Dermatitis Registry Informed Consent Form
INVESTIGATOR AND STUDY CODE
This consent form pertains to the following research study:
Study Title: Dermatitis Registry
Study Code: 2020-5565
This study is being conducted by a team of researchers under the supervision of the following investigator:
Principal Investigator: Principal Investigator Dr. Carolyn Jack (MDCM, PhD, FRCPC) Assistant Professor, McGill University, Founder of the MUHC Center of Excellence for Atopic Dermatitis (MUHC COE AD), Junior Scientist, Infectious Diseases and Immunity in Global Health Program, Research Institute-MUHC
Sub-study Principal Investigators:
- DBB: Dr. Carolyn Jack (MDCM, PhD, FRCPC) Assistant Professor, McGill University, Founder of the MUHC Center of Excellence for Atopic Dermatitis (MUHC COE AD), Junior Scientist, Infectious Diseases and Immunity in Global Health Program, Research Institute-MUHC
- CTTB: Bruce Mazer
- CACTI: Aaron Drucker
- MAADO: Dr. Carolyn Jack (MDCM, PhD, FRCPC) Assistant Professor, McGill University, Founder of the MUHC Center of Excellence for Atopic Dermatitis (MUHC COE AD), Junior Scientist, Infectious Diseases and Immunity in Global Health Program, Research Institute-MUHC
- Dermatitis Registry: Charlie Bouchard, Gaurav Isola
- DBB: Charlie Bouchard, Gaurav Isola
- CTTB: Dr. Carolyn Jack (MDCM, PhD, FRCPC) Assistant Professor, McGill University, Founder of the MUHC Center of Excellence for Atopic Dermatitis (MUHC COE AD), Junior Scientist, Infectious Diseases and Immunity in Global Health Program, Research Institute-MUHC
- CACTI: Dr. Carolyn Jack (MDCM, PhD, FRCPC) Assistant Professor, McGill University, Founder of the MUHC Center of Excellence for Atopic Dermatitis (MUHC COE AD), Junior Scientist, Infectious Diseases and Immunity in Global Health Program, Research Institute-MUHC
Anita Slominska, PhD, Qualitative Research Assistant, MUHC COE AD, McGill University Health Centre.
Charlie Bouchard, formal Patient Partner of the MUHC COE AD and co-director of registered non-profit Eczema Quebec.
Nickoo Merati, Kai Li, Anita Slominska
You are being invited to participate in the Dermatitis Biobank Registry, a research project consisting of four sub-studies focused on advancing the understanding and treatment of dermatitis and related conditions. You may be eligible to participate in one or more of these sub-studies due to your dermatitis diagnosis or as a healthy control subject. The four sub-studies within the Dermatitis Biobank Registry are:
- Dermatitis BioBank (DBB): This sub-study focuses on collecting and storing biological samples and data from individuals with atopic dermatitis, as well as healthy subjects and individuals with other inflammatory skin conditions such as psoriasis. The DBB aims to facilitate research on dermatitis and related conditions.
- CTTB Biobank and Registry for Atopic Dermatitis (CTTB-DBB): This sub-study, part of the Transdisciplinary Centre for Biological Therapies (CTTB), aims to store biological samples and related clinical data from individuals receiving immune system-targeting therapies for atopic dermatitis. Healthy subjects and individuals with other inflammatory skin conditions may also be included as control subjects in this sub-study.
- Canadian Atopic Dermatitis Cohort for Translational Immunology and Imaging (CACTI): The CACTI sub-study focuses on individuals with eczema (atopic dermatitis) that is difficult to control with topical therapies alone. It aims to investigate the immunology and imaging aspects of atopic dermatitis to advance our understanding and develop better treatments. Healthy subjects may be included for comparative analyses.
