Uphando ngamayeza amatsha? Masithethe ngolu vavanyo lwezonyango!

Mhlawumbi ukhe weva ngophando olwenziwayo lokufumana amayeza amatsha okanye unyango olutsha. Ngamanye amaxesha oogqirha bathetha ngezi zinto. Ngoko ke, usenokuba uzibuza ukuba ezi " zilingo zeklinikhi " okanye "zilingo zeklinikhi" zithetha ukuthini. Ungakhathazeki, masithethe ngale nto ngokulula nangokucacileyo.

Yintoni uvavanyo lwezonyango?

Ngamafutshane, uvavanyo lwezonyango luphando lwezonyango apho abantu bazinikela ngokuzithandela ukuba bathathe inxaxheba. Oku kubaluleke kakhulu kuba yindlela ekuphela kwayo abaphandi abanokuthi bazi ngayo ngokuqinisekileyo ukuba unyango olutsha luyasebenza na kwaye lukhuselekile na ebantwini.

Kukho iintlobo ezahlukeneyo zovavanyo lweklinikhi. Ezinye zimalunga nokufumana izifo ezintsha, ezinye zimalunga nokuthintela izifo, kwaye ezinye zimalunga nokuchongwa kwezifo. Kodwa namhlanje sithetha kakhulu ngovavanyo lweklinikhi olufuna unyango olutsha. Abaphandi bezonyango bakwabiza ezi "zilingo zonyango." Ezi zinokuvavanya amayeza amatsha, indlela amayeza akhoyo anikwa ngayo ukunyanga izifo ezahlukeneyo, izixhobo zonyango ezintsha, okanye ezinye iindlela zonyango.

Usenokuba uzibuza, "Ngubani oza kuzinikela koku?" Abanye abantu bathatha inxaxheba kuba benesifo esifundwayo, benethemba lokufumana unyango olutsha. Kukwakho nabantu abaphilileyo abangenaso isifo, abafuna ukunceda abanye kwaye bafake isandla ekuphuculeni isayensi yezonyango.

Kwenzeka ntoni ngaphambi kokuba kuqale uvavanyo lweklinikhi?

Cinga ngayo, awunakunika abantu iyeza elitsha ngaxeshanye. Kukho inkqubo ende ngaphambi koko. Ngokwesiqhelo, la manyathelo ayalandelwa:

• Uvavanyo lwangaphambi konyango: Lonke uvavanyo lwezonyango luqala ngengcinga yonyango olutsha (njengeyeza elitsha, indibaniselwano yamayeza, okanye isixhobo sezonyango). Olu vavanyo lwangaphambi konyango lwenziwa kwiilabhoratri okanye kwizilwanyana .
• Iprotokholi yovavanyo lwezonyango: Ukuba iimvavanyo zokuqala ezikhankanyiweyo apha ngasentla zibonisa ukuba unyango olutsha lunethuba lokuphumelela, abaphandi emva koko benza isicwangciso sokusebenza. Oku kubizwa ngokuba yiprotokholi yovavanyo lwezonyango. Ezi zicwangciso zinokwahluka ukusuka kwenye ukuya kwenye. Nangona kunjalo, kufuneka zibandakanye injongo yovavanyo, ukuba zeziphi unyango oluvavanywayo, kunye noko abaphandi banethemba lokukulinganisa ekupheleni kovavanyo (iindawo zokugqibela zovavanyo).
• Uhlolo kunye nokuvunywa ziiarhente zomthetho ezifana ne -FDA :Kwilizwe elifana neMelika, abaphandi kufuneka bafumane imvume kwi-FDA (Food and Drug Administration) ngaphambi kokuba baqalise uvavanyo lwezonyango. Kwilizwe lethu, imvume evela kumagunya afanelekileyo nayo iyafuneka.
• Uhlolo lweZiko kunye nokuVunywa: Oku kubandakanya uhlolo lweBhodi yoHlolo lweZiko (i-IRB) okanye iKomiti yoBulungisa yaso nasiphi na isibhedlele esibandakanyekayo kuvavanyo lwezonyango. Eyona njongo iphambili yale komiti kukhuseleko kunye namalungelo abathathi-nxaxheba kuvavanyo.

Kuphela emva kokuba zonke ezi mvume zifunyenwe apho abaphandi baqala ukukhangela abantu abazimisele ukuthatha inxaxheba. Ngamanye amaxesha, baya kuqhagamshelana nabantu abasele bebhalisile. Kwiimeko ezininzi, ugqirha wakho unokukuthumela kwisilingo seklinikhi.

Ukuba ucinga ngokuthatha inxaxheba kuvavanyo lweklinikhi, iqela lezonyango eliququzelela uphando liza kuqala likunike ingcaciso epheleleyo yokuba lumalunga nantoni na. Emva koko ungathatha isigqibo sokuba uyafuna na ukuthatha inxaxheba okanye hayi. Le nkqubo ibizwa ngokuba "kukufumana imvume enolwazi ."

Yintoni 'Imvume Enolwazi'?

Le yingxoxo ebaluleke kakhulu. Kulapho uza kufunda khona iinkcukacha ezipheleleyo malunga novavanyo lweklinikhi. Iqela lophando liza kukuchazela yonke into.

"Imvume enolwazi" ayisiyonto nje yokutyikitya. Lilungelo lakho!

Baza kukubonisa "uxwebhu lwemvume olunolwazi" baze bakuchazele lona inyathelo ngenyathelo. Olu xwebhu luchaza injongo kunye nenkqubo yovavanyo ngokweenkcukacha. Luchaza neengozi kunye neenzuzo ezinokubakho. Luchaza nokuba zeziphi iindlela zophando eziya kuba zeziphi kunye neendlela onokukhetha kuzo ukuba awuthathi nxaxheba kuvavanyo lweklinikhi. Luchaza nokuba uvavanyo luza kuhlala ixesha elingakanani, zeziphi iimfuno zokulandelela , zeziphi iindleko eziza kufuneka, kunye nokuba uza kufumana nayiphi na imbuyekezo. Okokugqibela, ichaza ngokucacileyo ukuba ukuthatha inxaxheba kuvavanyo lweklinikhi kukuzithandela ngokupheleleyo.

Incwadana inokuthi uvavanyo "lucwangcisiwe ngokungacwangciswanga." Kufana nokuphosa ingqekembe. Oku kuthetha ukuba ayinguye wonke umntu othatha inxaxheba kuvavanyo oza kufumana unyango olutsha, oluvavanywayo. Ukuba unesifo kwaye ujoyina uvavanyo ngethemba lokufumana unyango olutsha, kubalulekile ukwazi oku.

Iinkcukacha zovavanyo lweklinikhi ngamanye amaxesha zinokuba nzima ukuziqonda. Ngoko ke, zinike ixesha lakho ubuze nayiphi na imibuzo onayo, amaxesha amaninzi kangangoko ufuna. Ifomu ethi `Imvume Enolwazi` yiyo yonke into ethethwa luvavanyo lweklinikhi.Asikosivumelwano phakathi kwakho noogqirha abenza uphando. Ukuba ugqiba ekubeni ujoyine uphando, kuya kufuneka utyikitye elo phepha. Nangona kunjalo, ukusayina akuthethi ukuba ubophelelekile kuko. Unelungelo elipheleleyo lokutshintsha ingqondo yakho nokurhoxa nangaliphi na ixesha, nokuba sele luqalile uphando.

Kwenzeka ntoni ngexesha lovavanyo lweklinikhi?

Ngokwesiqhelo kukho amanqanaba amane ovavanyo lweklinikhi. Isigaba ngasinye sinenjongo ethile. Abaphandi bafuna abantu abatsha abazinikeleyo kwisigaba ngasinye. Amanqanaba amane ngala:

• Isigaba 1: Oku kudla ngokubandakanya iqela elincinci labantu (phakathi kwama-20 ne-100). Kusenokwenzeka ukuba ngabantu abasempilweni abangenazo iingxaki zempilo ezaziwayo. Abaphandi basebenzisa esi sigaba ukumisela idosi efanelekileyo yeyeza kunye nokubona ukuba unyango lubangela naziphi na iziphumo ebezingalindelekanga.
• Isigaba sesi-2: Oku kubandakanya abantu abaphakathi kwe-100 nama-300. Bonke banesifo esithile. Kweli nqanaba, abaphandi bajonga ukuba unyango luyasebenza ngokwenene na kwaye ingaba lutsha okanye luneziphumo ebezingalindelekanga ezibi kakhulu kunangaphambili.
• Isigaba sesi-3: Esi sigaba sinokubandakanya abantu abaphakathi kwama-300 nama-3,000. Kulapho abaphandi baqinisekisa khona ukuba unyango oluvavanyiweyo luyasebenza kwaye lukhuselekile. Banokuluthelekisa nonyango olukhoyo. Kwilizwe elifana ne-United States, i-FDA igqiba ekubeni iyaluvuma na unyango lwabantu abaninzi ngokusekelwe kwiziphumo zolu vavanyo lwesigaba sesi-3.
• Isigaba sesi-4: Abaphandi bayaqhubeka nokujonga unyango nokuba sele luvunyiwe yi-FDA. Ngenxa yokuba ezinye iindlela zonyango ezintsha zineziphumo ebezingalindelekanga ezibonakala kuphela emva kokuba abantu besebenzise eli yeza okwethutyana, abaphandi bayaqhubeka nokukhangela iziphumo ebezingalindelekanga okanye ezinye iingxaki.

Kwenzeka ntoni emva kovavanyo lweklinikhi?

Uvavanyo lweklinikhi lunokuphela ngezizathu ezahlukeneyo. Umzekelo, unyango olwalukwisigaba sophando lusenokuba lufumene imvume ye-FDA kwaye lufumaneka kubantu abaninzi. Nangona kunjalo, ngamanye amaxesha, ukuba uvavanyo lubonisa ukuba unyango alusebenzi njengoko bekulindelwe, okanye alungcono kunonyango olukhoyo, uvavanyo lweklinikhi lunokumiswa ngaphambi kokuba lugqibe zonke izigaba ezine.

Zithini iingenelo zokujoyina uvavanyo lweklinikhi?

Kukho iingenelo ezininzi zokuba yinxalenye yovavanyo lweklinikhi. Ukuba unesifo esithile:

• Kunokubakho ithuba lokufumana unyango olutsha olunokuba lusebenza ngakumbi kunonyango lwangoku.
• Ungadlala indima ebonakalayo ekwenzeni izigqibo malunga nonyango lwakho.
• Unganceda abanye abanesifo esifana nesakho.

Ukuba usempilweni, uya kuba novuyo lokunceda abaphandi bafumane unyango olungcono kwabanye.

Zithini iingozi?

Uvavanyo lweklinikhi lunokuza neengozi ezithile. Uya kwaziswa ngezi ngozi xa unika "imvume yakho enolwazi." Nangona kunjalo, ungacela ulwazi oluthe kratya nangaliphi na ixesha. Ukuba iingozi ziyatshintsha ngexesha lovavanyo, okanye ukuba kuvela iingozi ezintsha, uya kwaziswa. Emva koko ungacinga kwakhona ukuba ungathatha inxaxheba na. Ezinye zeengozi ezinokubakho ziquka:

• Unyango, olusesekwinqanaba lophando , lunokubangela iziphumo ebezingalindelekanga ezinokufuna unyango.
• Olu vavanyo lungathatha ixesha elide kunonyango oluqhelekileyo lwemeko yakho. Umzekelo, kunokubakho amaxesha amaninzi okubonana nogqirha, iimvavanyo, okanye ukulaliswa esibhedlele kunesiqhelo.
• Unyango olusekelwe kuphando lusenokungasebenzi, okanye lusenokungabi luhle njengonyango oluqhelekileyo.
• Usenokungafumani unyango olusekelwe kuphando oluvavanywayo. Unokufumana unyango oluqhelekileyo lwemeko yakho, okanye ungafakwa kwiqela le-"placebo", apho ungafumani nyango konke konke.

Yeyiphi imibuzo endifanele ndiyibuze malunga novavanyo lweklinikhi?

