Committee to Review the Clinical and Translational Science Awards Program at the National Center for Advancing Translational Sciences's Books

The CTSA Program at NIH

Opportunities for Advancing Clinical and Translational Research

By: Institute of Medicine,Board on Health Sciences Policy,Committee to Review the Clinical and Translational Science Awards Program at the National Center for Advancing Translational Sciences

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The CTSA Program at NIH

Opportunities for Advancing Clinical and Translational Research

By: Institute of Medicine,Board on Health Sciences Policy,Committee to Review the Clinical and Translational Science Awards Program at the National Center for Advancing Translational Sciences

In 2006 the National Institutes of Health (NIH) established the Clinical and Translational Science Awards (CTSA) Program, recognizing the need for a new impetus to encourage clinical and translational research. At the time it was very difficult to translate basic and clinical research into clinical and community practice; making it difficult for individual patients and communities to receive its benefits. Since its creation the CTSA Program has expanded, with 61 sites spread across the nation's academic health centers and other institutions, hoping to provide catalysts and test beds for policies and practices that can benefit clinical and translation research organizations throughout the country. The NIH contracted with the Institute of Medicine (IOM) in 2012 to conduct a study to assess and provide recommendations on appropriateness of the CTSA Program's mission and strategic goals and whether changes were needed. The study was also address the implementation of the program by the National Center for Advancing Translational Sciences (NCATS) while exploring the CTSA's contributions in the acceleration of the development of new therapeutics. A 13-member committee was established to head this task; the committee had collective expertise in community outreach and engagement, public health and health policy, bioethics, education and training, pharmaceutical research and development, program evaluation, clinical and biomedical research, and child health research. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research is the result of investigations into previous program evaluations and assessments, open-session meetings and conference class, and the review of scientific literature. Overall, the committee believes that the CTSA Program is significant to the advancement of clinical and translational research through its contributions. The Program would benefit from a variety of revisions, however, to make it more efficient and effective.

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179

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National Academies Press

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ISBN 10

0309284740

ISBN 13

9780309284745

The CTSA Program at NIH

Opportunities for Advancing Clinical and Translational Research

By: Institute of Medicine,Board on Health Sciences Policy,Committee to Review the Clinical and Translational Science Awards Program at the National Center for Advancing Translational Sciences

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The CTSA Program at NIH

Opportunities for Advancing Clinical and Translational Research

By: Institute of Medicine,Board on Health Sciences Policy,Committee to Review the Clinical and Translational Science Awards Program at the National Center for Advancing Translational Sciences

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National Academies Press

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0309284740

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9780309284745

Developing Capacities for Teaching Responsible Science in the MENA Region

Refashioning Scientific Dialogue

By: The World Academy of Sciences (TWAS),Bibliotheca Alexandrina,National Research Council,Division on Earth and Life Studies,Board on Life Sciences,Committee on Developing a Framework for an International Faculty Development Project on Education About Research in the Life Sciences with Dual Use Potential

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Developing Capacities for Teaching Responsible Science in the MENA Region

Refashioning Scientific Dialogue

Spurred on by new discoveries and rapid technological advances, the capacity for life science research is expanding across the globe-and with it comes concerns about the unintended impacts of research on the physical and biological environment, human well-being, or the deliberate misuse of knowledge, tools, and techniques to cause harm. This report describes efforts to address dual use issues by developing institutes around the world that will help life sciences faculty learn to teach about the responsible conduct of science. Based on the successful National Academies Summer Institute for Undergraduate Biology Education and on previous NRC reports on effective methods for teaching about dual use issues, the report's authoring committee designed a general framework for the faculty institutes and chose the Middle East-North Africa (MENA) region to test a prototype faculty institute. In September 2012, the first Institute was held in Aqaba, Jordan, bringing together 28 participants from Algeria, Egypt, Jordan, Libya, and Yemen to engage with effective, evidence-based teaching methods, develop curricular materials for use in their own classrooms, and become community leaders on dual use and related topics. Developing Capacities for Teaching Responsible Science in the MENA Region: Refashioning Scientific Dialogue offers insights from the institute that will help in the design and implementation of future programs in the MENA region, and in other parts of the world.

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153

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National Academies Press

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ISBN 10

0309286425

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9780309286428

Enhancing the Effectiveness of Team Science

By: National Research Council,Division of Behavioral and Social Sciences and Education,Board on Behavioral, Cognitive, and Sensory Sciences,Committee on the Science of Team Science

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Enhancing the Effectiveness of Team Science

By: National Research Council,Division of Behavioral and Social Sciences and Education,Board on Behavioral, Cognitive, and Sensory Sciences,Committee on the Science of Team Science

The past half-century has witnessed a dramatic increase in the scale and complexity of scientific research. The growing scale of science has been accompanied by a shift toward collaborative research, referred to as "team science." Scientific research is increasingly conducted by small teams and larger groups rather than individual investigators, but the challenges of collaboration can slow these teams' progress in achieving their scientific goals. How does a team-based approach work, and how can universities and research institutions support teams? Enhancing the Effectiveness of Team Science synthesizes and integrates the available research to provide guidance on assembling the science team; leadership, education and professional development for science teams and groups. It also examines institutional and organizational structures and policies to support science teams and identifies areas where further research is needed to help science teams and groups achieve their scientific and translational goals. This report offers major public policy recommendations for science research agencies and policymakers, as well as recommendations for individual scientists, disciplinary associations, and research universities. Enhancing the Effectiveness of Team Science will be of interest to university research administrators, team science leaders, science faculty, and graduate and postdoctoral students.

