﻿EKUFUZE UKWAZI NAWUTHATHA ISIQUNTO SOKUNGENELA IRHUBHULULO LOKULINGELELA IINHLAHLA ZOKWELAPHA






                 ( Emblem  as on the front page of the booklet ) 





                             UMNYANGO WEZAMAPHILO 





                                     ARHOSTOSI  2001 









                                             AMAGAMA WOKUVULA NOKUTHOKOZA 


Incwajana le iphethe ilwazi elimalungana nokulingelelwa kweenhlahla zokwelapha. Ilwazi elinqophene nehlelo lokulingelelwa kwenhlahla zokwelapha ofuna ukungena kilo namkha ofunelwa ukungena kilo litholakala ebaphenyeni ngalo ihlelo lokulingeleleli. 

Incwajana le ivezwe ngesizo lokubonisana nezazi namalungu wamakomidi ngamakomidi. Elinye ilwazi elingezelela lapha livela eemphathisweni zomNyango wezamaPhilo, khulu khulu ekorweni yezerhubhululo ngezamaphilo, i-Health Systems Research, nekorweni elungelela umsebenzi werhubhululo ngezokulawulwa kwehlelo lezifo ezimqedalizwe, i-Research Co-ordination and Epidemiology and Medicines Administration. 

Hlangana nemithombo esetjenziswe yincwajana le, kubalwa nale elandelako: 

* UmTlolo oyiKombandlela yesiko lokuziphatha nokuphathwa kwabantu ekulingelelwa ngabo iinhlahla zokwelapha -  i-Guidelines for  Good Practice in the conduct of Clinical Trials in Human Participants in South Africa --  womNyango wezamaPhilo  (2000);
*  UmTlolo womThethopatho wokuqalelela irhubhululo ngentumbantonga nangorhatjheka kwezifo ezimqedalizwe -  i-Ethical Consideration for HIV/AIDS and Epidemiological Research -- womNyango wezamaPhilo( 2000); 
*  UmTlamo womThethopatho ngeRhubhululo kezamaPhilo ? i-Draft Ethics in Health Research : Principles, Structures and Processes ? womNyango wezamaPhilo (2000). 


Abatloli bekombandlela yokulingelelwa kweenhlahla -- iSouth African Trials Guidelines :   

Dr H Rees, Dr P Onyebujoh, Dr W Bannenberg, Kosikazi P Matsotso, Dr I Franz, Dr NE Khomo, Dr L Makubalo, Mma E Dartnall, Nomzana N Ntuli kunye noMma P Netshidzivhani. 

Abatloli bekombandlela yomthethopatho  werhubhululo ngentumbantonga  -- i-Ethical Guidelines for  HIV Research:  

Dr H Rees, Mma K Barret-Grant, Prof. SR Benatar, Dr DM Allen, Dr G Gray, Dr C Evian, Prof. Schoub, Dr G Maartens, Dr G Neilson, Dr U Jentch kunye no Dr I Sanne. 



Amalungu weKomidi yaboNgqongqotjhe ngezomThethopatho kezeRhubhululo ngezamaPhilo ephiwe amandla ngoJuni 2000: 

Prof. SR Benatar ( uSihlalo ), Prof. LE Mazwai ( iSekela lakaSihlalo ) Mma D Biyela, Mma R Prinsloo, Dr LE Makubalo, Prof. H Rees, Mma P Matsotso, Dr P Mahlathi, Prof. YK Seedat, Prof, TJ Mariba, Prof. D du Toit, Mma M Dioke, Prof. S Clow, Dr W Bannenberg, Dr S Cooper, Mma K Nevhutalu, Prof. OBW Greef, Prof. C IJsselmuiden, Dr Hlongwane kunye noProf. L London.


KUYINI UKULINGELELWA KWEENHLAHLA ZOKWELAPHA 

Ukulingelelwa kwemithi yokwelapha kulirhubhululo elinqophe ukuhlola ukuthi isihlahla esitjha namkha esidala siphephe kangangani, nokuthi sihle kangangani, nokuthi siphumelela kangangani ukwenza umsebenzi esisetjenziselwa wona kunye nokuthi sinamandla kangangani  phezu komuntu esilingelelwa phezu kwakhe. Isihlahla-ke lapha kungatjho isihlahla ngokwaso, kungatjho isisetjenziswa sokwelapha, kungatjho indlela yokwelapha. 

