ANNEX C.2b: Prosperity4All Informed Consent Form (Template)

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1. GENERAL INFORMATION

This part will be pre-filled by the investigator for each test session

The Prosperity4All Ethics responsible members reviewed this study from the standpoint of the protection of interests and rights of human research participants. The Prosperity4All Ethics responsible members found this study to be in compliance with the relevant regulations. 

1.1 This version of the consent document was prepared on:

 

1.2 This study was approved by the Prosperity4All Ethics responsible members on:

 

1.3 Names and contact details of the investigators responsible for this project:


2. INFORMATION ON THE TEST SESSION

The following issues should be explained by the investigator for each test to the participant before beginning the trial.

2.1 Title of the test session

2.2 What is the purpose of this test session?

You are asked to take part in a research test under the direction of _______________________________. Other professional persons who work with him/her may assist or act for them.

These investigators are undertaking a research test to determine whether ________________________________________________________________. We expect to find _________________________________________, which could lead to better / improved _______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

2.3 Who can take part in this test session?

2.4 Why should I consider joining this test as a research participant?

2.5 Do I have to become a participant in this test?  If I join the test, can I change my mind and drop out before it ends?

2.6 What exactly will be done to me, and what kinds of treatments or procedures will I receive, if I agree to be a research participant in this test?

 2.7 What kinds of harm could I possibly experience in this test, and what will the investigators do to reduce the chances of harm? 

2.8 What will the investigators do to make sure that the information they will collect on me will not get in wrong hands? 

2.9 What kinds of benefit can I expect personally from taking part in this test?

2.10 What kinds of benefit to others can come out of this test?

2.11 What will the investigators do if I should get injured in the test?

2.12 Will I get paid for taking part in this test?

2.13 Will I myself or my (health) insurance company be charged for any of the costs of this test?

2.14 Once I start in this test as a participant, what do I do if I want to find out more about the test or if I should wish to complain about anything?

2.15 Who gets to keep this document, once I signed it? 

2.16 Which others may view or use the data of this document, if any?