Risks and Benefits
What are the risks or harms of participating?
There are no medical risks to you from participating in this study, but taking part in this study may make you feel uncomfortable. You may find the study questionnaires tiring or upsetting. You may not like all the questions that are asked. You do not have to answer any questions that make you uncomfortable.
We will be asking questions about both legal and illicit substance use and doing urine drug screening for these substances. Questionnaire answers, including disclosure of substance use, will not be provided to you, your doctor, any CAS case worker, other health care provider(s), law enforcement, your or your child(ren)’s education institution(s), friends, or family, except if you score 12 points or above on the modified Edinburgh Depression Scale. This information will not be added to your medical records and only delegated research personnel will have access to this information. Results from the urine drug screening will not be provided to you, your doctor, any CAS case worker, other health care provider(s), law enforcement, your or your child(ren)’s education institution(s), friends, or family. These reports will not be added to your medical records and only delegated research personnel will have access to these results.
If I use substances during pregnancy, will I be unfairly judged by the study team?
This study has been developed in collaboration with peer researchers who have lived experience of substance use in pregnancy. Our goal is to approach this work in an empathetic, non-judgmental, trauma informed, and anti-oppressive way. Ultimately, we wish to support people in their choices and lives. Our peer researchers have reviewed and will review every step of the project, ensuring that our approach and methods are appropriate. They will review all results before anything is presented or published. They will ensure that results are presented sensitively and in a manner that is relevant to the study participants.
What are the benefits of participating?
There are no benefits to you for taking part in this study. You will not learn any additional information about your own health or your baby’s health through participation in this study. However, we hope the information learned from this study will help other people who are using substances during pregnancy in the future.
Are you paid to participate?
Participation in this study will not involve any additional costs to you or your private health care insurance.
If you decide to participate in this study, you will receive a $10 gift card for Shoppers Drug Mart at each visit as a token of appreciation for your participation in this study. Participants recruited at 28 weeks gestation or later will receive up to a total of $20 for their 2 study visits. Participants recruited before 28 weeks gestation will receive up to a total of $30 for their 3 study visits.
What are the rights of participants?
You will be told, in a timely manner, about new information that may be relevant to your willingness to stay in this study.
You have the right to be informed of the results of this study once the entire study is complete. If you would like to be informed of the results of this study, please contact the research team.
Your rights to privacy are legally protected by federal and provincial laws that require safeguards to ensure that your privacy is respected.
By consenting to participate in this study, you do not give up any of your legal rights against the researcher, sponsor or involved institutions for compensation, nor does this form relieve the researcher, sponsor or their agents of their legal and professional responsibilities.
You will be given a copy of the signed and dated consent form prior to participating in this study.
If you have questions about your rights as a participant or about ethical issues related to this study, you can talk to someone who is not involved in the study at all.
That person is:
Queen’s University and Affiliated Teaching Hospitals Health Sciences Research Ethics Board at 1-844-535-2988 (Toll free in North America) or email HSREB@queensu.ca.