- McGill Adult Atopic Dermatitis Digital Outcomes Study: Validation of EczemaQ Mobile Health Application (MAADDO): This sub-study invites individuals with moderate-to-severe atopic dermatitis to participate in the validation of the EczemaQ mobile health application. The study aims to assess the app’s effectiveness in monitoring and managing atopic dermatitis. Healthy subjects may be included as a control group to compare the app’s performance and usability.
Before deciding to participate in any of the sub-studies, it is important to understand their requirements, risks, and benefits. This document provides information about the Dermatitis Biobank Registry and its sub-studies and may contain words you do not fully understand. Please read it carefully and ask the research team any questions you may have. They will discuss the study with you in detail. You may take this form with you and discuss the project with anyone else before making your decision. If you decide to participate, you will be asked to sign this form, and a copy will be given to you.
Taking part in any of the sub-studies is voluntary. You have the option not to participate at all, and you may choose to leave a sub-study at any time. Whatever you choose, it will not affect the usual medical care that you receive outside the study.
Please read the specific sections of this document that apply to the sub-studies you are eligible for, and make sure to ask any questions you may have to ensure your complete understanding.
Note that for each sub-study, healthy subjects may be included as a comparison group, depending on the specific research goals and objectives.
The Dermatitis Biobank Registry is composed of four sub-studies, each with a unique focus within the dermatitis research field. All sub-studies involve the collection, storage, and use of biological material and personal health data for current and future research. These biobanks and databanks serve as vital resources for advancing our understanding of dermatitis and related skin conditions, both locally and globally.
A biobank/databank is an organized collection of tissue and fluid samples, as well as personal health information, for the purpose of conducting specific or as-of-yet unspecified research. It acts as a resource for current and future investigations, providing an essential foundation for research across Canada and around the world.
The sub-studies within the Dermatitis Biobank Registry aim to address various aspects of dermatitis, such as investigating the immunology and imaging aspects of atopic dermatitis, validating a mobile health application for managing the condition, and studying the effects of immune system-targeting therapies. By combining these efforts, the Registry seeks to improve the efficiency of clinical encounters, reduce the burden of in-person knowledge translation, help patients remotely self-manage their disease, and ultimately, reduce the immense cost burden of dermatitis.
In addition to individuals with dermatitis, the Registry also includes a healthy subject arm, which serves as a comparison group for various research goals and objectives.
The EczemaQ mobile health app
The EczemaQ mobile health app is a key component of the MAADDO sub-study within the Dermatitis Biobank Registry. Developed by the research team at the MUHC Center of Excellence for Atopic Dermatitis, this app aims to empower adult patients living with atopic dermatitis by providing remote access to care and personalized medicine. EczemaQ facilitates shared decision-making and self-management of the disease, addressing the complex burdens associated with atopic dermatitis.
Digital tools, such as the EczemaQ app, are becoming increasingly important in healthcare. As patients face challenges accessing specialized care and navigating complex health information, digital resources offer a solution to bridge these gaps. Mobile health apps can provide patients with reliable, evidence-based information, tools to monitor their conditions, and resources to better communicate with their healthcare providers.
EczemaQ offers patients educational content centered around common questions about atopic dermatitis, a body map module for exploring treatment options per body part, a diagnostic tool, disease tracking through the validated patient-reported outcome measure POEM, and a dedicated photo gallery and notes module. In doing so, the app seeks to improve the efficiency of clinical encounters, reduce the burden of in-person knowledge translation, and support patients in remotely self-managing their disease.
As the healthcare landscape continues to evolve, digital tools like EczemaQ will play a vital role in improving patient care, outcomes, and overall quality of life for individuals living with chronic conditions such as atopic dermatitis.
Purpose of the Study
The purpose of these sub-studies is to advance our understanding and treatment of dermatitis through various approaches, with all sub-studies involving treatment options that are part of standard care. Participation does not affect the choice of treatments used.