* Ukuphepha kwesihlahla kutjho ukuhlukanisa ukuthi isihlahla esilingelelwa phezu komuntu loyo asinangozi na phezu komuntu esilingelelwa kuye.
* Ukuphumelela kwesihlahla kutjho ukuthi isihlahla leso siyaphumelela na ukuveza isifo esiphethe umuntu, nokuthi siyaphumelela na ukuselapha namkha ukusivimbela na. Lokhu-ke kungatjho nokulinganisa ukuthi iinhlahla ezimbili namkha ezingaphezu kwalokho ziphumelela kangangani ukwelapha isifo ezenzelwe sona. 
*  Amandla wesihlahla aveza ubungcono besihlahla ekwelapheni isifo nasilinganiswa nezinye iinhlahla zokwelapha sona leso sifo. 
*  Ubuhle besihlahla butjho ukuvuma kwesihlahla ukusetjenziswa isikhathi nanyana singaba side kangangani ngaphasi kobujamo obulungele ukusetjenziswa kwaso  ekulatjhweni kwesigulani, ngaphandle kokusilimaza isigulaneso.

Igama elithi  ? isihlahla ?  litjho iinhlahla nemitjhoga esetjenziselwa ukwelapha izifo, nesetjenziselwa ukuvimbela izifo ( njengemijovo nje ), neenhlahla ezisetjenziswa  ephenyweni elikhethekileko lokwelapha ( njengakuma-X-Ray wokuhlola iziso ). 

Iingaba zokulingelelwa kweenhlahla

Ngaphambi kobana isihlahla namkha isisetjenziswa sokwelapha silingelelwe emuntwini, sihlolwa sihlolisiswe isikhathi eside emalabhorathri neenyamazaneni, kobanyana kuzokuthonywa ngokuthola ntanzi ukuthi siphephe kangangani nokuthi siphumelela kangangani ukwenza lokho esenzelwe khona. 

Ukulingelelwa kweenhlahla ( ezitjha ), nemijovo kunye neensetjenziswa zokwelapha ebantwini kuvame ukukhanjiswa ngaleziindaba ezilandelako: 





Isigaba  1 
 
Lesi sigaba sokuthoma la isihlahla esitjha, umjovo omutjha namkha isisetjenziswa sokwelapha esitjha silingwa khona kokuthoma esiqhenyaneni sabantu; kuvamise ukuthi kube siqhenyana sabantu abaphile kuhle ekulingwa ngabo. Isigaba sokuthoma sokulingelelwa kwesihlahla sinqophe ukuthola ukuthi isihlahla siphephe kangangani, nokuthola ukuthi mthamo ongangani olungelwe ukusetjenziswa ngesikhathi esingangani, nokuthola ukuthi isihlahla leso asinangozi yokubangela eminye imiraro yangeqadi, nakube ikhona, kutholakale nokuthi miraro bani leyo.

Isigaba   11  

Esigabeni sesibili isihlahla esitjha esilingelelwako, umjovo omutjha olingelelwako namkha isisetjenziswa sokwelapha esitjha esilingelelwako kulingelelwa phezu kwesiqhema sabantu esikhudlwana kunesigabeni sokuthoma; kuvamise ukuba makhulu ambadlwana wabantu abaphilileko, nabantu esele sibangene isifo ekusalingelelwa isihlahla sokulwa naso. Umnqopho wesigaba (ii) kuhlola ukuya phambili ukuthi isihlahla, umjovo namkha isisetjenziswa sokwelapha kuphephe kangangani, nokuthi kuphumelela kangangani ukwenza lokho okufunelwa khona.  

Isigaba 111 

Kilesisigaba isihlahla esitjha, umjovo omutjha namkha isisetjenziswa sokwelapha esitjha 
kulingelelwa ebantwini abangaba makhulu ambadlwana ukuya eenkulungwaneni eziimbadlwana esele sibangene isifo. Umnqopho walesisigaba sesithathu sokulingelelwa kwesihlahla kuhlola ukuya phambili ukuthi isihlahla esitjha, umjovo omutjha namkha isisetjenziswa sokwelapha esitjha kuphumelela kangangani ukwenza umsebenzi ekufunelwa wona, nokuhlola ukuthi ziyibanga kangangani imingenela ngeqadi, kunye nokulinganisa amandla, nobuhle besihlahla esitjha, nomjovo omutjha namkha isisetjenziswa sokwelapha esitjha  nakulinganiswa neenhlahla ezidala ezitlolisiweko              ( enelayisense ). 

