiect
uman, consimtamant informat.
• Sectiunea C discuta cercetarea combinata cu ingrijrea
medicala daca are ca si scop profilaxia, dg, tratmentul.
– Par. 29 noi tratamente impotriva trat. Standard si
proscrierea trat. Placebo atunci cand se cunoaste un trat.
Eficace.
– Par. 30 subiectilor trebuie sa li se puna la dispozitie cel mai
bun tratament
In DoH din 1964 se mai atesta:
• Cercetarea pe subiect uman numai dupa exprimentare pe animal si de
laborator
• Protocolul de cercetare verificat de un comitet independent
• Consimtamant informat necesar
• Cercetare condusa de persoane calificate stiintific
• Riscuri care nu trebuie sa depaseasca beneficiile

Exista si controverse si conceptualizari fluide:

•terapia si cercetarea
•pacientul si subiectul
•medicul si investigatorul

• Distinctia intre cercetarea terapeutica si non-terapeutica devine subiect de

dezbatere
• Nevoia de ghiduri profesionale construite de medici pentru medici
• Experimentele se clasifica in :
– Experimente dg. si metode terapeutice
– Experimente menite sa serveasca altor scopuri decat doar cele de a vindeca o
persoana.
WMA Declaration of Helsinki - Ethical Principles for Medical Research
Involving Human Subjects
Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964
and amended by the:
29th WMA General Assembly, Tokyo, Japan, October 1975
35th WMA General Assembly, Venice, Italy, October 1983
41st WMA General Assembly, Hong Kong, September 1989
48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996
52nd WMA General Assembly, Edinburgh, Scotland, October 2000
53rd WMA General Assembly, Washington DC, USA, October 2002 (Note of Clarification
added)
55th WMA General Assembly, Tokyo, Japan, October 2004 (Note of Clarification added) 59th
WMA General Assembly, Seoul, Republic of Korea, October 2008
64th WMA General Assembly, Fortaleza, Brazil, October 2013
Preamble
1. The World Medical Association (WMA) has developed the Declaration of Helsinki as a
statement of ethical principles for medical research involving human subjects, including
research on identifiable human material and data.
The Declaration is intended to be read as a whole and each of its constituent paragraphs
should be applied with consideration of all other relevant paragraphs.
2. Consistent with the mandate of the WMA, the Declaration is addressed primarily to
physicians. The WMA encourages others who are involved in medical research involving
human subjects to adopt these principles.
General Principles

3. The Declaration of Geneva of the WMA binds the physician with the words, “The health of my
patient will be my first consideration,” and the International Code ofMedical Ethics declares that, “A
physician shall act in the patient's best interest whenproviding medical care.”
4. It is the duty of the physician to promote and safeguard the health, well-beingand rights of patients,
including those who are involved in medical research. Thephysician's knowledge and conscience are
dedicated to the fulfilment of this duty.
5. Medical progress is based on research that ultimately must include studiesinvolving human subjects.
6. The primary purpose of medical research involving human subjects is tounderstand the causes,
development and effects of diseases and improve preventive,diagnostic and therapeutic interventions
(methods, procedures and treatments). Eventhe best proven interventions must be evaluated continuall
through research for theirsafety, effectiveness, efficiency, accessibility and quality.
7. Medical research is subject to ethical standards that promote and ensurerespect for all human subjec
and protect their health and rights.
8. While the primary purpose of medical research is to generate new knowledge,this goal can never take
precedence over the rights and interests of individualresearch subjects.
9. It is the duty of physicians who are involved in medical research to protect thelife, health, dignity,
integrity, right to self-determination, privacy, and confidentiality ofpersonal information of research
subjects. The responsibility for the protection ofresearch subjects must always rest with the physician or
other health careprofessionals and never with the research subjects, even though they have givenconse
10. Physicians must consider the ethical, legal and regulatory norms andstandards for research involving
human subjects in their own countries as well asapplicable international norms and standards. No natio
or international ethical, legalor regulatory requirement should reduce or eliminate any of the protection
forresearch subjects set forth in this Declaration.
11. Medical research should be conducted in a manner that minimises possibleharm to the environmen
12. Medical research involving human subjects must be conducted only by ndividuals with the
appropriate ethics and scientific education, training andqualifications. Research on patients or healthy
volunteers requires the supervision of acompetent and appropriately qualified physician or other
health care professional.
13. Groups that are underrepresented in medical research should be providedappropriate access to
participation in research.
14. Physicians who combine medical research with medical care should involvetheir patients in
research only to the extent that this is justified by its potentialpreventive, diagnostic or therapeutic
value and if the physician has good reason tobelieve that participation in the research study will not
adversely affect the health ofthe patients who serve as research subjects.
15. Appropriate compensation and treatment for subjects who are harmed as aresult of participating
in research must be ensured.
Risks, Burdens and Benefits
16. In medical practice and in medical research, most interventions involve risksand burdens.
Medical research involving human subjects may only be conducted if theimportance of the objective
outweighs the risks and burdens to the research subjects.
17. All medical research involving human subjects must be preceded by carefulassessment of
predictable risks and burdens to the individuals and groups involved inthe research in comparison
with foreseeable benefits to them and to other individualsor groups affected by the condition under
investigation. Measures to minimise the risks must be implemented. The risks must becontinuously
monitored, assessed and documented by the researcher.
18. Physicians may not be involved in a research study involving human subjectsunless they are
confident that the risks have been adequately assessed and can besatisfactorily managed.
When the risks are found to outweigh the potential benefits or when there isconclusive proof of
definitive outcomes, physicians must assess whether to continue,modify or immediately stop the
study.
Vulnerable Groups and Individuals
19. Some groups and individuals are particularly vulnerable and may have anincreased
likelihood of being wronged or of incurring additional harm.
All vulnerable groups and individuals should receive specifically consideredprotection.
20. Medical research with a vulnerable group is only justified if the research isresponsive to
the health needs or priorities of this group and the research cannot becarried out in a non-
vulnerable group. In addition, this group should stand to benefitfrom the knowledge, practices
or interventions that result from the research.

Scientific Requirements and Research Protocols

21. Medical research involving human subjects must conform to generallyaccepted scientific
principles, be based on a thorough knowledge of the scientificliterature, other relevant
sources of information, and adequate laboratory and, asappropriate, animal experimentation.
The welfare of animals used for research mustbe respected.
22. The design and performance of each research study involving human subjectsmust be
clearly described and justified in a research protocol.
The protocol should contain a statement of the ethical considerations involvedand should
indicate how the principles in this Declaration have been addressed. Theprotocol should
include information regarding funding, sponsors, institutionalaffiliations, potential conflicts of
interest, incentives for subjects and informationregarding provisions for treating and/or
compensating subjects who are harmed as aconsequence of participation in the research
study.
In clinical trials, the protocol must also describe appropriate arrangements forpost-trial
provisions.
Research Ethics Committees
23. The research protocol must be submitted for consideration, comment,guidance and
approval to the concerned research ethics committee before the studybegins. This
committee must be transparent in its functioning, must be independent ofthe
researcher, the sponsor and any other undue influence and must be duly qualified.It
must take into consideration the laws and regulations of the country or countries
inwhich the research is to be performed as well as applicable international norms and
standards but these must not be allowed to reduce or eliminate any of the protectionsfor
research subjects set forth in this Declaration.
The committee must have the right to monitor ongoing studies. The researchermust provide
monitoring information to the committee, especially information aboutany serious adverse
events. No amendment to the protocol may be made withoutconsideration and approval by
the committee. After the end of the study, theresearchers must submit a final report to the
committee containing a summary of thestudy’s findings and conclusions.

Privacy and Confidentiality

24. Every precaution must be taken to protect the privacy of research subjectsand the
confidentiality of their personal information.

Informed Consent
25. Participation by individuals capable of giving informed consent as subjects inmedical
research must be voluntary. Although it may be appropriate to consult familymembers or
community leaders, no individual capable of giving informed consent maybe enrolled in a
research study unless he or she freely agrees.
26. In medical research involving human subjects capable of giving informedconsent, each
potential subject must be adequately informed of the aims, methods,sources of funding, any
possible conflicts of interest, institutional affiliations of theresearcher, the anticipated
benefits and potential risks of the study and thediscomfort it may entail, post-study provisions
and any other relevant aspects of thestudy. The potential subject must be informed of the
right to refuse to participate inthe study or to withdraw consent to participate at any time
without reprisal. Specialattention should be given to the specific information needs of
individual potentialsubjects as well as to the methods used to deliver the information.