The Dermatitis BioBank (DBB): aims to understand the biology of dermatitis and its response to treatments by collecting and storing blood, skin tissue, and other biological samples, as well as clinical information. This will allow researchers to investigate the impact of treatments on patient symptoms, disease outcomes, and quality of life, as well as characterizing skin lesions, cells, proteins, and genetic material to identify potential markers and targets for improved treatments.
The CTTB Biobank and Registry for Atopic Dermatitis (CTTB-DBB) is an intra-institutional multidisciplinary study that aims to collect real-world data on the long-term effects of biological therapies for immunological conditions, with a specific focus on atopic dermatitis. Sharing similar goals as DBB, the CTTB-DBB sub-study seeks to enhance our understanding of dermatitis by collecting and analyzing biological samples and clinical information. This comprehensive approach aims to identify potential markers and targets for the development of improved treatments, as well as to predict therapy responses and disease outcomes in the context of atopic dermatitis.
The Canadian Atopic Dermatitis Cohort for Translational Immunology and Imaging (CACTI) is a pan-Canadian collaboration between the University of Toronto, the University of British Columbia, and McGill University. This collaborative study focuses on deepening our understanding of eczema, evaluating current treatments, and developing improved therapies. By collecting information on patients’ eczema history, treatment responses, and biological specimens, researchers across these institutions aim to investigate the immune system’s role in eczema and work together to inform the development of innovative treatments for this condition.
The McGill Adult Atopic Dermatitis Digital Outcomes Study: Validation of EczemaQ Mobile Health Application (MAADDO) aims to iterate on the EczemaQ mHealth tool’s beta version and validate it with experts and patients. By recruiting participants to test-drive the tool, researchers will gather feedback on its usefulness as a resource for adult patients with atopic dermatitis.
In each sub-study, the healthy subject arm plays a crucial role in providing valuable control data, which allows researchers to better understand the differences between healthy individuals and those with dermatitis, ultimately leading to more effective treatments and management strategies.
This study has several parts, and the procedures for DBB, CTTB-DBB, and CACTI are similar, while the procedures for MAADO differ.
For DBB, CTTB-DBB, and CACTI:
- Participants will be asked to complete questionnaires during at least two doctor’s visits in the study.
- Participants can consent to storing their archived health data to contribute to the registry.
- Optionally, participants can choose to provide biospecimens to help researchers understand how the immune system and certain bacteria drive inflammation in the skin. These specimens include:
- blood specimen
- skin specimen
- microbial swab specimen
- Participation in this research study will last 2-6 months and will be conducted virtually, with no in-person visits required.
- The research study methods for MAADO include:
- Downloading the beta version of the EczemaQ app to the participant’s smartphone.
- Testing the app through at-home use.
- Completing online questionnaires.
- Optionally, participants can choose to take part in a minimum of one (1) and a maximum of three (3) online focus groups.
Please note that for all sub-studies, treatment options are part of standard care, and participation does not affect the choice of treatments used.
Questionnaire and archived data
All Sub-Studies (DBB, CTTB-DBB, CACTI, MAADO):
Participants in all sub-studies will be asked to complete questionnaires, which will be available in paper format or may be sent via email, according to their preference. The questionnaires will help determine the participant’s overall quality of life and collect additional information relevant to each sub-study. Participants may be contacted at a later time to see if their quality of life improves. Some questions may be personal, and participants have the option to not answer any questions they feel uncomfortable with.
For DBB, CTTB-DBB, and CACTI:
Participants will complete questionnaires during at least two doctor’s visits throughout the study, and the research team will collect information from medical charts and doctor’s notes. The collected data will be securely stored and maintained, and can only be accessed by authorized personnel involved in the study. In addition, participants are asked to authorize the research team to access their clinical information, paper and/or electronic-based, including doctor’s notes and assessments, to contribute to the respective databanks/registries. Participants should also allow the research team to access their “dossier de Santé Quebec” (a central database containing additional information not present in local hospital records) to obtain clinical, laboratory, and radiological data.