Isigaba 1V 

Kilesisigaba-ke ukulingelelwa kwenhlahla kwenziwa ngemva kobana isihlahla esitjha, umjovo omutjha namkha isisetjenziswa esitjha sesibhalisiwe emkhandlwini olawula iinhlahla zokwelapha ( i-MCC ) ukuthi isihlahla, umjovo namkha isisetjenziswa sokwelapheso singathengiswa.  Ukudlula lapho, isigaba (iv) sesilingelelo sesihlahla  sisebenza nokuhlola iinkulungwana eziimbadlwana zabantu : 

*  ukuthola ukuthi isihlahla siphephe kangangani, siphumelela kangangani ukwenza umsebenzaso, nokuhlola ukuthi siba namingenela miphi ngeqadi ngemva kwesikhathi eside;
*  nokuhlola isihlahla esitjha, umjovo omutjha kunye nesisetjenziswa sokwelapha ebantwini abathileko abavamise ukubanjwa kugula lula, njengabantwana, nabantu abadala abanezifo zesibindi nezeziso; 
* kunye nokuthola isihlahla esitjha, umjovo omutjha namkha isisetjenziswa sokwelapha esitjha ukuthi kungasetjenziselwani okhunye okutjha.

Esinye nesinye isigaba sinomnqopho waso, befuthi namandla wokusebenza kwesihlahla kunye nengozi yaso kuhlukahluka ngeengaba ngeengaba. 


Imingenela Emimbi 

Kizo zoke iingaba zokulingelelwa kweenhlahla, abantu ekulingelelwa ngabo beluswa ngelihlo elibukhali, kuqalwe ukuthi iinhlahla ezilingwa ngabo lezi kghani azinamingenela emimbi eziyibangako ngeqadi na. Imingenela emimbi kungaba matshwayo amambi angasimnqopho wesihlahla leso, namkha kube ngesinye isifo esibangwa kusebenzisa isihlahla leso. Nakufumaniseka ukuthi kunemingenela emimbi eba khona, i-: 

* ngambulala umuntu;
* ngabeka umuntu hlangana kokufa nokuphila;
* ngenza kufuneke umuntu alaliswe esibhedlela;
* ngenza umuntu kufuneke alale esibhedlela isikhathi eside;
* ngamqhwalisa namkha imrhwahlaphaze umuntu
* ngenza umntwana abelethwe aqhwalile;
* ingambulala umntwana unina othe asebantwini walingelelwa ngesihlahla esinemingenela loyo. 


Amagama avame ukusetjenziswa ekulingelelweni kweenhlahla

Isihlahla sokulingelela ( experimental drug )   sihlahla esitjha esisandukutholwa  namkha esakhiwako. 

Isihlahla esithengiswako  ( marketed drug )  sihlahla esele sitlolisiwe emkhandlwini olawula iinhlahla zokwelapha ( i-MCC ), esizokwelapha izifo ezithileko. Lesi sihlahla esele sidlulile esigabeni sokwakhiwa, futhi nobuhle baso nokuphumelela kwaso sekuyaziwa. Iinhlahla ezithengiswako zibizwa nangokuthi ziinhlahla ezitlolisiweko namkha ezinelayisense. 

Isihlahla esisaphenywako  ( investigational product )  sihlahla/umjovo/isisetjenziswa sokwelapha  esisahlolwako ehlelweni elithileko lokulingelelwa kweenhlahla ukuthi zihle kangangani ngomsebenzaso, nokuthi ziphephe kangangani kunye nokuthi zinamandla kangangani.  Kungaba neenhlahla ezidlulako kesisodwa ehlelweni linye lokulingelela iinhlahla. Isihlahla esisaphenywako singaba sihlahla esitlolisiweko namkha esingakatloliswa, umjovo otlolisiweko namkha ongakatloliswa, isisetjenziswa sokwelapha esitlolisiweko namkha esingakatloliswa. Amanye amagama asetjenziswako ngila: isihlahla sokufunda ( study drug/medicine), isihlahla esisalingwako ( trial drug/medicine/product ).