After ensuring that the potential subject has understood the information, thephysician or
another appropriately qualified individual must then seek the potentialsubject’s freely-given
informed consent, preferably in writing. If the consent cannot beexpressed in writing, the
non-written consent must be formally documented andwitnessed.
All medical research subjects should be given the option of being informedabout the general
outcome and results of the study.

27. When seeking informed consent for participation in a research study thephysician must be
particularly cautious if the potential subject is in a dependentrelationship with the physician
or may consent under duress. In such situations theinformed consent must be sought by an
appropriately qualified individual who iscompletely independent of this relationship.
28. For a potential research subject who is incapable of giving informed consent,the physician
must seek informed consent from the legally authorised representative.These individuals must
not be included in a research study that has no likelihood ofbenefit for them unless it is
intended to promote the health of the group representedby the potential subject, the
research cannot instead be performed with personscapable of providing informed consent,
and the research entails only minimal risk andminimal burden.
29. When a potential research subject who is deemed incapable of giving informedconsent is
able to give assent to decisions about participation in research, thephysician must seek that
assent in addition to the consent of the legally authorisedrepresentative. The potential
subject’s dissent should be respected.

30. Research involving subjects who are physically or mentally incapable of givingconsent, for
example, unconscious patients, may be done only if the physical ormental condition that
prevents giving informed consent is a necessary characteristicof the research group. In such
circumstances the physician must seek informedconsent from the legally authorised
representative. If no such representative isavailable and if the research cannot be delayed, the
study may proceed withoutinformed consent provided that the specific reasons for involving
subjects with acondition that renders them unable to give informed consent have been stated
in theresearch protocol and the study has been approved by a research ethics
committee.Consent to remain in the research must be obtained as soon as possible from
thesubject or a legally authorised representative.

31. The physician must fully inform the patient which aspects of their care arerelated to the
research. The refusal of a patient to participate in a study or thepatient’s decision to withdraw
from the study must never adversely affect the patient-physician relationship.
32. For medical research using identifiable human material or data, such asresearch on material
or data contained in biobanks or similar repositories, physiciansmust seek informed consent for
its collection, storage and/or reuse. There may beexceptional situations where consent would
be impossible or impracticable to obtain for such research. In such situations the research may
be done only afterconsideration and approval of a research ethics committee.

Use of Placebo
33. The benefits, risks, burdens and effectiveness of a new intervention must betested against
those of the best proven intervention(s), except in the followingcircumstances:
Where no proven intervention exists, the use of placebo, or no intervention, isacceptable; or
Where for compelling and scientifically sound methodological reasons the useof any
intervention less effective than the best proven one, the use of placebo, or nointervention is
necessary to determine the efficacy or safety of an intervention
and the patients who receive any intervention less effective than the bestproven one, placebo,
or no intervention will not be subject to additional risks of seriousor irreversible harm as a result
of not receiving the best proven intervention.
Extreme care must be taken to avoid abuse of this option.

Post-Trial Provisions
34. In advance of a clinical trial, sponsors, researchers and host countrygovernments should
make provisions for post-trial access for all participants who stillneed an intervention identified
as beneficial in the trial. This information must also bedisclosed to participants during the
informed consent process.
Research Registration and Publication and Dissemination of Results
35. Every research study involving human subjects must be registered in a
publiclyaccessible database before recruitment of the first subject.
36. Researchers, authors, sponsors, editors and publishers all have ethicalobligations with
regard to the publication and dissemination of the results of research.Researchers have a
duty to make publicly available the results of their research onhuman subjects and are
accountable for the completeness and accuracy of theirreports. All parties should adhere
to accepted guidelines for ethical reporting. Negativeand inconclusive as well as positive
results must be published or otherwise made publicly available. Sources of funding,
institutional affiliations and conflicts of interestmust be declared in the publication. Reports of
research not in accordance with theprinciples of this Declaration should not be accepted for
publication.

Unproven Interventions in Clinical Practice

37. In the treatment of an individual patient, where proven interventions do notexist or other
known interventions have been ineffective, the physician, after seekingexpert advice, with
informed consent from the patient or a legally authorisedrepresentative, may use an unproven
intervention if in the physician's judgement itoffers hope of saving life, re-establishing health or
alleviating suffering. Thisintervention should subsequently be made the object of research,
designed toevaluate its safety and efficacy. In all cases, new information must be recorded
and,where appropriate, made publicly available.

Disclaimer: © 2013 World Medical Association, Inc. All Rights Reserved. All intellectualproperty rights in the Declaration of Helsinki are vested i
the World MedicalAssociation. Previous permissions granted to publish or reproduce otherwise WMApolicy don’t apply to this version of the
Declaration of Helsinki until January 1st, 2014.For further questions, please contact the WMA secretariat atsecretariat@wma.net.
 Documentul Beecher
Henry K. Beecher was a professor of anesthesiology engaged in human
research at Harvard's Massachusetts General Hospital. Dr. Beecher had
followed the Nuremberg Trials very closely and was appalled at the
similarities between what Nazi scientists had done and what some
researchers in America seemed to be doing. He especially objected to
experiments that seemed to exploit participants—some from vulnerable
populations. 1966 New England Journal of Medicinespecial article entitled
“Ethics and Clinical Research. Beecher concludes by saying that, just as U.S.
courts reject evidence obtained unconstitutionally—even if it is useful in the
pursuit of justice—journal editors should reject papers with information
obtained unethically.
He cited a study that was designed to determine whether the central nervous
system or the cardiovascular system would collapse first. Patients' blood
pressures were decreased from a mean of 109 to a mean of 48 mmHg. The
investigators noted cerebral ischemia before the onset of cardiac problems,
thus determining that the nervous system was more sensitive.
 Grupul de la Vancouver
• The International Committee of Medical Journal Editors was
originally and is still best known as the Vancouver Group—after the
location of its first meeting. The group initially met in 1978 to
discuss issues of format, such as a uniform way to cite references.
However, it soon began addressing the many ethical issues in the
medical journal business.
• The group publishes the Uniform Requirements for Manuscripts
Submitted to Biomedical Journals, which was completely revised in
1997 and updated in 1999, 2000, and 2001. In 2003, official
statements of the group were incorporated into the Uniform
Requirements, resulting in the current, 2004, edition.
• The Vancouver Group requires that if humans participated in a
study, the authors must report whether they conducted the
research in accordance with local ethical review standards and the
Declaration of Helsinki.
 Etapa 5
Bioetica
• Actiunea: experimentul Tuskagee, 1932-1972
• Masuri: Raportul Belmont, 1979, Principiile
bioeticii, 1979 (Beauchamps , Childress)
• Cristiaan Barnard, 1967, Decembrie 3
• Criteriile de moarte cerebrala, Comitetul ad-hoc de la
Harvard, 1968
• Institutul de Societate, Etica si Stiinte ale Vietii (Institute of
Society, Ethics and the Life Sciences), cunoscut sub numele
de Hastings Center (Daniel Callahan si Willard Gaylin in
1969)
• Van Rensselaer Potter intelege disocierea care se produce
intre stiinta medicala si etica medicala si defineste bioetica
ca pe o etica globala care este “o nouă disciplină care să
combine cunoaşterea biologică cu cea a sistemului
valorilor cultural umane” (1970)
• Joseph and Rose Kennedy Institute for the Study of Human
Reproduction and Bioethics denumit Kennedy Institute of
Ethics (D. Hellegers, Universitatea Georgetown in 1971)
1972-1979 ancheta Senatului SUA cu
privire la cercetarea Tuskagee
Jean Heller
• Jean Heller, Washington Evening Star, 1972: “Pacienti cu sifilis au
murit fara tratament” . Cu aceste cuvinte studiul Tuskagee, unul dintre cele mai
infame studii de cercetare a devenit cunoscut publicului si astfel un larg subiect de presa.
“Pentru 40 de ani Departamentul medical de Stat al SUA a condus un studiu in care oamenii au "What was done
fost pe post de guinea pig, fara tratament adecvat si au murit de sifilis si de efectele acestuia”…. cannot be undone.
“Studiul a fost condus ca prin autopsiere sa se determine care sunt efectele pe care boala
aceasta le produce asupra omului”. But we can end the
• Intre anii 1932 - 1972 Serviciul de Sanatate Publica a SUA a condus un studiu de cercetare silence.
pe 399 de barbati de culoare bolnavi de sifilis, fara sa incerce sa-i vindece.
• Subiectii alesi pentru experimentul de la Tuskegee au fost in cea mai mare parte analfabeti
We can stop
din cele mai sarace regiuni ale statului Alabama si lipsiti de orice suport medical. turning our heads
• Li s-au oferit mese gratuite, asistenta medicala gratuita pentru ei si copii lor, educatie
scolara gratuita, ajutoare banesti pentru inmormantare si li s-a cerut consimtamantul
away.
pentru autopsie, se precizeaza pe site-ul Universitatii Tuskegee. We can look at you
• Nici unuia dintre ei nu i s-a spus ca fusese infectat cu sifilis dar li s-a spus in schimb ca in the eye and
sufereau de “sange rau” (bad blood) de care nu pot scapa niciodata. Ei nu au fost tratati
desi tratamentul pentru sifilis era deja cunoscut din 1947 si standardizat de catre OMS finally say, on
incepand cu anul 1948. behalf of the
• In cele din urma, sifilisul a determinat la cei mai multi aparitia unor tumori, a unor boli de
inima sau le-a provocat orbirea, paralizia si in final moartea. American people:
• In mai 1997, putinii supravietuitori ai experimentului au fost invitati la Casa Alba, unde what the United
presedintele SUA, Bill Clinton, le-a cerut iertare in numele poporului american, si a
administratiilor precedente. States government
• Catre sfarsitul anului 1972 doar 74 de subiecti mai erau in viata. Se cunoaste ca 100 au did was shameful.
murit de complicatii ale bolii iar restul de boala in sine, 40 si-au infectat sotiile iar 19 au
dat nastere unor copii cu sifilis congenital.
And I am sorry.“
• 1.8 miliarde de dolari despagubire: 37.000 USD la supravietuitori, mostenitori 15.000 USD Bill Clinton, 1997
1972-1979 in SUA
1972-1979 ancheta Senatului cu privire la cercetarea
Tuskagee.
Se instituie o Comisie indreptatita de catre Senatul
american ca sa elaboreze normele de etica pentru
cercetarea stiintifica pe subiecti umani pe teritoriul
SUA si care isi incheie lucrul emitand raportul de la
Belmont, document initiatic al cercetarii stiintifice pe
subiectul uman si al dezvoltarii bioeticii in SUA si in
lume
• Raportul Belmont (1979). Principiile cercetarii stiintifice pe
subiect uman trebuie sa cuprinda:
1. Respectul persoanei
2. Beneficenta
3. Justitie
Principiile bioeticii Imperative etice ale cercetarii Aplicatibilitatea
principiului
1.Respectul 1) Fiecare persoana este un agent • Autonomie
persoanei autonom • CONSIMTAMANTUL
(respectul fata de 2) Recunoasterea unicitatii, libertatii, INFORMAT
fiinta umana) independentei, valorii si
demnitatii umane, egale intre toti,
a dreptului la autodeterminare, a
dreptului de a fi informat

