IMPLEMENTATION OF A TRAINING PROGRAM FOR THE MEMBERS OF THE

1. IMPLEMENTATION OF A TRAINING PROGRAM FOR THE MEMBERS OF THE COMMITTEES OF BIOETHICS WITHIN THE COSTA RICA SOCIAL INSURANCE INTENDED OUTCOME COIBI Daniel Bustos-Montero, MD1,2; Maureen Carvajal-Calderón MSc1,2 ;Gabriela Clare-Lobo, MD 2 1Department of Bioethics, CENDEISSS, 2Caja Costarricense de Seguro Social HOW THE PROGRAM WAS EVALUATED PROGRAM DESCRIPTION STATEMENT OF THE PROBLEM Currently, the CCSS has a network of 40 Committees of Bioethics distributed along the country. As part of its activities, the Department of Bioethics visited each Committee, in order to identify priority issues requiring immediate approach. From these visits, we concluded that the training approach should be directed to the implementation of fundamental ethical principles and training in research methodology and, as a result, an initial training program in this area has been established for the members of these committees. This program is conducted through two different methodologies: the first one, with the revision of items in each committee meeting, section called "continuing education" and the second one through structured training courses in bioethics, taught at central and regional levels, section called "training". The continuing education program proposes the review of the national and international regulations related to the field of research ethics during the regular sessions carried out by each CLOBI. With this purpose, an anthology was made, called "Regulations related to bioethics in health", so that they could have information easily accessible. With regard to training, the courses scheduled combine conferences with participatory activities and practices, which are directed in such a way as to encourage greater use of participants. This section includes courses that range from the bioethical principles to formal evidence-based medicine. The conclusion of both sections of the program entails certification as a member of a CLOBI, awarded by the Department of Bioethics. This program has been complemented by the Master’s Degree in Bioethics at the University of Costa Rica and the National University, now being pursued by six (06) staff of the CCSS, in order to strengthen the presence of people with specific studies in this field. Ever since the program was initiated, 09 courses have been made, and a total of 126 members of the CLOBI has been trained (approximately 50% of all the members). In this sense, although it is still premature to assess the impact of this program, significant progress has been obtained, affecting directly the operation of each Committee. These changes have been demonstrated during the follow-up visits made by the Department of Bioethics, as it has found a greater understanding of the functions assigned to members of the Committees and greater expertise in reviewing proposals for biomedical research. In 2005, as part of the restructuring of the Medical Management Division of the Costa Rican Social Insurance (CCSS), the Department of Bioethics was created within the Center for the Strategic Development and Information in Health and Social Security (CENDEISSS), with the mission of "creating and developing qualified instances of reflection and dialogue for decision-making, informed by ethics principles, regarding clinical issues, problems or dilemmas of clinical management and the human subject research." As a result of this reform, a process was begun in 2005, to strengthen the existing Committees of Bioethics (a total of 7) and enabling the creation of new committees in the remaining centers of the CCSS. During this process, one of the main constraints encountered by the Department of Bioethics, in order to achieve its mission, was the lack of staff trained in bioethics, specifically, in human subject research ethics. Due to this fact, it was necessary to create a training program aimed at members of the Committees, in order to optimize its operation. SUGGESTIONS FOR FUTURE USAGE OF THE PROGRAM AT CCSS This program is in a process of constant improvement, required to obtain its consolidation within the CCSS. Nevertheless, it is necessary to allow sufficient time for its implementation, and over all, to be clear that the results will be observed over the medium term. REFERENCES • A renovated social insurance in the 2025. Caja Costarricense de Seguro Social. San Jose, 2007 • Regulation of biomedical research within the Costa Rican Social Insurance. La Gaceta:233.San Jose. 2005 • Executive decree 31078-S/2003. Regulation of research involving human subjects. San Jose. 2005 To achieve the proper training of members of the Committees of Bioethics (CLOBI) within the CCSS, so that they could develop their functions in accordance with national and international parameters applied in the field of research ethics and, therefore, safeguarding the welfare of those involved in biomedical research studies CONTACT Chart 1. Number of participants per course 2007-2008. Figure 2.Committees of Bioethics within CCSS as July 2008. Figure 1.Committees of Bioethics within CCSS 2005 Daniel Bustos-Montero, MD CENDEISSS-CCSS dbustos@ccss.sa.cr Phone: (506) 2519-3044 Website: www.cendeisss.sa.cr