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Sabbatical in Clinical Research Management Program
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Training Initiative
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FDA, OS
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CC, FIC, NCATS, NEI, NIAID, NLM, OD
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Experienced investigators come to the NIH to learn about management of a clinical research enterprise, including topics such as planning and budget development, protocol writing and tracking and scientific review. Sabbaticals are self-directed, meaning that the participant chooses from a list of electives and helps determine how much time to spend studying each topic. The electives are offered by leaders at the NIH and other HHS agencies with the NIH Clinical Center being the most heavily involved.
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Safety and Efficacy Evaluations of Topical Microbicide (TM)/Biomedical Prevention (BP) Products in the Repeat Low-Dose Macaque SIV/SHIV Infection Model
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Research Initiative
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CDC
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NIAID
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The NIAID and CDC recognize the need to perform preclinical safety and efficacy evaluations of candidate products in the repeat low-dose (RLD) macaque SIV/SHIV infection model that has been established by CDC. NIAID established an interagency agreement with CDC in order to: 1) conduct safety and efficacy evaluations of TM/BP products in the RLD macaque model -- including pharmacokinetic/pharmacodynamic analyses of candidate biomedical prevention products; 2) utilize relevant macaque species, virus strains, and routes of infection to accomplish the proposed evaluations; and 3) perform other macaque studies as needed.
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Safety Reporting Portal
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Resource Development
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FDA
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OD/OSP
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Development of a portal to streamline the process of reporting pre- and post-market safety data to the FDA and NIH and to serve as a prototype for a federal-wide system. The Portal is an important policy innovation and major step forward in the effort to eliminate unnecessary complexities and inefficiencies associated with the current system of reporting adverse events. The Portal uses a harmonized set of terms, the Basal Adverse Event Report, to provide a single, web-based interface for standardized electronic reporting of adverse events and unanticipated problems to NIH and FDA and also enables the transmission of reports to local oversight bodies such as IRBs and DSMBs.
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Science without Borders
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Training Initiative
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OS
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NCI, NHLBI, NIAID, NICHD, NINDS, OD
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Collaboration with the Brazil Ministry of Science and Technology and the National Council for Scientific and Technological Development (CNPq) “Science without Borders” Program - The focus of the CNPq/MCT program is to collaborate with select institutions (both in US and Brazil) to advance both infrastructure and human resources in areas of science, technology and innovation. CNPq priorities under the "Science without Borders" program are to train 75,000 Brazilians in areas of science and technology over the next 4-5 years, particularly in the health sciences and engineering. Training could be both short-term (workshops/conferences) and long term/capacity building (collaborations/joint programs). CNPq would focus on top level Brazilian research institutions to select post-docs for support, but would consider applications from smaller institutions. A Letter of Understanding was established by the CNPq of Brazil and NIH (DHHS) as of September 2011.
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Scientific Advisory Committee on Alternative Toxicological Methods (SACATM)
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Committee, Work group, Advisory group, or Task Force
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ATSDR, CDC, FDA
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NCI, NIEHS, NLM, OD
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To establish criteria for validation of testing methods to reduce, refine, or replace animals in toxicity testing.
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Screening and Brief Intervention Models to Address Unhealthy Drug Use (SBIRT)
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Research Initiative
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SAMHSA
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NIDA
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Randomized controlled trial 3 arm to determine efficacy of SBIRT using the SAMHSA funded SBIRT program in Massachusetts.
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SEARCH for Diabetes in Youth
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Research Initiative
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CDC
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NIDDK
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SEARCH is a multi-center study that identifies cases of diabetes in children/youth 20 years of agin in six geographically dispersed populations that encompass the ethnic diversity of the United States.
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Secretary''s Committee on Blood Safety and Availability (BSAC)
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Committee, Work group, Advisory group, or Task Force
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CDC, CMS, FDA, OS
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CC, NHLBI
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Oversees national status of blood safety and availability, investigates problems and proposes action.
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Senate Staff Delegation visit to India and Cambodia
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Other
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CDC
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NIAID, FIC, NHLBI, NIBIB
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A delegation of 4 bipartisan staffers from the Senate Appropriations Committee traveled in August 2011 to India (Aug 8-12) and Cambodia (Aug 13-17) to view research sites that are receiving NIH funds and possibly collaborating with US researchers and/or NIH or CDC. Research collaborations were both basic and/or applied (including clinical) with either direct funding to in-country researchers or indirect funding through collaborations with U.S. researchers.
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Sex Differences in Esophageal Cancer Incidence Rates by Census Region in the United States, 1999-2008
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Research Initiative
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CDC
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NCI
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An analysis of the National Program of Cancer Registries database to assess census region sex differences in trends of esophageal squamous cell carcinoma and esophageal adenocarcinoma.
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