Research Ethics Board (Reb) Consent Form Template (Page 2 of 6) in pdf

Consent Form Template (Expedited Review – Minimal Risk)

BUT, if the answer to any of the following is YES, you should not take part in this study:

List the Exclusion Criteria

All of these will be discussed in more detail with you. You will also be told the reasons why

they are important.

WHAT HAPPENS IN THIS STUDY?

Required Elements:

In this section, please provide an overview of the basic research design, in lay

terms (e.g. – how is the study going to answer the research question[s] which it

aims to answer?). Will participants be randomized? Will participants be asked to

complete questionnaires, or be expected to keep diaries? Please consult our

Consent Form Guidelines for requested wording related to the use of

randomization and blinding.

State how long participants will be involved with the study (e.g. – the length of

time over which the study visit[s] will occur) and the approximate overall amount

of time that the study activities will require of participants (if possible).

Describe where the study is being done. If the study is being done only at the

Queen Elizabeth Hospital or only in Prince Edward Island, please state “This

study is taking place only in Prince Edward Island.” If the study is being done in

multiple provinces but only in Canada, please state “This study is taking place

throughout Canada.” [and list provinces taking part] Finally, if the study is being

done in countries other than Canada, please state “This study is taking place

throughout Canada, as well as in [list participating countries].”

Please include the number of people expected to participate worldwide (globally)

and the number of people planned to participate locally (at this study centre/site).

Describe the research procedures or activities that participants will undergo or

participate in as part of the screening process and study.

Whenever possible, please use a table to describe the study procedures in regard to timelines. This is more

efficient and is much easier for the participant to follow along with, and understand. This is especially

true for studies that require a number of study visits. [If the study only involves one study visit and only a

couple of procedures or activities take place at the study visit, a table is not required.]

Describe any activities the participant will be asked to follow or undergo if he/she withdraws from the

research study. Distinguish between those procedures that will be recommended for the participant’s

benefit as well as those requested for the benefit of the research.

ARE THERE RISKS TO THE STUDY?

Required Elements:

Provide information about the risks of the study, especially addressing the issues

listed below:

List the possible adverse effects of the intervention or procedures.

Explain whether potential harms are reversible.

Include a statement acknowledging the possibility of unforeseen harms.

The risks of questionnaires/surveys and blood sampling need to be stated (our requested wording

for these risks are cited below; include these subsections only if applicable to your study).

Version 6, dated June 12, 2014

Page 2 of 6

Research Ethics Board (Reb) Consent Form Template Page 2

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