Returning Individual Research Results to Participants
Returning Individual Research Results to Participants

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2018-08-23

Total Pages: 399

ISBN-13: 0309475201

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When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research resultsâ€"such as results with unknown validityâ€"and the associated burdens on the research enterprise are competing considerations. Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholdersâ€"investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participantsâ€"and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations.

SMQs
SMQs

Author: Cioms

Publisher:

Published: 2004-01-01

Total Pages: 96

ISBN-13: 9789290360773

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The aim of this publication is to brief drug regulatory authorities, scientific institutions and pharmaceutical companies worldwide about the development, purpose and appropriate use of Standardized MedDRA Queries (SMQs) in drug surveillance. Two papers in this publication are to assist in the rational use of search queries in the identification and retrieval of potentially relevant individual case safety reports from a database and to harmonize presentation of search results. It also includes examples to illustrate the structure and content of end product.

Pain Models
Pain Models

Author: Hermann O. Handwerker

Publisher: Lippincott Williams & Wilkins

Published: 2015-06-01

Total Pages: 663

ISBN-13: 1496331931

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The neurobiology and mechanisms discovered in animals often do not translate to patients with a chronic pain condition. To help researchers and clinicians develop and use models that can help translate data from animals into humans, this book presents experimental animal models, with a focus on how they may translate into humans human experimental pain models, including details about pain induction and assessment human surrogate pain models clinical applications of pain models models that may link mechanisms of pain and pruritus Pain Models contains 29 chapters by internationally recognized experts. It is a comprehensive survey of pain models at different levels, and commentaries by clinicians directly address clinical perspectives. This unique book is unprecedented in its content. It's a quick reminder of the hard work needed to investigate the complex issue of pain perception. With the advent of increasingly sensitive noninvasive investigational tools, the authors want readers to know that basic research is still needed to help develop new drugs. This book will enrich anyone who wishes to know all that goes into conducting pain research with a lab-based pain model.

Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

Author:

Publisher: Columbia Books. Incorporated

Published: 2015

Total Pages: 532

ISBN-13:

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The Globally Harmonized System of Classification and Labelling of Chemicals (GHS) addresses classification and labelling of chemicals by types of hazards. It provides the basis for worldwide harmonization of rules and regulations on chemicals and aims at enhancing the protection of human health and the environment during their handling, transport and use by ensuring that the information about their physical, health and environmental hazards is available. The sixth revised edition includes, inter alia, a new hazard class for desensitized explosives and a new hazard category for pyrophoric gases; miscellaneous amendments intended to further clarify the criteria for some hazard classes (explosives, specific target organ toxicity following single exposure, aspiration hazard, and hazardous to the aquatic environment) and to complement the information to be included in section 9 of the Safety Data Sheet; revised and further rationalized precautionary statements; and an example of labelling of a small packaging in Annex 7.

Researching Violence Against Women
Researching Violence Against Women

Author: Mary Ellsberg

Publisher: WHO

Published: 2005

Total Pages: 257

ISBN-13: 9789241546478

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Draws on the collective experiences and insights of many individuals, and in particular from the implementation of the WHO Multi-country Study on Women's Health and Domestic Violence against Women in over 10 countries. Twenty years ago, violence against women was not considered an issue worthy of international concern. Gradually, violence against women has come to be recognized as a legitimate human rights issue and as a significant threat to women's health and well-being. Now that international attention is focused on gender-based violence, methodologically rigorous research is needed to guide the formulation and implementation of effective interventions, policies, and prevention strategies. The manual has been developed in response to the growing need to improve the quality, quantity, and comparability of international data on physical and sexual abuse. It outlines some of the methodological and ethical challenges of conducting research on violence against women and describes a range of innovative techniques that have been used to address these challenges.

Principles of Good Clinical Practice
Principles of Good Clinical Practice

Author: Michael J. McGraw

Publisher: Pharmaceutical Press

Published: 2010

Total Pages: 273

ISBN-13: 0853697906

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Part of "RPS Pharmacy Business Administration Series", this book offers good clinical practice guidelines. It includes standards on how clinical trials should be conducted, provide assurance of safety and efficacy of various drugs and protect human rights.

Nature and Art
Nature and Art

Author: Day & Son

Publisher: BoD – Books on Demand

Published: 2021-10-28

Total Pages: 266

ISBN-13: 3752522496

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Reprint of the original, first published in 1867.

Public Health, Innovation and Intellectual Property Rights
Public Health, Innovation and Intellectual Property Rights

Author:

Publisher: WHO

Published: 2006-01-01

Total Pages: 204

ISBN-13: 9789241563239

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The Commission was established by the World Health Assembly in 2003 to: "...collect data and proposals from the different actors involved and produce an analysis of intellectual property rights, innovation, and public health, including the question of appropriate funding and incentive mechanisms for the creation of new medicines and other products against diseases that disproportionately affect developing countries..." This report looks at the process of innovation, the path to application and the ways of getting products to patients, ways of fostering innovation in developing countries, and ways to promote both innovation and access