Ucwaningo ngomuthi omusha? Ake sixoxe ngalolu vivinyo lwezokwelapha!

Cishe uke wezwa ngocwaningo olwenziwayo ukuthola imithi emisha noma ukwelashwa okusha. Ngezinye izikhathi odokotela bakhuluma ngalezi zinto futhi. Ngakho-ke, ungase uzibuze ukuthi lezi " zivivinyo zemitholampilo " noma "izivivinyo zemitholampilo" zisho ukuthini. Ungakhathazeki, ake sixoxe ngalokhu kalula nangokucacile.

Kuyini ukuhlolwa kwezokwelapha?

Kalula nje, isivivinyo somtholampilo siwucwaningo lwezokwelapha lapho abantu bezithandela khona ukuhlanganyela. Lokhu kubaluleke kakhulu ngoba yindlela kuphela abacwaningi abangazi ngayo ngokuqinisekile ukuthi ukwelashwa okusha kuyasebenza ngempela nokuthi kuphephile yini kubantu.

Kunezinhlobo eziningana zezivivinyo zemitholampilo. Ezinye zimayelana nokuthola izifo ezintsha, ezinye zimayelana nokuvimbela izifo, kanti ezinye zimayelana nokuxilonga izifo. Kodwa namuhla sikhuluma kakhulu ngezivivinyo zemitholampilo ezifuna ukwelashwa okusha. Abacwaningi bezokwelapha babiza lezi ngokuthi "izivivinyo zokwelapha." Lezi zingahlola imithi emisha, ukuthi imithi ekhona inikezwa kanjani ukwelapha izifo ezahlukene, amadivayisi ezokwelapha amasha, noma ezinye izindlela zokwelapha.

Ungase uzibuze, "Ubani ongazinikela kulokhu?" Abanye abantu bahlanganyela ngoba banesifo esifundwayo, benethemba lokuthola ukwelashwa okusha. Futhi kukhona nabantu abaphilile abangenaso isifo, abafuna ukusiza abanye futhi banikele ekuthuthukisweni kwesayensi yezokwelapha.

Kwenzekani ngaphambi kokuba kuqale ukuhlolwa kwezokwelapha?

Cabanga ngakho, awukwazi ukuvele unike abantu umuthi omusha ngesikhathi esisodwa. Kunenqubo ende ngaphambi kwalokho. Ngokuvamile, lezi zinyathelo ziyalandelwa:

• Ukuhlolwa kwangaphambi kokwelashwa: Yonke isilingo somtholampilo iqala ngombono wokwelashwa okusha (njengomuthi omusha, inhlanganisela yemithi, noma idivayisi yezokwelapha). Lokhu kuhlolwa kwangaphambi kokwelashwa kwenziwa emalabhorethri noma ezilwaneni .
• Iphrothokholi yesivivinyo somtholampilo: Uma izivivinyo zokuqala ezishiwo ngenhla zibonisa ukuthi ukwelashwa okusha kunethuba lokuphumelela, abacwaningi babe sebedala uhlelo lokusebenza. Lokhu kubizwa ngokuthi iphrothokholi yesivivinyo somtholampilo. Lezi zinhlelo zingahluka kusuka kwesinye kuya kwesinye. Kodwa-ke, kufanele zifake inhloso yesivivinyo, ukuthi yiziphi izindlela zokwelapha ezihlolwayo, kanye nalokho abacwaningi abanethemba lokukukala ekupheleni kwesivivinyo (iziphetho zesivivinyo).
• Ukubuyekezwa nokuvunyelwa yizikhungo ezilawulayo ezifana ne -FDA :Ezweni elifana neMelika, abacwaningi kumele bathole imvume evela ku-FDA (Food and Drug Administration) ngaphambi kokuqala isivivinyo somtholampilo. Ezweni lethu, imvume evela ezikhulwini ezifanele nayo iyadingeka.
• Ukubuyekezwa Nokuvunyelwa Kwesikhungo: Lokhu kuhilela ukubuyekezwa kweBhodi Lokubuyekezwa Kwesikhungo (i-IRB) noma iKomidi Lokuziphatha lanoma yisiphi isibhedlela esihilelekile esivivinyweni somtholampilo. Inhloso eyinhloko yaleli komidi ukuphepha namalungelo abahlanganyeli esivivinyweni.

