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﻿ZWINE VHA TEA U ZWI IVHA
﻿MUSI VHA TSHI KHOU HUMBULA U SHELA
﻿MULENZHE KHA U LAFHA HA U LINGEDZA
﻿SA MUTHU A NO KHOU ITA HOISISO
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﻿HANGULE 2001
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﻿MVULATSWINGO NA DZINDIVHUWO
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﻿Kubugwana uku kwo fara mafhungo nga u angaredza a u lafha ha u lingedza (clinical trials).  Mafhungo o teaho a u lafha ha u lingedza hune vha khou humbula u shela mulenzhe khaho kana hune vha khou kungiwa uri vha shele mulenzhe khaho vha o a ewa na u wana kha vhaoisisi vha u lingedza.
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﻿Kubugwana uku kwo bveledzwa nga thuso na u tikedzwa nga vhaivhi na mirao i bvaho kha dzikomiti dzo fhambanaho.  Thikedzo yo dovha ya itiwa nga vhaofisiri vha Muhasho wa Mutakalo nga maana vha Sisieme dza hoisiso dza Mutakalo (Health Systems Research), Reasearch Cordination and Epidemiology na Ndangulo ya Mishonga (Medicines Administration).
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﻿Kubugwana uku kwo shumisa zwiko zwa vhalaho zwine zwa angaredza:
﻿* Muhasho wa Mutakalo (2000) Guidelines for Good Practice in the conduct of Clinical Trails in Human Participants in South Africa;
﻿* Muhasho wa Mutakalo (2000) Ethical Consideration for HIV/AIDS and Epidemiological Research;
﻿* Muhasho wa pfunzo (2001) Draft Ethics in Heath Research: Principles, Structures and Processes.
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﻿Thimu yo walaho: South Africa Clinical Trials Guidelines
﻿Dr H Rees, Dr P Onyebujoh, Dr W Banneberg, Mrs Matsoso, Dr I Franz, Dr NE Khomo, Dr L Makubalo, Ms E Dartnall, Mr N Ntuli na Ms P etshidzivhani
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﻿Thimu yo walaho: Ethical Guidelines for HIV Research
﻿Dr H Rees, Mrs Barret-Grant, Prof SR Benatar, Dr DM Allen, Dr G Gray, Dr C Evian, Prof S Schoub, Dr G Maartens, Dr G Neilson, Dr U Jentch na Dr I Sanne
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﻿Mirao ya Khomiti ya Minisia kha Maitele a hoisiso dza Mutakalo vho nangwaho u bva nga Fulwi 2000;
﻿Prof SR Benatar (Chair), Prof LE Mazwai (Deputy Chair), Ms D Biyela, Ms Prinsloo, Dr LE Makubalo, Prof H Rees, Ms P Matsoso, Dr P Mahlathi, Prof YK Seedat, Prof TJ Mariba, Prof D du Toit, Ms M Dioke, Prof S Clow, Dr W Bannenberg, Dr S Cooper, Ms K evhualu, Prof OBW Greeff, Prof C Ijsselmuiden, Dr Hlogwane na Prof L London
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﻿NAA U LAFHA HA U LINGEDZA NDI MINI?
﻿U lafha ha u lingedza ndi gudo ya hoisiso kana u sedzulusa ho livhiswaho kha u linga tsireledzo, vhuimo ha nha, u shuma zwavhui na u bveledza zwibveledzwa zwo teaho kana mishonga miswa kana ine ya vha hone kana nila dza u lafha dzo fhambanaho, hu tshi khou shumiswa vhathu.
﻿?	Tsireledzo zwi amba zwauri dzilafho kana mushonga u nga vha u na khombo kana u nga   vhaisa kana wa si vhaise mutakalo wa muthu
﻿?	U shuma zwavhui zwi amba zwauri u nga shuma zwavhui kana wa si shume zwavhui kha u wana vhulwadze, u lafha, u thivhela kana u lafha tshiimo tsha vhulwadze.  Hezwi zwi nga angaredza u vhambedza kushumele kwavhui vhukati ha mishonga mivhili kana mishonga minzhi kana nila dza u lafha.
