Research Ethics Board (Reb) Consent Form Template (Page 3 of 6) in pdf

Consent Form Template (Expedited Review – Minimal Risk)

WILL IT COST ME ANYTHING?

Required Elements:

Provide information about the costs of the study, especially addressing the

issues listed below:

Are there any costs to participants?

Will participants be paid?

State whether, and how much the participants out-of-pocket expenses (e.g travel) will be

reimbursed.

Indicate how, if at all, reimbursement will be handled if participants withdraw or is withdrawn

prior to study conclusion

WHAT ABOUT MY RIGHT TO PRIVACY?

Suggested Wording:

We will do everything possible to keep your personal information confidential. Although your name

may be used in the study records, no identifying information (such as your name, or hospital

number) will be sent outside of _______________. Instead we will use special numbers (which may

include your initials and date of birth) on any information sent outside of ____________. If the

results of this study are presented at a meeting, or published, nobody will be able to tell that you

were in the study.

Your records will be kept in a secure area such as a locked file cabinet and office during the study,

and after the study ends they will be kept for ___ years in a secure area owned or leased by

__________________.

Some other people or groups may need to check or see your study records to make sure all of the

information is correct. All of these people have a professional responsibility to protect your privacy.

These groups and people are:

 __________, the study sponsor and their assigned representatives

 The PEI Research Ethics Board which is responsible for the protection of people in

research here

 [List others as appropriate.]

The information they check may include _________________________________________________.

You also allow the collection, reporting and transfer of data collected from this study, including

limited personal data such as your date of birth, to ________________ for the purposes of this study

and further analyses related to it.

You may also be contacted personally by the PEI Research Ethics Board for quality assurance

purposes.

WHAT IF I WANT TO QUIT THE STUDY?

Required Elements:

Please ensure that this section includes all applicable information

requested below:

Reiterate any procedures the participant will be asked to follow or undergo if he/she withdraws

from the research. Distinguish between those procedures that will be recommended for the

participant’s benefit and those requested for the benefit of the research.

Version 6, dated June 12, 2014

Page 3 of 6

Research Ethics Board (Reb) Consent Form Template Page 3