Kuphela ngemva kokuba zonke lezi zimvume sezitholiwe lapho abacwaningi bangaqala khona ukufuna abantu abazimisele ukuhlanganyela. Ngezinye izikhathi, bazoxhumana nabantu asebebhalisile kakade. Ezimweni eziningi, udokotela wakho angakudlulisela ngisho nasesivivinyweni sezokwelapha.

Uma ucabanga ngokubamba iqhaza esivivinyweni somtholampilo, ithimba lezokwelapha eliqondisa ucwaningo lizoqala ngokukunikeza incazelo egcwele yokuthi lumayelana nani. Ngemuva kwalokho unganquma ukuthi uyafuna yini ukubamba iqhaza noma cha. Le nqubo ibizwa ngokuthi "Ukuthola Imvume Enolwazi ."

Kuyini 'Imvume Enolwazi'?

Lena ingxoxo ebaluleke kakhulu. Yilapho uzofunda khona imininingwane egcwele mayelana nokuhlolwa kwezokwelapha. Ithimba locwaningo lizokuchazela konke.

"Imvume enolwazi" akuyona nje into yokusayina. Yilungelo lakho!

Bazokukhombisa "idokhumenti yemvume enolwazi" bese bechaza yona isinyathelo ngesinyathelo. Lo mbhalo uchaza inhloso nenqubo yesivivinyo ngemininingwane eminingi. Uchaza futhi noma yiziphi izingozi nezinzuzo ezingaba khona. Uchaza nokuthi yiziphi izindlela zocwaningo ezizoba yizo nokuthi yiziphi izinketho zakho uma ungahlanganyeli esivivinyweni somtholampilo. Uchaza nokuthi isivivinyo sizohlala isikhathi esingakanani, yiziphi izidingo zokulandelela , yiziphi izindleko ezizodingeka, nokuthi uzothola yini isinxephezelo. Okokugcina, kusho ngokusobala ukuthi ukubamba iqhaza esivivinyweni somtholampilo kungokuzithandela ngokuphelele.

Incwajana ingase ithi ukuhlolwa "kuhleliwe ngokungahleliwe." Kufana nokuphonsa uhlamvu lwemali. Lokhu kusho ukuthi akuwona wonke umuntu ohlanganyela ocwaningweni ozothola ukwelashwa okusha, okulingayo. Uma unesifo futhi ujoyina ukuhlolwa ngethemba lokuthola ukwelashwa okusha, kubalulekile ukwazi lokhu.

Imininingwane yesivivinyo somtholampilo ngezinye izikhathi ingaba yinkimbinkimbi futhi kube nzima ukuyiqonda. Ngakho-ke, zinike isikhathi ubuze noma yimiphi imibuzo onayo, kaningi ngangokunokwenzeka. Ifomu elithi 'Imvume Enolwazi' yilokho isivivinyo somtholampilo esikuqukethe.Akuyona isivumelwano phakathi kwakho nodokotela abenza ucwaningo. Uma unquma ukujoyina ucwaningo, kuzodingeka usayine lelo phepha. Kodwa-ke, ukusayina akusho ukuthi ubophekile kukho. Unelungelo eliphelele lokushintsha umqondo wakho nokuhoxa nganoma yisiphi isikhathi, ngisho nangemva kokuba ucwaningo seluqalile.

Kwenzekani ngesikhathi sokuhlolwa kwezokwelapha?

Ngokuvamile kunezigaba ezine zesivivinyo somtholampilo. Isigaba ngasinye sinenjongo ethile. Abacwaningi bafuna izisebenzi zokuzithandela ezintsha zesigaba ngasinye. Izigaba ezine yilezi:

• Isigaba 1: Lokhu kuvame ukuhilela iqembu elincane labantu (abaphakathi kuka-20 no-100). Kungenzeka ukuthi bangabantu abaphilile abangenazo izimo zezokwelapha ezaziwayo. Abacwaningi basebenzisa lesi sigaba ukunquma umthamo ofanele womuthi nokubona ukuthi ukwelashwa kubangela noma yimiphi imiphumela emibi kakhulu.
• Isigaba sesi-2: Lokhu kuhilela abantu abaphakathi kwe-100 no-300. Bonke banesifo esithile. Kulesi sigaba, abacwaningi babheka ukuthi ukwelashwa kusebenza ngempela yini nokuthi kusha noma kunemiphumela emibi kakhulu kunangaphambili.
• Isigaba 3: Lesi sigaba singabandakanya abantu abaphakathi kuka-300 no-3,000. Yilapho abacwaningi beqinisekisa khona ukuthi ukwelashwa okuhlolwayo kuyasebenza futhi kuphephile. Bangaphinde bakuqhathanise nokwelashwa okukhona. Ezweni elifana ne-United States, i-FDA inquma ukuthi iyakuvuma yini ukwelashwa kwabantu abaningi ngokusekelwe emiphumeleni yalesi sigaba sesi-3 sokuhlolwa.
• Isigaba 4: Abacwaningi bayaqhubeka nokuqapha ukwelashwa ngisho nangemva kokuba sekuvunyelwe yi-FDA. Ngenxa yokuthi ezinye izindlela zokwelapha ezintsha zinemiphumela emibi ebonakala kuphela ngemva kokuba abantu sebesebenzise umuthi isikhathi esithile, abacwaningi bayaqhubeka nokufuna imiphumela emibi noma ezinye izinkinga.

Kwenzekani ngemva kokuhlolwa kwezokwelapha?

Isivivinyo somtholampilo singaphela ngezizathu ezahlukahlukene. Isibonelo, ukwelashwa okwakusesigabeni socwaningo kungenzeka ukuthi kuvunyelwe yi-FDA futhi kwatholakala kubantu abaningi. Kodwa-ke, ngezinye izikhathi, uma izivivinyo zibonisa ukuthi ukwelashwa akuphumelelanga njengoba bekulindelekile, noma akungcono kunezindlela zokwelapha ezikhona, isivivinyo somtholampilo singamiswa ngaphambi kokuqeda zonke izigaba ezine.

Yiziphi izinzuzo zokujoyina isivivinyo somtholampilo?

Kunezinzuzo eziningana zokuba yingxenye yesivivinyo somtholampilo. Uma unesifo esithile:

• Kungase kube nethuba lokuthola ukwelashwa okusha okungase kube ngcono kunezokwelapha zamanje.
• Ungadlala indima ekhuthele ekwenzeni izinqumo mayelana nokunakekelwa kwempilo yakho.
• Ungasiza abanye abanesifo esifana nesakho.

Uma uphilile, uzoba nenjabulo yokusiza abacwaningi ukuthola izindlela zokwelapha ezingcono zabanye.

Ziyini izingozi?

Izivivinyo zemitholampilo zingafika nezingozi ezithile. Uzokwaziswa ngalezi zingozi uma unikeza "imvume yakho enolwazi." Kodwa-ke, ungacela ulwazi olwengeziwe nganoma yisiphi isikhathi. Uma izingozi zishintsha ngesikhathi sesivivinyo, noma uma kuvela izingozi ezintsha, uzokwaziswa. Usungabe usucabanga kabusha ukuthi uhlanganyele yini. Ezinye zezingozi ezingaba khona zifaka:

• Ukwelashwa, okusesesigabeni socwaningo , kungabangela imiphumela emibi engadinga ukwelashwa.
• Lokhu kuhlolwa kungathatha isikhathi eside kunokwelashwa okuvamile kwesimo sakho. Isibonelo, kungase kube nokubonana nodokotela, ukuhlolwa, noma ukulaliswa esibhedlela okuningi kunokuvamile.
• Ukwelashwa okusekelwe ocwaningweni kungase kungasebenzi, noma kungase kungabi kuhle njengokwelashwa okujwayelekile.
• Ungase ungakutholi ukwelashwa okusekelwe ocwaningweni okuhlolwayo. Ungase uthole ukwelashwa okuvamile kwesimo sakho, noma ungase ubekwe eqenjini le-"placebo", lapho ungakutholi nhlobo ukwelashwa.

Yimiphi imibuzo okufanele ngiyibuze mayelana nokuhlolwa kwezokwelapha?

