Difference between revisions of "Instruction:D98206fa-96b8-475a-8909-3e8bfd4f9492"
From The Embassy of Good Science
(Created page with "{{Instruction |Title=Introduction to Research ethics: philosophical foundations and the history of human subjects research |Instruction Goal=By the end of te course, you shoul...") |
|||
| (11 intermediate revisions by the same user not shown) | |||
| Line 1: | Line 1: | ||
{{Instruction | {{Instruction | ||
| − | |Title=Introduction | + | |Title=Introduction: Guidelines and Discrepancies |
| − | |Instruction Goal= | + | |Instruction 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 | ||
|Has Duration=2 | |Has Duration=2 | ||
| − | |Important For=Doctoral students | + | |Important For=Doctoral students; Nurses; Research Ethics Committees; medical researchers |
|Has Method=eLearning | |Has Method=eLearning | ||
}} | }} | ||
| Line 13: | Line 14: | ||
{{Instruction Steps Foldout Trainee}} | {{Instruction Steps Foldout Trainee}} | ||
{{Instruction Perspective Trainee | {{Instruction Perspective Trainee | ||
| − | | | + | |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. |
| + | }} | ||
| + | {{Instruction Step Trainee | ||
| + | |Instruction Step Title=Ethical guidelines and principles for human subjects research | ||
| + | |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. | ||
| − | + | 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 on the right (under 'Related Resources') | ||
| + | *Complete the exercise below, identifying the ethical considerations in the Declaration of Helsinki | ||
| + | |Instruction Step Interactive Content=Resource:H5P-9 | ||
}} | }} | ||
{{Instruction Step Trainee | {{Instruction Step Trainee | ||
| − | |Instruction Step Title= | + | |Instruction Step Title=The Emanuel Framework |
| − | |Instruction Step Text= | + | |Instruction Step Text=In 2000 Ezekiel Emanuel, Christine Grady and David Wendler introduced a framework with seven requirements to ethically evaluate human subjects research. They introduced this framework as a response to the '''incompleteness and discrepancies''' between guidelines. They set out that many guidance documents have been ‘written in response to specific events’, like the Second World War (Nuremberg Code) or the Tuskegee Syphilis Study (Belmont Report). |
| + | |||
| + | '''Your task:''' | ||
| + | |||
| + | |||
| + | *Read [https://jamanetwork.com/journals/jama/fullarticle/192740 Emanuel et al. (2000)] | ||
| + | *Complete the activity below - Applying the Emanuel Framework | ||
| + | |Instruction Step Interactive Content=Resource:H5P-11 | ||
}} | }} | ||
{{Instruction Remarks Trainee}} | {{Instruction Remarks Trainee}} | ||
| Line 32: | Line 49: | ||
{{Instruction Remarks Trainer}} | {{Instruction Remarks Trainer}} | ||
{{Custom TabContent Close Trainer}} | {{Custom TabContent Close Trainer}} | ||
| − | {{Related To}} | + | {{Related To |
| + | |Related To Resource=Resource:013153a7-f3ed-40d9-ab03-6b0deecd31eb; Resource:5a9ad588-b163-494a-b4b3-fef69e519788; Resource:05f04469-5834-4411-9217-c2551a0c745a; Resource:8a1eb14c-bbdf-45ca-a4bd-489ded21a601; Resource:9984ebbc-f292-4b62-8c85-754cad2ce748; Resource:E9cd7ee1-bd54-4d5c-bdd9-786ef1c9f603; Resource:97d7c2bf-daa8-4162-9bae-5c94c9917384 | ||
| + | |Related To Theme=Theme:D44fd22a-ed5d-4120-a78b-8881747131fd | ||
| + | }} | ||
{{Tags}} | {{Tags}} | ||
Latest revision as of 11:58, 14 February 2024
InstructionsIntroduction: Guidelines and Discrepancies
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
Duration (hours)
2
For whom is this important?
Method
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 on the right (under 'Related Resources')
- Complete the exercise below, identifying the ethical considerations in the Declaration of Helsinki
2
The Emanuel Framework
In 2000 Ezekiel Emanuel, Christine Grady and David Wendler introduced a framework with seven requirements to ethically evaluate human subjects research. They introduced this framework as a response to the incompleteness and discrepancies between guidelines. They set out that many guidance documents have been ‘written in response to specific events’, like the Second World War (Nuremberg Code) or the Tuskegee Syphilis Study (Belmont Report).
Your task:
- Read Emanuel et al. (2000)
- Complete the activity below - Applying the Emanuel Framework
Steps