2.Beneficenta 1) Datoria de a face bine izvorand • Evaluarea riscurilor si

din calitatea morala
2) Subiectilor cercetarii sa nu li se
faca rau
3) Maximizarea beneficiilor si
minimizarea riscurilor
beneficiilor: balanta
riscuri-beneficii
• Beneficenta obligatorie

3.Justitie 1) Nondiscriminare • Justa distributie a

2) Ingrijire medicala egalitarian si beneficiilor si riscurilor
echitabil • Protectia celor
vulnerabili
 Sunt fundamentate conceptual principiile bioeticii:
Beauchamps si Childress, 1979, Principles of Bioethics
1. Beneficenta
2. Nonmaleficenta
3. Autonomia
4. Justitia (dreptatea)
Principlismul (principiile bioeticii) nu este singura paradigma morala
in practica medicala.

Beauchamps si Childress adauga principiilor atestate cu ocazia

Raportului Belmont in acelasi an, 1979, principiul bioetic al non-
maleficentei ( a nu face rau) aratand continuitatea principiilor
bioeticii cu cele ale eticii medicale si Juramantului Hipocratic.
RESPECTUL PERSOANEI, respectul fata de fiinta umana
Respect: sentiment de stimă, de considerație sau de prețuire deosebită față de cineva
(DEX)
• Presupune recunoasterea libertatii, independentei, unicitatii, valorii si demnitatii,
egale intre toti, a dreptului la autodeterminare (a decide asupra propriei sale
persoane), a dreptului de a fi informat, a dreptului la intimitate
• Cum se manifesta:
– Prin respectul fata de autonomia persoanei (competenta psihica, capacitate
decizionala, competenta legala)
– Recunoasterea persoanelor vulnerabile (susceptibile la vatamare fizica si
psihica) si protejarea lor: orice persoana cu autonomie diminuata (vulnerabila)
are dreptul la protectie
• Consimtamant informat (competenta si voluntariat; informare –corecta si
completa- si intelegere; decizie si autorizare).
Ghid CIOMS : “CI este C dat de o persoana competenta care (1) primeste informatia,
(2) intelege informatia, (3) decide in interesul propriei persoane fara a fi subiectul
coercitiului, intimidarii sau aflata intr-o stare de vulnerabilitate”
http://www.recerca.uab.es/ceeah/docs/CIOMS.pdf
(International Ethical Guidelines for Biomedical Research Involving Human Subjects ) Prepared by the Council for
International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization, Geneva
2002
 AUTONOMIA

• Autonomia are o tripla dimensiune:

– Filozofica; un principiu filozofic (Imm. Kant) si bioetic (Beauchamp,
Childress) –incarcatura filozofica, biologica si legala-
– Psihica: o capacitate psihica la baza exercitiului drepturilor civile:
capacitatea civila de exercitiu ce poate fi deplina, restransa sau
absenta.
– Legala: un fundament al dreptului la autodeterminare ce decurge din
dreptul fundamental la libertate (pentru a se putea autodetermina
pacientul trebuie sa fie autonom): capacitate civila de exercitiu

• Medicul are doua indatoriri de exercitat:

1. datorie negativa: sa nu interfere autonomia

1. datorie pozitiva: sa informeze astfel incat sa furnizeze

cunoasterea necesara exercitiului autonomiei

• Medicul este obligat sa asiste exercitiul liber al autonomiei pacientului sãu

 Autonomia unei persoane privita din perspectiva capacitatii sale
psihice este conditionata intern si extern

• Conditionalitati interne: intrunirea a 3 componente :

– Capacitatea de intelegere: a intelege situatia in care se afla

– Capacitatea de (voluntariat): a se manifesta voluntar in sensul

autoguvernarii (doreste sa se autodetermine; autos =propriu;
nomos= lege)

– Capacitate decizionala:
1. Intelege optiunile/alegerile pe care le are de facut
2. Decide prin rationament intre diferitele optiuni in raport cu
situatia in care se gaseste si in interesul sau
3. Comunica optiunea aleasa/decizia

• Conditionalitati externe: 2 conditionalitati externe influenteaza si

protejeaza autonomia:
– Libertatea
– Informarea
 Definitii care stau la baza notiunii de autonomie
• Legea sanatatii mintale si a protectiei persoanelor cu tulburari psihice (legea
487/2002 republicata in 2012)
• Art. 5
• h) prin capacitate psihica se intelege atributul starii psihice de a fi compatibila, la un
moment dat, cu exercitarea drepturilor civile sau a unor activitati specifice (poate fi
stabilita de catre medic);

• k) prin discernamant se intelege componenta capacitatii psihice, care se refera la o

fapta anume si din care decurge posibilitatea persoanei respective de a aprecia
continutul si consecintele acestei fapte;

Competenta legala (competenta psihica) reprezentand capacitatea civila de exercitiu a

persoanei fizice este acea aptitudine a persoanei fizice de a dobandi si exercita drepturi
subiective civile, dar si de a-si asuma si executa obligatii civile, prin incheierea de acte
juridice.
Capacitatea civila de exercitiu poate lipsi, poate fi restransa sau poate fi deplina. Poate fi
stabilita numai de catre o comisie psihiatrica.

