curs etica in cercetare final 2016
TRANSCRIPT
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Corin Badiu, 2015
Metodologia cercetării ştiinţifice
Etica in cercetarea ştiinţifică
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Etica
Definitii academice si practice
• Ramura a disciplinelor filozofice, considerata stiinta de
normare intrucat se ocupa de normele conduiteiumane. [academic]
• Procesul prin care se aplica valorile morale la situatii
actuale de viata. [practic]
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Protocolul de evaluare etica in cercetare
1. Fond, Scopuri, Obiective
2. Metodologia cercetarii
3. Participanti
. !ecrutare
". !i#curi #i $eneficii
%. &onfidentialitate
'. &o(pen#are
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). &onflict de *ntere#e
+. Elaborarea #i aplicarea con#i(ta(antului*nfor(at
1.Evaluarea prin co(itete #i in#titutii
11. &ontract
12.-rialuri &linice
13.ne/e
Protocolul de evaluare etica in cercetare
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Text Telefonic/email
Exemple de scrisori de consimtamant
Ghiduri de observatie clinica
Chestionare Interviu sau intrebari de grup
Anexe
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Principii ale eticii in cercetare
• One#titate• Obiectivitate
• *ntegritate 0cine e#ti, ce faci, ce #pui• tiliarea eficienta a re#ur#elor 0ti(p,
(ateriale, ec4ipa(ente, per#onal• &olegialitate 0utiliare in co(un
• !ecunoa#terea autoritatii 0ca aut4or#4ip #i(entor
• 5e#c4idere 0devaluirea detaliilor
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Etica cercetarii clinice
• Cerintele etice in cercetarea clinica au cascop:
♦ Limitarea posibilitatii de exploatare;
♦ Siguranta ca sunt respectate drepturilepacientilor in timp ce acestia ajuta laimbunatatirea cunoasterii.
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Coduri etice si Ghiduri
• Codul Nuremberg(1949)
• Declaratia de la Helsinki (1964- 2013)
• Raportul Belmont(1979)
• Ghiduri Internationale OMS(1993, 2002)
• ICH/GCP-International Conference onHarmonization- Good Clinical Practice (1996)
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Perspective istorice
• Tribunalul de razboi de la Nuremberg (1947) – judecarea a23 medici si militari germani care au comis crime de razboi si crimeimpotriva umanitatii Teste inadmisibile e!ectuate cu scop decercetare pe mii de prizonieri din lagarele de concentrare" !ara aobtine consimatamant in!ormat
•Tus#egee $%p&ilis $tud% (1932'1972) – a parte componenta aunui proiect de cercetare condus de serviciul public de sanatate din$* asupra +,, de barbati de culoare" provenind din categoriisociale de!avorizate" din care 4,, erau in!ectati cu s%p&ilis" au !ostmonitorizati timp de 4, ani onsulturile medicale erau gratuite-totusi" participantii nu au !ost in!ormati asupra bolii &iar cand aaparut posibilitatea terapiei antibiotice cu penicilina in anii 19.,"
studiul a continuat pana in 1972" participantii neprimind tratament/n anumite cazuri" cand participantii erau diagnosticati ca avandsi!ilis de catre alti medici" cercetatorii au intervenit pentru apreveni tratamentul 0ulti participanti au murit de si!ilis in timpulstudiului $tudiul a !ost oprit in 1973 de catre epartamentul de$anatate si ducatie din $* doar dupa ce a !ost mediatizat si adevenit un element politic
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6ure(berg, 7er(an8
5ece(ber +, 1+% to ugu#t 2, 1+'
♦ !e9uired voluntar8 con#entprior to participation
♦ *nve#tigator re#pon#ibilit8 toobtain con#ent
