Committee on a Review of the California Institute for Regenerative Medicine's Books

The California Institute for Regenerative Medicine

Science, Governance, and the Pursuit of Cures

By: Institute of Medicine,Board on Health Sciences Policy,Committee on a Review of the California Institute for Regenerative Medicine

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The California Institute for Regenerative Medicine

Science, Governance, and the Pursuit of Cures

By: Institute of Medicine,Board on Health Sciences Policy,Committee on a Review of the California Institute for Regenerative Medicine

The California Institute for Regenerative Medicine (CIRM) was created in 2005 by The California Stem Cell Research and Cures Act (Proposition 71) to distribute $3 billion in state funds for stem cell research. The passage of Proposition 71 by the voters of California occurred at a time when federal funding for research involving human embryonic stem cells was uncertain, given the ethical questions raised by such research. During its initial period of operations, CIRM has successfully and thoughtfully provided more than $1.3 billion in awards to 59 California institutions, consistent with its stated mission. As it transitions to a broadened portfolio of grants to stimulate progress toward its translational goals, the Institute should obtain cohesive, longitudinal, and integrated advice; restructure its grant application review process; and enhance industry epresentation in aspects of its operations. CIRM's unique governance structure, while seful in its initial stages, might diminish its effectiveness moving forward. The California Institute for Regenerative Medicine: Science, Governance, and the Pursuit of Cures recommends specific steps to enhance CIRM's organization and management, as well as its scientific policies and processes, as it transitions to the critical next stages of its research and development program.

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177

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National Academies Press

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ISBN 10

0309265908

ISBN 13

9780309265904

The California Institute for Regenerative Medicine

Science, Governance, and the Pursuit of Cures

By: Institute of Medicine,Board on Health Sciences Policy,Committee on a Review of the California Institute for Regenerative Medicine

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The California Institute for Regenerative Medicine

Science, Governance, and the Pursuit of Cures

By: Institute of Medicine,Board on Health Sciences Policy,Committee on a Review of the California Institute for Regenerative Medicine

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177

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National Academies Press

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ISBN 10

0309265908

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9780309265904

Final Report of the National Academies' Human Embryonic Stem Cell Research Advisory Committee and 2010 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research

By: National Research Council,Institute of Medicine,Board on Health Sciences Policy,Division on Earth and Life Studies,Board on Life Sciences,Human Embryonic Stem Cell Research Advisory Committee

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Final Report of the National Academies' Human Embryonic Stem Cell Research Advisory Committee and 2010 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research

By: National Research Council,Institute of Medicine,Board on Health Sciences Policy,Division on Earth and Life Studies,Board on Life Sciences,Human Embryonic Stem Cell Research Advisory Committee

In 2005, the National Academies released the book, Guidelines for Human Embryonic Stem Cell Research, which offered a common set of ethical standards for a field that, due to the absence of comprehensive federal funding, was lacking national standards for research. In order to keep the Guidelines up to date, given the rapid pace of scientific and policy developments in the field of stem cell research, the Human Embryonic Stem Cell Research Advisory Committee was established in 2006 with support from The Ellison Medical Foundation, The Greenwall Foundation, and the Howard Hughes Medical Institute. As it did in 2007 and 2008, the Committee identified issues that warranted revision, and this book addresses those issues in a third and final set of amendments. Specifically, this book sets out an updated version of the National Academies' Guidelines, one that takes into account the new, expanded role of the NIH in overseeing hES cell research. It also identifies those avenues of continuing National Academies' involvement deemed most valuable by the research community and other significant stakeholders.

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National Academies Press

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ISBN 10

0309156009

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9780309156004

2008 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research

By: National Research Council,Institute of Medicine,Board on Health Sciences Policy,Division on Earth and Life Studies,Board on Life Sciences,Human Embryonic Stem Cell Research Advisory Committee

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2008 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research

By: National Research Council,Institute of Medicine,Board on Health Sciences Policy,Division on Earth and Life Studies,Board on Life Sciences,Human Embryonic Stem Cell Research Advisory Committee

In 2005, the National Academies released the report Guidelines for Human Embryonic Stem Cell Research, which offered a common set of ethical standards for a field that, due to the absence of comprehensive federal funding, was lacking national standards for research. In order to keep the Guidelines up to date, given the rapid pace of scientific developments in the field of stem cell research, the Human Embryonic Stem Cell Research Advisory Committee was established in 2006 with support from The Ellison Medical Foundation, The Greenwall Foundation, and the Howard Hughes Medical Institute. As it did in 2007, the Committee identified issues that warranted revision, and this book addresses those issues in a second set of amendments. Most importantly, this book addresses new scientific developments in reprogramming of somatic cells to pluripotency by adding a new section and revising other relevant sections of the Guidelines.

