I-appendix ye Historical

Lesi sihlomelo somlando sinikeza isibuyekezo esifushane kakhulu sokuziphatha kocwaningo e-United States.

Noma yikuphi ukuxoxisana mayelana nokuziphatha kocwaningo kuyadingeka ukuthi ukuthi, esikhathini esidlule, abacwaningi benze izinto ezimbi ngegama lesayensi. Enye yezinto ezimbi kunazo zonke kwakuyiSifundo SeTuskegee Syphilis (itafula 6.4). Ngo-1932, abacwaningi be-US Public Health Service (PHS) babhalisa abantu abangaba ngu-400 abamnyama abathintekayo nge-syphilis ekuhloleni ukuhlola imiphumela yesifo. Laba bantu baqokelwe endaweni eseduze neTuskegee, Alabama. Kusukela ekuqaleni lolu cwaningo lwaluyi-nonherapeutic; kwaklanyelwe ukukhombisa kuphela umlando wesifo kubantu abesilisa abamnyama. Abahlanganyeli bakhohliswa mayelana nesimo socwaningo-batshelwa ukuthi kwakuyinto yokutadisha "igazi elibi" -nokuthi banikwe ukwelashwa okungamanga futhi okungenakusebenza, nakuba isifo sofuba yisifo esibulalayo. Njengoba lolu cwaningo luqhubekela phambili, ukwelashwa okuphephile futhi okuphumelelayo kwe-syphilis kwakhiwe, kodwa abacwaningi basabela ngenkuthalo ukuvimbela abahlanganyeli ukuba bangatholi ukwelashwa kwenye indawo. Isibonelo, phakathi neMpi Yezwe II, ithimba lokucwaninga laqinisekisa ukuxoshwa kwamabhalansi kuwo wonke amadoda ekucwaningweni ukuze kuvinjelwe ukwelashwa amadoda ayengayithola uma bengena eziNqabeni Zezikhali. Abacwaningi baqhubeka bekhohlisa abahlanganyeli futhi baphika ukuthi banakekela iminyaka engu-40.

Ucwaningo lwe-Tuskegee Syphilis lwenziwe ngokumelene nokwahlukana kobandlululo nokungalingani okwedlulele okwakuvamile engxenyeni eseningizimu ye-United States ngaleso sikhathi. Kodwa, ngaphezu komlando wawo weminyaka engama-40, lolu cwaningo lwabandakanya iningi labacwaningi, kokubili abamnyama nabamhlophe. Futhi, ngaphezu kwabacwaningi abahileleke ngokuqondile, abanye abaningi kumele bafunde enye yemibiko engu-15 yocwaningo olwanyatheliswa ezincwadini zezokwelapha (Heller 1972) . Maphakathi nawo-1960-eminyakeni engaba ngu-30 emva kokuqala kokutadisha-isisebenzi se-PHS okuthiwa uRobert Buxtun saqala ukunyakaza ngaphakathi kwe-PHS ukuqeda isifundo, esicabanga ukuthi sinobubi. Ephendula ku-Buxtun, ngo-1969, i-PHS yabiza iphaneli ukuba ibuyekeze ngokugcwele ukuziphatha kwesifundo. Ngokudabukisayo, iphaneli lokuhlola lokuziphatha lancume ukuthi abacwaningi kufanele baqhubeke nokugodla ukwelashwa kubantu abathintekayo. Ngesikhathi sokubheka, ilungu elilodwa lephaneli lathi: "Ngeke ube nesinye isifundo njengale; uyisebenzise " (Brandt 1978) . Iphaneli lonke elimhlophe, elalisetshenziswa kakhulu odokotela, lenze isinqumo sokuthi kufanele kutholakale uhlobo oluthile lwemvume enolwazi. Kodwa iphaneli lahluleka ukuthi la madoda angakwazi ukunikeza imvume enolwazi ngenxa yobudala bawo kanye nezinga eliphansi lemfundo. Ngakho-ke iphaneli yancoma ukuthi abacwaningi bathole "imvume yokuthola ulwazi" kusukela ezikhulwini zezokwelapha zendawo. Ngakho-ke, ngisho nangemva kokubuyekezwa okuphelele kokuziphatha, ukugodla ukunakekelwa kwaqhubeka. Ekugcineni, uBuxtun wathatha intatheli indaba, futhi ngo-1972, uJean Heller wabhala uchungechunge lwezincwadi zephephandaba ezaziveza lolu hlelo emhlabeni. Kwaphela emva kokuthukuthela komphakathi okwakusakazeka ukuthi isifundo sagcina siphelile futhi ukunakekelwa kwakunikezwa amadoda asinda.

