Download or read book Clinical Trials Registration and Results Information Submission Us Department of Health and Human Services Regulation Hhs 2018 Edition written by The Law The Law Library and published by Createspace Independent Publishing Platform. This book was released on 2018-11-07 with total page 330 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Trials Registration and Results Information Submission (US Department of Health and Human Services Regulation) (HHS) (2018 Edition) The Law Library presents the complete text of the Clinical Trials Registration and Results Information Submission (US Department of Health and Human Services Regulation) (HHS) (2018 Edition). Updated as of May 29, 2018 This final rule details the requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drug products (including biological products) and device products and for pediatric postmarket surveillances of a device product to ClinicalTrials.gov, the clinical trial registry and results data bank operated by the National Library of Medicine (NLM) of the National Institutes of Health (NIH). This rule provides for the expanded registry and results data bank specified in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) to help patients find trials for which they might be eligible, enhance the design of clinical trials and prevent duplication of unsuccessful or unsafe trials, improve the evidence base that informs clinical care, increase the efficiency of drug and device development processes, improve clinical research practice, and build public trust in clinical research. The requirements apply to the responsible party (meaning the sponsor or designated principal investigator) for certain clinical trials of drug products (including biological products) and device products that are regulated by the Food and Drug Administration (FDA) and for pediatric postmarket surveillances of a device product that are ordered by FDA. This book contains: - The complete text of the Clinical Trials Registration and Results Information Submission (US Department of Health and Human Services Regulation) (HHS) (2018 Edition) - A table of contents with the page number of each section
Download or read book The Belmont Report written by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published by . This book was released on 1978 with total page 614 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Clinical Trials Reporting and Publication written by and published by . This book was released on 2007 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The central issue before Congress with respect to clinical trials reporting and publication is how to balance the potential beneficial public health effects of requiring that clinical trials data be made public with the burdens that such requirements may place on companies and their innovation. Clinical trials, which are conducted regularly to test the effects of new pharmaceuticals and medical devices, cost a significant amount of money, and by their nature may present some risk to the people who participate in them. Manufacturers as well as medical journal editors have been reluctant to publish clinical trial data indicating that products in development are harmful or ineffective. The availability of such information might save a duplication of effort and studies that harm or fail to help patients. While current federal regulations require the publication of some clinical trials data, and some private entities have taken steps to encourage publication, there is no requirement that the public have access to all standardized clinical trials data -- be it notice of trial launch or research results through a centralized system such as a registry. Food and Drug Administration (FDA) regulations require sponsors of trials that test the effectiveness of new drugs for serious or life-threatening conditions to register with the Department of Health and Human Services (HHS) at [http://clinicaltrials.gov/], although not all such trials are listed there. Clinical trial data from National Institutes of Health (NIH)-funded research may be made public through a Freedom of Information Act request only if the findings were used by the federal government in developing an agency action that has the force and effect of law. The International Committee of Medical Journal Editors (ICMJE) requires, for publication of clinical trial results, that a sponsor have posted its trial in a public registry before enrolling patients. A voluntary registry of recent controlled trials results was created in October 2004 by the Pharmaceutical Research and Manufacturers of America (PhRMA). Proposals for public access to all or most clinical trial data raise a variety of issues. These relate to the goals of providing public access, the appropriateness of the information and its presentation for the audience, the timing of a trial's inclusion, whether reporting should be mandatory, potential conflicts of interest, and whether medical device trials should be included. Eight relevant bills have been introduced during the 110th Congress. One, the Fair Access to Clinical Trials (FACT) Act (S. 467), would require the registration of clinical trials, some of which must currently be registered at [http://clinicaltrials.gov], and the subsequent posting of their results. The act would also make public certain information about FDA's non-approval actions, which is currently not required to be released. Seven other bills, the Food and Drug Administration Revitalization Act (S. 1082), the Enhancing Drug Safety and Innovation Act of 2007 (S. 484 / H.R. 1561), the Food and Drug Administration Safety Act of 2007 (S. 468 / H.R. 788), and the Pediatric Medical Device Safety and Improvement act of 2007 (S. 830 / H.R. 1494) also contain provisions about clinical trials reporting and publication. This report will be updated on a regular basis.
Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Download or read book Human Subjects Research Regulation written by I. Glenn Cohen and published by MIT Press. This book was released on 2014-07-25 with total page 393 pages. Available in PDF, EPUB and Kindle. Book excerpt: Experts from different disciplines offer novel ideas for improving research oversight and protection of human subjects. The current framework for the regulation of human subjects research emerged largely in reaction to the horrors of Nazi human experimentation, revealed at the Nuremburg trials, and the Tuskegee syphilis study, conducted by U.S. government researchers from 1932 to 1972. This framework, combining elements of paternalism with efforts to preserve individual autonomy, has remained fundamentally unchanged for decades. Yet, as this book documents, it has significant flaws—including its potential to burden important research, overprotect some subjects and inadequately protect others, generate inconsistent results, and lag behind developments in how research is conducted. Invigorated by the U.S. government's first steps toward change in over twenty years, Human Subjects Research Regulation brings together the leading thinkers in this field from ethics, law, medicine, and public policy to discuss how to make the system better. The result is a collection of novel ideas—some incremental, some radical—for the future of research oversight and human subject protection. After reviewing the history of U.S. research regulations, the contributors consider such topics as risk-based regulation; research involving vulnerable populations (including military personnel, children, and prisoners); the relationships among subjects, investigators, sponsors, and institutional review boards; privacy, especially regarding biospecimens and tissue banking; and the possibility of fundamental paradigm shifts. Contributors Adam Braddock, Alexander Morgan Capron, Ellen Wright Clayton, I. Glenn Cohen, Susan Cox, Amy L. Davis, Hilary Eckert, Barbara J. Evans, Nir Eyal, Heidi Li Feldman, Benjamin Fombonne, Elisa A. Hurley, Ana S. Iltis, Gail H. Javitt, Greg Koski, Nicole Lockhart, Holly Fernandez Lynch, Michael McDonald, Michelle N. Meyer, Osagie K. Obasogie, Efthimios Parasidis, Govind Persad, Rosamond Rhodes, Suzanne M. Rivera, Zachary M. Schrag, Seema K. Shah, Jeffrey Skopek, Laura Stark, Patrick Taylor, Anne Townsend, Carol Weil, Brett A. Williams, Leslie E. Wolf
Download or read book Document Drafting Handbook written by Gladys Q. Ramey and published by . This book was released on 1991 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Optimizing the Nation s Investment in Academic Research written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-06-29 with total page 283 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Beyond the HIPAA Privacy Rule written by Institute of Medicine and published by National Academies Press. This book was released on 2009-03-24 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.
Download or read book Public Health Service Policy on Humane Care and Use of Laboratory Animals written by National Institutes of Health (U.S.). Office for Protection from Research Risks and published by . This book was released on 1986 with total page 40 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Protecting Human Subjects written by and published by . This book was released on 1981 with total page 282 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book The CMS Hospital Conditions of Participation and Interpretive Guidelines written by and published by . This book was released on 2017-11-27 with total page 546 pages. Available in PDF, EPUB and Kindle. Book excerpt: In addition to reprinting the PDF of the CMS CoPs and Interpretive Guidelines, we include key Survey and Certification memos that CMS has issued to announced changes to the emergency preparedness final rule, fire and smoke door annual testing requirements, survey team composition and investigation of complaints, infection control screenings, and legionella risk reduction.
Download or read book Pain Management and the Opioid Epidemic written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-09-28 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.
Download or read book Health and Human Services Acquisition Regulations Us Department of Health and Human Services Regulation Hhs 2018 Edition written by The Law The Law Library and published by Createspace Independent Publishing Platform. This book was released on 2018-11-08 with total page 138 pages. Available in PDF, EPUB and Kindle. Book excerpt: Health and Human Services Acquisition Regulations (US Department of Health and Human Services Regulation) (HHS) (2018 Edition) The Law Library presents the complete text of the Health and Human Services Acquisition Regulations (US Department of Health and Human Services Regulation) (HHS) (2018 Edition). Updated as of May 29, 2018 The Department of Health and Human Services (HHS) is issuing a final rule to amend its Federal Acquisition Regulation (FAR) Supplement, the HHS Acquisition Regulation (HHSAR), to update its regulation to current FAR requirements; to remove information from the HHSAR that consists of material that is internal, administrative, and procedural in nature; to add or revise definitions; to correct certain terminology; and to delete outdated material or material duplicative of the FAR. This book contains: - The complete text of the Health and Human Services Acquisition Regulations (US Department of Health and Human Services Regulation) (HHS) (2018 Edition) - A table of contents with the page number of each section
Download or read book Ethical Conduct of Clinical Research Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2004-07-09 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book ORI Introduction to the Responsible Conduct of Research written by Nicholas Hans Steneck and published by Government Printing Office. This book was released on 2004 with total page 188 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Cost Principles for Educational Institutions written by United States. Office of Management and Budget and published by . This book was released on 1979 with total page 72 pages. Available in PDF, EPUB and Kindle. Book excerpt:
