What was the principles contribution to clinical research

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Reference no: EM132981912

Introduction

In this assignment, you will work closely with a few ethical principles that will help you gain a better understanding of why there is a need for informed consent, protection of human subjects, and the disciplines needing to conduct a clinical trial in an ethical manner.

Instructions

Part 1: Ethical Principles
In this assignment we will be using the following Ethical Principles:
- Nuremberg Code
- Belmont Report
- Declaration of Helsinki

Part 1 Instructions
1. Choose one of the Ethical Principles listed above.
2. Write a short essay (minimum of two paragraphs) to answer the following questions:
1. Describe how the principle was established.
2. What was the principle's contribution to clinical research?
3. Make sure to cite at least three scholarly, peer-reviewed references.

Part 2: Institutional Review Board (IRB) and the Food and Drug Administration (FDA)
In this component of the assignment, we will take a further look into how Ethical Principles are reviewed and enforced. You will be continuing your essay by answering the following questions:

Part 2 Instructions
1. Compare and contrast the role of the IRB vs. the FDA in reviewing human subject research.
2. Discuss how the IRB review members are chosen for the position.
3. Explain the importance of the IRB review.

Attachment:- Review Board.rar

Reference no: EM132981912

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