Umsekeli  (sponsor)  mumuntu, ikhamphani namkha ihlangano ezithwesa umthwalo wokuthatha igadango lokuthoma, nokuphatha kunye nokusekela ihlelo lokulingelelwa kwenhlahla ngeemali. Abasekeli bavamise ukuba babantu abakha iinhlahla zabosokhemisi, aborhulumende, iinhlangano zerhubhululo, iHlangano yezamaPhilo yePhasi ( i-WHO ), aborhulumende bamazwe wangaphandle, njalo njalo. 

Umphenyi   ( investigator )  mumuntu ofundisiweko othwele umsebenzi wokutlama, nokwenza, nokucozulula kunye nokubika ngesilingelelo esithileko sesihlahla. Abaphenyi bavame ukusebenza basiqhema. Umrholi wabaphenyi kuthiwa mPhenyi omKhulu. UmPhenyi omKhulu wenza akulayelwa msekeli nebandla eliphetheko. Abaphenyi bangaba bodorhodera beenhlahla, abodorhodera bamazinyo, amanesi, izazi zokubala, abososayensi beenhlahla, abosokhemisi, izazi ezisebenza ngengqondo yomuntu namkha babe zizazi ezisebenza imisebenzi esabudorhodera, njalo njalo. 





UYINI UMSEBENZI WOMKHANDLU OLAWULA ZEENHLAHLA ZOKWELAPHA ?i-MEDICINES AND CONTROL COUNCIL

UmKhandlu oLawula zeenHlahla zokweLapha ( i-MCC ) yihlangano yalapha eSewula Afrika elawula ukusebenza kwamahlelo wokulingelelwa kweenhlahla zokwelapha nokubhaliswa  kweenhlahla neensetjenziswa zokwelapha ezizakusetjenziswa ezifeni ezithileko.  I-MCC kumsebenzi wawo ukuqinisekisa ukuthi woke amahlelo wokulingelela iinhlahla weenhlahla ezingakatloliswa neenhlahla ezitjha ezitlolisiweko ezikhambisana nayo imibandela yokuphepha, neyobuhle kunye neyamandla. 


Iimbawo zokulingelelwa kweehlahla nezokutloliswa kweenhlahla neensetjenziswa zokwelapha ziqalwa yikomidi yezazi ye-MCC, eqala hlangana nokhunye ihlangangothi lobusayensi, nelokwelapha kunye nelemithethopatho.  Imibiko yendima esele yenziwe ngerhubhululo lokulingelelwa kweenhlahla inande ithunyelwa ku-MCC. Nakwenziwa isibawo sokutloliswa kwesihlahla kwa-MCC kufuze kuvezwe nobufakazi bokuphepha besihlahleso, nobuhle baso kunye namandla waso, isihlahla leso nawuzakusebenza lapha eSewula Afrika. 

UMSEKELI NABAPHENYI BANESIBOPHO SINYE SOKUBIKA IMINGENELA EMIMBI KUNGAKADLULI AMA-AWA AMATJHUMI AMABILI-NANE, BAYIBIKE  EENHLANGANWENI EZIFANELEKO, EKUBALWA HLANGANA NAZO NAWO UMKHANDLU OLAWULA ZOKWELAPHA i-MCC KUNYE NAMAKOMIDI WEZOMTHETHOPATHO.


LITHINI ILUNGELO LAKHO OLIPHIWE MTHETHOSISEKELO

Nanyana ngubani othatha isiqunto sokungena ehlelweni lerhubhululo la kuzakulingelelwa ngaye ukusebenza kweenhlahla, namkha osele angene ehlelweni lelo, unelungelo lokwazi ngakho koke azifaka kikho namkha azifake kikho, avume asazi koke. UmThethosisekelo weRephabliki yeSewula Afrika, emThethweni 108 ka-1996: Isigaba 12 (2), uthi : ? Omunye nomunye unelungelo lesithunzi somzimbakhe nengqondwakhe, ekubalwa hlangana nakho nelungelo (c) lokwala ukufakwa emahlelweni wesayensi wokulingelela ngaphandle kobana umuntu avume anelwazi.?