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﻿?	U bveledza zwibveledzwa zwo teaho zwi amba zwauri zwi nga vha zwi si khwine kana zwi khwine musi hu tshi vhambedzwa dziwe nila dza u lafha kana mushonga kha vhuimo vhu fanaho
﻿?	Vhuimo ha nha zwi amba zwohe zwavhui zwine mushonga wa vha wo ita zwone, kana kushumisele kwa mushonga kune kwa tendela uri ku shumiswe u ya nga pulane yo lavhelelwaho kha tshifhinga tshiwe na tshiwe nga fhasi ha vhuimo ho teaho sa zwe zwa lavhelelwa kha maitele a u lafha mulwadze onoyo, hu si na u vhaisa mushumisi wawo.
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﻿Ipfi a ?mushonga? i angaredza mishonga ine ya shumiswa kha u lafha malwadze (therapeutic medicines), u thivhela malwadze (prophylatic medicines), sa tsumbo u haela kana u thavhela, na mishonga ine ya shumiswa kha hoisiso dza tshipeshala (diagonistic medicines ) sa tsumbo, mishonga ine ya shumiswa musi hu tshi dzhiiwa X reyi uri hu vhoniwe tshifanyiso tsha tshwio.
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﻿Vhuimo ha u lafha ha u lingedza
﻿Phana ha musi hu tshi edzisiwa mushonga muswa kha muthu, u vha wo gudiwa nga maana tshifhinga tshilapfu aborithari na kha zwifuwo zwo fhambanaho hu tshi khou itelwa u wana tsireledzo na kushumele kwawo.  U lingedza ha u sedzulusa zwidzidzivhadzi zwiswa, mihayo na mishonga kha vhathu hu anzela u tevhela vhuimo ho buliwaho afho fhasi.
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﻿Vhuimo ha 1: Hovhu ndi vhuimo ha u thoma vhune tshidzidzivhadzi tshiswa, muhayo kana mushonga zwi a  lingedzwa lwa u tou thoma kha tshigwada tshiuku tsha vhathu vha re na mutakalo wavhui.  U lafha ha u lingedza kha Vhuimo ha 1 ndivho yaho ndi ya u wana tsireledzo nga u angaredza, kushumisele kwa teaho na mvelele dzine dza si oee kha tshidzidzivhadzi tshiswa, muhayo kana mushonga.
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﻿Vhuimo ha II: Kha vhuimo ha II u lafha ha u lingedza nga tshidzidzivhadzi tshiswa, muhayo kana mushonga zwi a lingedzwa kha tshigwada tsha vhathu vhanzhi vha swikaho maana na maana vha na mutakalo wavhui hu tshi angaredzwa na vhathu vha re na vhulwadze vhane tshidzidzivhadzi tshiswa, muhayo na mushonga zwa khou itelwa vhone.  Ndivho ya vhuimo ha II kha u lafha ha u lingedza ndi ya u isa phana na u linga tsireledzo na kushumele kwa tshidzidzivhadzi tshiswa, muhayo na mushonga.
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﻿Vhuimo ha III: Kha vhuimo uhu, tshidzidzivhadzi tshiswa, muhayo kana mushonga zwi a lingedzwa kha tshigwada tsha vhathu vha swikaho maana na maana u swika kha vha tshigidi vhane vha vha na dwadze ine tshidzidzivhadzi tshiswa, muhayo na mushonga zwa khou itelwa one.  Ndivho ya u lingedza ya vhuimo ha III ndi u isa phana na u linga kushumele na zwithu zwine zwa nga bvelela zwi songo lavhelelwaho na u vhambedza vhukati ha tshishumisa tshiswa, muhayo na mushonga, kana dziwe nila dzine dza vha hone dza u lafha.