Njengabantu abaninzi, usenokuba nemibuzo emininzi malunga nokuzithandela kwisilingo seklinikhi. Nazi ezinye zemibuzo onokuyibuza:

• Kutheni kwenziwa olu phononongo?
• Kufuneka ndithathe inxaxheba ixesha elingakanani kolu phononongo?
• Ukuba ndifumana unyango, luza kunikwa njani (njengepilisi, njenge-`IV`, njenge-`implant`, njl.njl.)?
• Kuza kufuneka ndize kangaphi? Kufuneka ndize phi?
• Kuthatha ixesha elingakanani ukufika kube kanye?
• Ngaba kuya kufuneka ndihlawulele nayiphi na inxalenye yolu phando? Ngaba i-inshorensi yam iya kuhlawulela nantoni na ngale nto?
• Zithini iingozi zolu phononongo? Oku kuya kuyichaphazela njani impilo yam?
• Kuza kwenzeka ntoni kunyango lwam ukuba andithathi nxaxheba okanye andirhoxi kolu phando?
• Ngubani ophethe unyango lwam?
• Ngaba ndiza kufumana naziphi na iziphumo kolu phononongo?
• Ukuba unyango luvunyiwe, ngaba ndiza kuqhubeka ndilufumana?
• Ukuba ndineziphumo ebezingalindelekanga ezibi kakhulu ngenxa yonyango, ndingakwazi na ukurhoxa kolu phando?

Musa ukoyika ukubuza le mibuzo kuphela, kodwa nantoni na oyicingayo.

Ngubani oqinisekisa ukhuseleko lwezilingo zeklinikhi?

Amanyathelo okhuseleko aye asetyenziswa kuyo yonke inkqubo yovavanyo lweklinikhi ukuqinisekisa ukhuseleko lwabathathi-nxaxheba:

• IiBhodi zoKhuseleko noHlolo lweDatha (ii-DSMB):Ezi zenziwe ziingcali zonyango. Zihlola iziphumo kulo lonke uvavanyo lwezonyango. Ukuba zigqiba kwelokuba unyango oluphandwayo alusebenzi okanye ukuba iziphumo ebezingalindelekanga zimbi kakhulu kunokuba bekulindelwe, ezi bhodi zinokumisa uvavanyo ngokukhawuleza.
• Iiarhente zikarhulumente: Iiarhente ezifana ne-FDA kunye ne-Ofisi yoKhuselo loPhando lwaBantu zilawula kwaye zongamela zonke iimvavanyo zonyango e-United States. Oku kuyinyaniso nakwiiarhente zolawulo eSri Lanka.
• IiBhodi zoHlolo lweZiko (ii-IRB): Ezi bhodi, ezikwiindawo zophando, kufuneka zivume uvavanyo lwezonyango ngaphambi kokuba lwenziwe. Ezi bhodi ziqinisekisa ukuba amavolontiya awachanabeka kwiingozi ezingeyomfuneko kwaye akhusele ukhuseleko lwawo. Ii-IRB zihlala zenziwe ngamalungu oluntu, kunye noogqirha kunye nabaphandi abangeyonxalenye yeqela lophando.

Yintoni `Uvavanyo lweKlinikhi oluQhelekileyo`?

Kuvavanyo "olucwangcisiweyo", abaphandi babeka abantu abazithandelayo kumaqela ahlukeneyo. Iqela ngalinye lifumana unyango olwahlukileyo. Mhlawumbi bavavanya unyango oluqhelekileyo ngonyango lovavanyo, okanye unyango olubini lovavanyo. Amaqela afakwa kula maqela ngokungacwangciswanga, njengokujika ingqekembe. Emva koko amaqela afana. Oko kwenza kube lula kubaphandi ukufumanisa ukuba loluphi unyango olungcono.

Yintoni iTyala leKlinikhi eliSekelwe kwiindawo eziManyeneyo?

Uvavanyo lweklinikhi olulawulwa ngokweendidi luvavanyo apho uvavanyo luqhutywa kwiindawo ezininzi, endaweni yokuba lube lunye kuphela. Ngokwesiko, uvavanyo lweklinikhi lufuna ukuba abantu abazithandelayo baye kwindawo ethile. Nangona kunjalo, kuvavanyo olulawulwa ngokweendidi, abantu abazithandelayo banokuthatha inxaxheba ngaphandle kokuhamba. Umzekelo, ungafumana unyango ekhayeni lakho, kwiziko lezempilo elikufutshane, okanye kwilabhoratri ekufutshane.

