Introduction

Instructions

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

For whom is this important?

Doctoral studentsmedical researchersResearch Ethics CommitteesNurses

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 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