Roberto Canete VILLAFRANCA, Dirce GUILHEM, Luciana Neves Da Silva BAMPI

Responsibilities in research: The roles of sponsors

Bilimsel çalışmaların kamu denetiminde yapılması gerektiği kavramının ortayaçıkmasının dışında, sorumluluk ilkesinin de çağdaş bilimsel yaklaşım içinde özel birdurum taşıdığı kabul edilmektedir. Bu yazıda, ahlaki çatışmalar ortaya çıktığındafarklı kurumlar, ulusal ve uluslararası kuruluşlar ve ilaç endüstrisinden sponsorlarca bubağlamda yerine getirilen rollerin yansıtılması amaçlanmıştır. Denek olarak insanlarınkullanıldığı araştırmaların karmaşıklığı nedeniyle, bu konudaki tartışmaların bazı sosyalve endüstriel paydaşları da kapsayacak şekilde genişletilmesi zorunluluğu ortaya çıkmıştır. Bu özel durum farmasötik endüstriyi ilgilendiren problemlerin dışında yer alabilecek olası sponsorları tanımlama ihtiyacınıdoğurmuştur. Literatürde en çok adı geçen sponsorlar; özellikle yeni ilaçlar, aşılar ve tıbbi ürün ve ekipmanlar geliştirmekiçin uluslararası araştırmalar yürüten farmasötik endüstrisi; epidemiyolojik çalışmalar ile ihmal edilmiş hastalıklar için ilaçve aşı geliştirmeye yönelik çalışmalar yapan uluslararası organizasyonlar; bölgesel ve ulusal düzeyde özel sağlık problemlerikonusunda çalışan ulusal organizasyonlar ve araştırma alanında kendi politikalarına göre çalışmalar yapan araştırma veakademi enstitüleridir. Bu derlemede, araştırma protokol sonuçlarının hazırlık, çalışma ve dağıtım basamaklarındaki etiksorumluluğun farklı paydaşlar arasında paylaşılması gerektiği varsayılmaktadır. Bununla beraber, sponsorlar yürütülençalışmaların bütünlüğünün sağlanmasında gönüllülerin ve daha geniş anlamda toplumun korunması açısından kritik bir rolesahiptir.

Araştrımada sorumluluklar: Sponsorların rolü

The principle of responsibility assumed special status in the contemporary scenerybesides de emergence of the conception related to necessity of public control of thescientifc practice. The aim of this paper was to refect about the roles carried out bysponsors from different institutions, national and international organizations, andpharmaceutical industries when moral conficts emerge in this context. The complexityin the daily practice of researches involving human subjects points out the obligationto enlarge the panorama of the discussion on this theme, including several social andinstitutional partners. In this specifc case became necessary to know the potentialsponsors, exceeding the question concerning to the pharmaceutical industry. The mostfrequent sponsors listed in the literature were: the pharmaceutical industry, speciallyrelated to international research for development of new drugs, vaccines and medicalproducts and equipments; international organizations in the case of epidemiologicalstudies, drugs and vaccines for neglected diseases and research strengthening capabilities;national organizations working with specifc health problems of the countries or regionspopulations; and research and academic institutions that have their own policies forresearch. This paper assumes the position that an ethical conduct during the preparation,development and dissemination of a research protocol results need to be shared betweendifferent partners. However, the sponsors have a crucial role to maintain the integrity ofresearches, to guarantee the protection of volunteers and society at large.

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