Difference between revisions of "Instruction:D98206fa-96b8-475a-8909-3e8bfd4f9492"

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{{Instruction
 
{{Instruction
|Title=Introduction to Research ethics: philosophical foundations and the history of human subjects research
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|Title=Introduction
|Instruction Goal=By the end of te course, you should be able to:  
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|Instruction Goal=The objectives of the first section of this guide are:
  
* Discern the morally salient dimensions of a research project, and come to a well-considered judgment about the acceptability of such a project
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* Knowing which principles are essential to ethically evaluate human subjects research
* Reflect on moral dilemmas for researchers and Research Ethics Committees, and be able to systematically analyze such dilemmas
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* Knowing the principles mentioned in the Declaration of Helsinki
* Weigh the various arguments involved, and work towards a well-reasoned position or decision
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* Being able to discern differences between the formulations of principles in international ethical guidance documents
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* Being able to weigh and balance ethical principles in a concrete situation
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* Knowing main theories on philosophical justification of human subjects research  
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* Being able to argue whether and under what conditions the well-being of research participants must always take precedence over scientific interests
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* Knowing how to evaluate Tuskegee from an historical perspective
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* Knowing some historical scandals and cases which have led to the practice of ethically reflecting on human subjects research
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* Evaluating the moral aspects of Tuskegee
 
|Has Duration=2
 
|Has Duration=2
|Important For=Doctoral students
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|Important For=Doctoral students; medical researchers; Research Ethics Committees; Nurses
 
|Has Method=eLearning
 
|Has Method=eLearning
 
}}
 
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{{Instruction Steps Foldout Trainee}}
 
{{Instruction Steps Foldout Trainee}}
 
{{Instruction Perspective Trainee
 
{{Instruction Perspective Trainee
|Is About=Volunteers are often asked to take part in medical research in order to improve the health and well being of other people, now and in the future. However noble the aim, this raises many ethical questions.
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|Important Because=The focus of this instruction is on the philosophical justification of human subjects research, the main ethical guidance documents and on the history of human subject research. We will look at international ethical guidance documents for medical research involving human beings, like the WMA’s ''Declaration of Helsinki'', we become familiar with the seven-principle framework of Emanuel et al. for ethically evaluating human subjects research, we learn to apply the ethical principles in concrete cases, but also to reflect on these principles, we learn to reflect on the Tuskegee Syphilis Study from an historical perspective, and look into the Willowbrook Hepatitis Studies.
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}}
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{{Instruction Step Trainee
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|Instruction Step Title=Ethical guidelines and principles for human subjects research
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|Instruction Step Text=In research ethics we use various international ethical guidance documents to evaluate the ethical acceptability of research with human beings. Apart from international documents most countries have their own laws and regulations. This guide will not focus on guidelines and laws of specific countries, unless  the guideline plays an important role in the international ethical debate, such as the Canadian Tri-Council Policy Statement.
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International ethical guidelines for human subjects research are all concerned with the protection of human beings in medical research. Most ethical guidelines contain principles of obtaining genuine informed consent, ensuring a favorable balance between risks and potential benefits and ensuring scientific validity. Yet, the guidance documents explain the principles in different ways which has consequences for the protection of participants.
  
How can we ensure that participants give their genuinely informed consent? What should be provided to control groups during clinical trials? How can we weigh the risks and benefits of various studies? How can we ensure scientific integrity in research? When should we conduct research with vulnerable populations, such as children and people in low- and middle-income countries? How should we interpret the Tuskegee syphilis study from a historical perspective?
 
  
There’s never a shortage of questions; it’s the answers that are harder to determine. For example, what type of consent is appropriate for biobanking research? When are the risks and benefits of research appropriately balanced? What special protection mechanisms are needed to include “vulnerable” study populations? How can we ensure scientific integrity in research?
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'''To Do:'''
  
During this course, you will tackle these and other issues, while learning to apply theoretical insights to recent cases.
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* Read the Declaration of Helsinki and two of the other guidelines linked below (under 'Related Resources')
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* Complete the exercise below matching paragraphs from the Declaration of Helsinki to the ethical obligations they are related to.
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|Related To Theme=Theme:D44fd22a-ed5d-4120-a78b-8881747131fd
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Revision as of 13:49, 13 February 2024

Introduction

Instructions for:TraineeTrainer
Goal

The objectives of the first section of this guide are:

  • Knowing which principles are essential to ethically evaluate human subjects research
  • Knowing the principles mentioned in the Declaration of Helsinki
  • Being able to discern differences between the formulations of principles in international ethical guidance documents
  • Being able to weigh and balance ethical principles in a concrete situation
  • Knowing main theories on philosophical justification of human subjects research
  • Being able to argue whether and under what conditions the well-being of research participants must always take precedence over scientific interests
  • Knowing how to evaluate Tuskegee from an historical perspective
  • Knowing some historical scandals and cases which have led to the practice of ethically reflecting on human subjects research
  • Evaluating the moral aspects of Tuskegee
Duration (hours)
2
Method
Part of
Umc-utrecht-logo-black-and-white.png
UMC Utrecht

Why is this important?

The focus of this instruction is on the philosophical justification of human subjects research, the main ethical guidance documents and on the history of human subject research. We will look at international ethical guidance documents for medical research involving human beings, like the WMA’s Declaration of Helsinki, we become familiar with the seven-principle framework of Emanuel et al. for ethically evaluating human subjects research, we learn to apply the ethical principles in concrete cases, but also to reflect on these principles, we learn to reflect on the Tuskegee Syphilis Study from an historical perspective, and look into the Willowbrook Hepatitis Studies.
1
Ethical guidelines and principles for human subjects research

In research ethics we use various international ethical guidance documents to evaluate the ethical acceptability of research with human beings. Apart from international documents most countries have their own laws and regulations. This guide will not focus on guidelines and laws of specific countries, unless  the guideline plays an important role in the international ethical debate, such as the Canadian Tri-Council Policy Statement.

International ethical guidelines for human subjects research are all concerned with the protection of human beings in medical research. Most ethical guidelines contain principles of obtaining genuine informed consent, ensuring a favorable balance between risks and potential benefits and ensuring scientific validity. Yet, the guidance documents explain the principles in different ways which has consequences for the protection of participants.


To Do:

  • Read the Declaration of Helsinki and two of the other guidelines linked below (under 'Related Resources')
  • Complete the exercise below matching paragraphs from the Declaration of Helsinki to the ethical obligations they are related to.

Steps

Other information

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