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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...
Current Catalog
First multi-year cumulation covers six years: 1965-70.
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.
Practical Approaches to Risk Minimisation for Medicinal Products
Risk management of medicines is a wide and rapidly evolving concept and practice, following a medicine throughout its lifecycle, from first administration in humans through clinical studies and then marketing in the patient population at large. Previous reports from CIOMS I - VIII provided practical guidance in some essential components of risk management such as terminology and reporting of adverse drug reactions, management of safety information from clinical trials, and safety signal detection. Beyond the detection, identification, and characterization of risk, "risk minimization" is used as an umbrella term for the prevention or mitigation of an undesirable outcome. Risk management alway...
Clinical Practice Guidelines We Can Trust
Advances in medical, biomedical and health services research have reduced the level of uncertainty in clinical practice. Clinical practice guidelines (CPGs) complement this progress by establishing standards of care backed by strong scientific evidence. CPGs are statements that include recommendations intended to optimize patient care. These statements are informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options. Clinical Practice Guidelines We Can Trust examines the current state of clinical practice guidelines and how they can be improved to enhance healthcare quality and patient outcomes. Clinical practice guidelines now are ubiqu...
Evidence generation for development of health products
This document describes the main elements that World Health Organization (WHO) technical departments should elaborate on when providing guidance on evidence generation to research and development (R&D) specialists who are developing health products to address critical unmet needs in public health. While WHO’s TPPs, preferred product characteristics (PPCs) and target regimen profiles (TRPs) provide high-level information on the desired characteristics of the product, the target population, and the key endpoints for safety and efficacy evaluation, more detailed guidance is needed to enable the development of suitable trial/study designs aimed at producing relevant evidence for WHO’s normative products such as guidelines. The objective of the Guidance for evidence generation (GEG) process is to produce a guidance document on how best to perform studies for the development of novel products (diagnostics, drugs, vaccines, vector control) and thus how to enable the generation of robust data and evidence to inform a WHO evidence review process.
NIH Almanac
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