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National Academies Press

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ISBN 10

0309122201

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9780309122207

Building on Canada's Strengths in Regenerative Medicine

By: Workshop Steering Committee

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Building on Canada's Strengths in Regenerative Medicine

By: Workshop Steering Committee

K2P 2K3 Notice: The project that is the subject of this report was undertaken with the approval of the Board of Governors of the Council of Canadian Academies (CCA). [...] Any opinions, findings, or conclusions expressed in this publication are those of the authors, the Steering Committee of the Workshop on the Opportunities and Challenges for Regenerative Medicine in Canada and do not necessarily represent the views of their organizations of affiliation or employment, or the sponsoring organization, Innovation, Science and Economic Development Canada. [...] The Council of Canadian Academies iii the Council of Canadian academies Science Advice in the Public Interest The Council of Canadian Academies (CCA) is an The Canadian Academy of Engineering (CAE) independent, not-for-profit organization that supports The CAE is the national institution through which Canada's independent, science-based, authoritative expert assessments most distinguished and expe [...] My personal thanks also to the other members of the Steering Committee who donated their time and Recognition of the importance and potential of regenerative expertise to plan the workshop and ensure this summary medicine led to the workshop summarized in this report. [...] The role of the report review monitor is to ensure that the Steering Committee give full and fair consideration to the submissions of the report reviewers.

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Council of Canadian Academies

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1926522230

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9781926522234

Sharing Clinical Trial Data

Maximizing Benefits, Minimizing Risk

By: Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data

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Sharing Clinical Trial Data

Maximizing Benefits, Minimizing Risk

By: Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data

Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.

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236

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National Academies Press

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ISBN 10

0309316324

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9780309316323

2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research

By: National Research Council,Institute of Medicine,Board on Health Sciences Policy,Division on Earth and Life Studies,Board on Life Sciences,Human Embryonic Stem Cell Research Advisory Committee

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2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research

By: National Research Council,Institute of Medicine,Board on Health Sciences Policy,Division on Earth and Life Studies,Board on Life Sciences,Human Embryonic Stem Cell Research Advisory Committee

In 2005, the National Academies released the report Guidelines for Human Embryonic Stem Cell Research, which offered a common set of ethical standards for a field that, due to the absence of comprehensive federal funding, was lacking national standards for research. In order to keep the Guidelines up to date, given the rapid pace of scientific developments in the field of stem cell research, the Human Embryonic Stem Cell Research Advisory Committee was established in 2006 with support from The Ellison Medical Foundation, The Greenwall Foundation, and the Howard Hughes Medical Institute. This letter report is the committee's first set of amendments to the Guidelines and clarifies earlier recommendations and conclusions, including the criteria for determining which stem cell lines it is acceptable to use. Future deliberations of the committee will address items for which additional information gathering and more extensive debate and discussion will be necessary.

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National Academies Press

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ISBN 10

0309105595

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9780309105590

Addressing Sickle Cell Disease

A Strategic Plan and Blueprint for Action

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Population Health and Public Health Practice,Committee on Addressing Sickle Cell Disease: A Strategic Plan and Blueprint for Action

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Addressing Sickle Cell Disease

A Strategic Plan and Blueprint for Action

Sickle cell disease (SCD) is a genetic condition that affects approximately 100,000 people in the United States and millions more globally. Individuals with SCD endure the psychological and physiological toll of repetitive pain as well as side effects from the pain treatments they undergo. Some adults with SCD report reluctance to use health care services, unless as a last resort, due to the racism and discrimination they face in the health care system. Additionally, many aspects of SCD are inadequately studied, understood, and addressed. Addressing Sickle Cell Disease examines the epidemiology, health outcomes, genetic implications, and societal factors associated with SCD and sickle cell trait (SCT). This report explores the current guidelines and best practices for the care of patients with SCD and recommends priorities for programs, policies, and research. It also discusses limitations and opportunities for developing national SCD patient registries and surveillance systems, barriers in the healthcare sector associated with SCD and SCT, and the role of patient advocacy and community engagement groups.

