25 februari 2021
Al onderzoekend leren onderzoeken
Geslaagd voor het eBROK-examen
Het wordt steeds echter, mijn ‘carrière’ als medisch-wetenschappelijk onderzoeker. Gisteren ben ik namelijk geslaagd voor het eBROK examen! BROK staat voor ‘Basiscursus Regelgeving en Organisatie voor Klinisch onderzoekers’ en de e in eBROK staat voor de digitale variant daarvan.
Al bij het schrijven van de subsidieaanvraag voor COPIED wist ik dat ik niet alleen onderzoek zou gaan doen, maar ook nog zou mogen (en moeten) leren om medisch-wetenschappelijk onderzoek te doen. In mijn opleiding tot scheikundige heb ik tenslotte geleerd moleculen te onderzoeken en geen mensen.
Over de eBROK
Tijdens de eBROK cursus staan steeds de volgende twee principes centraal:De BROK-certificering is een in Nederland door de Nederlandse Federatie van Universitair Medische Centra (NFU) erkende proeve van bekwaamheid ten aanzien van organisatie, wet- en regelgeving voor medisch-wetenschappelijk onderzoek voor onderzoekers betrokken bij mensgebonden onderzoek. In de Universitair Medische Centra (umc’s) is een BROK-certificering vereist voor deze onderzoekers. Om je BROK-certificaat te behalen, moet je aan drie kernvoorwaarden voldoen:
- Het beschermen van de rechten en het welzijn van je onderzoeksdeelnemers
- Het garanderen van de data kwaliteit
- Je moet de verplichte modules van de eBROK en minimaal één verdiepingsmodule voltooien.
- Je moet een centrum-specifieke bijeenkomst (CSB) hebben gevolgd.
- Je moet het examen voldoende hebben afgerond.
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Geleerd
Het belangrijkste wat ik heb opgestoken van de eBROK is dat ik de andere kant van de tafel – die van de onderzoeker – nu veel beter begrijp. En dat is handig, want daar zit ik nu ook 😉
Want wat zijn er veel instanties, wat zijn er een hoop wetten en richtlijnen, wat zijn er veel zaken waar je rekening mee moet houden wil je een medisch-wetenschappelijke vraag mogen en kunnen beantwoorden, wil je de rechten en welzijn van je deelnemers zo goed mogelijk beschermen en wil je je onderzoeksdata zodanig verzamelen en analyseren dat het navolgbaar, generaliseerbaar en herbruikbaar is wat je gedaan hebt.
De eBROK cursus zelf bevatte ook veel informatie die ik persoonlijk niet direct nodig had en het geheel (en vooral het examen) voelde daardoor toch net weer alsof ik op de middelbare school zat. Je moet feitjes beantwoorden die helemaal niet voor jouw situatie van toepassing zijn en die je ook best uit zou kunnen vinden zodra die situatie zich wel voordoet. Moet ik – terwijl ik geen geneesmiddelenonderzoek uitvoer – nu echt weten of de verrichter van zo’n onderzoek een SUSAR (Suspected Unexpected Serious Adverse Reaction, een onverwachte serieuze bijwerking van een medicijn dat getest wordt in het onderzoek) waarbij iemand overlijdt binnen 24 uur, 48 uur, 7 of 15 dagen moet melden bij de toetsende instantie? Het antwoord is .. Ja.
Al met al ben ik natuurlijk wel weer een heel stuk wijzer geworden. En ik had dit – net als de middelbare school – niet willen missen 🙂 Het belangrijkste is dat ik nu ook officieel verder mag met het COPIED onderzoek. Binnen 6 maanden na de start moest ik dit examen halen.
Dit (toch ook best cognitieve) obstakel heb ik weten te omzeilen.
Marina
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References:
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70918248
References:
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