Izisulu zalesi sifundo azibandakanyi nje kuphela amadoda angama-399, kodwa nemindeni yabo: okungenani abafazi abangu-22, izingane ezingu-17, nabazukulu ababili abane-syphilis kungenzeka ukuthi banesi sifo ngenxa yokugodla ukwelashwa (Yoon 1997) . Ngaphezu kwalokho, ukulimala okubangelwa ukutadisha kwaqhubeka isikhathi eside ngemuva kokuphela. Ukucwaninga-ngokufanelekile-kunciphise ukwethemba ukuthi ama-Afrika aseMelika asebenalo emphakathini wezokwelapha, ukuguguleka kokuthembela okungenzeka kwaholela abaseMelika baseMelika ukuba bagweme ukunakekelwa kwezempilo ukuze balimale impilo yabo (Alsan and Wanamaker 2016) . Ngaphezu kwalokho, ukungabi nethemba kwakunqanda imizamo yokwelapha i-HIV / AIDS ema-1980 nasema-90 (Jones 1993, chap. 14) .

Nakuba kunzima ukuzibona ngeso lengqondo ucwaningo ezihlasimulisa umzimba kanjalo okwenzekayo namuhla, ngicabanga kukhona izifundo ezintathu ezibalulekile Tuskegee ugcunsula Study for abantu ucwaningo emphakathini yobudala digital. Okokuqala, sisikhumbuza ukuthi kukhona abanye izifundo ukuthi umane akufanele kwenzeke. Okwesibili, lisibonisa ukuthi ucwaningo ungakulimaza hhayi nje ababambiqhaza, kodwa futhi imindeni yabo kanye yonke imiphakathi esikhathini eside ngemva kokuba ucwaningo seluphelile. Ekugcineni, kubonisa ukuthi abacwaningi ungenza izinqumo esabekayo zokuziphatha. Empeleni, ngicabanga ukuthi kufanele ntombazane abanye ngokwesaba abacwaningi namuhla ukuthi abantu abaningi kangaka abathintekayo kulolu cwaningo wenza izinqumo ezinjalo angathandeki enkathini ethile enjalo eside. Futhi, ngeshwa, Tuskegee neze eziyingqayizivele; kwakukhona nezinye izibonelo yocwaningo eziyinkinga social and medical phakathi nale nkathi (Katz, Capron, and Glass 1972; Emanuel et al. 2008) .

Ngo-1974, ekuphenduleni Ucwaningo lwe-Tuskegee Syphilis kanye nalokhu okunye ukuhluleka kokuziphatha kwabacwaningi, i-US Congress yakha iKhomishana kaZwelonke yokuVikela kwaBantu abaSebenzi bezoBubulo kanye nokuBhekwa koBuchwepheshe futhi yenza umsebenzi wokuthuthukisa iziqondiso zokuziphatha eziphathelene nezifundo zabantu. Ngemva kweminyaka emine yokuhlangana eNhlanganweni Yenkomfa yaseBelmont, leli qembu lakhiqiza umbiko weBelmont , umbiko oye wafaka umthelela omkhulu kuzo zonke izingxabano ezingabonakali kwi-bioethics kanye nomkhuba wocwaningo lwansuku zonke.

Umbiko weBelmont unezigaba ezintathu. Emikhawulweni yokuqala phakathi kobuSebenzi noCwaningo-lo mbiko ubeka umbono wayo. Ikakhulukazi, iveza ukuhlukana phakathi kocwaningo , olufuna ulwazi olutholakalayo, nokusebenza , okubandakanya ukwelashwa kwansuku zonke nemisebenzi. Ngaphezu kwalokho, kuthiwa izimiso zokuziphatha zeBelmont Report zisebenza kuphela kumcwaningi. Kuye kwaphawulwa ukuthi lokhuhluko phakathi kokucwaninga nokusebenza kungenye indlela iBelmont Report ayihambisani ngayo nokucwaninga kwezenhlalo eminyakeni yobudala (Metcalf and Crawford 2016; boyd 2016) .