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523

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National Academies Press

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ISBN 10

030966960X

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9780309669603

Growing Innovation Clusters for American Prosperity

Summary of a Symposium

By: National Research Council,Policy and Global Affairs,Board on Science, Technology, and Economic Policy,Committee on Competing in the 21st Century: Best Practice in State and Regional Innovation Initiatives

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Growing Innovation Clusters for American Prosperity

Summary of a Symposium

Responding to the challenges of fostering regional growth and employment in an increasingly competitive global economy, many U.S. states and regions have developed programs to attract and grow companies as well as attract the talent and resources necessary to develop innovation clusters. These state and regionally based initiatives have a broad range of goals and increasingly include significant resources, often with a sectoral focus and often in partnership with foundations and universities. These are being joined by recent initiatives to coordinate and concentrate investments from a variety of federal agencies that provide significant resources to develop regional centers of innovation, business incubators, and other strategies to encourage entrepreneurship and high-tech development. This has led to renewed interest in understanding the nature of innovation clusters and public policies associated with successful cluster development. The Board on Science, Technology, and Economic Policy (STEP), conducted a symposium which brought together state and federal government officials, leading analysts, congressional staff, and other stakeholders to explore the role of clusters in promoting economic growth, the government's role in stimulating clusters, and the role of universities and foundations in their development. Growing Innovation Clusters for American Prosperity captures the presentations and discussions of the 2009 STEP symposium on innovation clusters. It includes an overview highlighting key issues raised at the meeting and a summary of the meeting's presentations. This report has been prepared by the workshop rapporteur as a factual summary of what occurred at the workshop.

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186

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National Academies Press

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ISBN 10

030915622X

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9780309156226

Stem Cells and the Future of Regenerative Medicine

By: Institute of Medicine,Board on Neuroscience and Behavioral Health,National Research Council,Division on Earth and Life Studies,Board on Life Sciences,Committee on the Biological and Biomedical Applications of Stem Cell Research

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Stem Cells and the Future of Regenerative Medicine

Recent scientific breakthroughs, celebrity patient advocates, and conflicting religious beliefs have come together to bring the state of stem cell researchâ€"specifically embryonic stem cell researchâ€"into the political crosshairs. President Bush's watershed policy statement allows federal funding for embryonic stem cell research but only on a limited number of stem cell lines. Millions of Americans could be affected by the continuing political debate among policymakers and the public. Stem Cells and the Future of Regenerative Medicine provides a deeper exploration of the biological, ethical, and funding questions prompted by the therapeutic potential of undifferentiated human cells. In terms accessible to lay readers, the book summarizes what we know about adult and embryonic stem cells and discusses how to go about the transition from mouse studies to research that has therapeutic implications for people. Perhaps most important, Stem Cells and the Future of Regenerative Medicine also provides an overview of the moral and ethical problems that arise from the use of embryonic stem cells. This timely book compares the impact of public and private research funding and discusses approaches to appropriate research oversight. Based on the insights of leading scientists, ethicists, and other authorities, the book offers authoritative recommendations regarding the use of existing stem cell lines versus new lines in research, the important role of the federal government in this field of research, and other fundamental issues.

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113

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National Academies Press

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ISBN 10

0309076307

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9780309076302

Oversight and Review of Clinical Gene Transfer Protocols

Assessing the Role of the Recombinant DNA Advisory Committee

By: Institute of Medicine,Board on Health Sciences Policy,Committee on the Independent Review and Assessment of the Activities of the NIH Recombinant DNA Advisory Committee

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Oversight and Review of Clinical Gene Transfer Protocols

Assessing the Role of the Recombinant DNA Advisory Committee

By: Institute of Medicine,Board on Health Sciences Policy,Committee on the Independent Review and Assessment of the Activities of the NIH Recombinant DNA Advisory Committee

Gene transfer research is a rapidly advancing field that involves the introduction of a genetic sequence into a human subject for research or diagnostic purposes. Clinical gene transfer trials are subject to regulation by the U.S. Food and Drug Administration (FDA) at the federal level and to oversight by institutional review boards (IRBs) and institutional biosafety committees (IBCs) at the local level before human subjects can be enrolled. In addition, at present all researchers and institutions funded by the National Institutes of Health (NIH) are required by NIH guidelines to submit human gene transfer protocols for advisory review by the NIH Recombinant DNA Advisory Committee (RAC). Some protocols are then selected for individual review and public discussion. Oversight and Review of Clinical Gene Transfer Protocols provides an assessment of the state of existing gene transfer science and the current regulatory and policy context under which research is investigated. This report assesses whether the current oversight of individual gene transfer protocols by the RAC continues to be necessary and offers recommendations concerning the criteria the NIH should employ to determine whether individual protocols should receive public review. The focus of this report is on the standards the RAC and NIH should use in exercising its oversight function. Oversight and Review of Clinical Gene Transfer Protocols will assist not only the RAC, but also research institutions and the general public with respect to utilizing and improving existing oversight processes.

