Future Research Studies - Participant Information and Consent Form

This content was archived on June 24, 2013.

Note to Researchers

For parents of participants under 16 years of age, a separate consent form must be included with this form, please see Parent/Guardian's Consent Form.

The child should provide his/her assent and may refuse to participate even if the parent has provided their consent. The age of consent to participate in research in the Province of Quebec is 18 years of age. Section 21 of the Quebec Civil Code should be referenced for additional information as to the involvement of children in research. The Assent form for the involvement of minors in research should be used for any individuals under the age of 18.

Language level of this assent form must not be any higher then grade 6 reading level. (Use a Microsoft Word software to determine the language level of the form)

Informed Consent Template

You are being asked for permission to be contacted in the future for participation in research studies. Please take your time to review this consent form and discuss any questions you may have. You are free to discuss this form with your friends, family and others before you make your decision.

If you agree to be contacted in the future for research purposes, information about you will be entered into an electronic database. The database will be maintained by

• Specify individual, unit or department and institution.

The Database will have the following information about you:

• List all that apply including, if applicable, name, mailing address, and phone number. Specify the type of health information that will be included in the database.

Confidentiality of your information will be maintained in the following manner:

• State how access to the database will be restricted and specify who will have direct access.
• Specify who the information may be shared with (for example, other researchers at the same institution; researchers in other institutions)
• State the type of information (for example, name, phone number) that may be provided to other researchers.
• Specify how long identifying information will be retained and how it will be destroyed, keeping privacy and confidentiality in mind.

Your decision to allow your information to be in the database is completely voluntary. While there may be no benefit to you, your information will help researchers to quickly identify individuals who may be suitable for a particular research study. If you change your mind after agreeing to this, your information can be removed from the database. You will not be penalized in any way if you refuse to participate, or if you change your mind and ask that your information be removed.

If you have any questions about this database, please contact:

• Name and phone number
• Collect calls will be accepted

If you have questions about your rights as a research participant, you may contact:

The Research Ethics Board Secretariat
Holland Cross Building, Tower B
1600 Scott Street , Room 410, Address Locator #3104A
Ottawa, Ontario K1A 0K9

Telephone: 613-941-5199 (Collect calls will be accepted)
Fax: 613-948-6781

Instructions for use of this template:

• Use official letterhead of the investigator for the first page of the Participant Information and Consent Form (photocopy is acceptable).
• Insert a version date in the footer.
• All sections of The Participant Information and Consent Form, except for the Statement of Consent, should be written in the third or second person perspective. The Statement of Consent should be written in the first person perspective.
• In the signature section, parts that are not relevant may be deleted.

Statement of Consent

I have read this consent form. I have had the opportunity to ask questions and discuss what is involved. I understand that my personal information will be kept confidential. By signing this consent form, I have not waived any of my legal rights.

Participant printed name:
Participant signature
Date

For participants who are children, consent should be obtained from the parent or legal guardian and assent should be obtained from the child as follows:

Parent/legal guardian's printed name:
Parent/legal guardian's signature
Date

Child's printed name:
Child's signature
Date

For participants who are incapable of giving consent, consent should be obtained from an authorized third party:

Third Party printed name:
Signature of individual authorized to provide consent
Date

If applicable, for example when third party signatures are required, the following should be added:

I, the undersigned, attest that the information in the Participant Information and Consent Form was accurately explained to and apparently understood by the participant or the participant's legally acceptable representative and that consent to participate was freely given by the participant or the participant's legally acceptable representative.

Witness printed name:
Witness signature
Date

I, the undersigned, have fully explained the relevant details of this research to the participant named above and believe that the participant has understood and has knowingly given their consent

Printed Name:
Signature
Date