Towards the development of a capacity development framework for research ethics administrators: lessons from South Africa

Abstract

𝑬𝒏𝒈𝒍𝒊𝒔𝒉 𝗜𝗻𝘁𝗿𝗼𝗱𝘂𝗰𝘁𝗶𝗼𝗻: Currently, research ethics capacity development is limited to research ethics committee (REC) members, and little research has been done on research ethics administrators, leading to lack of standardised requirements for this role, its responsibilities, and training requirements for fulfilling the supportive role for RECs. Although the role is administrative, research ethics administrators’ duties exceed those of just simple administration, and include complex demands such as preparing for audits. This study proposed and validated a capacity development framework for research ethics administrators in South Africa. 𝗠𝗲𝘁𝗵𝗼𝗱𝘀: A scoping review was done to gain deeper insight into the history and current status of REC administration, with a specific focus on capacity development programs available for research ethics administrators. A questionnaire was then distributed to 36 research ethics administrators to determine the current responsibilities, training requirements and needs of the role, focusing on the local situation of REC capacity development. The first draft of the capacity development framework was developed through triangulating findings from the scoping review and questionnaire. A Delphi survey of the designed framework, completed by 13 experts from South Africa and abroad, was then conducted until consensus was reached. 𝗥𝗲𝘀𝘂𝗹𝘁𝘀: From the 22 studies synthesised in the scoping review, two reported that there had been two capacity development efforts for administrators in Africa, namely the African Conference for Administrators of Research Ethics Committees, and the West African Bioethics Training Program. Thirty-six (36) administrators from National Health Research Ethics Council-registered ethics committees in South Africa participated in the online cross- sectional survey. Nearly 49% of the participants indicated that they had only received informal research-ethics-related training – not targeted formal training. Of the 23 research ethics experts approached, 13 participated in the Delphi Survey, and results show that 67% of them confirmed that research ethics administrators require basic, entry-level training at the level of a Bachelor’s degree to be able to fulfil their duties. 𝗖𝗼𝗻𝗰𝗹𝘂𝘀𝗶𝗼𝗻: Research ethics administrators need to have a Bachelor’s degree and be capacitated in ways comparable to the training received by research ethics committee members. The world of research is evolving fast and requires every role player in the research ethics committee to be adequately capacitated. ___________________________________________________________________ 𝑨𝒇𝒓𝒊𝒌𝒂𝒂𝒏𝒔 Tans is kapasiteitsontwikkeling van navorsingsetiek beperk tot lede van die navorsingsetiekkomitee (NEK), en min navorsing is oor navorsingsetiek-administrateurs gedoen, wat lei tot 'n gebrek aan gestandaardiseerde vereistes vir hierdie rol, die verantwoordelikhede en opleidingsvereistes om die ondersteunende rol vir NEKs te vervul. Alhoewel die rol administratief van aard is, oortref navorsingsetiek-administrateurs se pligte dié van net eenvoudige administrasie, en sluit dit komplekse eise in soos voorbereiding vir oudits. Hierdie studie het 'n kapasiteitsontwikkelingsraamwerk vir navorsingsetiek-administrateurs in Suid-Afrika voorgestel en bekragtig. 𝗠𝗲𝘁𝗼𝗱𝗲𝘀: ’n Oorsig is gedoen om ’n dieper insig te verkry in die geskiedenis en huidige status van NEK-administrasie, met 'n spesifieke fokus op kapasiteitsontwikkelingsprogramme wat beskikbaar is vir navorsingsetiek-administrateurs. ’n Vraelys is toe aan 36 navorsingsetiek-administrateurs uitgedeel om die huidige verantwoordelikhede, opleidingsvereistes en behoeftes van die rol te bepaal, met die fokus op die plaaslike situasie van NEK-kapasiteitsontwikkeling. Die eerste konsep van die kapasiteitsontwikkelingsraamwerk is ontwikkel deur bevindinge deur die omvangsoorsig en vraelys te trianguleer. ’n Delphi-opname van die ontwerpte raamwerk, voltooi deur 13 kundiges van Suid-Afrika en oorsee, is daarna gedoen totdat konsensus bereik is. 