Specific to the CTTB-DBB sub-study:
In the CTTB-DBB sub-study, data is collected and securely stored in the Dermatitis Biobank Registry Database, which is hosted on the McGill University Health Centre (MUHC) servers and operated through the RedCap platform. This data is then shared with the collaborating database of the CTTB-DBB, also hosted on the MUHC servers and operated through RedCap, ensuring a seamless and secure transfer of information between the two databases.
Specific to the CACTI sub-study:
For the CACTI sub-study, data is collected and securely stored in the Dermatitis Biobank Registry Database, hosted on the MUHC servers and operated through the RedCap platform. This data is subsequently shared with the collaborating database of the CACTI-MON, which is hosted on the University of Toronto servers and also operated through RedCap. This process ensures the safe and efficient sharing of data between the collaborating institutions.
For the MAADO sub-study:
Participants will be given access to download the beta version of the EczemaQ app and provided with testing instructions. They will then be asked to review the app through online questionnaires, which will be completed through a secure, anonymous, and confidential link sent to their email addresses. The questionnaires will take approximately 30 minutes to complete.
For the DBB, CTTB-DBB, and CACTI sub-studies, participants may be asked to provide various biological specimens to help researchers study the causes of eczema, including the immune system and bacteria. The collection of these samples is optional, and participants can still take part in the study even if they choose not to provide samples.
Biological materials that participants may be asked to contribute include:
- Nose swab specimen: A cotton swab will be used to rub the skin in the nose (surface of the nostrils) to test for bacteria that live in the nose.
- Skin swab specimen: A cotton swab will be used to rub the skin in areas of active dermatitis, resolved dermatitis, and/or normal skin to test for bacteria that live on the skin.
- Blood specimen (9 tubes or +/- 55mL) A trained phlebotomist or nurse will perform the blood draw. The participant’s arm will be cleaned with an antiseptic solution, and a tourniquet will be applied to the upper arm to make the veins more visible. A sterile needle will be inserted into a vein (usually in the arm), and blood will be collected in a tube. The needle will then be removed, and pressure will be applied to the site to prevent any bleeding. The procedure takes a few minutes and may cause minor discomfort or bruising at the site of the needle insertion.
- For RNA collection, blood will be drawn into PAX RNA tubes, which are specifically designed to stabilize and preserve RNA in whole blood samples. The needle will then be removed, and pressure will be applied to the site to prevent any bleeding. The procedure takes a few minutes and may cause minor discomfort or bruising at the site of the needle insertion.
- Skin specimen (Affected and unaffected skin) A health professional will perform the skin biopsy. First, the area where the biopsy will be taken will be cleaned with an antiseptic solution. A local anesthetic will be applied to numb the skin. Using a small, circular cutting instrument called a punch, the health professional will take a small sample of skin (approximately 5 mm in diameter). The procedure usually takes around 5 minutes. After the sample is collected, a small suture will be placed to close the wound, which will need to be removed in 10-14 days. There may be minor discomfort, swelling, or bruising at the biopsy site, but these symptoms generally resolve within a few days.
Members of the study team will store, analyze, and compare them with samples from other patients. Reports from these tests will not be made immediately available to participants, their doctors, or study staff due to anonymous processing and the time needed for analysis. Anonymous reportable findings will not be put in participants’ medical records but will be shared and published through peer-review processes.
Specific to the CACTI sub-study:
Skin and blood samples recruited for CACTI study will be tested at the University of Toronto or at the McGill University laboratories.
Specific to the MAADO sub-study:
Biospecimen collection is not applicable for the MAADO sub-study.
Focus groups (Applicable only to MAADO Sub-Study)
Participants in the MAADO sub-study will have the opportunity to take part in online focus groups conducted via Zoom. Each focus group will last approximately 1 hour and will involve between 3 to 5 participants, all of whom are adults with atopic dermatitis. One or two facilitators will lead the focus group, guiding participants through group discussions.