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﻿Vhuimo ha IV: U lafha ha u lingedza kha vhuimo uhu hu itiwa nga murahu ha musi tshidzidzivhadzi tshiswa, muhayo na mushonga zwo no waliswa nga Khoro ya u Langula Mishonga (MCC), nga mawe maipfi, nga murahu ha musi tshidzidzivhadzi tshiswa, muhayo kana mushonga zwo no waliwa na u fhiwa thendelo ya u rengiswa.  U lafha ha u lingedza kha Vhuimo ha IV ndi u isa phana na u linga tshidzidzivhadzi tshiswa, muhayo kana mushonga nga maana kha vhathu vha swikaho zwigidi zwo vhalaho kha:
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﻿* u alutshedza tsireledzo yawo, kushumele, mvelele dzi sa oeiho dza tshifhinga tshilapfu,
﻿* u edzisa tshidzidzivhadzi tshiswa, muhayo kana mushonga kha sekitha dziwe dza vhuimo ha khombo kha vhathu u fana na kha vhana, vhaaluwa, vhathu vhane vha vha na vhulwadze ha tshivhindi na ha tshwio, na
﻿* u wana kushumele kuswa (tsumbedzo) kwa tshidzidzivhadzi tshiswa, muhayo kana mushonga.
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﻿Vhuimo vhuwe na vhuwe vhu na mushumo wo teaho na khonadzeo ya u vhuedza, khombo na u tshinyadza zwi nga fhambana zwi tshi ya nga vhuimo vhuwe na vhuwe.
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﻿Zwiwo zwa ndeme zwi si zwavhui (Serious Adverse Events (SAEs))
﻿Kha vhuimo hohe ha u lingedza, vhathu vhane vha shela mulenzhe kha hoisiso vha a vhewa io kha zwiwo zwi si zwavhui.  Zwiwo zwi si zwavhui ndi tshithu tshiwe na tshiwe tshi si tsha vhui na tsumbo dzi songo lavhelelwaho, kana vhulwadze ho bveledzwaho nga mushonga kana nga dzilafho ine a khou gudiwa.  Musi zwiwo zwi si zwavhui zwo i fha maana kana zwi tshi khou endelela, zwi nga:-
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﻿?	bveledza lufu,
﻿?	thithisa vhutshilo,
﻿?	oa dzilafho a vhuongeloni,
﻿?	oa dzilafho a vhuongeloni a tshifhinga tshilapfu,
﻿?	fhedza zwo kunda kana u holefhala tshohe,
﻿?	thivhela mbebo,
﻿?	bveledza lufu kha wana ane a khou lavhelelwa nge mme  awe a dzhenela gudo ya dzilafho kana mushonga musi o vhifha muvhilini.
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﻿Mawe mathemo ane a shumiswa nga maana kha u lafha ha u lingedza
﻿Tshidzidzivhadzi tsha iedza ndi tshidzidzivhadzi tshiswa kana mushonga une wa kha i bva u tumbulwa une wa kha i bveledzwa.
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﻿Tshitshidzivhadzi tshi re maragani ndi mushonga wo no waliswaho kha vhalanguli vha MCC uri u shumiswe kha malwadze o teaho.  Mushonga uyu u vha wo no fhira vhuimo ha u bveledzwa nahone vhui hawo, tsireledzo na kushumele kwawo zwi vho ivhea.  Zwidzidzivhadzi zwi re maragani zwi dovha zwa ambelwa kha zwidzidzivhadzi zwi na iwalo a thendelo kana zwidzidzivhadzi zwo waliswaho.
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﻿Tshibveledzwa tshi re fhasi ha tsedzuluso ndi mushonga kana muhayo une vhui hawo, tsireledzo kana kushumele zwa vha zwi tshi khou lingiwa kha u linga ha tshipeshala ha lafha ha u lingedza.  Hu nga i vha na tshibveledzwa tshi fhiraho tshithihi kha u lafha ha u lingedza. Zwibveledzwa zwi re fhasi ha tsedzuluso zwi nga vha mishonga kana mihayo yo waliswaho kana i songo waliswaho,.  Mawe mathemo ane a shumiswa ndi gudo ya tshidzidzivhadzi, gudo ya mushonga, tshidzidzivhadzi tsha u linga kana mushonga na tshibveledzwa tsha u linga.