UKULINGELELWA KWEENHLAHLA NGAPHANDLE KWEMVUMO YOMUNTU EKULINGELELWA NGAYE, NAYE OVUMA NGELWAZI NGALOKHO, NAMKHA NGAPHANDLE KWEMVUMO YOMUNTU OJAMELE LOYO EKUZAKULINGELELWA NGAYE KUPHAMBANA NOMTHETHOSISEKELO, KUPHAMBANA NOMTHETHOPATHO, KANTI GODU KUPHAMBANA NEKAMBISO YESAYENSI.




Kuyini Ukuvuma Ngelwazi? 

Ukuvuma ngelwazi kutjho ihlelo elifundisa umuntu ekuzakulingwa ngaye iinhlahla ngezinto eziqakathekileko eziphathelene nokulingwa kweenhlahla phezu kwakhe, kobana azokugcina azikhethela yena ukuthi uyafuna na ukungena ehlelweni lokulingelelwa kwemithelo namkha akafuni na.

Ukuvuma ngelwazi akutjho kwaphela ukutlikitla/ukusayina iforomu lokuvuma ukungena ehlelweni lokulingelelwa kweenhlahla, futhi akutjho ikontraga, kodwa kutjho ukuzinikela ngokuthanda komuntu ehlelweni lokulingelelwa kweenhlahla. 


NJENGOMUNTU ONGAHLE ANGENE EHLEWLENI LOKULINGELELWA KWEENHLAHLA, NAKHU EKUFUZE UKWAZI: 

*  kufuneka imvumo yakho enelwazi nakuzakwenziwa irhubhululo lesayensi nelikhamba ngomthethopatho. Lokhu-ke kutjho ukuthi ilungelo lakho, nesithunzi sakho kunye nehlalakuhle yakho kufuze bona kuvikeleke bekuhlonitjhwe ngesikhathi soke ngaphambi kobana kuthome irhubhululo, nangesikhathi ekuzabe kwenziwa ngaso irhubhululwelo, nangemva kobana lizabe selenziwe;
* kufuze bona utjelwe ube uhlathululelwe ngakho koke okuphathelene nehlelo lokulingelelwa kwesihlahla ozakungena kilo ngaphambi kobana uqunte ukuthi uyangena namkha awungeni na kilo;
* ilwazi onikelwa lona kufuze bona unikelwe lona ngendlela elula, ngelimi lakho. Kuqakathekile ukuthi ukwazi ukuzwisise koke ohlathululelwa khona, ube ukwazi nokubuza nemibuzo;
* kufuze uzithathele wena ngokuthanda kwakho isiqunto sokungena ehlelweni lokulingelelwa kweenhlahla, ngaphandle kokukatelelwa, ukudurhiswa  namkha ukuhlohlozelwa nanyana kungaba ngayiphi indlela. Angeze uhlawuliswe nawubhalako ukungena ehlelweni lokulingelela iinhlahla; 
* imvumo enelwazi kufuze bona yenziwe ngomlomo, ibe itlolwe naphasi;
* imvumakho enelwazi kufuze bona itlolwe, kobanyana izokungena emarekhodini azakuhlala abonwa ngabanye nabafuna ukwenza elinye ilingelelo, nabahlola iincwadi, nekomidi yezomthethopatho kunye nalabo abahlola bona imisebenzi enjalo ikhanjiswa ngefanelo na;
*  unelungelo lokubuyela emva uphume ehlelweni lokulingelelwa kweenhlahla nakufumaniseka ukuthi ubona ukuthi awusakghoni ukuya phambili ngalo; 
* nakube ubuyela emva uyaphuma ehlelweni lokulingelelwa kweenhlahla okilo, lokho angeze kwehlise izinga otjhejwa ngalo.  
 
Ilwazi Elifunekako Ngemvumo Enelwazi 

Njengomuntu ekungalingelelwa ngaye namkha esele kulingelelwa ngaye iinhlahla, unelungelo lokwazi:

* umnqopho wehlelo lokulingelelwa kwesihlahla namkha kweenhlahla lezo;
* ikambiso yehlelo lokulingelela nomsebenzi ongahle unikelwe wona wehlelwelo;
* indlela nekambiso ezakulandelwa namkha ezakusetjenziswa;
* ezinye iindlela ezingasetjenziswa zokungena kwakho ehlelweni lerhubhululwelo;
* ingozi ongahle uhlangabezane nayo ngokungena kwakho ehlelwenelo;
* ubuhle ongalindela ukubuthola ngokungena kwakho ehlelwenelo, namkha ubuhle obungatholwa ngabanye abantu ngalo;
* ukuthi zizakuba yintumba kangangani iindaba eziphathelene nokungena kwakho kilelo ihlelo;
* ukuthi izakuba khona na itjhorense ezakusiza nange ungalimala namkha ungene kenye ingozi ngokuba kwakho sehlelwenelo;
* umuntu ongakhulumisana naye nakungenzeka ulimalele ehlelwenelo;
* ihlohlozela yokukhuthaza namkha yokuthokoza ukungena kwakho ehlelwenelo. Nakube ayifani ihlohlozela enikelwa abantu abangene ehlelwenelo, kufuze bona ihlathululwe;
* ukuthi ikhona na indlela ongalatjhwa ngayo ngemva kwehlelo lokulingelela;
* umsekeli wehlelo nokuphambana kweenrhuluphelo nakube kukhona;
* ubufakazi bemvumo yekomidi ephethe zomthethopatho. 

Ngalokhu esikutjho ngehla, kuyakhanya ukuthi  boke abantu abakghonako ukunikela imvumo enikelwa ngelwazi namkha abanikela imvumo egameni labanye bangakghona ukungenela ihlelo lokulingelelwa kweenhlahla. Abantu abangenela ihlelweli kungaba bantwana abangakabelethwa, ukuya ebantwini abadala, ukuya ebantwini abaduna nabesifazi, abaphile kuhle nabagula khulu, abaphilako nabangasekho ( abangakabelethwa, abantwana nabantu abakhulu.)

Kuqakathekile ukukhumbula ukuthi ungangena ehlelweni lokulingelela iinhlahla bunqopha namkha ngenye indlela ngokuvuma ukuthi kusetjenziswe imininingwana eserekhodini lakho lokwelatjhwa lakade namkha lakhathesi eliphethwe mumelaphi wakho. 

Ikombandlela elawula ukuthi umuntu ukulungele na ukungena ehlelweni lokulingelelwa kweenhlahla elithileko ibizwa ngokuthi yindlela yokukhethela ngaphakathi, bese kuthi indlela esetjenziselwa ukwalela abantu abathileko ukuthi bangangena ehlelweni lokulingelela ibizwe ngokuthi yindlela yokukhethela ngaphandle. 

Indlela yokukhethela ngaphakathi neyokukhethela ngaphandle ziqakatheke khulu, zenzelelwe ukuvikela abantu ekulingelelwa ngabo iinhlahla, nokuqinisekisa  ukuthi ihlelo lokulingelelwa kwemithelo liphumelela ngaphandle kokuraranisa izinto. 

OKWENZIWA MAKOMIDI WEZOMTHETHOPATHO UKUQINISEKISA UKUTHI ILUNGELO LAKHO, NESITHUNZI SAKHO KUNYE NEHLALAKUHLE YAKHO KUVIKELEKILE.

IKombandlela Yokulingelelwa Kweenhlahla eSewula Afrika   ifuna ukuthi imitlolo yeemphakamiso neminye imitlolo eqakathekileko yehlelo lokulingelela eliphakanyiswako ihlolwe yikomidi esemthethweni yezomthethopatho ekhambisana nekambiso ebekwe mKhandlu wezeRhubhululo kezamaPhilo ngezomThethopatho ? i-National Health Research Ethics Council.  Ukuhlolwa nokubuyekezwa komthethopatho kunqophe ukuqinisekisa ukuvikeleka kwabantu ekungalingelelwa ngabo iinhlahla. Amahlelo wokulingelela avunyelwe yikomidi esemthethweni yezomthathopatho ngiwo kwaphela avunyelweko ukwenziwa lapha eSewula  Afrikia. 