During the focus groups, participants may be asked questions such as, “How useful do you find the app?” These virtual discussions will be recorded (video/audio) to ensure accuracy and to reduce the chance of misinterpreting feedback during post-discussion analysis.
Overview of the study timeline
The participant group to which you will be assigned in this study depends on the specific treatment you will be using to manage your atopic dermatitis (AD). It is important to note that the selection of your treatment is determined through shared decision-making during your clinical appointment, independently from this research study. Your healthcare provider will work closely with you to establish the most appropriate treatment plan based on your individual needs and preferences, ensuring that your clinical care remains the priority, separate from your participation in this study.
Table 1: Timeline for Participation in DBB, CTTB-DBB, and CACTI
|Procedures||Baseline (t=0)||FU 1 (t=1 month)||FU 2 (t=1-3 months)||FU 3 (t=6 months)||FU 4 (t=12 months)||FU 5 (t=15 months)||FU 6 (t=18 months)||FU 7 (t=24 months)||FU (Other)|
|Healthy subject screening||HS|
|Informed consent form||All|
|Intake form/AD Questionnaire||All||O, R||O, R||O, B, R||O, B||O, R||O, B||O, B||R, AE|
|Patient Oriented disease measures||All||O, R||O, R||O, B, R||O, B||O, R||O, B||O, B||R, AE|
|Clinical assessment||All||O, R||O, R||O, B, R||O, B||O, R||O, B||O, B||R, AE|
|Blood specimen collection*||All*||O*, R*||O*, R*||O*, B*, R*||O*, B*, R*||O*, R*||O*, B*, R*||O*, B*, R*||R*, AE*|
|Skin specimen collection*||All*||O*, R*||O*, R*||O*, B*, R*||O*, B*, R*||O*, R*||O*, B*, R*||O*, B*, R*||R*, AE*|
|Microbial swab specimen*||All*||O*, R*||O*, R*||O*, B*, R*||O*, B*, R*||O*, R*||O*, B*, R*||O*, B*, R*||R*, AE*|
Legend: O: Participants on oral systemics B: Participants on injectable biologics R: Participants who experience disease relapse AE: Participants who experience adverse events HS: Healthy participants All: All participants, including healthy subjects *: Optional procedure
Note that your participation at each time point is optional and you can choose to withdraw at any time. For example, you can participate today and choose to withdraw from any other time points.
Table 2: Timeline for Participation in MAADO
|Procedure||Iterative round 1 (Jan-Apr 2023)||Iterative round 2 (May – Aug 2023)||Iterative round 3 (Sept – Dec 2023)|
|User testing app||Cohort A||Cohort A and Cohort B||Cohort A, Cohort B, and Cohort C|
|Questionnaires||Cohort A||Cohort A and Cohort B||Cohort A, Cohort B, and Cohort C|
|Focus Groups||Cohort A||Cohort A and Cohort B||Cohort A, Cohort B, and Cohort C|
Confidentiality and Privacy
Your privacy is of utmost importance to us. If you decide to participate in this study, we will only collect the information necessary for the study. Any personal information collected or obtained, whether you choose to participate or not, will be kept confidential and protected to the fullest extent of the law.
All personal information collected will be stored in a secure location, and only the project team members will have access to this information. The project staff, the Research Ethics Board, and employees of the sponsor or funder of the project may look at your personal information for purposes associated with the project. These authorized personnel may view your information only under the supervision of the Principal Investigator and will be obligated to protect your privacy and not disclose your personal information. None of your personal information will be given to anyone without your permission unless required by law.
Your name will not be used in any project records, except the consent form and a document linking your name with a study participant number. These will be stored separately from the other project records. Following the completion of the project, hard copies of questionnaires will be kept in a secure location for five years, then destroyed as required according to policy.
Records identifying you at this 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. 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 used in analyses and will be published/presented to the scientific community at meetings and in journals.
