Frequently Asked Questions
How will you maintain confidentiality for my information/data/samples?
If you choose to participate, it will not affect the usual medical care that you receive outside the study. All information collected in this study is confidential and only shared between members of the research team. Results from the urine drug screening questionnaires will not be provided to you, your doctor, any Children’s Aid Society (CAS) case worker, or 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.
If you agree to participate in this study, you will be given a study specific code that is used to refer to your data anonymously. It will be in this format:
IMPACT – (site number) – (a number assigned to you)
For example, you might be: IMPACT - 2 - 144
All the data collected for this study will be securely stored in an electronic database maintained by the Study Coordinating Centre. The database can only be accessed by authorized individuals who are directly involved in the research and Queen’s Centre for Advance Computing REDCap administrators where the database resides.
To protect your identity, the information that will be on your samples will be limited to your study specific ID.
Here is how your samples will be labelled:
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 connect their findings with clinical conditions. The pathologist will not have access to any study data. The report generated and the samples prepared by the pathologist will be deidentified using your study specific ID before they are entered into the study database or shipped to the study's Placenta Lab.
Why do you need my urine? What drugs are you specifically testing it for?
Urine samples are being tested for chemical components of the most commonly used drugs and their metabolites. Metabolites are substances made or used when your body breaks down foods, drugs, chemicals or its own tissue.
There are several reasons this is being done:
We would like to ensure that we are properly assigning participants into groups (i.e. non-substance users, opioid users, cannabis users, nicotine users, opioid agonist therapy users). Some people may fall into more than one group, so we want to make sure that we identify if this is happening.
We do not know the extent and significance of secondhand substance exposure. For example, if a participant is not a substance user, but their urine identifies the presence of cannabis, perhaps it is due to their partner’s smoking habits.
It is possible that a substance is identified other than the ones we are specifically interested in for this study. If this substance comes up for multiple participants, there may be a need to investigate why this might be the case.
Urine samples will NOT be tested at study visits. They will be stored for up to several months and then sent in large batches to a testing facility at St. Michael’s Hospital in Toronto. When they are sent to be tested, they will not be identifiable and will not be entered into any medical records. The testing to be performed is known as broad spectrum toxicology testing.
What does broad spectrum toxicology testing mean?
Broad spectrum urine testing is more comprehensive than the typical drug testing that is done on a routine basis at hospitals or other medical facilities. Broad spectrum urine toxicology screens are usually performed using mass spectrometry. This is a laboratory technique that separates components of a sample based on their size and their charge. There are three main parts of a mass spectrometer: an ion source, the analyzer, and the detector. First, the ion source vaporizes the sample (i.e. urine) into a gas. This occurs in a vacuum with no air. Then the ionized particles accelerate through a chamber and are focussed into a beam (in the analyzer). The beam of ions passes through a magnetic field, which causes the different charges and/or sizes of particles to deflect to differing degrees. Finally, in the detector, the number of ions and their differences in deflection are measured and compared to known patterns for specific chemicals.
For example, here is the pattern created by cocaine:
Source: National Institute of Standards and Technology (NIST). U.S. Department of Commerce. NIST Chemistry WebBook SRD 69. Cocaine (nist.gov)
For our study, the mass spectrometer will identify the following substances:
Who is paying for this study?
This study is being supported by the Canadian Institutes of Health Research (CIHR). The Canadian Institutes of Health Research (CIHR) is Canada's federal funding agency for health research. CIHR invests approximately $1 billion each year to support health research. CIHR approved an application for funding for the IMPACT project
I do not use drugs/nicotine/cannabis. Why are you asking me to join this study?
A subset of individuals being approached for this study is expected to be non-substance users with no previous exposure in pregnancy to drugs, nicotine, or cannabis). This subset is called a “control group” in scientific research. Control groups serve an important comparison role allowing us to properly identify whether observations being made about the study population (i.e., substance users) are significantly different from those observed amongst the control group. This will help us determine if differences in fetal development and outcome are likely to be related to substance use in pregnancy or if they might be related to some other factor(s). Thusly, establishing a baseline describing pregnant non-substance users is a critical piece of the research process.
Are you doing genetic testing on my samples?
