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Emergency Care Research Interagency Program Officer Working Group
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA, HRSA
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NICHD, FIC, NCI, NHLBI, NIA, NIAID, NIAMS, NIBIB, NIDDK, NIGMS, NIMH, NINDS, NLM
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This working group aims to share common challenges in conducting emergency care research; identify innovative solutions amongst the projects in NIH Institutes/Centers portfolios for common problems; discuss performance evaluation of emergency care networks; and discuss models for funding and evaluating data coordinating centers.
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Emergency Preparedness, Medical Countermeasures
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Resource Development
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OS
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NCI
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NCI provides expertise in radiation biology and radiation oncology to help guide the research and development for medical countermeasures for radiation injury and for biomarkers for assessing injury, dose and who needs treatment.
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End-stage Renal Disease (ESRD) Collaboration
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Committee, Work group, Advisory group, or Task Force
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CMS, FDA
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NIDDK, NIBIB
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Participating agencies and patient and physician groups are collaborating to help the medical product development community to understand the challenges and milestones needed to achieve the goal of a successful alternative to dialysis. Research, regulatory, and reimbursement needs for such a product are discussed on phone calls and structured meetings.
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Endocrinologic and Metabolic Drugs Advisory Committee
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Committee, Work group, Advisory group, or Task Force
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FDA
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NIAID
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This Committee provides expertise in the evaluation of evidence submitted by pharmaceutical companies to the FDA for drug approval.
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Enhanced NIH Reporting on Research Spending
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Resource Development
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CDC
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OD/OSP, OD/OER
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In early 2016, in response to a Congressional request from the FY16 Omnibus budget, NIH collaborated with the National Center for Health Statistics (NCHS) at the CDC to post federally sourced data on prevalence, from the National Health Interview Survey, and mortality, from the National Vital Statistics system, leveraging NCHS expertise to match these data sources to disease categories for which NIH reports spending totals. NIH intends to update these data on an annual basis, in regular consultation with NCHS, in order to maintain as accurate and comprehensive a dataset as possible. These data are posted alongside the RCDC spending categories on the NIH RePORT web site. NIH provided mortality data for 103 RCDC categories, and prevalence for 36, out of 265 total RCDC categories.
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Ethical, Legal and Social Issues (ELSI) Sub-study in the Biospecimen Pre-Analytical Variables (BPV) Project
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Research Initiative
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OS
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NCI, CC
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Pre-Analytical Variables (BPV) Ethical Legal and Social Implications (ELSI) Substudy is a study of the ethical, legal and social implications related to the informed consent process for biobanking. The ELSI study is designed to address current issues related to informed consent for biobanking, particularly the issues of consent for broad future research use and return of research results. The objective of the ELSI Substudy is to assess research participant comprehension and concerns related to informed consent and data sharing for biobanking across the diverse patient populations included in the BPV program. The intent of this evaluation is to improve our understanding of the issues that impact donor participation in such programs and to identify factors that may result in decreased rates of donor participation. This study provides a unique and unprecedented opportunity to address these issues in a diverse patient population of actual biospecimen contributors approached for consent using a highly harmonized informed consent document. Each Biospecimen Source Site collecting tumor tissue from surgical procedures is participating in the ELSI study. To date, several hundred interviews with BPV participants have been submitted for analysis. Data collection concluded in May of 2015 and data analysis is in progress.
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European-US Pediatric Formulations Excipients Committee
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Committee, Work group, Advisory group, or Task Force
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FDA
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NICHD
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Multinational academic, industry, and regulatory group convened to determine toxicity of excipients in pediatrics. Accomplishments include developing a database that is tested both in the EU and US.
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Evaluation of Patient Reported Outcomes Following LASIK Surgery
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Research Initiative
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FDA
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NEI
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In October 2009, the FDA, the National Eye Institute (NEI), and the Department of Defense (DoD) launched the LASIK Quality of Life Collaboration Project (LQOLCP) to help better understand the potential risk of severe problems that can result from LASIK. The project published three manuscripts in 2016 on the new questionnaire developed by the group that can be used to assess the percent of patients who develop difficulties performing their usual activities following LASIK, and to identify predictors for those patients.
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Evaluation of the Association between Maté Consumption and urinary PAH in Brazil
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Research Initiative
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CDC
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NCI
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This collaboration between CDC and NCI will measure metabolites of polycyclic aromatc hydrocarbons (PAHs) in the urine samples from individuals with different amounts of daily maté drinking.
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Evidence-Based Review & Report Program
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Resource Development
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AHRQ
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OD/DPCPSI/ODP, NCCIH, OD/DPCPSI/ODS
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This Congressionally mandated NIH Office of Dietary Supplements program reviews current scientific evidence on the efficacy and safety of dietary supplements; identifies research needs; and prepares reports of their findings.
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