Conform Codului Civil, persoanele lipsite de capacitate civila de exercitiu sunt:

-minorii sub 14 ani
-persoanele puse sub interdictie judecatoreasca (incapabilii). Lipsirea acestor persoane
de capacitate civila are ca scop ocrotirea lor in ce priveste incheierea actelor juridice.
 Stare psihica
Libertate Capacitate psihica Functii psihice Informare
atributul starii psihice de a fi compatibila,
Compe- la un moment dat, cu exercitarea drepturilor
civile sau a unor activitati specifice
tenta
legala
(compe- AUTONOMIE DISCERNAMANT
tenta Psihism
Comportament
psihica) Actiuni Capacitatea
de a
Capacitatea de intelegere
persoanei respective

Capacitatea de decizie
Capacitatea de a fi voluntar in decizii
exercita legale de a aprecia
drepturi continutul si
civile consecintele unei
fapte

Drepturi civile

Actiuni ilegale

O fapta ilicita anume

• O persoana care nu intelege si/sau nu este voluntara
spre a se autoguverna si/sau nu poate decide NU este
autonoma (A absenta).
• O persoana care intelege, este voluntara spre a se
autoguverna si poate decide este autonoma (A deplina).
• O persoana se prezuma a avea capacitate psihica
deplina astfel de a fi autonoma. Contrariul se probeaza.
• O persoana poate sa fie autonoma dar sa isi
autolimiteze expresia ei in societate. De exemplu poate
intelege, poate decide dar alege sa nu fie voluntara.
• O persoana nelibera si neinformata poate avea o
perceptie eronata asupra realitatii ceea ce nu modifica
campul autonomiei acesteia.
• Capacitatea psihica este umbrela sub care se regaseste
autonomia.
• Autonomia sta la baza capacitatii de exercitiu civila ceea ce in
terminologia psihiatrica judiciara este sinonima cu competenta
psihica (competenta legala) a persoanei.
• O persoana lipsita de capacitate de intelegere si/sau de voluntariat
si/sau de capacitate de decizie NU este autonoma.
• Nefiind autonoma ea nu isi poate exercita drepturile civile
(capacitate de exercitiu civila/competenta legala/competenta
psihica) in interes propriu.
• O persoana care are capacitate psihica se prezuma a fi autonoma
• O persoana care ARE autonomie ARE competenta legala
(capacitate de exercitiu civila)
• O persoana care NU are autonomie NU are competenta legala
BENEFICENTA: a induce si a proteja binele fizic, psihic, social
• Fata de individ
•A nu face rau (non-maleficenta)
•A opri actiunea raului
•A indeparta actiunea raului (vatamarii)
•A preveni raul
•A face bine (din calitatea vointei si datorie)
• Fata de societate
•A intentiona producerea binelui public prin rezultatele cercetarii
sau aplicatii
• Principii ale actiunii medicale a binelui
•Binele este obligatoriu sa fie prezent (principiul Hipocratic: “Daca
nu poti sa faci bine, sa nu faci rau”)
•A reduce riscul individual la minim
•Vatamarea nu trebuie sa depaseasca binele
•Balanta risc/beneficiu favorabila beneficiului
JUSTITIE
• Distributie echitabila a riscurilor si beneficiilor (justitie distributiva).
• Criteriile echitabile de selectie/excludere. Recrutare echitabila a
subiectilor
• Protectie speciala grupurilor vulnerabile. Plasand pe unii in riscul de a
fi vatamati pentru binele altora, cercetarea clinica are potentialul de
exploatare, discriminare, rasism, etc. (dupa Emanuel et al)
• Este echitate in cercetarea intreprinsa? Putem stii daca este echitate
in studiul de cercetare daca:
1. Vom cauta cine are beneficiile si cine are riscurile si vom afla ca
ele se afla de aceeasi parte, cel ce risca fiind si cel ce afla
beneficiu
2. Daca cercetarea realizeaza o distributie egala si echitabila a
riscurilor si beneficiilor: cei ce risca sa fie cei ce beneficiaza,
oricine beneficiaza si risca
3. Cum se face inrolarea, excluderea (criterii, selectie, etc.)
 Istoria „consimtamantului informat”
• “Vointa pacientului “(orice testare “nu trebuie in nici un caz sa fie folosita impotirva vointei
pacientului”, PRIMA DIRECTIVA A MINISTERULUI PRUSAC al Sanatatii, religiei si educatiei privind
Autonomia, 1891)
• “Consimtamant dupa corecta explicare “(Interventiile medicale non-terapeutice sunt excluse
“daca subiectul uman este minor ori incompetent din orice motive” sau subiectul nu a dat “ un
consimtamant lipsit de ambiguitate” dupa prealabila si “corecta explicare a posibilelor
consecinte negative” A DOUA DIRECTIVA A MINISTERULUI PRUSAC al Sanatatii, religiei si
educatiei, cu privire la Interventiile non-terapeutice, 1900)
• “Consimtamant dupa informare corecta” ("Noua terapie poate fi aplicata numai atunci cand
consimtamantul ori proxi consimtamantul a fost dat clar si intr-o maniera indiscutabila dupa
informare corecta CIRCULARA A MINISTERULUI DE INTERNE a REICH-ULUI GERMAN, 1931:
“Ghiduri pentru noua terapie si experimentarea umana”
• “Consimtamantul voluntar al subiectului uman este absolut esential”. (Codul de la Nuremberg,
1947)
• “Consimtamantul informat” , Declaratia de la Helsinki 1964-2013 (“The physician should then
obtain the subject's freely given informed consent, preferably inheriting”, “When obtaining
informed consent for the research project the physician should be particularly cautious if the
subject is in dependent relationship to him”, “In case of legal incompetence, informed consent
should be obtained from the legal guardian in accordance with national legislation”)
• ‘Consimtamantul informat” Principiile bioeticii, Beauchamps and Childress, 1979
• ‘Consimtamantul informat”, “CI este C dat de o persoana competenta care (1) primeste
informatia, (2) intelege informatia, (3) decide in interesul propriei persoane fara a fi subiectul
coercitiului, intimidarii sau aflata intr-o stare de vulnerabilitate”1982-2002 CIOMS
ELEMENTELE CI in cercetarea stiintifica
1. DESCRIEREA CERCETARII IN AMANUNT
2. BENEFICII ASTEPTATE
3. RISCURI REZONABILE SI DISCOMFORT
4. ALTERNATIVE
5. COSTUL PARTICIPARII
6. COMPENSATII
7. CONFIDENTIALITATE
8. VOLUNTARIAT. PARTICIPARE. RETRAGERE . TERMINAREA
PARTICIPARII.
9. NOI DESCOPERIRI.
10. CONFLICT DE INTERESE
10. INTREBARI
11. CONTACTE
12. SEMNATURI, DATAREA VERSIUNII SI NR. PAGINILOR

Completat si modificat dupa [http://www.virginia.edu/vpr/irb/hsr/consent_forms.html]