There will not be genetic testing on samples in the way that most people mean when they say “genetic testing”. Concerns about this type of testing usually arise because people feel that performing genetic tests mean that their samples will be identifiable as ‘them’ (i.e., such as when you do an ancestral test/family tree testing kit through a service like ). This type of testing is DNA based. The type of testing that we are doing is RNA based. Although this is still considered “genetic material” it is and someone could not examine our data later and connect it to a specific person. We are investigating mRNA, also known as messenger RNA. mRNA is the code used by your cells to create proteins in your body. It does not describe your heredity (like DNA).
What is trauma-informed research?
We aim to take a trauma-informed approach throughout the research process. From the outset, we have engaged peer researchers in our research process who have lived experiences of drug use during pregnancy. By incorporating their voices and listening to their concerns about how we organize and conduct our study, we hope to make our research protocols (e.g., how we recruit participants, our questionnaires, etc.) and outcomes (e.g., presentations, publications) sensitive, meaningful, and appropriate to the lived realities of pregnant people who use substances.
We are aware that we are asking you to talk about a sensitive topic and that there is a lot of stigma that surrounds people who use various substances, especially during pregnancy. We want our participants to feel safe and supported at all times during their involvement in our study. We know our participants will have had a range of life experiences and we do not wish to add to the violence and trauma in their lives. If you do not feel comfortable with any aspect of the study, you can simply choose not to participate in it, or you can withdraw from the study completely at any time with no consequences to you.
Nothing that you contribute to this study will have any impact on the usual medical care that you receive during and after your pregnancy. Results from the urine drug screening questionnaires will not be provided to you, your doctor, any Children’s Aid Society (CAS) case worker, or 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.
We will be able to offer you a small token of appreciation for your participation in this study, a $10 gift card to Shoppers Drug Mart for each study visit you complete. Participants recruited before 28 weeks gestation will receive up to a total of $30 for their three (3) study visits. Participants recruited at 28 weeks gestation or later will receive up to a total of $20 for their two (2) study visits. Of course, your contribution to this study is invaluable in terms of the potential for advances in research knowledge and, hopefully, better outcomes for babies and their parents in the future.
What is peer research?
Peer research is a collaborative partnership between traditional researchers/scientists and individuals from the community who have lived experiences that reflect the question(s) being investigated by the study team. Peer researchers may or may not have educational backgrounds related to the research question. These individuals bring a unique perspective to the study team because they typically share more common experiences with the study participants than the primary investigators and clinical team. Because of their unique perspectives, they are better able to advocate for the study participants and ensure the research being done is meaningful and appropriate. They review all study materials and results before anything is implemented, presented, or published. They help ensure that results are presented sensitively and in a manner that is relevant to the study participants and community at large.
What is a placenta?
The placenta is an organ that develops over a pregnancy and is contained in the uterus. Its appearance is relatively round and flat (like a small pizza, if it were flattened out; a healthy placenta is about 10 inches long and 1 inch thick). It provides oxygen and nutrients to the baby during development. It also removes waste from the baby’s bloodstream. The umbilical cord also connects the baby to the placenta.
Why do you want to study my placenta?
The placenta transfers the substances that your body makes or consumes (or are exposed to) from you to your baby via the sharing of blood. Most of these substances represent important nutrients, hormones, or antibodies needed by your baby for healthy growth and development. However, some substances that are passed to your baby have an unknown role and may or may not be healthy for their development. Some of these substances may also impact the formation of the placenta itself. For our study, we would like to examine the impact of specific substances (e.g., cannabis, nicotine, opioids, opioid agonist therapy) on the development of the placenta.
Why do you need my baby’s cord blood? What are you specifically testing it for?
Tests done on the umbilical cord blood sample specifically will measure levels of micronutrients. Micronutrients are the vitamins and minerals necessary for healthy human growth and development. While children and adults get their micronutrients from proper nutrition and supplements, babies in utero receive their micronutrients from their birth parent through the umbilical cord. This is why pregnant people are encouraged to take a prenatal vitamin that includes calcium, docosahexaenoic acid (DHA), folic acid, and iron, amongst other vitamins and minerals, as these micronutrients are important for the healthy development of their growing baby(ies) (1). Results of these tests will help us to understand how substance use and other lifestyle factors might impact the level of micronutrients in babies at birth.