Ngubani onokuthatha inxaxheba kuvavanyo lweklinikhi?

Uvavanyo lweklinikhi lunezikhokelo zokufaneleka . Zikuxelela ukuba ngubani onokuthi athathe inxaxheba nongenakuthatha inxaxheba. Ayingabo bonke abafuna ukuba kuvavanyo lweklinikhi abanokuthi bathathe inxaxheba. Ezi zikhokelo zinokwahluka. Kodwa, ngokubanzi, zixhomekeke kwizinto ezifana neminyaka yakho, isini, impilo iyonke, uhlobo lwesifo onaso, kunye nonyango olusebenzisayo ngoku.

Ndingayifumana njani inkcazelo ngeemvavanyo zonyango?

Okokuqala, thetha nogqirha wakho onyangayo. Uyakwazi wena kunye nemeko yakho, ukuze akwazi ukucebisa uvavanyo olulungele wena. Enye indlela kukujonga iidathabheyisi zovavanyo lweklinikhi kwi-intanethi. Umzekelo, ungajonga idatabheyisi egcinwe yi-US National Center for Biotechnology Information. ESri Lanka, unokufumana ulwazi malunga nolu phando ngokusebenzisa amaziko ezempilo afanelekileyo.

Uvavanyo lweklinikhi lwahluke njani kunyango oluqhelekileyo?

Umahluko uluhlobo lonyango olufumanayo. Ukuba uyagula kwaye uthatha inxaxheba kuvavanyo lweklinikhi, iqela lakho eliqhelekileyo lezonyango liya kujongana neengxaki zakho zempilo eziqhubekayo. Iqela lovavanyo lweklinikhi liza kugxila kuphela kwiyeza okanye isixhobo esitsha esivavanywayo. Iqela liza kujonga impendulo yakho kunyango lophando kwaye linyange naziphi na iziphumo ebezingalindelekanga onokuba nazo.

Uvavanyo lwezonyango lulo oluqhubela phambili unyango. Ngaphandle, kunokubonakala ngathi konke kumayelana nesayensi. Kodwa ngokwenene malunga nabantu abanceda ekwenzeni unyango lube ngcono. Ngaphandle kwamavolontiya, abaphandi abanakwazi ukuba ingcamango iya kuba lunyango olukhuselekileyo nolusebenzayo.

Uvavanyo olunye lunokunyanga isifo okanye lufumane unyango oluphumelelayo olunceda abantu baphile ixesha elide. Nokuba uvavanyo aluvelisi ziphumo zilindelekileyo, lusenokukhokelela abaphandi kwicala elahlukileyo kwaye bafumane iziphumo eziphumelelayo ngakumbi. Ukugqiba ekubeni ngovolontiya kuvavanyo lweklinikhi sisigqibo esikhulu. Ukuba ucinga ngako, ungathandabuzi ukubuza nayiphi na imibuzo onayo, amaxesha amaninzi kangangoko ufuna, ude uzive uqinisekile ngesigqibo sakho.

Umyalezo Wokuya Ekhaya

Ngoko ke, ndiyathemba ukuba ngoku uyaqonda ngcono ukuba yintoni "uvavanyo lwezonyango" esithethe ngalo.

• Olu luphando olubalulekileyo lokufumana unyango olutsha.
• "Imvume yakho enolwazi" ibaluleke kakhulu. Yazi yonke into, ubuze imibuzo, kwaye wenze isigqibo.
• Qaphela iingenelo kunye neengozi.
• Unelungelo lokurhoxa kuvavanyo nangaliphi na ixesha.
• Ezi ziphantsi kwemiqathango engqongqo kunye nemiqathango yokhuseleko.

Ukuba wena okanye umntu omaziyo ucinga ngokuthatha inxaxheba kuphando olufana nolu, olu lwazi lunokuba luncedo nakuye. Soloko uthetha nogqirha wakho ukuze ufumane ulwazi oluthe kratya.

Uvavanyo lwezonyango , amayeza amatsha, uphando lwezonyango, imvume enolwazi, amanqanaba onyango, ulwazi lwezempilo, umsebenzi wokuzithandela