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International Ethical Guidelines for Health-Related Research Involving Humans
"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.
International Ethical Guidelines for Biomedical Research Involving Human Subjects
The present text is the revised/updated version of the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. It consists of 21 guidelines with commentaries. A prefatory section outlines the historical background and the revision process and includes an introduction an account of earlier instruments and guidelines a statement of ethical principles and a preamble. An Appendix lists the items to be included in the research protocol to be submitted for scientific and ethical review and clearance. The Guidelines relate mainly to ethical justification and scientific validity of research; ethical review; informed consent; vulnerability - of individuals groups comm...
CIOMS Guide to Active Vaccine Safety Surveillance
This guide offers a practical step-by-step approach and algorithm to aid immunization professionals and decision-makers in determining the best course of action if additional vaccine safety data is needed. The guide provides a structured process for evaluating whether significant knowledge gaps exist, whether passive safety surveillance is adequate, and if not, methods for and practical aspects of conducting active vaccine safety surveillance. The guide also includes an essential vaccine information source list for evaluating the extent of data resources and several case studies for review. With more vaccine solutions available and opportunities for earlier availability of new vaccine produc...
Ethics and Research on Human Subjects
Not the issue: W.K. Mariner
Glaucoma
None
Ethics, Equity, and the Renewal of WHO's Health-for-all Strategy
Records the main presentations of an international conference convened to identify the ethical concerns that need to be addressed as WHO renew its health for all policy for the 21st century. The meeting was attended by more than 150 experts in the fields of ethics, human rights, philosophy, medicine, and public health. Their contributions illustrate the many complex issues that need to be addressed when formulating global health policies for the future, particularly in view of striking recent changes in health care, disease patterns, market forces, and political systems. The report opens with a description of the WHO policy framework for achieving four goals in the 21st century: attainment b...
Evidence Synthesis and Meta-analysis for Drug Safety
At any point in the drug development process, systematic reviews and meta-analysis can provide important information to guide the future path of the development program and any actions that might be needed in the post-marketing setting. This report gives the rationale for why and when a meta-analysis should be considered, all in the context of regulatory decision-making, and the tasks, data collection, and analyses that need to be carried out to inform those decisions. There is increasing demand by decision-makers in health care, the bio-pharmaceutical industry, and society at large to have access to the best available evidence on benefits and risks of medicinal products. The best strategy w...