 Karen Ann Quinlan (29 martie 1954 – 11 iunie 1985)
 1975: la 21 ani, Quinlan a suferit un SCR si apoi a intrat in
SVP. Dupa ce a fost menţinuta în viaţa pe un ventilator timp
1975 in SUA
de cateva luni, fără ameliorare, părinţii ei au solicitat
spitalului sa intrerupa îngrijirea activa pentru a-i permite sa
moara.
 Conducerea spitalului a refuzat
 Cazul este creditat ca debut al domeniului modern al Karen Ann
bioeticii.
 Desi Quinlan a fost inlaturata in 1976 de la aparatele care o
Quinlan
tineau in viata, a mai supravietuit in stare de PVS timp de
circa 9 ani pana cand a murit de pneumonie in 1985.
 Cazul Quinlan continua sa ridice întrebări importante în
teologia morală, bioetica, eutanasie, tutore legal şi drepturile
civile.
 Cazul Quinlan a afectat practica medicala si juridica din
întreaga lume.
 Cazul a venit ca o confirmare a nevoii de etica in medicina
intocmai dupa cum a prefigurat van Potter in manifestul sau
pentru bioetica.
 Cazul a condus spre infiintarea comisiilor de etică în spitale,
aziluri şi case de îngrijire
 De asemenea a condus spre dezvoltarea directivelor de
sănătate in avans (living will, power of attorney, engl.) in SUA
 ETAPA 6
1980-
GHIDURI SI NORME PRIVIND ETICA CERCETARII
• Actiunea: Actiunea: continuarea incalcarilor normelor
etice in cercetarea stiintifica pe subiectul uman in
practica medicala (vezi lista cazuri cu abateri etice-
materiale de studiu-)
• Masuri: ghidul CIOMS, revizii ale DoH, GCP
1982 “PROPOSED INTERNATIONAL ETHICAL GUIDELINES FOR BIOMEDICAL
RESEARCH INVOLVING HUMAN SUBJECTS”,CIOMS, Council for International
Organizations of Medical Sciences, organizatie nonguvernamentala sub egida ONU si a
UNESCO (1949), prin cooperare cu ONU normeze practic aplicarea principiilor etice ale Decl.
de la Helsinki (ca un fel de norme de aplicare pentru declaratie) privind cercetarea biomedicala
pe subiecti umani la orizontul tarilor in dezvoltare si a legislatiilor si administratiilor lor.
1975, 1983, 1989 AMENDAREA DECLARATIEI DE LA HELSINKI, Asoc. Med. Mondiala:
• “Deosebirea cercetarii combinate cu actul terapeutic si a cercetarii pentru scopul stiintific”.
• "Cand un copil este subiect al cercetarii, consimtamantul acelui minor trebuie obtinut”
• ”Protocolul de cercetare trebuie sa fie submis unui comitet de etica inainte ca studiul sa
inceapa spre aprobare. Acest comitet trebuie sa fie independent de cercetator, sponsor si
orice alta influenta.Trebuie sa tina cont de legile si regulamentele tarii sau tarilor in care se
desfasoara cercetarea cat si fata de normele internationale dar fara a reduce protectia
subiectilor cercetarii. Comitetul are dreptul sa monitorizeze studiile. Cercetatorul trebuie sa
puna la dispozitia comitetului infomratia monitorizata, mai ales informatia privind efectele
adverse. Nici o modificare a protocolului nu se poate face fara aprobarea comitetului.

1981 Declaratia cu privire la drepturile pacientului Lisabona

1987 Declaratia de la Madrid cu privire la Eutanasie
• 1991 CIOMS INTERNATIONAL GUIDELINES FOR ETHICAL REVIEW OF
EPIDEMIOLOGICAL STUDIES

• 1993 CIOMS INTERNATIONAL ETHICAL GUIDELINES FOR

BIOMEDICAL RESEARCH INVOLVING HUMAN SUBJECTS . Conceptul
controversat de tratamente adecvate nivelurilor economice ale
unor tari cu standard economic redus. Evitarea paternalismului
tarilor bogate. Viziunea naste conflict de opinii sugerandu-se
exploatare, consimtamant viciat, rasism. Se recomanda consultari
si revizii.

• 1995 GUIDELINES FOR GOOD CLINICAL PRACTICE FOR TRIALS ON

PHARMACEUTICAL PRODUCTS, ONU

• 1996 GUIDELINE ON GOOD CLINICAL PRACTICE, ONU

 Ghidul CIOMS 1982, 1993, 2002
(CIOMS Council for International Organizations of Medical Sciences
International Ethical Guidelines for Biomedical Research Involving
Human Subject
• The Council for International Organizations of Medical Sciences (CIOMS), a nongovernmental
organization founded in 1949, was established to collaborate with the United Nations and its
subgroups—such as the World Health Organization (WHO). After the WMA adopted the
Declaration of Helsinki in 1964, the WHO directed CIOMS to translate the declaration into a
document that could be used to guide member countries—especially Third World countries.
The CIOMS manual, Proposed International Ethical Guidelines for Biomedical Research
Involving Human Subjects, was released in 1982.
• The first 3 guidelines require that a study be scientifically sound and approved by the
appropriate IRB. In the case of researchers sponsoring studies in foreign countries, this
includes having sponsors get approval from their own IRB—not just the host country's
equivalent.
• Guidelines 4 through 7 are concerned with informed consent. The information disclosed
should include the voluntary nature of the study, the right to quit at any time, how the
project differs from clinical care, terms like blinding and randomization as appropriate, the
duration, compensation (including compensation for study-related injury/death), risks and
benefits, the right to access the study results and the individual's data, steps to maintain
privacy, and disclosure of sponsors/funding sources. Only after the potential subject
understands this information should consent be sought. In obtaining consent, the researcher
or representative should “refrain from deception, undue influence, or
intimidation.”13(p25) Subjects can be compensated—but only within reason and not to bribe
them into participation.
• http://www.cioms.ch/frame_guidelines_nov_2002.htm
• http://www.recerca.uab.es/ceeah/docs/CIOMS.pdf
Guidelines 8 and 9 discuss the risks and benefits of studies. If there is no possible benefit to the
individuals entering a study, risks “must be reasonable in relation to the importance of the
knowledge to be gained.”13(p30) If individuals entering a study cannot give informed consent and
the research does not allow for the individuals involved to benefit, the risks can be “no more
likely and no greater than the risk attached to routine medical or psychological examination of
such persons.”13(p31)

Guidelines 10 and 12 are designed to limit exploitative research in low-resource areas.

Guideline 10 states that the research must be useful to the community in which it is carried out
and that results must be made reasonably available to the community. Guideline 12 states that
the “burdens and benefits” of research should be shared equitably within the community and
globally.13(p40)

Guideline 11 is concerned with the choice of control interventions. According to the CIOMS, it
is only ethical to use a placebo in 1 of 3 situations: when there is no established intervention,
when withholding an intervention would only cause “temporary discomfort or delay in relief of
symptoms,” or when using placebo is scientifically necessary and would “not add any risk of
serious or irreversible harm.”13(pp34–35) (It is under Guideline 11's commentary that the
controversy over HIV drug trials in Africa sponsored by institutions in the United States is
discussed.)
Guideline 13 states that vulnerable populations should only participate in research under certain
conditions. These conditions are set forth in Guidelines 14 and 15. Guideline 14 deals with
pediatric research. Children can only be used as subjects if adults cannot be used, the research is
“relevant to the health needs of children,” the legal representative of the child consents, and the
child provides continuous assent.13(p43) Guideline 15 pertains to the mentally ill. As with children,
it states that people with psychiatric illness can only participate if the research is intended to
benefit this population and cannot be carried out on people without mental illness. The mentally ill
must also provide consent or assent as appropriate and, when not able to provide consent, have a
legal guardian give permission.

Guidelines 16 and 17 concern women participating in research. Women should not automatically
be excluded from research because of the possibility that they could become pregnant. Rather, the
researchers should inform potential subjects of the study-related risks in becoming pregnant and
offer pregnancy testing and “access to effective contraceptive methods before the research
commences.”13(p47) If a woman is pregnant, she may be included in research provided she is
informed of risks, the research is relevant to the pregnancy, and animal models have previously
examined teratogenic risk.

Guidelines 18 states that individual's data must be safeguarded as confidential. Guideline 19

makes the controversial claim that any injury resulting from the research must receive free
medical care and that the individual must receive “financial or other” compensation.13(p51) On the
occasion of a participant's death as a result of the research, the subject's survivors are entitled to
such compensation. The remaining 2 guidelines are aimed at improving the quality of ethical
review in the Third World and specifying that the above guidelines apply to sponsors and not just
hosts of a project.
 International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human
Use's Guideline for Good Clinical Practice

Every industrialized country in which pharmaceuticals are manufactured has a

regulatory system to ensure that medications are appropriate for the public.
Until recently, the ways in which these systems operated were all different.

The major areas of harmonization are the areas on which approval of a new
drug is based: safety, quality, and efficacy. Although the text of the
harmonization documents spans hundreds of pages, the document most
pertinent to this article is “The Guideline for Good Clinical Practice.”

