Introduction: Guidelines and Discrepancies

Instructions

Introduction: 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?

Doctoral studentsNursesResearch Ethics Committeesmedical researchers

Method

eLearning

Part of

UMC Utrecht

Steps

1Ethical guidelines and principles for human subjects research

2The Emanuel Framework

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

  Helsinki Declaration - highlight the obligation

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

  Case: Apply the Emanuel Framework

Steps

Other information