♦ *nfor(ation gained b8 u#ing4u(an #ub:ect# ;ould be
unprocurable an8 ot4er ;a8
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-u#<egee S8p4ili# Stud8
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• olosirea Talidomidei ' Talidomida a !ost
!olosita in anii 19., pentru a combate
disgravidia /n perioada utilizarii sale" nu s'a
transmis gravidelor !aptul ca medicamentul era incurs de investigare" in !aza de testare pentru
obtinerea autorizatiilor upa ce multe !emei din
uropa" anada" si $* au !ost tratate" s'a
descoperita ca are e!ecte teratogene"
determinand ma!ormatii !etale severe
Talidomida a !ost oprita de la comercializare
imediat in intreaga lume in pacate" aproimativ
12,,, copii s'au nascut cu mal!ormatii severe
datorate talidomidei
Per#pective i#torice
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• perimente de /radiere(194,s – 19+,s) – 5!iciali
din $* au studiat e!ectele radiatiei prin eperimente
pe pacienti spitalizati" !emei gravide" copii cu intarziere
mentala" cadre militare sau puscariasi 6utini dintreparticipantii la eperimente au dat consimtamant
in!ormat 0ajoritatea nu stiau ca sunt epusi la materiale
radioactive 5!icialii proiectului 0an&attan au autorizat
eperimente din timpul razboilui pentru a stabilii
standarde de sanatate si siguranta pentru sutele de
muncitori din !abricile de armament atomic
Per#pective i#torice
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Eventi(ente Santinela
• &ri(e de raboi nai#te
• E/peri(ente de iradiere
• -u#<egee S8p4ili# #tud8
Proce#ul de la6ure(berg 01+)
5eclaratia de la=el#in<i 01+%3
!aportul $el(ont01+''
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Raspunsul la aceste abuzuri incercetare
• *trocitatile naziste in al doilea razboi mondial au atras atentia *supra lipseistandardelor internationale in cercetarea cu subiecti umani si au dus la!ormularea odului de la Nuremberg (194)
• ezastrul talidomidei a dus la adoptarea 8*mendamentului e!auver8 (19+2)din *ctul asupra alimentelor" cosmeticelor si medicamentelor" solicitand!abricantilor de medicamente sa puna la dispozitia * normele de sigurantasi e!icacitate a produselor lor iar medicii au !ost obligati sa obtinaconsimtamant in!ormat de la pacientii care ar putea primi o medicatie incurs de investigare
• eclaratia de la :elsin#i a rezumat munca *sociatiei 0edicale 0ondiale in19+4 (reevaluata in 2,,,) construita pe codul de la Nuremberg si este bazaNormelor de ;una 6ractica linica !olosite azi
• *ctul National de ercetare (1974) care a aparut ca urmare a raspunsului la$tudiului Tus#egee si!ilis" instaureaza necesitatea ca subiectii umani sa !ieprotejati si sa bene!icieze de ac&izitiile cele mai recente in cercetare" !iindbaza de pornire pentru <aportul ;elmont
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5eclaratia de la =el#in<i0#ociatia Medicala Mondiala
• rticulated et4ical principle# for u#e b8p48#ician# conducting 4u(an re#earc4
• ffir(ed t4e autono(8 of t4e individual
• niver#all8 adopted to en#ure t4e rig4t#
and ;elfare of 4u(an #ub:ect# ofre#earc4
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5eclaratia de la =el#in<i
• >orld Medical ##ociation, 1+%.
• ?a#t a(ended 213 0%t4 >M 7eneral ##e(bl8,Fortalea, $rail, October 213
• Et4ical Principle# for Medical !e#earc4 *nvolving=u(an Sub:ect#
•-a<e 4o(e point@ !e#earc4 ;it4 4u(an #ub:ect# i#
:u#tified onl8 ;4en t4e degree of ri#< to #ub:ect# doe#not e/ceed t4e 4u(anitarian i(portance of t4e<no;ledge to be gained. -4e 5= i# t4e ba#i# for7ood &linical Practice u#ed toda8.
