Author: CanadaPublisher:
ISBN:
Category :
Languages : en
Pages : 14
Book Description
Government response to the second report of the Standing committee on Health, a study on Compassionate access to investigational therapies, first report of the Sub-Committee on HIV/AIDS
Author: CanadaCompassionate Access to Investigational Therapies
Author: Canada. Parliament. House of Commons. Sub-Committee on HIV/AIDS.Publisher:
ISBN:
Category :
Languages : en
Pages : 62
Book Description
During this study on compassionate access to experimental therapies, Health Canada generously provided the Sub- Committee with a tour of the Drugs Directorate, a seminar on new drug development and regulation in Canada, and documentation on the Emergency Drug Release Program and is proposed replacement program, the Special Access Program. This rather large volume of information has been summarized. Details of new drug development and regulation in Canada are provided in Appendix I; while a concise review of the Emergency Drug Release Program and the Special Access Program appear in Appendix II.
International Ethical Guidelines for Health-Related Research Involving Humans
Author: Council for International Organizations of Medical Sciences (CIOMS)Publisher: World Health Organization
ISBN: 9789290360889
Category : Bioethics
Languages : en
Pages : 0
Book Description
"In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.
Oversight and Review of Clinical Gene Transfer Protocols
Author: Institute of MedicinePublisher: National Academies Press
ISBN: 030929665X
Category : Medical
Languages : en
Pages : 78
Book Description
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.
Pain Management and the Opioid Epidemic
Author: National Academies of Sciences, Engineering, and MedicinePublisher: National Academies Press
ISBN: 0309459575
Category : Medical
Languages : en
Pages : 483
Book Description
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.
Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection
Author: World Health OrganizationPublisher:
ISBN: 9789241549684
Category : AIDS (Disease)
Languages : en
Pages : 429
Book Description
These guidelines provide guidance on the diagnosis of human immunodeficiency virus (HIV) infection, the use of antiretroviral (ARV) drugs for treating and preventing HIV infection and the care of people living with HIV. They are structured along the continuum of HIV testing, prevention, treatment and care. This edition updates the 2013 consolidated guidelines on the use of antiretroviral drugs following an extensive review of evidence and consultations in mid-2015, shared at the end of 2015, and now published in full in 2016. It is being published in a changing global context for HIV and for health more broadly.
The Health of Lesbian, Gay, Bisexual, and Transgender People
Author: Institute of MedicinePublisher: National Academies Press
ISBN: 0309210658
Category : Medical
Languages : en
Pages : 293
Book Description
At a time when lesbian, gay, bisexual, and transgender individuals-often referred to under the umbrella acronym LGBT-are becoming more visible in society and more socially acknowledged, clinicians and researchers are faced with incomplete information about their health status. While LGBT populations often are combined as a single entity for research and advocacy purposes, each is a distinct population group with its own specific health needs. Furthermore, the experiences of LGBT individuals are not uniform and are shaped by factors of race, ethnicity, socioeconomic status, geographical location, and age, any of which can have an effect on health-related concerns and needs. The Health of Lesbian, Gay, Bisexual, and Transgender People assesses the state of science on the health status of LGBT populations, identifies research gaps and opportunities, and outlines a research agenda for the National Institute of Health. The report examines the health status of these populations in three life stages: childhood and adolescence, early/middle adulthood, and later adulthood. At each life stage, the committee studied mental health, physical health, risks and protective factors, health services, and contextual influences. To advance understanding of the health needs of all LGBT individuals, the report finds that researchers need more data about the demographics of these populations, improved methods for collecting and analyzing data, and an increased participation of sexual and gender minorities in research. The Health of Lesbian, Gay, Bisexual, and Transgender People is a valuable resource for policymakers, federal agencies including the National Institute of Health (NIH), LGBT advocacy groups, clinicians, and service providers.
The CMS Hospital Conditions of Participation and Interpretive Guidelines
Author: Publisher:
ISBN: 9781683086857
Category :
Languages : en
Pages : 546
Book Description
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.
Research on Women's Health
Author: Guidelines for the Programmatic Management of Drug-resistant Tuberculosis
Author: World Health OrganizationPublisher: World Health Organization
ISBN: 9241547588
Category : Business & Economics
Languages : en
Pages : 271
Book Description
The emergence of extensively drug-resistant strains of tuberculosis, especially in countries with a high prevalence of human immunodeficiency virus, is a serious threat to global public health and jeopardizes efforts to effectively control the disease. This publication offers updated recommendations for the diagnosis and management of drug-resistant tuberculosis in a variety of geographical, economic and social settings, and the recording of data that enables the monitoring and evaluation of programs.--Publisher's description.