Consent Form for DNA Spit Sample

Principal Investigator: Jennifer O’Loughlin

Co-Investigators: Gilles Paradis, James Hanley, Rachel F. Tyndale, Joseph DiFranza, & André Gervais

Funded by: National Cancer Institute of Canada/ Canadian Cancer Society

Project Title: Study on the Natural History of Nicotine Dependence: Long term follow-up of the Nicotine Dependence In Teens (NDIT) cohort

Description: The NDIT Study is a prospective investigation of 1293 students recruited from grade 7 classes in 10 Montreal secondary schools in 1999. Our funding was first renewed first in 2002, and then again in 2006. The purpose of this latest extension is to study smoking in young adults and to continue to investigate how sociodemographic, psychosocial, and genetic factors relate to cigarette smoking and nicotine dependence.

Participation: In this phase, we ask that you agree to provide a saliva sample. DNA will be extracted from the sample and genotyped for selected genes that may relate to smoking. We need the sample whether or not you smoke because we need to compare if smokers have different genotypes than non-smokers. The DNA sample will be stored without any identifying information for 15 years. We also ask you to accept that your DNA sample (which will include no information that could identify you) be used for additional analyses in the future, either by the same researchers or by other research teams, possibly in link with questionnaire data.

Procedure: You have received the DNA sample kit through the mail. Instructions on how to use the kit are provided on the back of this sheet. You will be asked to provide a saliva sample in a plastic container, seal it, and return it to us by mail in a stamped, addressed envelope. Our research team may telephone you to make sure that you received the kit and to ask if you have any questions.

Benefits and Risks: There are no risks or benefits expected for participants in this project. However the results will allow increased understanding of the natural history of smoking and nicotine dependence, which will help us to develop more effective strategies to prevent smoking and to help young adults quit smoking.

Withdrawal from Study: Your participation in providing a DNA sample is completely voluntary. If you decide not to provide a sample, there will be no prejudice against you. You may withdraw from the study at any time with no prejudice. The DNA sample will be destroyed if you decide to withdraw from the study.

Confidentiality: The DNA sample will be stored without any identifying information. It will be labeled with a code that is different from the code used to identify your questionnaire data. A Master List linking your name to your codes will be kept in locked filing cabinets. Only the researchers and the project coordinator will have access to the DNA and the data.

Consent: Please complete the consent form on the back of this page to indicate if you will provide a saliva sample, and return the form in the stamped, addressed envelope enclosed. If you have any questions, please contact the Project Coordinator, Erika Dugas at 514-890-8000 x15858 or by email at . We thank you for your help in this important project.

Jennifer O’Loughlin Erika Dugas

Principal Investigator Project Coordinator

PLEASE SIGN ON BACK

Last update: February 1st 2009Page 1/2

DNA Self-Collection Kit - User Instructions

Before using, rinse your mouth with drinking water. After rinsing, discard or swallow drinking water. Then wait 5 minutes before spitting saliva sample in Step 1. Do NOT spit drinking water into the container.

STEP 1
/ STEP 2 / STEP 3

/ STEP 4
Spit saliva into the empty container / Spit until the amount of liquid saliva (not foam) reaches the level shown above / Put the container on a flat surface. Screw the cap onto the container. Make sure that the cap is closed tightly as shown / Tighten firmly and mix gently
User Tips
  • Do NOT remove plastic film from the white lid.
  • Be patient: It takes 2-5 minutes to provide a saliva sample.
  • Some people find it hard to spit the recommended amount of saliva. To make more saliva, close your mouth and wiggle your tongue or rub your cheeks. It is easier to spit more if you place ¼ tsp of plain white sugar on your tongue.
  • Finish spitting within 15 minutes and immediately close the container.
/ Mailing Instructions
  • Place closed collection vial (containing saliva) in the plastic bag.
  • Remove as much air as possible and seal the bag by removing the white strip.
  • Place the sealed plastic bag (containing the vial) into the bubble envelope with the questionnaire and consent forms
  • Seal the bubble envelope and send back to us by mail

------

Please fill in the box and return the form

in the stamped addressed envelope

Consent to participate to the DNA Component of the NDIT Study
Please check either “Yes” or “No” below
  • Yes, I accept to participate in the DNA sample collection component of the NDIT Study
  • No, I do not accept to participate in the DNA sample collection component of the NDIT Study
If you checked “Yes” above, please check either “Yes” or “No” below
  • Yes, I accept that my sample be part of a bank that could be used for other studies in the future.
  • No, I do not accept that my sample be part of a bank that could be used for other studies in the future.
_____________
Name (please print) Signature Date

Last update: February 1st 2009Page 1/2