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255

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National Academies Press

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ISBN 10

0309316855

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9780309316859

Returning Individual Research Results to Participants

Guidance for a New Research Paradigm

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories

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Returning Individual Research Results to Participants

Guidance for a New Research Paradigm

When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research resultsâ€"such as results with unknown validityâ€"and the associated burdens on the research enterprise are competing considerations. Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholdersâ€"investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participantsâ€"and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations.

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399

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National Academies Press

Published Date

ISBN 10

0309475171

ISBN 13

9780309475174

Progress Toward Transforming the Integrated Risk Information System (IRIS) Program

A 2018 Evaluation

By: National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee to Review Advances Made to the IRIS Process

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Progress Toward Transforming the Integrated Risk Information System (IRIS) Program

A 2018 Evaluation

By: National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee to Review Advances Made to the IRIS Process

Over the past several years, the US Environmental Protection Agency (EPA) has been transforming the procedures of its Integrated Risk Information System (IRIS), a program that produces hazard and doseâ€'response assessments of environmental chemicals and derives toxicity values that can be used to estimate risks posed by exposures to them. The transformation was initiated after suggestions for program reforms were provided in a 2011 report from the National Academies of Sciences, Engineering, and Medicine that reviewed a draft IRIS assessment of formaldehyde. In 2014, the National Academies released a report that reviewed the IRIS program and evaluated the changes implemented in it since the 2011 report. Since 2014, new leadership of EPA's National Center for Environmental Assessment (NCEA) and IRIS program has instituted even more substantive changes in the IRIS program in response to the recommendations in the 2014 report. Progress Toward Transforming the Integrated Risk Information System Program: A 2018 Evaluation reviews the EPA's progress toward addressing the past recommendations from the National Academies.

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130

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National Academies Press

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ISBN 10

0309474949

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9780309474948

NIH Extramural Center Programs

Criteria for Initiation and Evaluation

By: Institute of Medicine,Board on Health Sciences Policy,Committee for Assessment of NIH Centers of Excellence Programs

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NIH Extramural Center Programs

Criteria for Initiation and Evaluation

By: Institute of Medicine,Board on Health Sciences Policy,Committee for Assessment of NIH Centers of Excellence Programs

Grants for research centers located in universities, medical centers, and other nonprofit research institutions account for about 9 percent of the National Institutes of Health budget. Centers are popular because they can bring visibility, focus, and increased resources to bear on specific diseases. However, congressional debate in 2001 over proposed legislation directing NIH to set up centers for muscular dystrophy research highlighted several areas of uncertainty about how to decide when centers are an appropriate research mechanism in specific cases. The debate also highlighted a growing trend among patient advocacy groups to regard centers as a key element of every disease research program, regardless of how much is known about the disease in question, the availability of experienced researchers, and other factors. This book examines the criteria and procedures used in deciding whether to establish new specialized research centers. It discusses the future role of centers in light of the growing trend of large-scale research in biomedicine, and it offers recommendations for improving the classification and tracking of center programs, clarifying and improving the decision process and criteria for initiating center programs, resolving the occasional disagreements over the appropriateness of centers, and evaluating the performance of center programs more regularly and systematically.

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233

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National Academies Press

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ISBN 10

0309091527

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9780309091527

Genomic Epidemiology Data Infrastructure Needs for SARS-CoV-2

Modernizing Pandemic Response Strategies

By: National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Life Sciences,Health and Medicine Division,Board on Health Sciences Policy,Committee on Data Needs to Monitor the Evolution of SARS-CoV-2

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Genomic Epidemiology Data Infrastructure Needs for SARS-CoV-2

Modernizing Pandemic Response Strategies

In December 2019, new cases of severe pneumonia were first detected in Wuhan, China, and the cause was determined to be a novel beta coronavirus related to the severe acute respiratory syndrome (SARS) coronavirus that emerged from a bat reservoir in 2002. Within six months, this new virusâ€"SARS coronavirus 2 (SARS-CoV-2)â€"has spread worldwide, infecting at least 10 million people with an estimated 500,000 deaths. COVID-19, the disease caused by SARS-CoV-2, was declared a public health emergency of international concern on January 30, 2020 by the World Health Organization (WHO) and a pandemic on March 11, 2020. To date, there is no approved effective treatment or vaccine for COVID-19, and it continues to spread in many countries. Genomic Epidemiology Data Infrastructure Needs for SARS-CoV-2: Modernizing Pandemic Response Strategies lays out a framework to define and describe the data needs for a system to track and correlate viral genome sequences with clinical and epidemiological data. Such a system would help ensure the integration of data on viral evolution with detection, diagnostic, and countermeasure efforts. This report also explores data collection mechanisms to ensure a representative global sample set of all relevant extant sequences and considers challenges and opportunities for coordination across existing domestic, global, and regional data sources.