Nakhu okuqalwa makomidi wezomthethopatho nakahlola iimphakamiso zokulingelelwa kwemithi: 

* ukuthi irhubhululwelo liphathelene belikhambisana kangangani nesayensi;
* ukuthi abarhubhululi abafanele ukuraga ihlelwelo bakhona na, nokuthi bafundiswe kangangani ngerhubhululwelo, nokuthi banelimuko elingangani;
* ukuthi amagama wokukhulumela irhubhululwelo alilungele kangangani;
* ukuthi ihlelo lokulingelela likhambisana kangangani nomnqopho werhubhululo;
* ukuthi abantu ekuzakulingelelwa ngabo bakufanele kangangani ukungena kilelo ihlelo, nokuthi zanele na iindlela zokuvikela abantu ekuzakulingelelwa ngabo;
* ukuthi inani labantu ekuzakulingelelwa ngabo lanele na;
* ukuthi lenziwe na icozululo lokuthi abantu ekulingelelwa ngabo bazakusizakala nangemva kwerhubhululo ngokwalo, nokuthi ingozi abangangena kiyo bazakusala basese kiyo nangemva kwehlelo lokulingelelwa na;
* ukuthi ukwelatjhwa kokulingisa kufuzile nangambala na ukuthi kwenziwe nakube kuyenziwa;
* ukuthi ukungena kwabo ehlelweni lokulingelelwa kwemithi akubadimi ithuba lokwelatjhwa kusese nesikhathi na abantu abangene kilo namkha abanye nanyana bangakangeni kilo. 
* ukuthi lanele na ilwazi elitloliweko ekufuze linikelwe abantu ekuzakulingelelwa ngabo, bemakhabo, ababaphetheko namkha amagcwethabo;
* ukuthi abantu ekuzokulingelelwa ngabo namkha bemakhabo banikelwe ithuba elaneleko na lokuqala bahlole ilwazi elitloliweko ngehlelo lokulingelelwa ngaphambi kobana bangabuzwa ukuthi bayavuma na ukungena emveni kobana sebasazi ngehlelwelo;
* ukuthi isikhangiso esenziweko ngehlelo lokulingelela nezasizo ezazisa umphakathi zokufuna abantu ekuzakulingelelwa ngabo kulifanele na ihlelwelelo; 
* ukuthi irhubhululwelo liyawavikela na amalungelo wangeqadi wabantu ekuzakulingelelwa ngabo;
* ukuthi kuyaqalelelwa na ukuliliswa namkha ukwelatjhwa kwabantu abangahle balimale namkha bafe ngenca yokungena kwabo ehlelweni lokulingelelwelo;
* ukuthi abarhubhululi nabantu ekulingelelwa ngabo bazakuthokozwa kangangani ngokungena kwabo ehlelweni lokulingelela. 

 IKombandlela Yokulingelelwa Kweenhlahla eSewula Afrika  ifuna ukuthi amakomidi wezomthethopatho abaqalelele ngokukhethekileko abantu abathileko, njengabantwana, nelutjha, nabomma abasebantwini, neembotjhwa, nabaqhwalileko, nabagula ngengqondo, nemiphakathi engangena lula engozini, nabagulela ukukhamba, nabadala, nemihlobo yabantu eyimbijana kunye nabasebenzi. 

Obunye Bobuhle Bokungenela Ihlelo Lokulingelelwa Kweenhlahla

Ukulingelelwa kweenhlahla zokwelapha kwenzelelwe ukuhlola iinhlahla, iinsetjenziswa zokwelapha kunye neendlela zokwelapha ezizakugcina zisetjenziselwa ukuphilisa abantu kuhle. Ngokungenela ihlelo lokulingelelwa kweenhlahla: 

* Ungahle ube lisizo erhubhululweni lokwelapha nekuthuthukisweni kweendlela zokuqalelela amaphilo wabantu, kanti godu ungahle ube lisizo kabanye abantu;
* Ungahle uthole isizo lokwelatjhwa ngemithi engakabukubakhona emphakathini ngesikhathi ekuzabe kulingelelwa ngaso, nangemva kwalokho.
* Ungahle ulatjhwe mahala. 

Nokho-ke ukungena ehlelweni lokulingelelwa kweenhlahla akusindlela yokuzenzela imali, ngitjho nanyana pheze boke abasekeli babathokoza ngemadlana nje abantu ekulingelelwa ngabo; phela abantu ekulingelelwa ngabo bavamise ukuthokozwa ngokuphiwa imali yokukhamba nabakhamba malungana nehlelo lokulingeleleli, baphiwe nemali yokudla, baphiwe nemithi yokubelapha, babuye godu bahlawulwe nakube kuba nento  embi ebavelelako ngenca yokungena kwabo ehlelweni lokulingelela, kufumaniseke nokuthi ikhona netjhorense yalokho okubaveleleko; kodwa-ke kufuneka ubufakazi bokuthi nangambala kubavelele ngenca yokuba kwabo sehlelwenelo abantwabo lokho okumbi okukhulunywa ngakho okungahle kubavelele. 

