[Declaration of the Chilean Academy of Medicine of Law 20.850 “On clinical trials of pharmaceutical products and medical devices” and of the bylaw that will regulate its application]. / Declaración de la Academia Chilena de Medicina sobre el Título V de la Ley 20.850 (Ley Ricarte Soto) y su proyecto de reglamento “De los ensayos clínicos de productos farmacéuticos y elementos de uso médico”.

In Chile, high cost treatments required by selected medical conditions are financed by the State, according to Law 20.850. A bylaw under discussion by the Senate regulates clinical trials, posing complex issues that will endanger local interest in front-line research: 1. The exclusive and mandatory control bestowed to the Institute of Public Health during all stages of the trials and also the surveillance of institutions performing clinical trials, overriding their Clinical Research Review Boards; 2.The 10 year period during which any adverse event is assumed to have been caused by the medication or devise evaluated by the trial, unless the contrary is proven in a judicial process; 3. Individuals submitted to the trials are entitled to free post trial access to the treatment received during the study, financed by the trial supporting entities and as long as the drug or devise is considered to be useful. While agreeing with the need to have a National Registry of Clinical Trials, we predict that the mentioned critical issues in the bylaw will lead to difficulties and unnecessary judicial processes, thus limiting clinicians’ interest in performing research. We propose to modify the bylaw, excluding responsibilities on events associated with the natural evolution of the medical condition, with patients’ ageing or with comorbidities and clinical events considered unpredictable when the protocol was accepted. We recommend that the free post trial access should be a joint decision involving the patient and the attending physician, taking in consideration that the volunteer has been exposed to risks and burdens, or when discontinuation of treatment entails a vital risk until the treatment under study has been approved and becomes available in the national market.

[Diagnosis of the productive capacity of the IMSS regarding health technologies]. / Diagnóstico de la capacidad productiva del IMSS para la generación de tecnologías en salud.

OBJECTIVE: To quantify the production capacity and performance in research and technological developments of the Mexican Social Security Institute (IMSS). MATERIAL AND METHODS: We identified and analyzed information of the legislation, human and financial resources, and infrastructure addressed for research and technological development of IMSS. We analyzed whether the information on the legal framework contained key features to boost research and technological development. Information on the human, financial, and infrastructure resources were obtained from official sources. The research productivity was identified by a bibliometric analysis in 2014; productivity in technological developments was identified by intellectual products. RESULTS: The legal framework of the IMSS has several areas for improvement to boost research and technological development, especially the guidelines for technology transfer. The IMSS has 438 researchers, 39 research units, and a budget of US$ 37.4 million for research and technological development. The rate of articles published per 10 researchers was 4.8; while rate patients was 1.8. CONCLUSIONS: The IMSS has a great potential to translate research into technological developments, it is only necessary to make some changes to the legal framework.

Final priority; National Institute on Disability and Rehabilitation Research--Disability and Rehabilitation Research Projects and Centers Program. Final priority.

The Assistant Secretary for Special Education and Rehabilitative Services announces a priority under the Disability and Rehabilitation Research Projects and Centers Program administered by the National Institute on Disability and Rehabilitation Research (NIDRR). Specifically, we announce a priority for a Disability and Rehabilitation Research Project (DRRP) on Improving Methods of Evaluating Return on Investment (ROI) for the State Vocational Rehabilitation Services Program (VR Program). The Assistant Secretary may use this priority for competitions in fiscal year (FY) 2014 and later years. We take this action to focus research attention on an area of national need. We intend for the priority to contribute to improved employment outcomes for individuals with disabilities.

Final priority; Rehabilitation Training: Rehabilitation Long-Term Training program--rehabilitation specialty areas. Final priority.

