1. Slide Deck: 01

2. Introduction to the AoU Training
Introduction - Slide Deck: 01
Introduction to the AoU Training
Deck 1
My name is ________ and I work with _________________________.
My assistant today is ________________________________________.
We are going to be training you today on the Assessment of Understanding tool when seeking Informed Consent from research volunteer.
First we will begin with brief introductions.
Then we will review the ground rules and agendas, followed by the objectives of the training.
Finally we will review the critical concepts of informed consent.
SLIDE # 2

3. Introductions Introduction - Slide Deck: 01 Who is sitting beside you?
Please turn to the person on your right and ask for him or her for the name s/he prefers to be called during this training; his or her current position at the place where her or she works; and the nature of the research work that they are involved in – for example, does your neighbor work in clinical TB research, clinical malaria research or clinical HIV research and the kind of clinical research – drug, vaccine or otherwise that he or she is involved with!
is sitting beside you?

4. Introductions Game 1 Introduction - Slide Deck: 01
Please introduce your neighbor to the group
Please introduce your neighbor to the bigger group.

5. Ground Rules Introduction - Slide Deck: 01
Please be on time – at the start and after breaks!
Turn off your mobile phones: you can put them on outside during breaks and switch them off before returning to the training room.
Support one another and always use constructive communication throughout the training.
There are some housekeeping issues to review before we begin the training:
The restrooms/toilets are located …………..
The tea break is scheduled for __:__ and will last __:__ minutes.
Our training ground rules are:
1) Please be on time;
2) Please turn off your mobile phones – you can put them on during breaks and switch them off before returning to the training room;
3) Please support one another & always use constructive feedback throughout the training

6. For those learning to adapt the tool during Day 2:
Introduction - Slide Deck: 01
Training Objectives
Refresh understanding of informed consent concepts;
Develop a full understanding of the purpose of the assessment of understanding (AoU) tool;
Be very comfortable and familiar with the tool so as to leave the training skilled in administering and scoring the AoU tool;
For those learning to adapt the tool during Day 2:
Be able to adapt the tool to your research settings, while retaining the AoU’s key features.
The overall goal of this training is to give you the skills necessary to protect potential research participants in your trials by ensuring that they have fully understood the benefits, burdens and risks of participating in the clinical trial.
Therefore the objectives of the training are fourfold:
First we want you to leave after two days with a refreshed understanding of the purpose of informed consent ;
Second we want you to fully understand the value of the assessment of understanding (AoU) tool;
Third, we want you to become very comfortable and familiar with the tool and to leave the training skilled in administering the AoU tool;
Finally, for those learning to adapt the tool to other research settings, we want you to be so proficient with the tool that you are able to adapt the tool to your other research settings, while retaining the tools’ key features.

7. Training Agenda - Day 1 Introduction - Slide Deck: 01 Topics
Time Allocated
Deck 1: Introduction
30 minutes
Deck 2 Overview of Informed Consent & the relevance of the AoU studies
60 minutes
Deck 3 The AoU tool – the key components
90 minutes
Deck 4 Learning how to administer the AoU tool and score responses
Consolidation & Practice
60-90 minutes
To ensure we cover all that we need to cover during the training we need to adhere to the agenda.
This is the agenda for Day 1
Deck 1 - Introduction to the training
30 minutes
Deck 2 Overview of Informed Consent & the relevance of the AoU studies
60 minutes
Module 2 The AoU tool – the key components
90 minutes
Deck 3 Learning how to administer the AoU tool and score responses
Consolidation & Practice
60-90 minutes

8. Training Agenda - Day 2 Introduction - Slide Deck: 01 Topics
Time Allocated
Deck 5
Adapting the Tool to other clinical trial contexts
60 minutes
Break
Consolidation and Practice Session
90 minutes
Summary and Closure
30 minutes
This is Day 2 agenda for those learning to adapt the tool to other contexts.
Deck 5 – Adapting the AoU Tool to other clinical trial contexts
60 minutes
Consolidation & Practice
60-90 minutes
Summary & Closure

9. Defining Informed Consent - Activity 2
Introduction - Slide Deck: 01
Defining Informed Consent - Activity 2
Each group has FIVE minutes to:
Come up with their definition of the term ‘informed consent’ – IC.
AND
3 reasons why IC is an important part of research ethics;
Then to write these answers on a sheet of flip chart paper and tape it to the wall for others to read.
Each group has FIVE minutes to:
Come up with their definition of the term ‘informed consent’ – IC.
AND
3 reasons why IC is an important part of research ethics;
Then to write these answers on a sheet of flip chart paper and tape it to the wall for others to read.

10. Defining Informed Consent
Introduction - Slide Deck: 01
Defining Informed Consent
INFORMED CONSENT is a process by which potential research participants:
Receive and fully understood all the information needed to make an informed decision;
Then, freely decide whether to participate or not to participate in a research study.
INFORMED CONSENT is a process by which potential research participants:
Receive and fully understood all the information needed to make an informed decision;
Then, freely decide whether to participate or not to participate in a research study.

11. Defining Informed Consent - Role Play
Introduction - Slide Deck: 01
Defining Informed Consent - Role Play
What happens when there is inadequate informed consent?
Let us see you role play! Please keep them to 1 minute!
What happens when someone does not give true informed consent – in other words – what happens when someone is not given the correct information about a trial, or does not understand the information and consents because she or he feels pressured or has misunderstood the benefits and risks?
Let us see you role play! Please keep them under one minute!

12. Summary - Role Play – Follow up
Introduction - Slide Deck: 01
Summary - Role Play – Follow up
Without informed consent, it is possible that the volunteer may:
Not be fully informed and understand his or her role in the research study;
Choose to participate in the study without understanding the risks and benefits of participating.
Let us review the consequences when informed consent is not properly administered or assessed:
Without informed consent, it is possible that the volunteer may:
Not be fully informed and understand his or her role in the research study;
Choose to participate in the study without understanding the risks and benefits of participating.

13. Overview of Informed Consent and the relevance of the AOU studies
Introduction - Slide Deck: 01
Next Step Deck 2
Overview of Informed Consent and the relevance of the AOU studies
Deck 2 will review Informed Consent in more details as well as the detailed background to introducing the Assessment of Understanding and remind you how critical it is to your work in clinical research.

14. Introduction - Slide Deck: 01

15. Introduction - Slide Deck: 01
This toolkit is made possible by the generous support of the American people through the United States Agency for International Development (USAID). The contents are the responsibility of the International AIDS Vaccine Initiative and do not necessarily reflect the views of USAID or the United States Government.