A STREAMLINED APPROACH TO ETHICS REVIEW IN BRAZIL

Author(s)

Minowa E1, Bueno C1, Piedade A1, Julian G2, Matos GM3, Colabone D3, Hashimoto DA3, Clark LG2
1Evidências - Kantar Health, Campinas, Brazil, 2Evidências - Kantar Health, São Paulo, Brazil, 3Universidade de São Paulo, São Paulo, Brazil

Objectives: The number of clinical trials (CT) performed in Latin America has been growing in the last decades. Despite the favorable numbers tough, the full potential of the region is still to be reached. CT must be reviewed by an independent ethics committee (IRB), a process that may result in unusually long delays, hindering patient accrual.  Different ethics review approaches are available worldwide. In Brazil, bureaucracy and duplicity of evaluation are already established as regulatory barriers and few recommendations are available for a more streamlined ethics review system. Therefore, we aimed to evaluate the ethics review system, regulations and guidelines in selected countries in order to propose recommendations for streamlined approach in Brazil. Methods: Guidelines and regulations from Brazil, Canada, Germany, New Zealand, Australia, USA and UK were reviewed to evaluate the ethics approval system for CT in order to propose recommendations to the Brazilian ethics system. Results: Clear requirements for ethics review and ethics system definitions are available among evaluated countries. Australia and New Zealand underwent reforms in their systems that increased efficacy and shortened the time for approval. Based on those requirements and reforms, we suggest a streamlined process to improve efficiency of the Brazilian ethics system. Our proposal has four main recommendations: review of the responsibilities of local IRBs and the national IRB, development of a new regulatory process for multicenter study submissions, development of guidelines and certification of IRBs and transparency of the metrics report on research quality from IRBs. Conclusions:  Removal of duplicity of evaluation and responsibilities represented one of the mainstays of streamlined process for some countries. Guidance, certification and transparency are intended to draw the attention of IRBs, investigators and sponsor to the need to consider carefully the ethical implications of research, and thus to achieve high scientific and ethical standards.

Conference/Value in Health Info

2015-09, ISPOR Latin America 2015, Santiago, Chile

Value in Health, Vol. 18, No. 7 (November 2015)

Code

PHP55

Topic

Health Policy & Regulatory

Disease

Multiple Diseases

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