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National Academies Press

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ISBN 10

030929665X

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9780309296656

Evaluation of the Congressionally Directed Medical Research Programs Review Process

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on the Health of Select Populations,Committee on the Evaluation of Research Management by DoD Congressionally Directed Medical Research Programs (CDMRP)

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Evaluation of the Congressionally Directed Medical Research Programs Review Process

The medical research landscape in the United States is supported by a variety of organizations that spend billions of dollars in government and private funds each year to seek answers to complex medical and public health problems. The largest government funder is the National Institutes of Health (NIH), followed by the Department of Defense (DoD). Almost half of DoD's medical research funding is administered by the Congressionally Directed Medical Research Programs (CDMRP). The mission of CDMRP is to foster innovative approaches to medical research in response to the needs of its stakeholdersâ€"the U.S. military, their families, the American public, and Congress. CDMRP funds medical research to be performed by other government and nongovernmental organizations, but it does not conduct research itself. The major focus of CDMRP funded research is the improved prevention, diagnosis, and treatment of diseases, injuries, or conditions that affect service members and their families, and the general public. The hallmarks of CDMRP include reviewing applications for research funding using a two-tiered review process, and involving consumers throughout the process. Evaluation of the Congressionally Directed Medical Research Programs Review Process evaluates the CDMRP two-tiered peer review process, its coordination of research priorities with NIH and the Department of Veterans Affairs, and provides recommendations on how the process for reviewing and selecting studies can be improved.

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165

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National Academies Press

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ISBN 10

0309450047

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9780309450041

Finding What Works in Health Care

Standards for Systematic Reviews

By: Institute of Medicine,Board on Health Care Services,Committee on Standards for Systematic Reviews of Comparative Effectiveness Research

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Finding What Works in Health Care

Standards for Systematic Reviews

By: Institute of Medicine,Board on Health Care Services,Committee on Standards for Systematic Reviews of Comparative Effectiveness Research

Healthcare decision makers in search of reliable information that compares health interventions increasingly turn to systematic reviews for the best summary of the evidence. Systematic reviews identify, select, assess, and synthesize the findings of similar but separate studies, and can help clarify what is known and not known about the potential benefits and harms of drugs, devices, and other healthcare services. Systematic reviews can be helpful for clinicians who want to integrate research findings into their daily practices, for patients to make well-informed choices about their own care, for professional medical societies and other organizations that develop clinical practice guidelines. Too often systematic reviews are of uncertain or poor quality. There are no universally accepted standards for developing systematic reviews leading to variability in how conflicts of interest and biases are handled, how evidence is appraised, and the overall scientific rigor of the process. In Finding What Works in Health Care the Institute of Medicine (IOM) recommends 21 standards for developing high-quality systematic reviews of comparative effectiveness research. The standards address the entire systematic review process from the initial steps of formulating the topic and building the review team to producing a detailed final report that synthesizes what the evidence shows and where knowledge gaps remain. Finding What Works in Health Care also proposes a framework for improving the quality of the science underpinning systematic reviews. This book will serve as a vital resource for both sponsors and producers of systematic reviews of comparative effectiveness research.

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267

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National Academies Press

Published Date

ISBN 10

0309216710

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9780309216715

Book's by Committee on a Review of the California Institute for Regenerative Medicine

The California Institute for Regenerative Medicine

The California Institute for Regenerative Medicine

The California Institute for Regenerative Medicine

The California Institute for Regenerative Medicine

Final Report of the National Academies' Human Embryonic Stem Cell Research Advisory Committee and 2010 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research

Final Report of the National Academies' Human Embryonic Stem Cell Research Advisory Committee and 2010 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research

2008 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research

2008 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research

Building on Canada's Strengths in Regenerative Medicine

Building on Canada's Strengths in Regenerative Medicine

Sharing Clinical Trial Data

Sharing Clinical Trial Data

2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research

2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research

Addressing Sickle Cell Disease

Addressing Sickle Cell Disease

Growing Innovation Clusters for American Prosperity

Growing Innovation Clusters for American Prosperity

Stem Cells and the Future of Regenerative Medicine

Stem Cells and the Future of Regenerative Medicine

Oversight and Review of Clinical Gene Transfer Protocols

Oversight and Review of Clinical Gene Transfer Protocols

Evaluation of the Congressionally Directed Medical Research Programs Review Process

Evaluation of the Congressionally Directed Medical Research Programs Review Process

Finding What Works in Health Care

Finding What Works in Health Care

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