𝗥𝗲𝘀𝘂𝗹𝘁𝗮𝘁𝗲: Uit die 22 studies wat in die oorsig van die omvang gekombineer is, het twee gerapporteer dat daar twee kapasiteitontwikkelingspogings vir administrateurs in Afrika was, naamlik die Afrikakonferensie vir Administrateurs van Navorsingsetiekkomitees, en die Wes-Afrikaanse Bio-etiekopleidingsprogram. Ses-en-dertig (36) administrateurs van die Nasionale Gesondheidsnavorsingsetiekraad-geregistreerde etiekkomitees in Suid-Afrika het aan die aanlyn deursnit-opname deelgeneem. Byna 49% van die deelnemers het aangedui dat hulle slegs informele navorsingsetiekverwante opleiding ontvang het, nie geteikende formele opleiding nie. Van die 23 navorsingsetiekkundiges wat genader is, het 13 aan die Delphi-opname deelgeneem, en resultate toon dat 67% van hulle bevestig het dat navorsingsetiek-administrateurs basiese, intreevlakopleiding op die vlak van ’n Baccalaureusgraad benodig om hul pligte te kan nakom. 𝗚𝗲𝘃𝗼𝗹𝗴𝘁𝗿𝗲𝗸𝗸𝗶𝗻𝗴: Navorsingsetiekadministrateurs moet ’n Baccalaureusgraad hê en in só ’n mate bekwaam wees dat dit vergelykbaar met die opleiding is wat deur navorsingsetiekkomiteelede ontvang word. Die wêreld van navorsing ontwikkel vinnig en vereis dat elke rolspeler in die navorsingsetiekkomitee voldoende bekwaam is. ___________________________________________________________________ 𝑺𝒆𝑺𝒐𝒕𝒉𝒐 Ha jwale ntshetsopele ya bokgoni ba melawana ya boitshwaro diphuputsong e phethahatswa ke ditho tsa komiti ya diphuputso (REC) feela, mme ho entswe diphuputso feela tse fokolang mabapi le batsamaisi ba melawana ya boitshwaro diphuputsong, mme hona ho bakile hore ho se ke ha ba le ditshwanelo tse lokileng bakeng sa mosebetsi ona, boikarabelo ba ona, esita le ditshwanelo tsa kwetliso tsa ho phethahatsa seabo sa tshehetso bakeng sa di-REC. Le hoja seabo e le sa botsamaisi, mesebetsi ya batsamaisi ba melawana ya boitshwaro diphuputsong e feta botsamaisi, ebile e kenyeletsa ditlhoko tse ngata jwaloka ho hlophisa ditlhahlobo tsa dibuka kapa dioditi. Diphuputso tsena di kgothaleditse le ho tiisa tlhokeho ya moralo wa bokgoni ba ntshetsopele ya batsamaisi ba melawana ya boitshwaro bakeng sa batsamaisi ba melawana ya boitshwaro diphuputsong mona Afrika Borwa. 𝗠𝗲𝗸𝗴𝘄𝗮: Ho ile ha etswa tekolobotjha e le ho tseba haholwanyane ka nalane esita le maemo a jwale a tsamaiso ya REC, ka ho toboketsa ho ba teng ha mananeo a ntshetsopele ya bokgoni a ka fumanehang bakeng sa batsamaisi ba melawana ya boitshwaro diphuputsong. Ho ile ha ajwa lenane la dipotso ho batsamaisi ba 36 ba melawana ya boitshwaro diphuputsong e le ho theha boikarabelo esale jwale, ditshwanelo tsa kwetliso esita le ditlhoko tsa seabo, ho tadimilwe maemo a lehae a REC a ntshetsopele ya bokgoni. Tokomane ya pele ya moralo wa ntshetsopele ya bokgoni o ile wa hlahiswa ka ho eketsa diphihlello tse tswang ditekodisisong le ho lenane la dipotso. Patlisiso ya Delphi ya moralo o hlophisitsweng e tlatsitsweng ke ditsebi tse 13 tse tswang Afrika Borwa le mose ho mawatle, e ile ya etswa ho fihla tumellano ya bohle e fihlellwa. 