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5eclaration of =el#in<i
*##ue# addre##ed@ !e#earc4 ;it4 4u(an# #4ould be ba#ed on
laborator8 and ani(al e/peri(entation
E/peri(ental protocol #4ould be revie;ed b8independent co((ittee *nfor(ed con#ent !e#earc4 conducted b8 (edicall8 A
#cientificall8 9ualified individual# !i#<# and benefit# Privac8 of t4e #ub:ect Publication of re#earc4 re#ult#
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Raportul BELMONTNational Commission for the Protection of Human Subjects of Biomedical
and Behavioral Research
• Distinction between clinical researchand clinical practice
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-4e $el(ont !eport
Et4ical Principle# and 7uideline# for t4eProtection of =u(an Sub:ect# of !e#earc4
0pril, 1+'+• E#tabli#4ed t4ree ba#ic principle# ;4ic4 are
t4e corner#tone of regulation# involving4u(an #ub:ect# protection♦ utono(8 A re#pect for per#on#♦ $eneficence♦ Bu#tice
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Federal regulation#
• 1++1 Federal Polic8 for Protection of=u(an Sub:ect# 0-4e &o((on !ule♦ dopted b8 all agencie# ;4ic4 conduct,
#upervi#e, regulate, fund or #pon#or4u(an re#earc4
♦ -;o (a:or re9uire(ent#@
• *nfor(ed &on#ent• *!$ approval
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!o(anian regulation#
• 6ational et4ic# co((ittee
• 6ational 5rug genc8 C Medical 5evice#
• 6onclinical #tudie# re#earc4 guide♦ M=O 122A2 according to International
Conference for Harmonisation – ICH , Committee forProprietary Medicinal Products - CPMP guide 2)%A+"
• 7ood clinical practice regulation# D M=O %1"A2
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Et4ical fra(e;or<@ ' principle#
• aluable #cientific 9ue#tion• alid #cientific (et4odolog8
• Fair #ub:ect #election• Favorable ri#<Dbenefit evaluation• *ndependent revie;• *nfor(ed con#ent
• !e#pect for enrolled #ub:ect#
E(anuel E, >endler 5, 7rad8 &. >4at (a<e# clinical re#earc4 et4ical Journal of the American Medical Association 2G 2)302@2'1D11
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Fond !copuri "biective
&are e#te #ubiectul cercetarii
&e #copuri #e vor indeplini prin cercetare
&are #unt principalele intrebari la care #e dore#tera#pun#
5e#crie pe #curt fondul #tiintific al #tudiului
H pagina
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#etodologia cercetarii
!ecventa logica de evenimente din cadrul studiului$protocol%
Cum se vor obtine datele&
Descriere detaliata pentru fiecare metoda' Pune
urmatoarele intrebari(
Cat dureaza interviul/chestionarul/observatia experimentala&
Cand $in ce perioada% va avea loc&
Unde va avea loc&
Participantii vor avea posibilitatea sa intervina in chestionar /studiu& Daca da ofera detalii'
Care sunt implicatiile /aplicatiile cercetarii&
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Practica re#pon#abilitatii cercetarii
• &e in#ea(na♦ r(arirea #i aplicarea unui protocol #cri#♦ erificarea #i docu(entarea datelor 0inclu#iv lotul
de reactivi, date de e/p., etc.♦ Pa#trarea adecvata a reultatelor #i #peci(enelor ♦ Pa#trarea adecvata a reactivilor #i c4i(icalelor ♦ Mentinerea #i calibrarea adecvata a
ec4ipa(entelor ♦ tiliarea Standardelor Procedurilor de Operare
0SOP♦ 7ri:a pentru ani(alele de e/perienta
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&ine #unt participantii Organiatii *ndivii
5e ce au fo#t ale#i pentru #tudiu 0criterii dee/cludere A includere
&ati #unt
rgu(enteaa di(en#iunea e#antionului
Participanti
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Cum veti obtine o lista a potentialilor participanti&
!istem de contact
telefonic
scrisoare &
Grupuri de studiu(
Control
Test
)ecrutare
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*u exista risc minim anticipat'
Participantii vor fi informati despre natura studiului si
modalitatii de participare inclusiv asupra faptului ca se
pot retrage oricand'
Participantii $si raspunsurile lor privind includerea in
studiu% vor fi luate ca atare
Standarde de aplicare:
)iscuri si +eneficii
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Cine va avea acces la date&
!e va inregistra interviul&
Cum va fi prote,ata identitatea participantilor& !e codifica toate
datele&
Cum se stochea-a datele in timpul studiului&
Cand se distrug datele&
Cum se va pastra confidentalitatea & !e va exclude orice
informatie de identificare&
Confidentialitate
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• Fundamental in cercetarea pe #ubiecti u(ani
• E#te un proces #i nu un formular'
• Formularul e#te doar docu(entul care ate#taca proce#ul de infor(are liber con#i(tita aavut loc.