Njengabantu abaningi, ungase ube nemibuzo eminingi mayelana nokuzithandela ekuhlolweni kwezokwelapha. Nansi eminye imibuzo ongayibuza:

• Kungani kwenziwa lolu cwaningo?
• Kudingeka ngibambe iqhaza isikhathi esingakanani kulolu cwaningo?
• Uma ngithola ukwelashwa, kuzonikezwa kanjani (njengephilisi, njenge-`IV`, njenge-`implant`, njll.)?
• Kuzodingeka ngize kangaki? Kuzodingeka ngize kuphi?
• Kuthatha isikhathi esingakanani ukufika kanye?
• Ingabe kuzodingeka ngikhokhele noma iyiphi ingxenye yalolu cwaningo? Ingabe umshwalense wami uzokukhokhela noma yini ngalokhu?
• Ziyini izingozi zalolu cwaningo? Lokhu kuzoyithinta kanjani impilo yami?
• Kuzokwenzekani ekwelashweni kwami ​​​​kwezokwelapha uma ngingahlanganyeli noma ngingahoxi ocwaningweni?
• Ubani ophethe ukunakekelwa kwami ​​​​kwezokwelapha?
• Ingabe ngizoyithola imiphumela kulolu cwaningo?
• Uma ukwelashwa kuvunyiwe, ngizoqhubeka nokukuthola?
• Uma nginemiphumela emibi kakhulu ngenxa yokwelashwa, ngingahoxa yini ocwaningweni?

Ungesabi ukubuza le mibuzo kuphela, kodwa nanoma yini oyicabangayo.

Ubani oqinisekisa ukuphepha kwezivivinyo zemitholampilo?

Kusetshenziswe izinyathelo zokuphepha kuyo yonke inqubo yokuhlolwa kwezokwelapha ukuqinisekisa ukuphepha kwabahlanganyeli:

• Amabhodi Okuphepha Nokuqapha Idatha (ama-DSMB):Laba bakhiwe ochwepheshe bezokwelapha. Babuyekeza imiphumela kulo lonke uvivinyo lomtholampilo. Uma benquma ukuthi ukwelashwa okuphenywayo akusebenzi noma ukuthi imiphumela emibi mibi kakhulu kunalokho obekulindelekile, la mabhodi angamisa uvivinyo ngokushesha.
• Izikhungo zikahulumeni: Izikhungo ezifana ne-FDA kanye neHhovisi Lokuvikelwa Kocwaningo Lwabantu zilawula futhi ziqondisa zonke izivivinyo zemitholampilo e-United States. Kunjalo nangezinhlanganweni ezilawulayo eSri Lanka.
• Amabhodi Okubuyekeza Ezikhungo (ama-IRB): Lawa mabhodi, atholakala ezindaweni zocwaningo, kumele avume ukuhlolwa kwezokwelapha ngaphambi kokuba kwenziwe. Lawa mabhodi aqinisekisa ukuthi izisebenzi zokuzithandela azivezwa ezingozini ezingadingekile futhi avikele ukuphepha kwazo. Ama-IRB ngokuvamile akhiwa amalungu omphakathi, kanye nodokotela nabacwaningi abangeyona ingxenye yeqembu locwaningo.

Kuyini 'Isivivinyo Somtholampilo Esingahleliwe'?

Esivivinyweni "esingahleliwe", abacwaningi bafaka izisebenzi zokuzithandela emaqenjini ahlukene. Iqembu ngalinye lithola ukwelashwa okuhlukile. Mhlawumbe bahlola ukwelashwa okujwayelekile ngokwelashwa kokuhlola, noma ukwelashwa okubili kokuhlola. Amaqembu afakwa kula maqembu ngokungahleliwe, njengokuphonsa uhlamvu lwemali. Khona-ke amaqembu afana. Lokho kwenza kube lula kubacwaningi ukuthola ukuthi yikuphi ukwelashwa okungcono kakhulu.

Kuyini Isivivinyo Somtholampilo Esihlukaniswe Ngezindawo Eziningi?

Isivivinyo somtholampilo esihlukaniswe ngokwezigaba yiso lapho isivivinyo senziwa khona ezindaweni eziningi, kunokuba kube yisodwa nje. Ngokwesiko, izivivinyo zomtholampilo zidinga izisebenzi zokuzithandela ukuba ziye endaweni ethile. Kodwa-ke, esivivinyweni esihlukaniswe ngokwezigaba, izisebenzi zokuzithandela zingahlanganyela ngaphandle kokuhamba. Isibonelo, ungathola ukwelashwa ekhaya lakho, esikhungweni sezempilo esiseduze, noma elabhorethri eseduze.

