Principles and Practices of Research Quality Assurance - Ethics

Table of Contents

1 Coursework Assignment / Section 1 Ethics

2 Selection of Research Areas/ Ethical Issue

3 Introduction
3.1 Genetically Engineered Drugs
3.2 Genetically Modified Organisms in Field Studies
3.3 Genetic Testing in Humans

4 The Sensitivity of Human Genetic and Proteomic Data in Bio-medical Research
4.1 Prenatal Diagnostics
4.2 Genetic Research

5 Conclusion

6 References

1 Coursework Assignment / Section 1 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.

- Bio-medical research on humans
- Pre-clinical research (animal or in-vivo)
- Animal health research
- Field studies
- 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.

2 Selection of Research Areas/ Ethical Issue

For comparison of opposing opinions concerning an ethical issue the following research areas were selected:

- Manufacture, packaging and handling of investigational medicinal products,
- Field studies, and
- Bio-medical research on humans.

For a detailed discussion whether applicable national and international laws, EU-Directives, ethical standards and guidelines address public, ethical and scientific concerns, benefits, risks and social interactions, the sensitivity of human genetic data within the research area

- Bio-medical research on humans was chosen.

3 Introduction

The crux regarding interferences and experiments within all areas of research is the reverence for life. Ensuring the dignity and the freedom of all organisms should be the top priority while bearing in mind the freedom of research. The core of ethical considerations is the risk/benefit evaluation. The principle should be: Do good! Do no harm!

3.1 Genetically Engineered Drugs

Is it ethically arguable to manufacture genetically engineered drugs? Those drugs are generally accepted due to their positive risk / benefit evaluation. They are broadly used for the treatment of various diseases, e.g. cancer, diabetes, cardiac infarction or as vaccines [7, 8].

Obviously, the advantages are:

- High purity and tolerability of the obtained drugs,
- The production of reasonable amounts,
- The reduction of manufacturing expenses, and
- The decrease of risk of infections [9, 10, 11].

However, there are risks to overestimate the efficacy of genetically engineered drugs, to induce autoimmune diseases by genetically modified human proteins due to deactivating the body’s defences and even risks of abuse, e.g. erythropoietin used as a drug to increase physical performance in sports [11, 17]. If not thoroughly manufactured they may also pose a risk to health, e.g. contaminated L-tryptophan produced by the Japanese company Showa Denko [12].

3.2 Genetically Modified Organisms in Field Studies

According to the Declaration of Helsinki [2] “appropriate caution must be exercised in the conduct of research which may affect the environment”. The EU Directive 2001/18/EC reflects this requirement in Article 4 (1) by stating that Member States shall ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the deliberate release or the placing on the market of genetically modified organisms [3]. Globally, there is already a wide variety of manipulated plants, e.g. soybeans, maize, cotton or canola with pronounced tolerance to herbicide and/or resistance against insects [6].

Despite the on-going public debate in Europe, the European Union and, e.g. Germany seem to be convinced of ensuring safety by implementing detailed risk analysis and continuous control and monitoring by the manufacturer and government authorities [3, 5]. Moreover, scientists demand opportunities of advanced research.

In contrary, nature conservation associations, e.g. BUND in Germany, warn against unpredictable and unprovable impacts on the ecosystem, e.g. the loss of the biological variety. Absence of evidence is not equal to evidence of absence [4].

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