Procesul de consimtamant informat
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!e va obtine consimtamant informat scris&
De la nivel institutional&
De la decan/ rector&
Consimtamantul informat trebuie obtinut de la toti participantii
Pentru studii avand ca subiecti copii consimtamantul scris al
parintilor / tutorilor este obligatoriu
Interviu . consimtamant scris
Chestionare . Prin completarea chestionarelor
Procesul de consimtamant informat
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&u( obtine( &*
• ariaa in functie de de#ignul #tudiului#i natura participarii
• erbal v#. Scri#• *nve#tigator v#. &oDinve#tigatori A a#i#tenti
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Ele(entele proce#ului de con#i(ta(ant infor(at• *nfor(atie orala #i #cri#a pe grade de in#truire•
fir(atia e/plicita ca #tudiul i(plica cercetare,cu de#crierea procedurilor, duratei, identificareaprocedurilor e/peri(entale
• !i#curi #i eventual di#co(fort anticipat
• $eneficii anticipate pentru #ubiecti #au altii• 6atura voluntara a participarii la #tudiu• &apacitatea de a #e retrage oricand
Procesul de consimtamant informat
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• Enu(erarea alternativelor • fir(atie legata de confidentialitate A
anoni(at• fir(atie legata de co(pen#are A trata(ent(edical
• fir(atie legata de per#oana de contact
pentru intrebari legate de drepturile#ubiectilor, protocolul de cercetare, ri#curia#ociate protocolului
Procesul de consimtamant informat
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&o#turi
• &on#i(ata(antul infor(at trebuie #a
tran#(ita clar e/plicatia co#turilorpentru care #ubiectul e#te re#pon#abil.
Procesul de consimtamant informat
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Evaluarea ri#curilor participantilor
!aportarea eveni(entelor adver#e• Proble(e neanticipate
• Eveni(ente adver#e #erioa#e
6oi date pot duce la@• !eevaluarea ri#cului
• Modificarea for(ularului de con#i(ta(ant
• -er(inarea pre(atura a protocolului de cercetare
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Populatii vulnerabile
• &opii
• Prionieri
• *ndivii cu retard (ental
• 5e(entaA &o(aA Starea vegetativa
• $oli (entale
• 7ravide
• Pacienti in urgenta
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&on#i(ta(ant deplin infor(at
o ?iber de coercitiefara tea(a A e/ploatarea puterii A
poitiei
o &on#i(ta(ant oficial
6u e#te tacit ci e/plicit, #cri#I
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&on#i(ta(ant deplin infor(at
o Scopul #i (etodele #tudiului
o &e #e a#teapta de la participanti
o&u( #e colecteaa datele
o Participantii pot #a co(entee Ainterpretee datele
o
Se va publica cercetareao &are #unt beneficiile #i reervele in a fiparticipant la #tudiu
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!e#pect pentru copii
• &on#ideratii legale@ datoria de ingri:ire
• Obtinerea con#i(ta(antului infor(at dela copii 0de la %D) ani
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&onflict of *ntere#t
• Financial♦ E9uit8 intere#t, con#ultant, paid #pea<er
•6onDfinancial♦ !ecognition, de#ire to advance one’# t4eor8
• Jou (ig4t not be able to eli(inate 8ourconflict# of intere#t, but t4ere are ot4er
option#@ reduce, avoid, di#clo#e
& fli t f * t t i =
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&onflict of *ntere#t in =u(an!e#earc4 Studie#
• *(po##ible to eli(inate all conflict# of intere#t#
• -8pe# can be financial, per#onal, individual, or in#titutional
• 6o;ada8#@ focu#e# on financial
• 6evert4ele##, et4ic# dictate# for inve#tigator# to be#en#itive to all t8pe#
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• #uall8 re#ulting fro( a re#earc4erK# dual role
e.g. a teac4erAre#earc4er ;anting to collect datafro( 4erA4i# o;n #tudent#, or anot4er t8pe ofrelation#4ip ;4ere t4e re#earc4er 4a# anevaluative role in relation to participant#
• *##ue@• Potential participant# (a8 feel #o(e pre##ure to
participate re#ulting fro( t4e power relationship bet;een teac4erA#tudent and not feel co(pletel8co(fortable #a8ing LnoK to participation
Conflicts of interest
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>4at i# a &onflict of *ntere#t
• #ituation in ;4ic4 financial or ot4erper#onal con#ideration# (a8 bia#, or be
perceived b8 ot4er# a# bia#ing,profe##ional :udg(ent or action.