(1) Adeli K, Higgins V, Nieuwesteeg M, et al. Biochemical marker reference values across pediatric, adult, and geriatric ages: establishment of robust pediatric and adult reference intervals on the basis of the Canadian Health Measures Survey. Clin Chem. 2015;61(8):1049-1062.
Why should I feel comfortable sharing sensitive information about my drug use to this research team?
Our research team is comprised of individuals who have a broad range of experiences working with and/or living as pregnant person(s) using substances. We work from a non-judgmental, trauma-informed approach that centres the lived experiences of women and pregnant people. As such, we want to hear your stories and you will not be judged by any member of the research team for whatever you share. Be assured we will only collect information that is absolutely necessary for the accuracy of the study and only members of the research study team will have access to this information. Your information (or study data) will be stored using a study-specific ID number and all your identifying information will be removed. When we publish our results, we will use aggregate (grouped) data and attribute quotations to pseudonyms – we will never release your name, contact information, or any information you share with the researchers to any outside person or agency including, but not limited to, your doctor or any other healthcare provider, any Children’s Aid Society worker or other social service provider, any criminal justice agent, educational institution, or your family or friends.
We respect your time and dignity, so you can either fill out our questionnaires at the healthcare provider’s office during your study visit, or you can go home and complete it online at your earliest convenience. You are an integral member of the research study team and we want you to feel safe, respected, and valued. Please contact us using the contact form on this page if you have any questions or concerns about our project or your role in it.
Who is benefitting from this research?
The study is funded by a research grant from the Canadian Institutes of Health Research (CIHR), Canada's federal government funding agency for health research. This study is NOT funded or supported in any way by private corporations or business.
The primary benefit of this research is to contribute to the body of research knowledge on how drugs like opioids and cannabis affect fetal development by determining the exact mechanisms that disrupt placental growth (e.g., placental vascularity, micronutrient transport from pregnant person to fetus, metabolic signaling, etc.). Babies whose development is compromised during pregnancy can be at risk for things like preterm delivery, low birth weight, small gestational age, or even stillbirth (1,2). Further, complications during pregnancy and childbirth can have lifelong impacts for the infant, including diabetes, hypertension, and metabolic syndrome in adulthood (3) Understanding the exact mechanisms through which the placenta is affected by different substances will help inform future prevention and harm reduction practices. It is our goal that the ultimate beneficiaries of our research will be a) pregnant people, who could have access to more evidence-based strategies for limiting the harm associated with substance use and abuse, and b) babies, who will have improved birth outcomes if healthcare providers and pregnant people understand the specific developmental processes affected by substance use.
(1) Breeze AC, Lees CC. Prediction and perinatal outcomes of fetal growth restriction. Semin Fetal Neonatal Med. 2007;12(5):383-397
(2) Halliday HL. Neonatal management and long-term sequelae. Best Pract Res Clin Obstet Gynaecol. 2009;23(6):871-880.
(3) Crispi F, Miranda J, Gratacós E. Long-term cardiovascular consequences of fetal growth restriction: biology, clinical implications, and opportunities for prevention of adult disease. Am J Obstet Gynecol. 2018;218(2S):S869-S879.
de Boo HA, Harding JE. The developmental origins of adult disease (Barker) hypothesis. Aust N Z J Obstet Gynaecol. 2006;46(1):4-14.
I use opioids prescribed by a doctor, can I still participate?
Yes! We want to include participants who have a range of experiences with opioids and/or cannabis and/or no substances at all. You may participate if you are pregnant with one (1) baby and are using opioids prescribed by a doctor (e.g., codeine, morphine, oxycodone, fentanyl, etc.) for any reason.
Will this study be able to improve or give me insights into my or my baby’s health?
Unfortunately no, as a participant in the IMPACT study, you will not be provided with any additional information or insight into your health or the health of your baby. The samples and information collected from you will not be used to understand the individual dynamics of your pregnancy, but be used in aggregate form to understand how opioids and cannabis might affect various processes necessary for placental development and fetal growth.
Will my baby be taken away by children’s services if I use drugs during pregnancy?
The IMPACT research study team will not disclose any information about participant drug use to any outside person or agency, including Children’s Aid Societies or other social service provider, your doctor or any other healthcare provider, any criminal justice agent, educational institution, or your family or friends