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﻿Muthusi (Sponsor) ndi muthu muwe na muwe, khamphani, tshivhumbeo kana dzangano ine a dzhia vhuifhinduleli kha u thoma, ndangulo na u lambedza u lafha ha u lingedza.  Vhathusi kanzhi vha anzela u vha mamaga a zwibveledzwa zwa mishonga, muvhuso, zwivhumbeo zwa dzihoisiso, Dzangano a Mutakalo a ifhasi (World Health Organisation (WHO)), mivhuso ya kha mawe mashango, na zwiwe.
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﻿Muoisisi ndi muthu a re na pfunzo yo teaho ane a vha na vhuifhinduleli ha u vhumba, u tshimbidza, u sengulusa kana u fha muvhigo nga u lafha ha u lingedza ho teaho.  Vhaoisisi vha anzela u shuma sa thimu.  Murangaphana wa thimu u vhidzwa hoho ya hoisiso (Principal Investigator (PI). hoho ya hoisiso u na vhuifhinduleli kha muthusi na vhalanguli.  Vhaoisisi vha nga i vha madokotela, dokotela wa mao, ese, muvhali wa vhathu, rasaintsi wa mishonga, ramishonga, vhaphurofeshinala vha mutakalo wa vhuluvhi, kana murao wa phurofesheni ya u thusa madokotela (paramedical professions) na vhawe.
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﻿NAA VHUIFHINDULELI HA MISHONGA NA KHORO YA U LANGULA NDI VHUFHIO?
﻿Khoro ya u Langula Mishonga (Medicines Control Council (MCC)) ndi tshivhumbeo tsha kha ino shango tshine tsha anga kushumele kwa u lafha ha u lingedza na u waliswa ha mishonga na tshumelo dza mishonga uri dzi shumiswe kha malwadzwe o teaho.  Khoro ya u Langula Mishonga (MCC) i na vhuifhinduleli ha u vhona zwauri u linga hohe ha u lafha ha u lingedza ha mishongo yohe i songo waliswaho na tsumbo ntswa ya mishonga yo waliswaho i tevhedze hoea dzo teaho dza u tsireledza, vhui na kushumele kwo teaho.
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﻿Khumbelo dza u lafha ha u lingedza na dza u waliswa ha mishonga na tshumelo dza mishonga dzi sedzuluswa nga khoro ya vhaivhi ya u Langula Mishonga ine ya sedza tshiimo tsha saintsi, mishonga na  mafhungo a yelanaho na milayo kha khumbelo.  Muvhigo wa mvelaphana ya gudo u rumelwa tshifhinga tshohe kha Khoro ya u Langula Mishonga.  Tsumbo ya tsireledzo, vhui na mvelele dzo lavhelewaho zwi fanela u ekedzwa musi hu tshi itiwa khumbelo kha Khoro ya u Langula Mishonga uri hu wanale thendelo na u waliswa ha mushonga uri u shumiswe kha a Afurika Tshipembe.
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﻿MUTHUSI NA VHASEDZULUSI VHOHE VHA NA VHUIFHINDULELI HA U FHA MUVHIGO WA ZWIWO ZWI SI ZWAVHUI HU SAATHU U FHELA AWARA DZA 24 KHA ZWIVHUMBEO ZWO TEAHO HU TSHI ANGAREDZA KHORO YA U LANGULA MISHONGA NA KOMITI DZA MAITELE
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﻿NAA PFANELO DZAVHO DZA MULAYOTEWA NDI DZIFHIO?
﻿Muthu muwe na muwe ane a humbula u shela mulenzhe kana we a vhuya a shela mulenzhe sa muoisisi kha u lafha ha u lingedza u na pfanelo ya u ivhadzwa.  Mulayotewa wa Riphabuliki ya Afurika Tshipembe Mulayo wa 108 wa 1996: Tshipia tsha 12 (2) u ri ?Muthu muwe na muwe u na pfanelo na tshirunzi tsha muvhili na mihumbulo zwi tshi katela na pfanelo - (c) a nga si shumiswe kha maedza a zwa mushonga kana zwa saintsi hu si na thendelo yo tikwaho nga ndivho ya muthu onoyo?.
