Research Regulatory Compliance

Research Regulatory Compliance
Author: Mark A. Suckow,Bill Yates
Publsiher: Academic Press
Total Pages: 344
Release: 2015-06-14
Genre: Medical
ISBN: 9780124200654

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Research Regulatory Compliance offers the latest information on regulations and compliance in the laboratory. With the increasing complexity of regulations and need for institutional infrastructure to deal with compliance of animal use issues, as well as a requirement surrounding human subjects, this publication provides reputable guidance and information. The book is extremely helpful as a resource for researchers, administrators, and technicians in the laboratory, and is also a great asset for faculty or new researchers coming in to the laboratory environment. It will help prepare users for the deluge of regulatory and compliance issues they will face while conducting their scientific programs. The book is edited and authored by known leaders in the field of compliance and regulations, and contains extensive research on the topics. It represents the new standard for information in every laboratory. Provides a “one-stop" , go-to resource for the many regulatory and compliance issues that affect laboratory study and research models Extremely helpful as a resource for researchers, administrators, and technicians in the laboratory, and also a great asset for faculty or new researchers coming in to the laboratory environment Focuses on United States regulations, covering both animal models and human subjects Written and edited by known leaders in the field of regulatory compliance who bring many years of collective experience to the book

Ethical Conduct of Clinical Research Involving Children

Ethical Conduct of Clinical Research Involving Children
Author: Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children
Publsiher: National Academies Press
Total Pages: 445
Release: 2004-07-09
Genre: Medical
ISBN: 9780309133388

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In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

Clinical Trials and Human Research

Clinical Trials and Human Research
Author: Fay A. Rozovsky,Rodney K. Adams
Publsiher: Jossey-Bass
Total Pages: 0
Release: 2003-06-10
Genre: Medical
ISBN: 0787965707

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This easy-to-read reference book provides a practical approach for dealing with the legal and regulatory compliance issues involved in human research. Covering a broad range of topics, such as consent, confidentiality, subject recruitment and selection, the role of the investigator and Institutional Review Board, it offers timely and useful strategies for achieving regulatory compliance while reducing liability. In addition, insurance, quality management, accreditation, and risk management are topics examined in the book. The practical insights found in this volume are not found in other books on the subject. Clinical Trials and Human Research is a practical tool to help anyone involved in clinical research.

Management of Animal Care and Use Programs in Research Education and Testing

Management of Animal Care and Use Programs in Research  Education  and Testing
Author: Robert H. Weichbrod,Gail A. (Heidbrink) Thompson,John N. Norton
Publsiher: CRC Press
Total Pages: 872
Release: 2017-09-07
Genre: Medical
ISBN: 9781498748452

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AAP Prose Award Finalist 2018/19 Management of Animal Care and Use Programs in Research, Education, and Testing, Second Edition is the extensively expanded revision of the popular Management of Laboratory Animal Care and Use Programs book published earlier this century. Following in the footsteps of the first edition, this revision serves as a first line management resource, providing for strong advocacy for advancing quality animal welfare and science worldwide, and continues as a valuable seminal reference for those engaged in all types of programs involving animal care and use. The new edition has more than doubled the number of chapters in the original volume to present a more comprehensive overview of the current breadth and depth of the field with applicability to an international audience. Readers are provided with the latest information and resource and reference material from authors who are noted experts in their field. The book: - Emphasizes the importance of developing a collaborative culture of care within an animal care and use program and provides information about how behavioral management through animal training can play an integral role in a veterinary health program - Provides a new section on Environment and Housing, containing chapters that focus on management considerations of housing and enrichment delineated by species - Expands coverage of regulatory oversight and compliance, assessment, and assurance issues and processes, including a greater discussion of globalization and harmonizing cultural and regulatory issues - Includes more in-depth treatment throughout the book of critical topics in program management, physical plant, animal health, and husbandry. Biomedical research using animals requires administrators and managers who are knowledgeable and highly skilled. They must adapt to the complexity of rapidly-changing technologies, balance research goals with a thorough understanding of regulatory requirements and guidelines, and know how to work with a multi-generational, multi-cultural workforce. This book is the ideal resource for these professionals. It also serves as an indispensable resource text for certification exams and credentialing boards for a multitude of professional societies Co-publishers on the second edition are: ACLAM (American College of Laboratory Animal Medicine); ECLAM (European College of Laboratory Animal Medicine); IACLAM (International Colleges of Laboratory Animal Medicine); JCLAM (Japanese College of Laboratory Animal Medicine); KCLAM (Korean College of Laboratory Animal Medicine); CALAS (Canadian Association of Laboratory Animal Medicine); LAMA (Laboratory Animal Management Association); and IAT (Institute of Animal Technology).

Ethical and Regulatory Aspects of Clinical Research

Ethical and Regulatory Aspects of Clinical Research
Author: Ezekiel J. Emanuel
Publsiher: Unknown
Total Pages: 532
Release: 2003
Genre: Medical
ISBN: UOM:39015058788673

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Professionals in need of such training and bioethicists will be interested.

Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development

Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development
Author: Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publsiher: National Academies Press
Total Pages: 118
Release: 2012-04-04
Genre: Medical
ISBN: 9780309222174

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The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.

Optimizing the Nation s Investment in Academic Research

Optimizing the Nation s Investment in Academic Research
Author: National Academies of Sciences, Engineering, and Medicine,Policy and Global Affairs,Board on Higher Education and Workforce,Committee on Science, Technology, and Law,Committee on Federal Research Regulations and Reporting Requirements: A New Framework for Research Universities in the 21st Century
Publsiher: National Academies Press
Total Pages: 283
Release: 2016-06-29
Genre: Science
ISBN: 9780309379519

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Research universities are critical contributors to our national research enterprise. They are the principal source of a world-class labor force and fundamental discoveries that enhance our lives and the lives of others around the world. These institutions help to create an educated citizenry capable of making informed and crucial choices as participants in a democratic society. However many are concerned that the unintended cumulative effect of federal regulations undercuts the productivity of the research enterprise and diminishes the return on the federal investment in research. Optimizing the Nation's Investment in Academic Research reviews the regulatory framework as it currently exists, considers specific regulations that have placed undue and often unanticipated burdens on the research enterprise, and reassesses the process by which these regulations are created, reviewed, and retired. This review is critical to strengthen the partnership between the federal government and research institutions, to maximize the creation of new knowledge and products, to provide for the effective training and education of the next generation of scholars and workers, and to optimize the return on the federal investment in research for the benefit of the American people.

Research Ethics and Integrity for Social Scientists

Research Ethics and Integrity for Social Scientists
Author: Mark Israel
Publsiher: SAGE
Total Pages: 286
Release: 2014-10-20
Genre: Social Science
ISBN: 9781473909168

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Ethics and integrity in research are increasingly important for social scientists around the world. We are tackling more complex problems in the face of expanding and not always sympathetic regulation. This book surveys the recent developments and debates around researching ethically and with integrity and complying with ethical requirements. The new edition pushes beyond the work of the first edition through updated and extended coverage of issues relating to international, indigenous, interdisciplinary and internet research. Through case studies and examples drawn from all continents and from across the social science disciplines, the book: demonstrates the practical value of thinking seriously and systematically about ethical conduct in social science research identifies how and why current regulatory regimes have emerged reveals those practices that have contributed to the adversarial relationships between researchers and regulators encourages all parties to develop shared solutions to ethical and regulatory problems.