>4 5 > & b t
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>48 5o >e &are bout&onflict#
• *(pact on rig4t# and ;elfare of #ub:ect#
• ppearance of bia# lead to lo## of public confidence
• *(pact on integrit8 of data #ub(itted to regulator#and :ournal#
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5igital 5ata Et4ic#
• Si(ple ad:u#t(ent# to t4e E6-*!E i(age are usually acceptable.
• Selectivel8 (anipulating one area of t4e i(age i#
9ue#tionable.
• &ropping an i(age i# usually acceptable.
• *f u#ed, #oft;are filter# (u#t be noted in t4e figure
caption.
• -4e (ore proce##ing 8ou L4aveK to do, t4e (oreet4icall8 proble(atic t4e (anipulation# beco(e.
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5ile((a# ;it4 7el# C 5igital 5ata
Gels, X-Rays, photos are considered DATA
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5ata Selection C !etention
• $e careful 4o; 8ou pic< and c4o#eN
• $e con#i#tent ;it4 regard to 4ig4bac<groundN, artifactN, lo; confidence
value#N, and noi#eN 0ver#u# #ignal• >4en reporting 8our data, disclose ;4at 8ou
did@♦ -;o obe#e rat# ;ere e/cluded becau#e♦ -4e fir#t t4ree data point# ;ere e/cluded
becau#e
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>4o O;n# JourN 5ata C Material#
• E(plo8ee# C (edical #tudent# t4at relate in an8 ;a8 to4i#A4er :obAre#earc4 re#pon#ibilitie# (u#t be a##igned tot4e &linic.
• E/c4ange# of re#earc4 (aterial ;it4 out#ide re#earc4er#(u#t be fra(ed in ;ritten agree(ent#, #ince furt4erdi#coverie# (a8 be (ade u#ing t4e (aterial. &linic (a8be co(pen#ated for #uc4 e/c4ange#.
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Practica re#pon#abilitatii cercetarii
• &e in#ea(na♦ r(arirea #i aplicarea unui protocol #cri#♦ erificarea #i docu(entarea datelor 0inclu#iv lotul de
reactivi, date de e/p., etc.♦ Pa#trarea adecvata a reultatelor #i #peci(enelor ♦ Pa#trarea adecvata a reactivilor #i c4i(icalelor ♦ Mentinerea #i calibrarea adecvata a ec4ipa(entelor ♦
tiliarea Standardelor Procedurilor de Operare 0SOP♦ 7ri:a pentru ani(alele de e/perienta
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Pa#trarea datelor
• &aiet de laborator #e(nat #i datat
• Scri# ?**$*?
• Fara pa#ta corectoare• Se taie cu o linie, #e #e(neaa #i #e
dateaa.
• Fara Po#tit 0#tic<8 note#.
• Fara pagini albe.
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ut4or !e9uire(ent#Q
ut4or#4ip credit #4ould be ba#ed on@ 1 #ub#tantial contribution# to conception and de#ign,
or ac9ui#ition of data, or anal8#i# and interpretation ofdataG and
2 drafting t4e article or revi#ing it criticall8 for i(portantintellectual contentG and
3 final approval of t4e ver#ion to be publi#4ed.
ut4or# #4ould (eet condition# 1, 2, and 3.
Intl Comm of #edical ournal Editors' 0niform )e1uirements for
#anuscripts !ubmitted to +iomedical ournals( 2riting and Editing for
+iomedical Publication' November 2009.
http://www.icmje.or/ethical!"author.html
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ut4or#4ip
• -4o#e credited ;it4 aut4or#4ip#4ould be able to ta<e publicre#pon#ibilit8 for t4e re#earc4.
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ut4or#4ipQ
c9ui#ition of funding, collection of data, or
general #upervi#ion of t4e re#earc4 group,alone, doe# not :u#tif8 aut4or#4ip.
Intl Comm of #edical ournal Editors' 0niform )e1uirements for
#anuscripts !ubmitted to +iomedical ournals( 2riting and Editing for
+iomedical Publication' http(//333'icm,e'org/.
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ut4or#4ip
5ecide up front ;4o ;ill ;or< on t4e (anu#cript
and ;4at t4e order of aut4or# ;ill be.