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﻿U LAFHA HA U LINGEDZA HUNE HA ITIWA HU SI NA THENDELO YO TIKWAHO NGA NIVHO YA ONOYO MUTHU KANA VHATHU VHANE VHA KHOU IMELA UYO MUTHU A HU HO MULAYONI, A HO NGO TENDELWA NA U VHA YA TSHISAINTSI.
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﻿Na thendelo yo tikwaho nga nivho ya muthu onoyo ndi mini?
﻿Thendelo yo tikwaho nga nivho ya muthu onoyo ndi maitele ane khao muthu ane a khou shela mulenzhe a guda hoea dza ndeme dza u linga ha u ilafha honoho uri a kone a humbula uri a nga kona naa u bvela phana na u shela mulenzhe kana a nga si kone kha u lafha ha u lingedza honoho.  Thendelo yo tikwaho nga nivho ya muthu onoyo i fhira u saina fomo ya u fha tendelo nahone a si koniraka, fhedzi i vhumba mutheo wa thendelo ya muthu muwe na muwe wa uri a shele mulenzhe kha u linga hohe.
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﻿SA MUOISISI A NA VHUKONI KANA MUTHU ANE A KHOU SHELA MULENZHE KHA U LAFHA HA U LINGEDZA, vha fanela u ivha zwauri:
﻿?	thendelo yo tikwaho nga nivho ya muthu onoyo ndi hoea ya ndeme kha maitele na kha  hoea dza saintsi.  Hezwi zwi amba zwauri pfanelo dzavho, tshirunzi na vhutshilo havho sa muthu ane a khou shela mulenzhe kha hoisiso zwi tea uri zwi tsireledziwe tshifhinga tshohe na u iswa phana na nga murahu ha musi hu tshi itiwa hoisiso;
﻿?	vha fanela u wana mafhungo ohe a ndeme phana ha musi vha tshi humbulo u shela mulenzhe;
﻿?	mafhungo a fanela u fhiwa nga nila i pfalaho nahone i re khangala nga u shumisa luambo lwavho.  Ndi zwa ndeme u pfesesa na u vhudzisa mbudziso;
﻿?	muhumbulo wavho wa u shela mulenzhe u fanela u vha u songo tou kombetshedzwa, wo uuwedziwa lwo kalulaho kana wo itiswa nga malamba.  Vha nga si waniwe mulandu arali vha nga hana u shela mulenzhe;
﻿?	thendelo yo tikwaho nga nivho ya muthu onoyo i nga vha yo tou waliwaho kana ya mulomo;
﻿?	thendelo yo tikwaho nga nivho ya muthu onoyo i fanela u fhiwa yo tou waliwa, ya u tenda uri hu vhe na u lavheleswa ha rekhode yavho ya mutakalo kha mafhungo ane a yelana na u linga na u sedzulusa, tsedzuluso nga komiti ya mulayo na tsedzuluso ya u laula;
﻿?	vho tendelwa u i bvisa kha u shela mulenzhe kha u lafha ha u lingedza tshifhinga tshiwe na tshiwe;
﻿?	arali vha nga i bvisa kha u lafha ha u lingedza, hezwi a zwi nga kwami vhuimo ha tsireledzo ine ya vha hone.