“The Guideline for Good Clinical Practice” (GCP) was released in 1996.18 It
was meant to reflect the “current good clinical practices of the European
Union, Japan, and the United States, as well as those of Australia, Canada, the
Nordic countries, and the World Health Organization.”18(p1) The most relevant
sections it contains are a section defining terms, a section enumerating the
principles of good clinical practice, and a section on IRBs (see table 1 for
elements of informed consent required by the GCP).
• The glossary defines technical terms such as blinding, protocol,
and randomization—however, it also defines terms involved in the
practice of ethically sound research. The document describes IRBs but
also what it calls “Independent Ethics Committees (IECs).”
• The IECs are a more general form of review committee. Whereas IRBs
are, by definition, “institutional,” IECs could be institutional, regional,
national, or international. Therefore, IRBs are a specific type of IEC.
• Another definition worth examining is that of “vulnerable subjects.”
According to the GCP, vulnerable subjects are “individuals whose
willingness to volunteer in a clinical trial may be unduly influenced by
the expectation, whether justified or not, of benefits associated with
participation, or of a retaliatory response from senior members of a
hierarchy in case of refusal to participate.”18(p9)
• Interestingly, the list of vulnerable people does not mention psychiatric
patients per se at all. The groups mentioned are health profession
trainees, health industry employees, the military, prisoners, the
chronically ill, the terminally ill, residents of nursing homes, the
impoverished, emergency patients, ethnic minority groups, minors, and
“those incapable of giving consent.”18(p9)
• Although psychiatric patients may fit into more than 1 above category, it
is important to note that psychiatric patients were not singled out for
mention in the definition any more than individuals with diabetes were.
The second section of the GCP document is an actual enumeration of what
constitutes good clinical practice. The section starts by saying that research
should be done using the principles that have come from the Declaration of
Helsinki (although the principles underlying the declaration are older than
the declaration itself and, arguably, do not owe their origin to that specific
document).
Additionally, a study can occur only if the potential benefits outweigh the
risks—“the rights, safety, and well-being of the trial subjects are the most
important considerations and should prevail over interests of science and
society.”18(p9) Before a trial can be conducted, the product to be investigated
must have been through adequate nonclinical testing.
A trial should be conducted in a manner approved by the relevant IRB/IEC.
The medical care of each subject must be overseen by a competent
physician, and all members of the project must be qualified for their roles.
Informed consent should be obtained.
Clinical data should be “recorded, handled, and stored in a way that allows
its accurate reporting, interpretation, and verification.”18(p9) Identifying
information should be kept confidential.
Finally, any product tested should be made and managed according to
“applicable good manufacturing practice.”18(p9)
 CLONAREA SI DREPTURILE OMULUI (OVIEDO)
• Actiunea: dezbaterea cu privire la clonare, 1997
• Masuri: 1997 CONVENTIA PENTRU PROTECTIA
DREPTURILOR OMULUI SI A DEMNITATII FIINTEI
UMANE CU PRIVIRE LA APLICAREA BIOLOGIEI SI
MEDICINII: CONVENTIA ASUPRA DREPTURILOR
OMULUI SI BIOMEDICINII, Oviedo, Uniunea
Europeana
 Principiile atestate la Oviedo
1. Protectia Drepturilor omului si a Demnitatii Fiintei Umane cu privire
la aplicarea Biologiei si Medicinei
2. Interesul si binele fiintei umane prevaleaza asupra interesului
societatii si stiintei
3. Acces echitabil la resursele de sanatate
4. Standarde profesionale
5. Consimtamant informat
6. Dreptul la informare si la viata privata
7. Non-discriminare, teste genetice pe motive de boala, interventii
genomice preventiv, diagnostic ori terapeutic lipsind selectia de sex
8. Cercetare doar daca; nu exista alternativa comparabila, riscuri care
nu sunt excesive fata de beneficii, cercetare aprobata etic, informare
prealabila, consimtant informat necesar dat specific, expres si
documentat.
9. Crearea embrionilor pentru cercetare este interzisa
10. Transplant numai pe criteriu terapeutic cand nu exista alte posibilitati
comparabile numai cu consimtamant prealabil explicit
11. Corpul uman nu va determina castig financiar
• 2000 revizia DoH. In oct. 2000 revizia a VI a DoH a fost adoptata fara distinctia explicita intre cercetarea
terapeutica si non-terapeutica care dispare.

• Argumente impotriva reviziei:

– Scut care protejeaza copilul, persoana vulnerabila
– If it ain’t broke, don’t fix it’ (AREC, 1999)
– Piatra unghiulara a cercetarii stiintifice: o ancora de nediscutat (Crawley & Hoet, 1999)
– Devine ghidul unanim acceptat
– Diferentierea este importanta practic si privind cercetarea si protocoalele de cercetare cat si
pentru pacient
• Argumente pentru revizie:
– Cercetarea avanseaza mai repede decat normarea
– Distinctia artificiala generatoare de consecinte:Ex. rolul transmitatorilor in patogeneza depresia
(non-terapeutica si totusi f. utila, subiectii fiind normali ori fara depresie, Levine 1986, 1999)
– Standardele terapeutice mai putin severe fata de cele non-terapeutice astfel incat lipsa distinctiei
foloseste cresterii eticismului protocolului de studio (Levine 1986, 1999)
• Se desfasoara un razboi pe etica DoH intre USA si UK
– AMA si WMA cu grupul Robert J. Levine pentru revizie
– Buletinul de Etica Medicala si Richard Nicholson (imperialismul american bioetic si revizia in
sprijinul cercetatorior americani in slujba propriilor interese).
• Categoria non-terapeutica dispare
• O noua categorie apare: “Principii aditionale pt. cercetare medicala combinata cu ingrijirea medicala”
• ‘Although the language has been removed, the concept stays the same.’(Levine, 2000)
• 2000, 2001 BIOMEDICAL RESEARCH ETHICS: UPDATING
INTERNATIONAL GUIDELINES. A CONSULTATION CIOMS

• 2002 INTERNATIONAL ETHICAL GUIDELINES FOR

BIOMEDICAL RESEARCH INVOLVING HUMAN SUBJECTS
CIOMS Geneva 2002 : Anuleaza editia din 1993
constituind varianta actuala. Ghid CIOMS 2002 : “CI
este C dat de o persoana competenta care (1) primeste
informatia, (2) intelege informatia, (3) decide in
interesul propriei persoane fara a fi subiectul
coercitiului, intimidarii sau aflata intr-o stare de
vulnerabilitate”
 ETAPA 7
A 4-a incercare de normare etica a cercetarii stiintifice
pe subiect uman: declaratii universale si internationale
privind cercetarea stiintifica pe subiectul uman si
reatestarea recunoasterii drepturilor universale ale
omului

• Actiunea: continuarea incalcarilor normelor etice in

cercetarea stiintifica pe subiectul uman in practica
medicala (Cazul fenfluramine 1998 -si vezi lista cazuri
cu abateri etice-materiale de studiu-)
• Masuri: Declaratia universala a UNESCO, Constitutia
OMS , Carta Drepturilor Fundamentale a Uniunii
Europene
2003-2005 sub egida Unesco se defineste Bioetica
“La solicitarea Directoratului General Comitetul International de Bioetica a emis Raportul
Comitetului International de Bioetica cu privire la posibilitatea elaborarii unui instrument
universal al Bioeticii

(Report of the IBC on the Possibility of Elaborating a Universal Instrument on Bioethics) ,13 Junie 2003.”
[http://unesdoc.unesco.org/images/0013/001302/130223e.pdf]

Universal Declaration on Bioethics and Human Rights, Declaratia Universala a Bioeticii si

Drepturilor Omului, UNESCO, 2005

Bioetica in sens larg (gr. Bios = viata, ethos = comportament): Camp de studiu stiintific
care abordeaza teoretic si practic problemele morale generate de medicina si stiintele
vietii in raport cu omul si relatiile omului cu biosfera.