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111

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National Academies Press

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ISBN 10

0309680913

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9780309680912

Compounded Topical Pain Creams

Review of Select Ingredients for Safety, Effectiveness, and Use

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on the Assessment of the Available Scientific Data Regarding the Safety and Effectiveness of Ingredients Used in Compounded Topical Pain Creams

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Compounded Topical Pain Creams

Review of Select Ingredients for Safety, Effectiveness, and Use

Pain is both a symptom and a disease. It manifests in multiple forms and its treatment is complex. Physical, social, economic, and emotional consequences of pain can impair an individual's overall health, well-being, productivity, and relationships in myriad ways. The impact of pain at a population level is vast and, while estimates differ, the Centers for Disease Control and Prevention reported that 50 million U.S. adults are living in pain. In terms of pain's global impact, estimates suggest the problem affects approximately 1 in 5 adults across the world, with nearly 1 in 10 adults newly diagnosed with chronic pain each year. In recent years, the issues surrounding the complexity of pain management have contributed to increased demand for alternative strategies for treating pain. One such strategy is to expand use of topical pain medicationsâ€"medications applied to intact skin. This nonoral route of administration for pain medication has the potential benefit, in theory, of local activity and fewer systemic side effects. Compounding is an age-old pharmaceutical practice of combining, mixing, or adjusting ingredients to create a tailored medication to meet the needs of a patient. The aim of compounding, historically, has been to provide patients with access to therapeutic alternatives that are safe and effective, especially for people with clinical needs that cannot otherwise be met by commercially available FDA-approved drugs. Compounded Topical Pain Creams explores issues regarding the safety and effectiveness of the ingredients in these pain creams. This report analyzes the available scientific data relating to the ingredients used in compounded topical pain creams and offers recommendations regarding the treatment of patients.

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353

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National Academies Press

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030967218X

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9780309672184

Future Uses of the Department of Defense Joint Pathology Center Biorepository

By: Institute of Medicine,Board on the Health of Select Populations,Committee on the Review of the Appropriate Use of AFIP's Tissue Repository Following Its Transfer to the Joint Pathology Center

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Future Uses of the Department of Defense Joint Pathology Center Biorepository

By: Institute of Medicine,Board on the Health of Select Populations,Committee on the Review of the Appropriate Use of AFIP's Tissue Repository Following Its Transfer to the Joint Pathology Center

Founded during the Civil War as the Army Medical Museum, the Armed Forces Institute of Pathology (AFIP) amassed the world's largest collection of human pathologic specimens and was considered a premier consultation, education, and research facility by the end of the 20th century. Samples from the AFIP were instrumental in helping to solve public health mysteries, such as the sequence of the genome of the 1918 influenza virus that killed more than 40 million people worldwide. In 2005, the federal Base Realignment and Closure Commission recommended that the AFIP be closed, and its biorepository was transferred to the newly created Joint Pathology Center. During the transition, the Department of Defense asked the IOM to provide advice on operating the biorepository, managing its collection, and determining appropriate future use of specimens for consultation, education, and research. Future Uses of the Department of Defense Joint Pathology Center Biorepository, the IOM proposes a series of protocols, standards, safeguards, and guidelines that could help to ensure that this national treasure continues to be available to researchers in the years to come, while protecting the privacy of the people who provided the materials and maintaining the security of their personal information.

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183

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030926068X

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9780309260688

Book's by Committee to Review the Clinical and Translational Science Awards Program at the National Center for Advancing Translational Sciences

The CTSA Program at NIH

The CTSA Program at NIH

The CTSA Program at NIH

The CTSA Program at NIH

Developing Capacities for Teaching Responsible Science in the MENA Region

Developing Capacities for Teaching Responsible Science in the MENA Region

Enhancing the Effectiveness of Team Science

Enhancing the Effectiveness of Team Science

Returning Individual Research Results to Participants

Returning Individual Research Results to Participants

Progress Toward Transforming the Integrated Risk Information System (IRIS) Program

Progress Toward Transforming the Integrated Risk Information System (IRIS) Program

NIH Extramural Center Programs

NIH Extramural Center Programs

Genomic Epidemiology Data Infrastructure Needs for SARS-CoV-2

Genomic Epidemiology Data Infrastructure Needs for SARS-CoV-2

Compounded Topical Pain Creams

Compounded Topical Pain Creams

Future Uses of the Department of Defense Joint Pathology Center Biorepository

Future Uses of the Department of Defense Joint Pathology Center Biorepository

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