Research Ethics Board (Reb) Consent Form Template printable pdf download

Consent Form Template (Expedited Review – Minimal Risk)

CONSENT FORM

The Full Study Title Should Be Placed Here.

Principal Investigator:

Dr. John Smith

Sub-Investigator: Dr. Jane Smith

Queen Elizabeth Hospital

60 Riverside Drive

Charlottetown, PE C1A 8T5

Tel: 1-902-XXX-XXXX

Study Sponsor:

[Where applicable; do not include if the study is unfunded.]

INTRODUCTION

Suggested Wording:

You are invited to join a research study. The study is being offered at (insert location). We are

doing this study to find out more about ________________ . This information will help you decide

if you want to be part of the study or not.

WHY IS THIS STUDY BEING DONE?

Required Elements:

Provide background information, in lay terms, about the research and why it is

being undertaken.

WHY AM I BEING ASKED TO JOIN THIS STUDY?

Required Elements:

Include a statement indicating why any particular person was flagged as a

possible candidate for inclusion in the study.

Suggested Wording:

You are being asked to join this study either because you were identified by ____ as _____

and expressed an interest when told about the study, or because you contacted us after

seeing our advertisement, expressing interest in the study. It is your choice whether you wish to

participate or not. If you do decide to take part, you can still change your mind and stop

participating at any time.

WHO CAN TAKE PART IN THIS STUDY?

The REB requires that potential participants be informed of the criteria relevant to their inclusion or

exclusion in a particular research study. However, please note that only those criteria that potential

participants would understand and would be able to deliberate about should be included.

IMPORTANT:

Remember that the inclusion and exclusion criteria in the consent form should

match those in the protocol. Remember to simplify these criteria so that potential

participants can understand them.

Suggested Wording:

You may take part in this study if the answer is YES to all of the following:

List Inclusion Criteria

Version 6, dated June 12, 2014

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Research Ethics Board (Reb) Consent Form Template