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﻿Mafhungo a Ndeme a Thendelo yo Tikwaho nga Nivho ya muthu ononoyo
﻿Sa muthu ane a khou shela mulenzhe vha na pfanelo ya u ivha:-
﻿?	ndivho ya u lafha ha u lingedza;
﻿?	u lafha ha u lingedza hune ha o itiwa na mushumo une wa o itiwa kha u lafha huwe na huwe;
﻿?	ngona na maitele ane a o tevhelwa kana u shumiswa;
﻿?	dziwe nila dza u shela mulenzhe kha hoisiso;
﻿?	zwine vha nga vhuelwa ngazwo sa muthu ane a khou shela mulenzhe na vhawe vhathu;
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﻿?	tshiimo tsha tshiphiri tshine tsha o tevhelwa;
﻿?	u vha hone ha ndindakhombo ya u huvhala kana u vhaisala musi vha tshi khou shela mulenzhe kha u lafha ha u lingedza;
﻿?	muthu ane a nga kwamiwa musi hu na tshiwo tsha u huvhala tshine tsha nga bvelela kha u lafha ha u lingedza;
﻿?	malamba ane a fhiwa kha u shela mulenzhe.  U fhambana huwe na huwe kha kubadelele hu fanela u alutshedziwa;
﻿?	u vha hone ha dzilafho nga murahu ha u lafha ha u lingedza;
﻿?	muthusi na khuano ine ya nga vha hone;
﻿?	thendelo i bvaho kha khoro ya maitele.
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﻿Kha zwo buliwaho afho nha zwi tou vha khagala zwauri vhathu vhohe, vhane vha kona u fha thendelo yo tikwaho nga nivho ya muthu onoyo kana vhane ha nga kona u waniwa thendelo yo tikedzwaho khavho, vha nga kona u shela mulenzhe kha u lafha ha u lingedza.  U shela mulenzhe hu thoma kha wana a saathu u bebiwaho u swika kha mualuwa, vhanna na vhafumakadzi, muthu a na mutakalo wavhui na ane a khou lwala vhukuma, muthu a tshilaho na o faho (vhana na vhaaluwa).
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﻿Ndi zwa ndeme u humbula zwauri vha nga shela mulenzhe tshohe kana nga nha kha u lafha ha u lingedza nga u tenda uri hu shumiswe mafhungo a u lafha ane a wanala kha muvhigo wa dzilafho avho wa kale kana wa zwino une wa wanala kha muthu ane a khou vha fha dzilafho io.
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﻿Maga ane a sumbedza uri naa muthu muwe na muwe o tendelwa u shela mulenzhe kha u lafha ha u lingedza honoho a vhidzwa u pfi ndi hoea, ngeno ayo ane a hana uri muthu a shele mulenzhe kha u lafha ha u lingedza honoho a tshi vhidzwa u pfi ndi hoea dza u sa tendelwa.
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﻿hoea dza u tendelwa na dza u sa tendelwa dzi na ndeme nga maana, dzo itelwa u tsireledza vhathu vhane vha shela mulenzhe kha u lafha ha u lingedza na u vhona uri nivho dza u linga dzi a swikelelwa hu si na zwithithisi zwi sa ri tshithu.
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﻿NDI ZWIFHIO ZWINE KHORO YA KUSHEMELE YA ITA ZWONE U VHONA ZWAURI PFANELO DZAVHO, TSHIRUNZI NA MUTAKALO WAVHO ZWO TSIRELEDZWA?
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﻿Maga a u lafha ha u lingedza kha a Afurika Tshipembe a oa zwauri nila ya u tshimbidza mafhungo na mawe mawalo a ndeme a u kumedzwa ha u lafha ha u lingedza a tea u sedzuluswa nga khoro ya kushumele ine ya tevhela vhuimo ho vhewaho nga Khoro ya Lushaka ya Maitele kwa hoisiso dza Mutakalo (National Health Research Ethics Council).  Ndivho ya tsedzuluso ya maitele ndi ya u vhona uri hu vhe na tsireledzo kha vhathu vhane vha o kona u shela mulenzhe kha hoisiso.  Ndi u lingedza ho tendelwaho nga dzikomiti dza maitele hune hu nga itiwa kha a Afurika Tshipembe.