06ot all people ;or<ing on t4e pro:ect ;ill
(eet aut4or#4ip re9uire(ent#.
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!e#earc4 Mi#conduct
• Fabrication 0creating data
• Fal#ification 0c4anging data
• Plagiari#( 0u#ing anot4erK# ;ord# oridea# ;it4out giving t4e( credit.♦ -4i# include# cutting and pa#ting fro( t4e
*nternet.
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>48 i# Mi#conduct $adN
• *t affect# t4e integrit8 of #cience a# a profe##ion 0;4ic4potentiall8 adver#el8 affect# re#earc4 funding
• *t i# not collegial
• Propel# furt4er generation of badN data a# t4e initialdata foundation i# badN
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Mi#conduct !e#earc4
• Surve8 of 32' re#earc4er#@♦ 2)R ad(itted to poor record <eeping♦ 1%R ad(itted to c4anging t4e de#ign, (et4odolog8, or
re#ult# of a #tud8 in re#pon#e to pre##ure fro( t4eirfunding #ource
♦ 1"R ad(itted to dropping ob#ervation#Adata point# ba#edon a gut feeling
♦ 1R ad(it to giving aut4or#4ip to people ;4o didnt earn it
ref@ Martin#on et al. 6ature 2"G3"@'3'D'3)
>4at to do if 8ou #u#pect
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>4at to do if 8ou #u#pect(i#conduct
• 5onKt a##u(e 8ou are rig4tN
• 5onKt accu#e
• -r8 to verif8 8our #u#picion 0t4ere (a8 be anacceptable rea#on for ;4at i# going on
• #< 8our#elf, “what is my motive for ettin
involved!"
• #< t4e advice of #o(eone 8ou tru#t
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*##ue# in ni(al !e#earc4
Jour 7uide@
• 7uide for t4e &are and #e of ?aborator8 ni(al# . info about vet care, 4ou#ing, paincontrol eut4ana#ia, etc.04ttp@AA;;;.nap.eduAreadingroo(Aboo<#Alabrat#A
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*##ue# in ni(al !e#earc4
• =ave 8ou atte(pted to )EP4ACE ani(al# ;it4anot4er (odel
• =ave 8ou )ED0CED t4e nu(ber of ani(al# to t4e
(ini(u( needed for #tati#tical purpo#e#• =ave 8ou )EFI*ED 8our lab tec4ni9ue# #o t4at
ani(al pain and #uffering are a# lo; a# po##ible
• *# 8our protocol approved b8 t4e &&F *n#titutional
ni(al &are and #e &o((ittee
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*dentification
• Ma<e #ure 8our ani(al# are clearl8 identifiable,
;4et4er #ingularl8 or in group#.
• Option# include cage label#, nec< label#, tattoo,
(icroc4ip, etc.
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=ou#ing Jour ni(al#
• &on#ider t4e ani(al #pecie#
• =ou#ing #4ould con#ider #ie of ani(al,te(perature, bedding need#, food, clean;ater, lig4t, noi#e, 4u(idit8, contact ;it4 ot4erani(al#, air e/c4ange, vibration, etc.
• Teep t4e cage# clean, and t4e ani(al# freefro( 4ar( fro( ot4er ani(al#. 0-4i# include#avoiding cro;ding ;it4in a cage.
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voiding ni(al Stre##
*f po##ible, #efore #tarting 8our pro:ect,
&O65*-*O6 8our ani(al# to t4eirenviron(ent, procedure#, and re#earc4per#onnel.
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PainASuffering
• An animal with signs of pain or distress notpredicted in the protocol, must have the painor distress alleviated promptly.
• Alleviation of such pain or distress must takeprecedence over completing a project.
• If this is not possible the animal must be
euthanized without delay.
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Moral proble( in clinical re#earc4
• The !oal o" clinical research is !eneration o" use"ul
#no$led!e a%out hu&an health and illness
•Bene"it to participants is
not
the purpose o" research'althou!h it does occur(
• )eople are the means to de*elopin! use"ul #no$led!e+
and are thus at ris# o" eploitation
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&O6&?S*O6S
• thics is research starts $ith !rant application
•Applies to all in*ol*ed in research process
• nds $ith pu%lication and "urther "ollo$ - up
'clinical . scienti"ic(