|_€thies of clinical Research - > “the gosto, clintral_ research 1st _gencrate wieful_knowledg ehout human ‘health’ aud illness , and ways 4o_prevent, Magnose and treat diseas. =the goals not benefit fo the indtyiduale who _arbtipate —__ CAttheugh there tometimel benehit) Feople “we the means, to. develofeng use trowsledge » anda Mn ot sk =k exploitabin, + promote benefits 40 Soctehy ard future patrons + frotect and _vesbeck " wyhte: tnd _wettare os parttpants | Selected Codes f Guidelines - . Nvemberg— Code (1144) Fy Conduct bs Declaration « oly» Helermbi by berld Hedical Avouation C1964-2600 20017) 2 The Belmont Rebort (naa) ~ = by wational Commicsten Research, + ctoms] WHO Intern: al _brsideine “(ints oor) TEU of Tate ogee of EST FART. . salen Intemational’ Conferenee’ on’ HAimon(eartion ~ “hood « Clinteal Prachice, L Allows for Regulatory rahorse EG> part of TCH) HCP + Speak. Sheu'Rely to ethics MA It i does Adopt mort» of the _briniples hg _dectara on Helens ' + Gtnisl Fimupls “andatying te Conduct sh "esearch: > Respeet Br _pesons £) Tuskice i pees ’ =) BeneReence Wok nik, bencht # Assessment: . z |research and clinical prachee eal > gives distinction between Clinical pi + Goats + Hethods © Risks : 0! Kk bout AH Te crample, Tn clintcat practice the physiumm did not a6 i : itl beneBite — pakgent. Choosing drags which witl x“8? Ethical Requirements: Cuniversat) © Collaborative fartnersh'p ® Souwal Value ® Scientibre Validity @ Law Subject Selection © Favourable Rick benefit rato © Avdependent Review @ Tehormed Consent ® Respect for Human Subjects W) Collaborative terineeshib - “4 do be ethital , clinical research must mole the: Community ia shich Rocce. > Ahis vequives : + Community © farkiulpation and twtegrating —retearch + Avwidenee of — Subplanding shanng — Nusarde een the Community, Collaborative partnerthi in Jlawning »- Conductrng and. overseeing research, vesuth inte tha health, System, evicting health care Gerices » aod the 3 techawism to acheeve may — nelude the Date of?+ Community Advisory Board Rahent Advocates on Setenhifte Advicorg boards + Advocates for Funding of research. | Cat) Soeral value ~ 3 Aw __be ‘athical » Clenreal research muck lead to improvements in heath ov sdvercement tn generalize Knowledge = hust Grsider how the research vill improve health of» + Hhe _parktipanh in “the _reseaeth «Fhe Communsty in __uhich _research _is Guducted + the World a Valutetess research includes ! . Non -generaliea bl Studies |" He too” shutter (doa net need adathinal shed) + Non -diccemmated —vesearch Cit) _Serentifire Malidithy - 3 _Revearch _ metct tee __Gouducted dr 2 methedalgg tally "ovary _ | manner thet _prachca tly Reacible To te ethreat the research must” produce _reliatle andl Valid data that (an _be _interbreted, > Tnvatid _veseareh Includes _underbovered _Studver, shudser vith Viased__ewdpounts , inshumanh sor Stateteal ech ond chads est Cannot _evoll__ Suj\orontt__ Subjects. Civ) Fai. Subject Selection ~ = ‘the _Suienbilye objective the Ghd not Vulnerability ov Ipivilege =" should guide tnelusion Gritena tnd targeted Yofutabons.a Lowering risk and tubancing — generabaabitity Can then be Considerey 7 Convenrent groups Cine, children i Mapita() theald wot be Selected Gey te ed Get ee & A Maghe nsie a rere reason Gheukd exclude Cera rouse. Should not Select nich, polthically fowerPul or othenrse bell Commected Yeap for “ promising restarch”” shades Cv) Favorable Risk -benefit Retro - Catreace mk med edge) A_stely Evaluation + CD Bike tdenhfred , Assessed and Hinimrted © Risks tnclude! > physical - death, Aisabiltly , infechon > peyeholognal - depeenion and annreby + Soal - diserminatn > Economic - Tob loss» + Gratuate magnitude 4+ Liteetthood of harm, . Tdentty methanisms +e minimize risk, Roberta benekib) Ab | Tediveduale fartinpan bs ehemced ” 3 Consider aysteal + Yeyetolagral 1 Social 4 eton ome bench tthe \natuiduels. 2 Constder only endlity hem wenearth fakervertits mat bench Som added heath Serviter or” Feyment Ahad ate wot hecessamy te the research geal. * ® sk yotentel bene + sh. individual ouboe’g h wh bt jadividuat then proceed. ie Kh omske hey ee eeAgainst Sout bene® ok foouledge pened vid Tadebendent Revigus Because investigators have _mulirpte _legikiwale interests thew have Fotembial _Conflihy _*]_ intevent. Lndebindent Revr'ers the ach minimize the Conflicts. 1 _Tndebencent_ Review ako _asiures Soucy it will not bene Rit fon abuse 40 Subjects, Cutt) tnformed Consent ~ > Informed _Goncent _ewsures individuals deurde _ vhether thea envell im research ancl __chether research fits with hei oun Values, inkeresbs avd geels. i > Tr _dhose who Canna _Gansent_- Such et _childvtn aud mentally impatred = must enstre dhat research Abs beth their interest Cle, Surogate decision makers’) dL Informed Consent Consists of 4 Elements : Ue) Competence of the Subject 2) Disclosure of informabion fo the Subject: ' ) Understanding or Conbchensiom by dhe Subjed. S) “Woluntavines of the decision ! > Federal Requialvans reduire € elements | to be _iweluded "in 7 every _infomded Consent form, f }) purpose + duration ob perbispetion 5) Confidentiality of Retords + 2) Ricks = 89) Gomer tbe fay Injures, fe 3) Atternalives : 3) Yerion’ do Contact for _aniwers i 4) Bowkts Ne duerbied + t ft ¥) Volunlanines and wht to Withdraw. &(vit) Respect for Numen Subjects - 2 the ethical requirements ok, Research do oct eA a a Consent — datumments, Ahey also include : 3) Monitoring Subjects velkers 2) protecting Confidenbialg DS Yemnittng — withebaul \) Rrouldmg Neo teformahion 5) Informog — Subjecb what, was, leamecl fom — the Research. 3 Thee B ne Sinple Formula to resolve Comflicks + Adjust design te meek the. muvements . Ahi 6 Semebime —ermed “ng oor Taegan 7 te pra