𝗗𝗶𝗽𝗵𝗲𝘁𝗵𝗼: Ho tswa ho diphuputso tse 22 tse hokahantsweng ho tekolobotjha, tse pedi di hlalositse hore ho bile le boiteko ba bokgoni ba ntshetsopele ba batsamaisi mona Afrika, e leng African Conference for Administrators of Research Ethics Committees, le West African Bioethics Training Program. Batsamaisi ba mashome a mararo (36) ba tswang National Health Research Ethics Council ba dikomiti tse ngodisitsweng tsa melawana ya boitshwaro mona Afrika Borwa ba bile le seabo ka patlisiso ya mehala. Ekaba 49% ya bankakarolo ba bontshitsweng hore ba kwetliseditswe melawana ya diphuputso ka tsela eo e sa tlwaelehang ya molao eseng kwetliso e lebeletsweng ya molao. Ho ditsebi tse 23 tsa melawana ya boitshwaro diphuputsong tse ileng tsa botswa, ba 13 ba bile le seabo ho Dipatlisiso tsa Delphi, mme diphetho di bontsha hore 67% ya bona e tiisa hore batsamaisi ba melawana ya boitshwaro diphuputsong ba tshwanela ho ba le kwetliso ya motheo, kwetliso ya ho qala boemong ba kgau ya thuto ya Bachelor’s degree e le hore ba kgone ho phethahatsa mesebetsi ya bona. 𝗤𝗲𝘁𝗲𝗹𝗹𝗼: Batsamaisi ba melawana ya boitshwaro diphuputsong ba lokela ho ba le lengolo la kgau ya BA la komiti ya melawana ya boitshwaro diphuputsong. Lefatshe la diphuputso le hola kapele mme le hloka hore motho ka mong a be le seabo ka hara komiti ya melawana ya boitshwaro diphuputsong e le hore a be le bokgoni ka tshwanelo. ___________________________________________________________________ 𝑰𝒔𝒊𝒁𝒖𝒍𝒖 𝗜𝘀𝗶𝗻𝗴𝗲𝗻𝗶𝘀𝗼: Njengamanje, ukuthuthukiswa kwamakhono ocwaningo kunqunyelwe kumalungu ekomiti lezimiso zocwaningo (REC), futhi luncane ucwaningo olwenziwe ngabaphathi bezimiso zocwaningo, okuholele ekuntulekeni kwezidingo ezijwayelekile zale ndima, izibopho zayo, kanye nezidingo zokuqeqesha ukuze kufezwe indima yokusekela. Ama-RECs. Nakuba indima ingeyokuphatha, imisebenzi yabaphathi bezimiso zocwaningo idlula leyo yokuphatha nje elula, futhi ihlanganisa nezidingo eziyinkimbinkimbi ezifana nokulungiselela ukuhlolwa. Lolu cwaningo luhlongoze futhi lwaqinisekisa uhlaka lokuthuthukisa amakhono kubaphathi bezimiso zocwaningo eNingizimu Afrikha. 𝗜𝘇𝗶𝗻𝗱𝗹𝗲𝗹𝗮: Ukubuyekezwa kwesikophu kwenziwa ukuze kutholakale ukuqonda okujulile ngomlando kanye nesimo samanje sokuphatha i-REC, kugxilwe ngokukhethekile ezinhlelweni zokuthuthukisa amandla ezitholakalayo kubaphathi bezimiso zocwaningo. Uhlu lwemibuzo lwabe selusatshalaliswa kubaphathi bezimiso zocwaningo abangama-36 ukuze kutholwe izibopho zamanje, izidingo zokuqeqeshwa kanye nezidingo zendima, kugxilwe esimweni sendawo sokuthuthukiswa kwamandla e-REC. Uhlaka lokuqala lohlaka lokuthuthukiswa kwamandla lwathuthukiswa ngokuhlanganisa okutholwe ngonxantathu okuvela ekubuyekezweni kwesikophu kanye nohlu lwemibuzo. Ucwaningo lweDelphi ngohlaka olwakhiwe, oluphothulwe ngochwepheshe abangu-13 baseNingizimu Afrikha nakwamanye amazwe, lwenziwa kwaze kwaba kufinyelelwa esivumelwaneni. 𝗜𝗺𝗶𝗽𝗵𝘂𝗺𝗲𝗹𝗮: Ezifundweni ezingama-22 ezididiyelwe ekubuyekezweni kwesikophu, ezimbili zibike ukuthi kube nemizamo emibili yokuthuthukisa amakhono kubaphathi e-Afrikha, okuyiNgqungquthela Yase-Afrikha Yabaphathi Bamakomiti Ezimiso Zokuziphatha, kanye noHlelo Lokuqeqesha i-Bioethics lwaseNtshonalanga Afrikha. Abaphathi abangamashumi amathathu nesithupha (36) abavela emakomitini ezimiso zokuziphatha abhaliswe eMkhandlwini Kazwelonke Wezempilo eNingizimu Afrikha babambe iqhaza ocwaningweni lwe-inthanethi. Cishe u-49% wabahlanganyeli babonise ukuthi bathole kuphela ukuqeqeshwa okungahlelekile okuhlobene nezimiso zokuziphatha – hhayi ukuqeqeshwa okusemthethweni okuhlosiwe. Kochwepheshe bezimiso zocwaningo abanga-23 abahlanganyele ocwaningweni, abangu-13 babambe iqhaza ku-Delphi Survey, futhi imiphumela ibonisa ukuthi u-67% wabo uqinisekisile ukuthi abaphathi bezimiso zocwaningo badinga ukuqeqeshwa okuyisisekelo, ezingeni le-Bachelor's degree ukuze bakwazi ukufeza imisebenzi yabo. 𝗜𝘀𝗶𝗽𝗵𝗲𝘁𝗵𝗼: Abaphathi bezimiso zocwaningo kumele babe neziqu zeBachelor futhi babe namandla ngezindlela eziqhathaniswa nokuqeqeshwa okutholwe amalungu ekomiti lezimiso zocwaningo. Umhlaba wocwaningo uthuthuka ngokushesha futhi udinga wonke umuntu obambe iqhaza ekomitini lezimiso zocwaningo ukuthi anikwe amandla anele. ___________________________________________________________________