Bioetica medicala (etica biomedicala) in sens restrans, este o aplicatie a bioeticii care
abordeaza sistematic, pluralistic si interdisciplinar teoretic si practic problemele morale
generate de mijloacele moderne de investigatie si tratament in medicina (transplant,
reproducerea umana asistata, dializa renala, mijloacele de sustinere a vietii, noua
eugenie, avortul, clonarea, terapia genica, diagnosticul preimplantational , stergerea
amintirilor dureroase, prelungirea vietii, augmentarea calitatilor umane, ingineria
genetica, etc.
• Etica medicala si bioetica medicala sunt aplicatii ale eticii ale eticii si respectiv ale bioeticii (etica
aplicativa).
• Etica provine din campul larg al filozofiei ca studiu al moralitatii. Bioetica este o abordare globalista,
multidisciplinara asupra moralitatii care creaza punti intre teologie, filozofie, medicina, biologie, stiintele
juridice, sociologie, ecologie, etc.
• Efortul care a construit bioetica se axeaza pe constatarea ca nu tot ceea ce este tehnic posibil este in
acelasi timp si moral.
Filozofie

Etica Etica
medicina

Tehnologii medicale moderne

Relatia medic-pacient

Teologie Ecologie, etc

Stiinte
Teologie
juridice Stiinte
Biologie
juridice
Etica medicala
Sociologie Economie
Bioetica medicala
 Principiile bioeticii atestate de UNESCO
1. “Demnitate umana si drepturi ale 14. Protectia generatiilor viitoare
omului 15. Protectia mediului, biosferei si
2. Beneficiu si vatamare biodiversitatii
3. Autonomie si responsabilitate 16. Luarea deciziilor si recunoasterea
individuala problematicii bioeticii
4. Consimtamant 17. Comitetele de etica
5. Persoane fara capacitatea de a 18. Evaluarea si managementul riscurilor
consimti 19. Practici transnationale
6. Respectul pentru vulnerabilitatea 20. Rolul statelor
umana si intergritatea personala 21. Educatia bioetica, training si
7. Confidentialitate si intimitate informare
8. Egalitate, justitie, echitate 22. Cooperare internationala
9. Non-disscriminare si non-stigmatizare 23. Continuarea actiunii de catre
10. Respect pentru diversitatea culturala si UNESCO
pluralism 24. Interrelatie si complementaritatea
11. Colidaritate si cooperare principiilor
12. Responsabilitate sociala si sanatate 25. Limitarea aplicarii principiilor
13. Impartirea beneficiilor 26. Negarea actiunilor impotriva
drepturilor omului, libertatilor
fundamentale si demnitatii umane.”
2006 2007
• Carta Drepturilor Fundamentale a Uniunii Europene
• Constitutia • Articolul 1 Demnitatea umană
OMS (Basic • Demnitatea umană este inviolabilă. Aceasta trebuie respectată
Documents, și protejată.
Forty-fifth • Articolul 2 Dreptul la viață
edition, • (1) Orice persoană are dreptul la viață.
October 2006) • Articolul 3
• Dreptul la integritate al persoanei
• “De a promova • (1) Orice persoană are dreptul la integritate fizică și psihică.
si a conduce • (2) În domeniile medicinei și biologiei trebuie respectate în
cercetare special:
stiintifica in • (a) consimțământul liber și în cunoștință de cauză al persoanei
domeniul interesate, în conformitate cu procedurile prevăzute de lege;
sanatatii” • (b) interzicerea practicilor de eugenie, în special a celor care au
drept scop selecția persoanelor;
• (c) interzicerea utilizării corpului uman și a părților sale, ca atare,
ca sursă de profit;
• (d) interzicerea clonării ființelor umane în scopul reproducerii.
• Articolul 4
• Interzicerea torturii și a pedepselor sau tratamentelor inumane
sau degradante
• Nimeni nu poate fi supus torturii și nici pedepselor sau
tratamentelor inumane sau degradante.
 SEMICENTENAR DoH