Ubani ongabamba iqhaza esivivinyweni somtholampilo?

Izivivinyo zemitholampilo zineziqondiso zokufaneleka . Zikutshela ukuthi ubani ongakwazi ukuhlanganyela nongakwazi ukuhlanganyela. Akuwona wonke umuntu ofuna ukuba sesilingo semitholampilo ongahlanganyela. Lezi ziqondiso zingahluka. Kodwa, ngokuvamile, zincike ezintweni ezifana neminyaka yakho, ubulili, impilo iyonke, uhlobo lwesifo onaso, kanye nokwelashwa okuthathayo njengamanje.

Ngingayithola kanjani imininingwane ngezivivinyo zemitholampilo?

Okokuqala, khuluma nodokotela wakho okwelaphayo. Uyakwazi wena nesimo sakho, ukuze akwazi ukuncoma ukuhlolwa okufanele wena. Enye indlela ukubheka izizindalwazi zesilingo semitholampilo ku-inthanethi. Isibonelo, ungabheka izizindalwazi ezigcinwe yi-US National Center for Biotechnology Information. ESri Lanka, ungathola futhi ulwazi mayelana nocwaningo olunjalo ngezikhungo zezempilo ezifanele.

Isivivinyo somtholampilo sihluke kanjani ekwelashweni okuvamile?

Umehluko usehlobo lokunakekelwa kwezokwelapha okutholayo. Uma ugula futhi uhlanganyela esivivinyweni somtholampilo, ithimba lakho lezokwelapha elivamile lizonakekela izinkinga zakho zempilo eziqhubekayo. Ithimba lesivivinyo somtholampilo lizogxila kuphela emuthini omusha noma kudivayisi ehlolwayo. Ithimba lizoqapha impendulo yakho ekwelashweni okuphenywayo futhi lelaphe noma yimiphi imiphumela emibi ongase ube nayo.

Izivivinyo zemitholampilo yizo ezithuthukisa ezokwelapha. Uma ubheka ngaphandle, kungase kubonakale sengathi konke kumayelana nesayensi. Kodwa empeleni kumayelana nabantu abasiza ekwenzeni ezokwelapha zibe ngcono. Ngaphandle kwabavolontiya, abacwaningi abakwazi ukwazi ukuthi umbono uzoba yini ngempela ukwelashwa okuphephile nokuphumelelayo.

Isivivinyo esisodwa singelapha isifo noma sithole ukwelashwa okuphumelelayo okusiza abantu baphile isikhathi eside. Ngisho noma isivivinyo singavezi imiphumela elindelekile, sisengaholela abacwaningi endleleni ehlukile futhi bathole imiphumela ephumelelayo kakhulu. Ukunquma ukuzithandela esivivinyweni somtholampilo kuyisinqumo esikhulu. Uma ucabanga ngakho, ungangabazi ukubuza noma yimiphi imibuzo onayo, kaningi ngangokunokwenzeka, uze uzizwe uqiniseka ngesinqumo sakho.

Umlayezo Wokuya Nawe Ekhaya

Ngakho-ke, ngithemba ukuthi manje usunokuqonda okungcono ngokuthi "Isivivinyo Sezokwelapha" esasikhuluma ngaso siyini.

• Lolu ucwaningo olubalulekile ukuthola izindlela zokwelapha ezintsha.
• "Imvume Yakho Enolwazi" ibaluleke kakhulu. Yazi konke, ubuze imibuzo, bese wenza isinqumo.
• Qaphela izinzuzo kanye nezingozi.
• Unelungelo lokuhoxa esivivinyweni nganoma yisiphi isikhathi.
• Lokhu kungaphansi kwemithethonqubo eqinile kanye nezinyathelo zokuphepha.

Uma wena noma othile omaziyo ecabanga ukuhlanganyela ocwaningweni olufana nalolu, lolu lwazi lungaba usizo nakubo. Njalo khuluma nodokotela wakho ukuze uthole ulwazi olwengeziwe.

Izivivinyo zemitholampilo , imithi emisha, ucwaningo lwezokwelapha, imvume enolwazi, izigaba zokwelapha, ulwazi lwezempilo, umsebenzi wokuzithandela