Example Of NIH- Bioethics Brochure Essay

ICH- E5 Guidance of Ethnic Factors in the Acceptability of Foreign Clinical Data

This document provides a comprehensive guidance on factors ethnic factors that should be considered when is provided with clinical services in a different region. The basis of this guidance stems from the desirability of regions in: European Union, United States of America and Japan (ICH Regions) to utilize foreign clinical data that meets the regulatory standards of clinical practices. It provides guidance on how ethnical factors may be applied in the ICH regions to ensure effective medical service provision in ICH foreign countries.

This article focuses on medical research ethics. It gives a comprehensive discussion on seven core principle of medical research ethics that should be taken into consideration, which include: Independent review, social value, informed consent, fair subject selection, scientific validity and favorable risk benefit ration. Additionally it highlights various unethical medical research activities that have been conducted in the past for instance; the Tuskegee Syphilis study. It also elaborates how these medical research principles may be applied and other importance concepts in medical research such as: Coercion, payment and undue inducement, integrity of data, conflict of interest and exploitation.

HHS- International Compilation of Human Research Standards

The major purpose of this article is to describe the major role played by the International Compilation of Human Research Standards. It gives an overview of the role played by this organ as in: Enumeration of over one thousand rules and regulation that guides human subject research in 103 countries. It specifies the 103 countries and indicates the purpose of this compilation.

NAS- Chapter 6-7

Chapter 6 of the article published by National Academy of Science focuses on description of the outcome of a conference that was undertaken to determine the barriers to harmonization and efficient operation of biomedical regulations. The chapter discusses solutions that were proposed from different stakeholders on how the identified barriers could be eliminated. Chapter 7 of this article provides a comprehensive discussion concerning a workshop that was held to provide a platform for various stakeholders to generate ideas on how the health sector can move towards harmonized regulations as well as regulatory structures.