Ingxenye yesibili neyesithathu yeBelmont Report ibeka izimiso ezintathu zokuziphatha-Inhlonipho yabantu; Ukuzuza; kanye nobulungiswa-futhi uchaze ukuthi lezi zimiso zingasetshenziswa kanjani ekucwaningeni. Lezi yizimiso engizichazile ngokuningiliziwe kumbhalo oyinhloko walesi sahluko.

Umbiko weBelmont ubeka imigomo ebanzi, kodwa akuyona idokhumenti engasetshenziswa kalula ukuphatha imisebenzi yansuku zonke. Ngakho-ke, uHulumeni wase-US wadala imithethonqubo ebizwa ngokuthi i- Common Rule (igama layo elisemthethweni yi-Title 45 Code of Regulations Federal, Part 46, Subparts AD) (Porter and Koski 2008) . Lezi zimiso zichaza inqubo yokubuyekeza, yokuvuma, nokuhlola ucwaningo, futhi yiyo imithethonqubo yamabhodi okubuyekezwa kwezikhungo (IRBs) anikezwe umsebenzi wokuphoqelela. Ukuze uqonde umehluko phakathi kweBelmont Report ne-Common Rule, cabanga ukuthi ngamunye ukhuluma kanjani ngemvume enolwazi: Umbiko weBelmont uchaza izizathu zefilosofi zokwamukela ulwazi nolwazi olubanzi oluzobonisa imvume yemininingwane, kanti i-Common Rule ibhala okuyisishiyagalombili okudingekayo kanye nesithupha izakhi zokuzikhethela zedokhumenti yokuvuma enolwazi. Ngokomthetho, i-Common Rule ilawula cishe yonke ucwaningo oluthola imali evela kuHulumeni wase-US. Ngaphezu kwalokho, izikhungo eziningi ezithola izimali ezivela kuHulumeni wase-US zisebenzisa uMthetho ovamile kuzo zonke izicwaningo ezenzeka kuleso sikhungo, kungakhathaliseki ukuthi umthombo wenkxaso. Kodwa i-Common Rule ayisebenzisi ngokuzenzakalelayo ezinkampanini ezingenayo imali yokucwaninga evela kuHulumeni wase-US.

Ngicabanga ukuthi cishe bonke abacwaningi bahlonipha imigomo ebanzi yokucwaninga ngokobuciko njengoba kuboniswe eBelmont Report, kodwa kukhona ukukhathazeka okujwayelekile ne-Common Rule kanye nenqubo yokusebenza ne-IRBs (Schrag 2010, 2011; Hoonaard 2011; Klitzman 2015; King and Sands 2015; Schneider 2015) . Ukuze kucace, labo abagxeka ama-IRB akuhambisani nokuziphatha. Kunalokho, bakholelwa ukuthi uhlelo lwamanje aluthathi ibhalansi elifanele noma ukuthi lungcono ukufeza imigomo yalo ngokusebenzisa ezinye izindlela. Nokho, mina, ngizothatha lezi zi-IRB njengoba kunikeziwe. Uma kudingeka ukuba ulandele imithetho ye-IRB, kufanele wenze kanjalo. Nokho, ngingathanda ukukhuthaza ukuba futhi enze izinto ngendlela izimiso ezisekelwe lapho sicabangela izimiso ucwaningo lwakho.

Lesi sizinda sifingqa ngokufingqiwe ukuthi sifinyelele kanjani esimisweni esisekelwe emthethweni sokubuyekezwa kwe-IRB e-United States. Uma sicabangela umbiko weBelmont ne-Common Rule namuhla, kufanele sikhumbule ukuthi badalwe ngenkathi ehlukile futhi babe-ngokuqonda-bephendula ezinkingeni zaleso sikhathi, ikakhulukazi ukwephulwa kwemithetho yezokwelapha ngesikhathi nangemva kweMpi Yezwe II (Beauchamp 2011) nangemva kweMpi Yezwe II (Beauchamp 2011) .

