Will my participation in this study and possible substance use be kept confidential?

Yes!  Your participation in this study is both voluntary and confidential.

Taking part in this study is voluntary. If you choose to participate you may choose to leave the study at any time. Whatever you choose, it will not affect the usual medical care that you receive outside the study.

Taking part in this study is confidential. Results from the urine drug screening will not be provided to you, your doctor, any Children’s Aid Society (CAS) case worker, other health care provider(s), law enforcement, your or your child(ren)’s educational 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. 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. This information will not be added to your medical records and only delegated research personnel will have access to
 

How will my information be kept confidential?

If you decide to participate in this study, the research team will only collect the information they need for this study.

Records identifying you at the Study Coordinating Centre will be kept confidential and, to the extent permitted by the applicable laws, will not be disclosed or made publicly available, except as described in this consent document.

Authorized representatives of the following organizations may look at your original (identifiable) medical records at the site where these records are held, to check that the information collected for the study is correct and follows proper laws and guidelines.

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• Queen’s Department of Obstetrics & Gynaecology Research Group, the Study Coordinating Centre of this study

• The research ethics board who oversees the ethical conduct of this study in Ontario

• This institution and affiliated sites, to oversee the conduct of research at this location

If the results of this study are published, your identity will remain confidential. It is expected that the information collected during this study will be published and/or presented to the scientific community at meetings and in journals as anonymized or aggregate data. Even though the likelihood that someone may identify you from the study data is very small, it can never be completely eliminated.

A copy of the consent form that you sign to enter the study may be included in your health record/hospital chart.

How will the samples you collect from me be kept safe and confidential?

Sample storage and testing:  
All biological samples collected during this study will be used only for these purposes outlined above.  The samples will not be sold. Once tests have been completed, any leftover samples will be kept by the Study Coordinating Centre and the Placenta Lab for future research purposes, with your permission.

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The collection and testing of the urine, cord blood and placenta samples are a necessary part of this study. Hereditary genetic testing will not be done on these samples.

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Sample identification: 
To protect your identity, the information that will be used to label your samples will be limited to your study specific ID.

The only instance in which a sample will be identified using your name is when your placenta is sent to pathology for the standard pathology assessment. This is necessary as the pathologist completing the assessment must be able to correlate pathology findings with clinical conditions. The pathologist will not have access to any study data. The report generated and the samples prepared will be deidentified using your study specific ID before they are entered into the study database or shipped to the Placenta Lab.

Reports about any research tests done with your samples will not be given to you, your doctor, or other health care provider(s). These reports will not be put in your medical records.