A ranar 22 ga Janairu, 2024, an kammala gyara kuma an aiwatar da gyare-gyare ga ka'idojin Hukumar Abinci da Magunguna (FDA) (21 CFR 50) da suka shafi Hukumomin Bita (IRBs). gyare-gyaren sun ƙara wani sabon sashe na 50.22 wanda ke ba da izinin keɓancewa ga buƙatun yarda da aka sanar don ƙaramin bincike na haɗari.
Yayin da ƙarin sashe na 50.22 ya daidaita ka'idodin FDA IRB tare da Sashen Lafiya da Sabis na Jama'a (DHHS) dokokin IRB (wanda aka sani da Dokar gama gari: 45 CFR 46) waɗanda Ofishin Kare Binciken Bil Adama (OHRP) ke gudanarwa, kulawar harbin Covid a cikin shekaru 3-4 da suka gabata yakamata ya ɗaga tutoci ja.
A halin yanzu, ni ne shugaban IRB a wata hukumar kula da lafiyar marasa lafiya mai zaman kanta wacce ba ta riba ba wacce ke yin bincike a cikin abin da ake ɗaukar masu rauni. Don haka, na san da kyau cewa takaddun tushe waɗanda OHRP suka haɓaka tsarin tsari waɗanda IRBs ke aiki a ƙarƙashin su sune Lambar Nuremberg da Rahoton Belmont.
Komawa cikin Oktoba 2023, rubutun Brownstone na farko, Ina Ofishin Kare Bincike na Dan Adam yake, yayi tambaya game da yadda za a iya yin amincewa da samfurin magani na Phase 3 (maganin rigakafi na mRNA) ba tare da shigar da IRBs na yau da kullun ba. Musamman, lambar Nuremberg, da ke ba da sanarwar yarda, da Rahoton Belmont, wanda ke tattare da wasu abubuwa, yancin kai na jiki, waɗanda ke da tushe don sa ido kan binciken ɗan adam, da buƙatun bayanai da tsarin sa ido na aminci gaba ɗaya an yi watsi da su. Shin an tuntubi OHRP don shigar da ita, kuma idan ba haka ba, shin wani daga OHRP ya nuna damuwa? Ganin cewa an sanya waɗannan kariyar don mayar da martani ga kisan-kiyashi na likita (Holocaust da gwajin Tuskegee), za ku yi tunanin cewa za su zama sacrosanct. Ka sake tunani!
Duk da yake ban bayar da amsa kai tsaye ga tambayar da na yi ba, abubuwan Debbie Lerman, Ana Bukatar Alurar Covid mRNA Babu Sa ido kan Tsaro da kuma Ana Bukatar Alurar Covid mRNA Babu Sa ido kan Tsaro: Sashi na Biyu, da Sasha Latypova's post, Matakan EUA Ba Bincike bane ko Gwaji, ya ba da cikakken taswirar hanya game da ayyukan da aka ɗauka a zahiri wajen aiwatar da Izinin Amfani da Gaggawa (EUA) don harbin Covid. A gare ni, mafi mahimmancin binciken shine cewa halaccin amfani da EUA a cikin farar hula yana da wahala, a mafi kyau.
Tare da abin da ya gabata a matsayin baya, bari mu shiga cikin ƙwaƙƙwaran sabbin ƙa'idodin FDA, lura da cewa ban da kasancewa shugaban IRB, ni ma likita ne mai ritaya, wanda ya shafe shekaru 50 a fannin kiwon lafiya. Wannan ya haɗa da shekaru 19 na kulawar marasa lafiya kai tsaye a cikin ƙauye a matsayin Kwamitin Certified Internist, shekaru 17 na bincike na asibiti a wata hukumar kula da marasa lafiya mai zaman kanta mai zaman kanta, da sama da shekaru 35 na shiga cikin lafiyar jama'a, da kayan aikin kiwon lafiya da gudanarwa. Don haka, na kawo ɗimbin horo, ilimi, da gogewa ga wannan al'amari wanda ya keɓanta.
Abu na farko da ya kamata in nuna shine shugaban takardar rajista na IRB da nake shugabanta (kuma ga duk IRBs a Amurka):
Ma'aikatar Lafiya ta Amurka da Sabis na Jama'a (HHS)
Yin Rajista na Hukumar Binciken Cibiyoyi (IRB)
Ana amfani da wannan fom ta cibiyoyi ko ƙungiyoyi masu aiki da IRBs waɗanda ke bita:
a) Bincike da ya shafi batutuwan ɗan adam da Ma'aikatar Lafiya da Ayyukan Jama'a ke gudanarwa ko tallafawa, ko wasu sassan tarayya ko hukumomin da ke amfani da Manufofin Tarayya don Kare Abubuwan Dan Adam ga irin wannan binciken; da/ko
b) Binciken asibiti da Hukumar Abinci da Magunguna (FDA) ta Ma'aikatar Lafiya da Sabis ɗin Jama'a ta tsara.
Na zo ne don sanin cewa FDA ta fara neman ra'ayi ga canje-canjen tsarin da suka gabatar a baya a cikin 2018. Yayin da nake karɓar saƙonnin imel a kai a kai daga OHRP, Ban taba samun wani sadarwa daga FDA ba game da waɗannan canje-canjen tsari. Dangane da abu b) a sama, kuna tunanin cewa da na kusa da saman jerin. Har ila yau, ba rashin hankali ba ne a yi tsammanin wannan zai haifar da sadarwa daga OHRP, idan aka yi la'akari da dangantaka ta kut da kut tsakanin waɗannan hukumomin dangane da ayyukan IRB. A'a!
A cikin shekaru 5+ masu zuwa, sharhi 50 ne kawai aka karɓa don amsa canje-canjen tsari. Babu ɗaya daga cikin maganganun da aka ambata keɓanta don yarda da sanarwa a cikin mahallin bincike da ya shafi samfurin magunguna. Zan tattauna mahimmancin wannan a ƙasa. Zan kuma lura cewa a cikin ɗayan ƙungiyoyin taɗi na Brownstone, waɗannan canje-canjen sun haifar da sharhi kusan dozin biyu a cikin awanni 12 (7pm zuwa 7am). Yana sa mutum ya yi zargin cewa an yi ƙoƙarin kiyaye wannan al'amari a ƙarƙashin radar gwargwadon yiwuwar. Zan tattauna mahimmancin wannan kuma.
Baya ga daidaita ka'idojin FDA da DHHS, wani dalili na canje-canjen tsari shine don rage nauyin gudanarwa akan IRBs. Wannan yana tunatar da shawarar da shugabannin ƙungiyar martani na Covid (Fauci, Collins, Walensky, da Offit) suka yanke na rashin karɓar rigakafin kamuwa da cuta (na halitta) a matsayin mai inganci saboda ciwon kai na gudanarwa wanda hakan zai haifar, yana haɓaka ilimin shekaru 2,500 game da rigakafi.
Komawa ga abin da aka yi a ƙarƙashin EUA tare da magunguna na bincike na Phase 3, yana da wahala kada a yi zargin cewa an yi sauye-sauyen ka'idojin FDA, a wani ɓangare, don daidaitawa da al'amuran EUA na yau da kullun don ba wa waɗannan ayyukan alkyabbar haƙƙin haƙƙin haƙƙin haƙƙin halaccin, a ganina, ba a ba da garanti ba. Ba abin mamaki bane FDA ta so ta ci gaba da bayanin sanarwa a ƙarƙashin rufewa!
Daga hangen nesa na, IRBs sun zama bangon wuta don kare marasa lafiya daga zama batutuwan bincike marasa sani. Koyaya, nine shugaban ƙaramin IRB ɗaya wanda ke bitar, aƙalla, kusan ƙa'idodin bincike dozin a kowace shekara, kuma kaɗan ne suka haɗa da samfuran magunguna. Me game da waɗancan cibiyoyin da ke nazarin ɗaruruwan ayyukan bincike kowace shekara da suka haɗa da samfuran magunguna? Idan kuna tunanin wannan ba zai yiwu ya haifar da matsaloli ba, tunatarwa cewa shugabar Sashen Nazarin Halittu a Cibiyar Kula da Lafiya ta Kasa (abin da ke da gaske NIH's IRB) a lokacin da ake tantance magungunan Covid shine Christine Grady, matar Anthony Fauci. Da yawa don la'akari da rikici-na-sha'awa!
Idan aka yi la’akari da rashin mutuncin da manyan hukumomin lafiyar mu na jama’a ke fuskanta a halin yanzu, wanda ya haɗa da FDA, za ku yi tunanin za su yi la’akari da hakan yayin ƙoƙarin dawo da martabar su. Maimakon haka, daga inda na zauna, yana kama da sun yanke shawarar ninka kan wani mummunan tsari na yanke shawara na siyasa. Dole ne a sanar da IRBs a duk faɗin ƙasar game da waɗannan yanayi, kuma su amsa daidai. Duk abin da ake buƙata shine IRBs su nace cewa duk wani aikin bincike da ya shafi samfurin harhada magunguna dole ne ya haɗa da izini na sanarwa; ba tare da togiya ba.
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Steven Kritz, MD likita ne mai ritaya, wanda ya kasance a fagen kiwon lafiya tsawon shekaru 50. Ya sauke karatu daga SUNY Downstate Medical School kuma ya kammala zama na IM a Asibitin Kings County. Wannan ya biyo bayan kusan shekaru 40 na ƙwarewar kiwon lafiya, ciki har da shekaru 19 na kulawa da haƙuri kai tsaye a cikin ƙauyen ƙauye a matsayin Kwamitin Certified Internist; Shekaru 17 na bincike na asibiti a wata hukumar kiwon lafiya mai zaman kanta-ba don riba ba; kuma sama da shekaru 35 na shiga cikin lafiyar jama'a, da tsarin kiwon lafiya da ayyukan gudanarwa. Ya yi ritaya shekaru 5 da suka gabata, kuma ya zama memba a Hukumar Binciken Institutional Review (IRB) a hukumar da ya yi bincike a asibiti, inda ya kasance shugaban IRB tsawon shekaru 3 da suka gabata.
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