Ngaphezu kwemizamo yososayensi bezokwelapha nokuziphatha ukudala amakhodi ezinkambiso, kwakuneminye imizamo encane futhi engaziwa kakhulu ososayensi bekhompyutha. Eqinisweni, abacwaningi bokuqala ukubhekana nezinselele zokuziphatha ezidalwe yi-digital-age ucwaningo kwakungewona ososayensi bezenhlalakahle: babengabosayensi bekhompyutha, ikakhulukazi abacwaningi ekuvikelekeni kwekhompyutha. Phakathi neminyaka yama-1990 kanye no-2000, abacwaningi bezokuphepha kwekhompiyutha baqhuba izifundo eziningi ezingathandabuzi ezibandakanya izinto ezinjengokuthatha ama-botnets nokuhlaselwa ezinkulungwaneni zama-computer (Bailey, Dittrich, and Kenneally 2013; Dittrich, Carpenter, and Karir 2015) . Ephendula lezi zifundo, uHulumeni wase-US-ikakhulukazi uMnyango wezokuThuthukiswa koMakhaya-wadala ikhomishana ye-blue-ribbon ukubhala uhlaka lokuziphatha oluqondisayo lwezocwaningo oluhilela ulwazi nobuchwepheshe bokuxhumana (ICT). Umphumela walo mzamo wawuyi- Menlo Report (Dittrich, Kenneally, and others 2011) . Nakuba ukukhathazeka kwabacwaningi bezokuphepha kwekhompiyutha akufani ncamashi nabacwaningi bezenhlalakahle, i-Menlo Report inikeza izifundo ezintathu ezibalulekile kubacwaningi bezenhlalakahle.

Okokuqala, umbiko we-Menlo uqinisekisa izimiso ezintathu ze-Belmont-Inhlonipho yabantu, inzuzo, nobulungiswa-futhi yanezela okwesine: Inhlonipho yoMthetho Nesithakazelo Somphakathi . Ngichaze lesi simiso sesine nokuthi kufanele sisetshenziswe kanjani ekucwaningweni kwezenhlalakahle emibhalweni esemqoka yalesi sahluko (isigaba 6.4.4).

Okwesibili, i-Menlo Report icela abacwaningi ukuba bahambise ngaphezu kwencazelo encane "yocwaningo olubandakanya izifundo zabantu" kusukela eBelmont Report kuze kube nombono ogcwele "wokucwaninga ngamakhono okulimaza abantu." Ukulinganiselwa kobubanzi beBelmont Report kuhlelwe yi-Encore. Ama-IRB asePrinceton naseGeorgia Tech anqume ukuthi u-Encore wayengekho "ucwaningo olubandakanya izifundo zabantu," ngakho-ke aluzange lubuyekezwe ngaphansi koMthetho Ovamile. Kodwa-ke, ngokucacile i-Encore ikwazi ukulimaza abantu; ngesikhathi esibi kakhulu, i-Encore ingase ibangele abantu abangenacala beboshwa abahulumeni abacindezelayo. Indlela yokusekela imigomo isho ukuthi abacwaningi akufanele bafihle ngemuva kwencazelo encane, esemthethweni ye "ucwaningo oluhilela izifundo zabantu," ngisho noma ama-IRB ayakuvumela. Kunalokho, kufanele bathole umbono ovamile "wokucwaninga ngamakhono angonakalisa abantu" futhi kufanele bahambisane nokucwaninga kwabo siqu ngamandla okulimaza abantu ekucabangeni ngokuziphatha.

Okwesithathu, umbiko we-Menlo ucela abacwaningi ukuba bandise ababandakanyekayo abathintekayo uma besebenzisa izimiso zeBelmont. Njengoba ucwaningo luye lwasuka emkhakheni ohlukile wokuphila into ehlanganiswe kakhulu emisebenzini yansuku zonke, ukucabangela kokuziphatha kufanele kwandiswe ngaphandle kwababambiqhaza abathile bezocwaninga ukuba bahlanganise abangenayo kanye nemvelo lapho ucwaningo lwenzeka khona. Ngamanye amazwi, i-Menlo Report ifuna abacwaningi ukuba bandise insimu yabo yokuziphatha ngaphandle kwababambiqhaza.

Lesi sithasiselo somlando sinikeze ukubuyekezwa okufushane kakhulu kokuziphatha kocwaningo emayelana nesayensi yezenhlalakahle nezezokwelapha nasesayensi yekhompyutha. Ukuze uthole ukwelashwa ubude bezincwadi zokuziphatha kocwaningo kwisayensi yezokwelapha, bheka u- Emanuel et al. (2008) noma Beauchamp and Childress (2012) .