Obunye Bobumbi Bokungenela Ihlelo Lokulingelelwa Kweenhlahla

Ukusebenzisa iinhlahla ezilingelelwako, iinsetjenziswa zokwelapha ezilingelelwako namkha iindlela zokwelapha ezilingelelwako kungahle kubange imingenela emimbi phezu komuntu; nokho-ke abantu ekulingelelwa ngabo bahlala baluswe ngelihlo elibukhali, ukwenzelela ukuthi imingenela emimbi nayivelako ibonwe msinyana ibe ithathelwe amagadango afaneleko. Ngaphandle kwalokho, ikhona netjhorense ethathelwa ukuqala imingenela emimbi, kobanyana abantu ekulingelelwa ngabo bazokuliliswa ngayo nakwenzekako bangenwe mingenela emimbi. Iinhlahla ezilingelelwa ngawe, nemijovo elingelelwa ngawe kunye neendlela zokwelapha ezilingelelwa ngawe kungenzeka zingabi lisizo esifeni esikuphetheko; kodwa-ke nokho kuneendlela zokuphepha ezenzelwe ukusiza abantu abangasizakaliko ngokungena kwabo ehlelweni lokulingelela; bayathathwa bafakwe kelinye ihlelo lokulinga ukubelapha khonokho nakubonakala ukuthi abasizakali, namkha bafakwe kilo ekupheleni kwehlelo lokulingelela. Ikombandlela yokulingelela ingafuna ukuthi kube namatjhugulukwana owenzako ngepilwakho, njengalawa alandelako: 

* kungafuneka ukuthi uzenzele isikhathi ozasisebenzisela ihlelo lokulingelela, njengokuthi nje wenze isikhathi sokunande uvakatjhela indawo la kulingelelwa khona; 
* kungenzeka ukuthi walelwe ukusebenzisa iinhlahla ezithileko nawusesehlelweni lokulingelelwa, ngitjho neenhlahla ezijayelekileko imbala, ngaphandle kwemvumo kadorhodera ophethe ihlelo lokulingelela okilo;
* ukungena kwakho ehlelweneli kungahle kuliyane nepilwakho yangeqadi, njengokuthi nje kuliyane neendaba zakho zomseme, imbeleko, ukusela utjwala, ukubhema namkha ukusebenzisa iindakamizwa, njalo njalo. 
* kungenzeka kufuneke ukuthi uragele phambili ngokuya la uvame ukuthola khona isizo lokwelatjhelwa ezinye izifo onazo ezingakaphathelani nehlelo lokulingelelwa kwemithi okilo; kodwa nokho nanyana kunjalo, kuyafuneka ukuthi umelaphi wakho umtjele ukuthi ungene ehlelweni lokulingelela iinhlahla, umbikele nokuthi iinhlahla ezithileko namkha iindlela zokukwelapha ezithileko kungenzeka zingakhambisani nekambiso yehlelo lokulingelelwa okilo. 

Umqatjhi wakho, i-medical aid yakho, itjhorense yakho, namkha uKomitjhinari oqalene nembadalo yokulimalela kwakho emsebenzini  -- i-Commissioner for Compensation for Occupational Injuries -- kungenzeka bangakubhadaleli ukulimalela kwakho ehlelweni lokulingelela ongena kilo; ngalokho-ke kuqakatheke khulu ukuthi uthole iqiniso lokuthi umsekeli wehlelo lokulingelela okilo unayo na itjhorense epheleleko yokukulilisa nawungavelelwa ngokumbi usehlelwenelo. 

Ngalokho-ke kuqakathekile ukuthi ukhulumisane nomndenakho nabo boke abazakuthinteka ngokungena kwakho ehlelweni lokulingelela iinhlahla zokwelapha ngaphambi kobana ungangena kilo, nawufuna ukungena. 





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Ministerial Committee on Health Research Ethics 
C/O Health Systems Research, Research Coordination and Epidemiology 
Department of Health 
Private Bag X828 
Pretoria
0001 

Umtato :    012 312-0995 
IFeksi   :    012-328-9381 
E-mail  :    hsrrce@health.gov.za


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