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﻿Khomiti dza maitele dzi dzhiela nha zwi tevhelaho musi dzi tshi sezulusa makumedzwa a u lafha ha u lingedza:-
﻿-	u tea ha gudo hu yelanaho na saintsi
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﻿-	u tea ha vhasedzulusi zwi tshi ya nga ndalukanyo dzavho, u wanala, na tshenzhemo
﻿-	u tea ha huhuwedzo ya u guda
﻿-	u tea ha khumbelo ya u guda zwi tshi ya nga ndivho dza u guda
﻿-	u tea ha vhathu vha u guda arali vhe tshigwada tsha vhathu vho huvhalaho na uri ho dzhiiwa naa maga a u vha tsireledza
﻿-	U tea ha tshivhala tsha vhathu tsha vhathu vhane vha o oiwa uri vha shela mulenzhe
﻿-	U dzhielwa nha ha mbuelo ya u huvhala nga nna ha tshifhinga tsha u guda nga tsedzuluso ya mbuelo ya khombo
﻿-	arali hu tshi o shumiswa mishonga i si ya vhukuma (dummy treatment), kushumele kwayo ku vhe ku tshi tendelwa
﻿-	arali nga u shela mulenzhe havho kha u alafha ha u edzisa, vhathu vha no shela mulenzhe na vhawe-vho a vho nga o thivhelwa tshifhinga tsha u wana dzilafho kha tshiafu tsha u lafha, kha hoisiso, kha zwishumiswa kana kha matshimbidzele
﻿-	mafhungo a vhui nahone o fhelelaho ane a o fhiwa vhathu vhane vha o shela mulenzhe, mashaka avho, vhaundi na vhaimeleli vhavho vha mulayo
﻿-	uri vhathu vhane vha khou shela mulenzhe na vhaimeleleli vhavho vha khou fhiwa tshifhinga tsho teaho tsha u lavhelesa mafhungo ohe phana ha musi hu tshi oiwa thendelo yo tikwaho nga nivho
﻿-	u tea ha mafhungo a re kha khungedzelo na u ivhadza vhathu ane vha o shumiswa kha u kunga vhathu vhane vha o shela mulenzhe
﻿-	U tsireledzea ha pfanelo dza vhathu vha no khou shela mulenzhe kha gudo
﻿-	mbetshelwa ya ndivhuwo kana dzilafho arali ha nga vha na u huvhala kana lufu lwa muthu a no khou shela mulenzhe lwo vhangwaho nga u lafha ha u lingedza
﻿-	tshiimo tshine vhathu vhane vha khou ita hoisiso na vhane vha khou shela mulenzhe vha o badeliswa zwone
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﻿Maga a u lafha ha u lingedza kha a Afurika Tshipembe a oa uri khoro ya maitele i dzhiele nzhele tshiwe tshigwada tsha vhathu hu tshi angaredziwa vhana; vhaswa; vhafumakadzi vho vhifhaho muvhilini; zwivhotshwa; vhathu vho holefhalaho; vhathu vho thithiseaho mihumbulo; zwitshavha zwo tshinyalaho; vhathu vha lwalaho vhukuma; vhaaluwa; zwigwada zwiuku zwa vhathu na vhashumi.
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﻿Zwiwe zwa zwivhuya zwa u shela mulenzhe kha u lafha ha u lingedza
﻿U lafha ha u lingedza hu itiwa ndivho i nthihi ya u edzisa mushonga, kushumele kwa mushonga na u dzilafho ine a o itwa uri i vhe hone kha mutakalo wa vhathu.  Nga u shela mulenzhe kha u lingedza:-
﻿* Vha nga vha vha tshi khou thusa kha hoisiso dza mishonga na u bvelaphana ha ndondolo ya mutakalo nga u angaredza na u dovha vha thusa vhawe vhathu
﻿* Vha nga kona u dzhenele kha nila ntswa dza u lafha dzi saathu u vha hone kha tshitshavha tshohe tshifhingani tsha u lafha ha u edzisa
﻿* Vha nga kona u wana dzilafho a mishonga mahala
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﻿U shela mulenzhe kha u lafha ha u lingedza a si nila ya u ita tshelede kana ya u engedzedza malamba; fhedzi vhathusi vhohe vha badela vhathu vhohe vhane vha shela mulenzhe kha u lafha ha u lingedza kha mbadelo tshohe dzi yelanaho na u shela mulenzhe kha u lafha ha u lingedza, hu tshi angaredziwa tshelede ya zwinamelwa, zwiiwa, dzilafho a mishonga na mbadelo ya zwiwo zwine zwa vhonala nahone zwi na ndindakhombo zwine zwa yelana na u lafha ha u edzisa.