The Assistant Secretary for Special Education and Rehabilitative Services announces a priority under the Rehabilitation Training: Rehabilitation Long-Term Training program. The Assistant Secretary may use this priority for competitions in fiscal year (FY) 2014 and later years in order to fund any of the rehabilitation specialty areas listed in this notice. The specific rehabilitation specialty areas to be funded in a given year will be listed in a notice inviting applications. This priority is designed to ensure that the Department funds high-quality rehabilitation programs in the following nine rehabilitation specialty areas of national need: Rehabilitation Administration (84.129C); Rehabilitation Technology (84.129E); Vocational Evaluation and Work Adjustment (84.129F); Rehabilitation of Individuals Who Are Mentally Ill (84.129H); Rehabilitation Psychology (84.129J); Rehabilitation of Individuals Who are Blind or Have Vision Impairments (84.129P); Rehabilitation of Individuals Who are Deaf or Hard of Hearing (84.129Q); Job Development and Job Placement Services (84.129R); and Comprehensive System of Personnel Development (84.129W). These programs must meet rigorous standards in order to provide rehabilitation professionals the training and qualifications necessary to meet the current challenges facing State vocational rehabilitation (VR) agencies and related agencies and assist individuals with disabilities in achieving high-quality employment outcomes.

Final priority; National Institute on Disability and Rehabilitation Research--Rehabilitation Research and Training Centers. Final priority.

The Assistant Secretary for Special Education and Rehabilitative Services announces a priority for the Rehabilitation Research and Training Center (RRTC) Program administered by the National Institute on Disability and Rehabilitation Research (NIDRR). Specifically, we announce a priority for an RRTC on Vocational Rehabilitation Practices for Youth and Young Adults. The Assistant Secretary may use this priority for competitions in fiscal year (FY) 2014 and later years. We take this action to focus research attention on an area of national need. We intend for this priority to contribute to improved outcomes for youth and young adults with disabilities in the State Vocational Rehabilitation Services program.

Final priority; National Institute on Disability and Rehabilitation Research--Research Fellowships Program (also known as the Mary E. Switzer Research Fellowships). Final priority.

The Assistant Secretary for Special Education and Rehabilitative Services announces a priority for the Research Fellowships Program administered by the National Institute on Disability and Rehabilitation Research (NIDRR). Specifically, this notice announces a priority for a Distinguished Residential Disability and Rehabilitation Policy Fellowship. We take this action to focus attention on an area of national need. We intend the priority to build research capacity by providing support to highly qualified, experienced researchers, including those who are individuals with disabilities, to conduct policy research in the areas of disability and rehabilitation.

Final priorities; Rehabilitation Services Administration--Capacity Building Program for Traditionally Underserved Populations--vocational rehabilitation training institute for the preparation of personnel in American Indian Vocation Rehabilitation Services projects. Final priorities.

The Assistant Secretary for Special Education and Rehabilitative Services announces two priorities under the Capacity Building Program for Traditionally Underserved Populations administered by the Rehabilitation Services Administration (RSA). The Assistant Secretary may use one or more of these priorities for competitions in fiscal year (FY) 2014 and later years. Priority 1 establishes a new vocational rehabilitation (VR) training institute for the preparation of personnel in American Indian Vocational Rehabilitation Services (AIVRS) projects (the Institute). Priority 2 requires a partnership between a four-year institution of higher education (IHE) and a two-year community college or tribal college. This partnership is designed to successfully implement the VR training Institute established in Priority 1. In addition, the partnership agreement required under Priority 2 provides a brief description of how the partnership will be managed, the partners' roles and responsibilities and a strategy for sustaining the partnership after the Federal investment ends.

Final priority; National Institute on Disability and Rehabilitation Research--Rehabilitation Engineering Research Centers. Final priority.

The Assistant Secretary for Special Education and Rehabilitative Services announces a priority under the Disability and Rehabilitation Research Projects and Centers Program administered by the National Institute on Disability and Rehabilitation Research (NIDRR). Specifically, we announce a priority for a Rehabilitation Engineering Research Center (RERC) on Improving the Accessibility, Usability, and Performance of Technology for Individuals who are Deaf or Hard of Hearing. The Assistant Secretary may use this priority for competitions in fiscal year (FY) 2014 and later years. We take this action to focus research attention on an area of national need. We intend the priority to contribute to improving the accessibility, usability, and performance of technology for individuals who are deaf or hard of hearing.