• Actiunea: continuarea incalcarilor normelor

etice in cercetarea stiintifica pe subiectul
uman in practica medicala (vezi lista cazuri cu
abateri etice-materiale de studiu-)
• Masuri: Amendarea DoH, 2013
• A noua revizie a DoH, WMA Declaration of
Helsinki - Ethical Principles for Medical Research
Involving Human Subjects
• Semicentenar, 50 ani de manifest al cercetarii pe
subiect uman DoH
• Fundamentul oricarui proeict stiintific
international sau a oricarei lucrari stiintifice care
include cercetare pe subiect uman.
• [http://www.wma.net/en/30publications/10polic
ies/b3/]
• Preamble
• 1. The World Medical Association (WMA) has
developed the Declaration of Helsinki as a statement of
ethical principles for medical research involving human
subjects, including research on identifiable human material
and data.
• The Declaration is intended to be read as a whole
and each of its constituent paragraphs should be applied
with consideration of all other relevant paragraphs.
• 2. Consistent with the mandate of the WMA, the
Declaration is addressed primarily to physicians. The WMA
encourages others who are involved in medical research
involving human subjects to adopt these principles.
http://www.wma.net/en/30publications/10policies/b3/
General Principles
3. The Declaration of Geneva of the WMA binds the physician with the words,
“The health of my patient will be my first consideration,” and the International Code of
Medical Ethics declares that, “A physician shall act in the patient's best interest when
providing medical care.”
4. It is the duty of the physician to promote and safeguard the health, well-being
and rights of patients, including those who are involved in medical research. The
physician's knowledge and conscience are dedicated to the fulfilment of this duty.
5. Medical progress is based on research that ultimately must include studies
involving human subjects.
6. The primary purpose of medical research involving human subjects is to
understand the causes, development and effects of diseases and improve preventive,
diagnostic and therapeutic interventions (methods, procedures and treatments). Even
the best proven interventions must be evaluated continually through research for their
safety, effectiveness, efficiency, accessibility and quality.
7. Medical research is subject to ethical standards that promote and ensure
respect for all human subjects and protect their health and rights.
8. While the primary purpose of medical research is to generate new knowledge,
this goal can never take precedence over the rights and interests of individual research
subjects.
9. It is the duty of physicians who are involved in medical research to protect the life,
health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal
information of research subjects. The responsibility for the protection of research subjects
must always rest with the physician or other health care professionals and never with the
research subjects, even though they have given consent.
10. Physicians must consider the ethical, legal and regulatory norms and standards
for research involving human subjects in their own countries as well as applicable
international norms and standards. No national or international ethical, legal or regulatory
requirement should reduce or eliminate any of the protections for research subjects set
forth in this Declaration.
11. Medical research should be conducted in a manner that minimises possible harm
to the environment.
12. Medical research involving human subjects must be conducted only by individuals
with the appropriate ethics and scientific education, training and qualifications. Research
on patients or healthy volunteers requires the supervision of a competent and
appropriately qualified physician or other health care professional.
13. Groups that are underrepresented in medical research should be provided
appropriate access to participation in research.
14. Physicians who combine medical research with medical care should involve their
patients in research only to the extent that this is justified by its potential preventive,
diagnostic or therapeutic value and if the physician has good reason to believe that
participation in the research study will not adversely affect the health of the patients who
serve as research subjects.
15. Appropriate compensation and treatment for subjects who are harmed as a result
of participating in research must be ensured.
Risks, Burdens and Benefits
16. In medical practice and in medical research, most interventions involve
risks and burdens.
Medical research involving human subjects may only be conducted if the
importance of the objective outweighs the risks and burdens to the research
subjects.
17. All medical research involving human subjects must be preceded by careful
assessment of predictable risks and burdens to the individuals and groups involved
in the research in comparison with foreseeable benefits to them and to other
individuals or groups affected by the condition under investigation.
Measures to minimise the risks must be implemented. The risks must be
continuously monitored, assessed and documented by the researcher.
18. Physicians may not be involved in a research study involving human
subjects unless they are confident that the risks have been adequately assessed
and can be satisfactorily managed.
When the risks are found to outweigh the potential benefits or when there is
conclusive proof of definitive outcomes, physicians must assess whether to
continue, modify or immediately stop the study.
Vulnerable Groups and Individuals
19. Some groups and individuals are particularly vulnerable and may
have an increased likelihood of being wronged or of incurring additional
harm.
All vulnerable groups and individuals should receive specifically
considered protection.
20. Medical research with a vulnerable group is only justified if the
research is responsive to the health needs or priorities of this group and
the research cannot be carried out in a non-vulnerable group. In addition,
this group should stand to benefit from the knowledge, practices or
interventions that result from the research.
Scientific Requirements and Research Protocols
21. Medical research involving human subjects must conform to generally
accepted scientific principles, be based on a thorough knowledge of the scientific
literature, other relevant sources of information, and adequate laboratory and, as
appropriate, animal experimentation. The welfare of animals used for research must
be respected.
22. The design and performance of each research study involving human
subjects must be clearly described and justified in a research protocol.
The protocol should contain a statement of the ethical considerations
involved and should indicate how the principles in this Declaration have been
addressed. The protocol should include information regarding funding, sponsors,
institutional affiliations, potential conflicts of interest, incentives for subjects and
information regarding provisions for treating and/or compensating subjects who are
harmed as a consequence of participation in the research study.
In clinical trials, the protocol must also describe appropriate arrangements for
post-trial provisions.
Research Ethics Committees
23. The research protocol must be submitted for consideration, comment,
guidance and approval to the concerned research ethics committee before the study
begins. This committee must be transparent in its functioning, must be independent
of the researcher, the sponsor and any other undue influence and must be duly
qualified. It must take into consideration the laws and regulations of the country or
countries in which the research is to be performed as well as applicable international
norms and standards but these must not be allowed to reduce or eliminate any of the
protections for research subjects set forth in this Declaration.
The committee must have the right to monitor ongoing studies. The
researcher must provide monitoring information to the committee, especially
information about any serious adverse events. No amendment to the protocol may
be made without consideration and approval by the committee. After the end of the
study, the researchers must submit a final report to the committee containing a
summary of the study’s findings and conclusions.
Privacy and Confidentiality
24. Every precaution must be taken to protect the privacy of research subjects and
the confidentiality of their personal information.
Informed Consent
25. Participation by individuals capable of giving informed consent as subjects in
medical research must be voluntary. Although it may be appropriate to consult family
members or community leaders, no individual capable of giving informed consent may
be enrolled in a research study unless he or she freely agrees.
26. In medical research involving human subjects capable of giving informed
consent, each potential subject must be adequately informed of the aims, methods,
sources of funding, any possible conflicts of interest, institutional affiliations of the
researcher, the anticipated benefits and potential risks of the study and the discomfort
it may entail, post-study provisions and any other relevant aspects of the study. The
potential subject must be informed of the right to refuse to participate in the study or to
withdraw consent to participate at any time without reprisal. Special attention should be
given to the specific information needs of individual potential subjects as well as to the
methods used to deliver the information.
After ensuring that the potential subject has understood the information, the
physician or another appropriately qualified individual must then seek the potential
subject’s freely-given informed consent, preferably in writing. If the consent cannot be
expressed in writing, the non-written consent must be formally documented and
witnessed.
All medical research subjects should be given the option of being informed
about the general outcome and results of the study.
27. When seeking informed consent for participation in a research study the physician
must be particularly cautious if the potential subject is in a dependent relationship with the
physician or may consent under duress. In such situations the informed consent must be
sought by an appropriately qualified individual who is completely independent of this
relationship.
28. For a potential research subject who is incapable of giving informed consent, the
physician must seek informed consent from the legally authorised representative. These
individuals must not be included in a research study that has no likelihood of benefit for
them unless it is intended to promote the health of the group represented by the potential
subject, the research cannot instead be performed with persons capable of providing
informed consent, and the research entails only minimal risk and minimal burden.
29. When a potential research subject who is deemed incapable of giving informed
consent is able to give assent to decisions about participation in research, the physician
must seek that assent in addition to the consent of the legally authorised representative.
The potential subject’s dissent should be respected.
30. Research involving subjects who are physically or mentally incapable of giving
consent, for example, unconscious patients, may be done only if the physical or mental
condition that prevents giving informed consent is a necessary characteristic of the
research group. In such circumstances the physician must seek informed consent from
the legally authorised representative. If no such representative is available and if the
research cannot be delayed, the study may proceed without informed consent provided
that the specific reasons for involving subjects with a condition that renders them unable
to give informed consent have been stated in the research protocol and the study has
been approved by a research ethics committee. Consent to remain in the research must
be obtained as soon as possible from the subject or a legally authorised representative.
31. The physician must fully inform the patient which aspects of their care are
related to the research. The refusal of a patient to participate in a study or the
patient’s decision to withdraw from the study must never adversely affect the patient-
physician relationship.
32. For medical research using identifiable human material or data, such as
research on material or data contained in biobanks or similar repositories, physicians
must seek informed consent for its collection, storage and/or reuse. There may be
exceptional situations where consent would be impossible or impracticable to obtain
for such research. In such situations the research may be done only after
consideration and approval of a research ethics committee.
Use of Placebo
33. The benefits, risks, burdens and effectiveness of a new intervention must be
tested against those of the best proven intervention(s), except in the following
circumstances:
Where no proven intervention exists, the use of placebo, or no intervention, is
acceptable; or
Where for compelling and scientifically sound methodological reasons the use
of any intervention less effective than the best proven one, the use of placebo, or no
intervention is necessary to determine the efficacy or safety of an intervention
and the patients who receive any intervention less effective than the best
proven one, placebo, or no intervention will not be subject to additional risks of
serious or irreversible harm as a result of not receiving the best proven intervention.
Extreme care must be taken to avoid abuse of this option.
Post-Trial Provisions
34. In advance of a clinical trial, sponsors, researchers and host country
governments should make provisions for post-trial access for all participants who
still need an intervention identified as beneficial in the trial. This information must
also be disclosed to participants during the informed consent process.
Research Registration and Publication and Dissemination of Results
35. Every research study involving human subjects must be registered in a
publicly accessible database before recruitment of the first subject.
36. Researchers, authors, sponsors, editors and publishers all have ethical
obligations with regard to the publication and dissemination of the results of
research. Researchers have a duty to make publicly available the results of their
research on human subjects and are accountable for the completeness and
accuracy of their reports. All parties should adhere to accepted guidelines for
ethical reporting. Negative and inconclusive as well as positive results must be
published or otherwise made publicly available. Sources of funding, institutional
affiliations and conflicts of interest must be declared in the publication. Reports of
research not in accordance with the principles of this Declaration should not be
accepted for publication.
Unproven Interventions in Clinical Practice
37. In the treatment of an individual patient, where proven interventions do not
exist or other known interventions have been ineffective, the physician, after
seeking expert advice, with informed consent from the patient or a legally
authorised representative, may use an unproven intervention if in the physician's
judgement it offers hope of saving life, re-establishing health or alleviating
suffering. This intervention should subsequently be made the object of research,
designed to evaluate its safety and efficacy. In all cases, new information must be
recorded and, where appropriate, made publicly available.
REFERINTE BIBLIOGRAFICE
[1] "The Hippocratic Oath". The London Medical Repository 23 (135): 258. 1 March 1825. Retrieved 22
September 2014. . For the Greek text, see Jones, W. H. S., ed. (1868). Hippocrates Collected Works (in Greek)
I. Cambridge Harvard University Press. pp. 130–131. 22 Dec. 2014.
[2] Al- Shaizari’s book. On Supervision (Hisbah) over Physicians, Oculists, Orthopedists and Surgeons
[http://earchiving.wordpress.com/category/medical-record-keeping-islam-5th-century/]
[3]M. Zuheir Al Kawi, History of medical records and peer review, Editorial, King Faisal Specialist Hospital,
1997
[4] Ibn Abi Osaibiaa. Uyunul Anbaa fi Tabaqatil Atibbaa (Sources of the News in the Ranks of Physicians).
Verification by Nizar Reda. Beirut: Al Haya House, Beirut, 1992:302.
[5]Ishaq bin Ali Al Rahawi. Adabul Tabib (Ethics of the Physician). Verification by Dr. Muraizen Saeed
Assiri. Issue No. 9. Riyadh: King Faisal Center for Research and Islamic Studies, 1992:264-5.
[6] http://web.archive.org/web/20080304153538/http://www.bmj.com/archive/7070nd1.htm]
[7] http://legislatie.resurse-pentru-democratie.org/legea/declaratia-universala-a-drepturilor-omului.php
[8] http://www.wma.net/en/60about/70history/01declarationHelsinki/
[9] http://www.wma.net/en/30publications/10policies/b3/17c.pdf
[10]"http://archives.who.int/eml/expcom/expcom14/ceftriaxone/ceftriaxone_ERI_application_final.2.pdf".
Retrieved 1 Nov 2013.
[11] Study on babies did not disclose risks US FInds (April 11, 2013) Andrew Rosenthal, follow
[http://www.nytimes.com/2013/04/16/opinion/an-ethical-breakdown-in-medical-research.html?_r=0] accesat
/] accesat in 17.10.2014
[12] http://unesdoc.unesco.org/images/0014/001461/146180E.pdf
[13] http://www.who.int/governance/eb/who_constitution_en.pdf
[14]http://europa.eu/legislation_summaries/justice_freedom_security/combating_discrimination/l33501_ro.ht
m
http://anp.gov.ro/documents/10180/1863054/LexUriServ.pdf/3925bd4c-b834-4719-801c-0789b45dc392