Principles and Practices of Research Quality Assurance - Ethics

Select three of the five following areas of research, and identify one ethical issue that is controversial or subject to opposing opinions in each of the three chosen areas. Briefly describe the controversy or opposing viewpoints for these three issues, with reference to the ethical principles or values involved.

x Bio-medical research on humans
x Pre-clinical research (animal or in-vivo)
x Animal health research
x Field studies
x Manufacture, packaging and handling of investigational medicinal products

For one of the three selected areas, critically evaluate how the applicable laws, regulatory requirements and guidelines address public concerns about the identified ethical issue and the extent to which these achieve a balance between ethical and scientific concerns.

Inhaltsverzeichnis (Table of Contents)

• Coursework Assignment / Section 1 Ethics
• Selection of Research Areas/ Ethical Issue
• Introduction
  • Genetically Engineered Drugs
  • Genetically Modified Organisms in Field Studies
  • Genetic Testing in Humans
• The Sensitivity of Human Genetic and Proteomic Data in Bio-medical Research
  • Prenatal Diagnostics
  • Genetic Research
• Conclusion
• References

Zielsetzung und Themenschwerpunkte (Objectives and Key Themes)

This coursework assignment examines ethical considerations in different areas of research. The objective is to identify and analyze ethical issues that are controversial or subject to opposing opinions within three selected research areas. The assignment explores the application of laws, regulations, and guidelines in addressing public concerns related to these ethical issues, aiming to achieve a balance between ethical and scientific considerations.

• Ethical issues in research
• Balancing ethical and scientific concerns
• The sensitivity of human genetic data
• Public perception of research
• The role of regulations in safeguarding ethical research

Zusammenfassung der Kapitel (Chapter Summaries)

• The introduction outlines the importance of ethical considerations in research, emphasizing the reverence for life and the need to prioritize the dignity and freedom of all organisms involved. The central principle is risk/benefit evaluation, emphasizing the motto "Do good! Do no harm!"
• The section on genetically engineered drugs discusses the advantages and risks associated with their use, such as high purity and tolerability, reduced manufacturing expenses, and potential for abuse or health risks.
• The chapter on genetically modified organisms in field studies explores the ongoing public debate, highlighting the need for careful risk analysis and monitoring, while acknowledging concerns regarding unpredictable impacts on ecosystems.
• The section on genetic testing in humans focuses on the sensitivity of human genetic data and its potential implications for individuals, families, and future generations. The chapter stresses the importance of ethical standards, informed consent, and transparent procedures in collecting, processing, and utilizing such data.

Schlüsselwörter (Keywords)

This coursework assignment explores ethical issues in research, focusing on the sensitivity of human genetic and proteomic data, the balance between ethical and scientific concerns, and the role of laws, regulations, and guidelines in safeguarding ethical research practices. It delves into areas such as genetically engineered drugs, genetically modified organisms, and genetic testing, examining public concerns, benefits, risks, and the potential for abuse.

Details

• College: Anglia Ruskin University
• Grade: good
• Author: Konstanze Frank (Author)
• Publication Year: 2004
• Pages: 11
• Catalog Number: V41151
• ISBN (eBook): 9783638394796
• Language: English
• Tags: Principles Practices Research Quality Assurance Ethics