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﻿Zwiwe zwa zwivhi zwa u shela mulenzhe kha u lafha ha u edzisa
﻿Hu nga vha hu na zwiwe zwiwo zwa ndeme zwi si zwavhui (Serious Adverse Events (SAEs)) zwi yelanaho na mishonga yo shumiswaho kana maitele ane a itiwa kha u lafha ha u edzisa; fhedzi u shela mulenzhe kha u guda hu langiwa zwavhui uri zwiwo zwa ndeme zwi si zwavhui zwi kone u avhanya u vhonala na u langulwa nga nila yo teaho.  Hu dovha ha vha na ndindakhombo ya zwiwo zwa ndeme zwi si zwavhui, u itelwaho zwauri vhathu vhane vha khou shela mulenzhe vha kone u lambedzwa nga nila yo teaho.  Mishonga, mihayo, nila dza kulafhele kune kwa shumiswa kha u edzisa ku nga i vha ku sa shumi zwavhui kha vhulwadze havho, ngauraho, hu na maitele a u tsireledza a u itela uri vhathu avho vhane vha khou shela mulenzhe vha sa vhuelwi nga dziwe nila dza u laula dza mishonga ya u lingedza vha nga iswa kha iwe nila ya u lafha ine ya vha hone nga u avhanya kana magumoni a u edzisa.  Maga a u linga a nga oa uri hu vhe na u dzudzanywa ha tshiwe kana zwithu zwinzhi kha vhutshilo havho sa tsumbo;
﻿* vha nga oa u vhetshela thungo tshifhinga tsha zwithu zwi yelanaho na u edzisa u fana na u dalela fhethu ha edzisa
﻿* vha nga i litsha u shumisa miwe mishonga hu tshi katelwa na mishonga ya tshirema vha songo thoma vha wana tendelo i bvaho kha dokotela wavho ane vha khou shumisana nae kha u lingedza
﻿* vhutshilo havho kana kutshilele kwavho ku nga kwamea, sa tsumbo; kha zwa vhunzekani,  mbembo, u nwa halwa, u daha fola na kushumisele kwo kalulaho kwa zwidzidzivhadzi, na zwiwe
﻿* vha nga tea u kwamana na munekedzi wa dzilafho kha malwadze ohe ane a si kwamane na u lingedza, fhedzi vha tea u ivhadza muthu ane a khou vha lafha zwauri vha muwe wa vhathu vhane vha khou edzisa na zwauri miwe mishonga kana dziwe nila dza u lafha a dzi yelani na maitele avho a u linga.
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﻿Mutholi wavho, tshikwama tsha thuso ya mishonga, ndindakhombo yavho vhone vhane kana Khomishinari wa Ndifhelo ya Mafuvhalo a Mushumoni (Commissioner for Compensation for Occupational Injuries) vha nga si badele u vhilwa hune ha si yelane na zwiwo zwo bveledzwaho nga u shela havho mulenzhe kha u lafha ha u lingedza; ngauralo ndi zwa ndeme nga maana zwauri vha sedzuluse zwauri muthusi u na ndifhelo yo teaho ya ndindakhombo ya u vha linda.
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﻿Ngauralo ndi zwa ndeme zwauri vha fare nyambedzano na vha mua wavho nga ha u shela mulenzhe havho kha u lafha ha u edzisa na vhohe avho vhane vha nga kwamea phana ha musi vha tshi dzhenela u lingedza.
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﻿Ministerial Committee on Health Research Ethics
﻿c/o Heath Systems Research,
﻿Research Coordination and Epidemiolgy
﻿Department of Health
﻿Private Bag X828
﻿Pretoria
﻿0001
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﻿Phone:	012-312-0995
﻿Fax:		012-328-9381
﻿Email:	hrrce@health.gov.za
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﻿NOMBORO YA LUINGO YA U THUSA YA AIDS   0800-01023-22
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