Even though the likelihood that someone may identify you from the study data is very small, it can never be completely eliminated. Your rights to privacy are legally protected by federal and provincial laws that require safeguards to ensure that your privacy is respected. By signing this form, you do not give up any of your legal rights against the study doctor, sponsor or involved institutions for compensation, nor does this form relieve the study doctor, sponsor or their agents of their legal and professional responsibilities.
You will be given a copy of this signed and dated consent form prior to participating in this study.
Risks associated with participation
This section covers the potential risks associated with the various study procedures in the different sub-studies. It is important to note that the risks associated with these studies are minimal and do not represent an increased risk compared to what a patient would face during a routine clinical encounter. Please remember that you are free to opt in or out of any procedure at any time during your participation or to stop participating in the study at any time, without providing a reason
Questionnaires: Completing the questionnaires may take around 10-15 minutes. You have the option to complete them during routine clinical visits or via email. Some topics addressed in the study may involve hardships or conditions experienced by the adult atopic dermatitis community, potentially causing discomfort. At any point, you may choose to leave questions unanswered, stop filling out the questionnaires, or decide not to complete any part of the questionnaire.
Nose and skin swabs: The process involves gently rubbing cotton swabs on the inner lining of your nostrils and your skin to test for certain organisms, such as Staphylococcus aureus. The risks associated with this procedure are minimal, but could include local irritation, discomfort, and in extremely rare cases, bleeding.
Skin biopsies: While serious side effects are rare, the skin biopsy procedure does carry some risks. The study doctor will use a numbing medicine (anesthetic) to minimize pain during the procedure. The anesthetic may cause a brief burning sensation, and in very rare cases, an allergic reaction. After the skin sample is taken, the biopsy area might feel uncomfortable, and a small scar will form as it heals. There is a small chance that the biopsy site may become infected, leading to pain, redness, or swelling. Discomfort or pain might persist for a few weeks following the biopsy.
Blood samples: Trained and qualified personnel will draw a blood sample using a sterile needle, typically from the arm. The risks involved with drawing blood include pain, swelling, bruising, feeling faint, and in rare cases, infection at the needle stick site.
Please note that we do not anticipate any other risks or harm associated with these studies. However, if you have concerns or questions, feel free to discuss them with the research team.
Benefits associated with participation
You will not directly benefit from your participation in the Dermatitis Biobank, CTTB Biobank and Registry for Atopic Dermatitis, and the CACTI study. However, the results of the research projects conducted with your biological material and data could benefit individuals suffering from dermatitis. It is possible that the patient community at large benefits as a consequence of your contribution. Your donation will hopefully result in new scientific insights that will be made available to the scientific community with the aims of innovating and improving patient care. A list of the publications generated as a consequence of the Dermatitis Biobank, CTTB Biobank and Registry for Atopic Dermatitis, and CACTI study will appear on the divisional website when this is active.
For the MAADO study, you may benefit from using the EczemaQ mHealth tool as it may increase your knowledge about atopic dermatitis and management of your condition. You may or may not personally benefit from your participation in this research project. However, we hope that the study results will contribute to the advancement of disease management in this field and help us develop better digital tools for patients.
Participation in these sub-studies may involve certain costs and time commitments. To acknowledge your contribution and help defray some of these costs, financial compensation will be provided for certain procedures.
DBB – CACTI – CTTB-DBB Compensation
If you meet all the requirements and are enrolled in either the DBB, the CACTI, or the CTTB-DBB sub-studies, you will be eligible for financial compensation. The compensation details for these sub-studies are as follows:
- Skin Biopsy: Participants enrolled in the CTTB Biobank and Registry for Atopic Dermatitis (DBB) will receive a financial compensation of $50 for each skin biopsy. This compensation is intended to help offset your travel and parking expenses and to acknowledge your time and commitment to the study.
- Optional Blood Draw: In addition to the skin biopsy compensation, an extra financial compensation of $25 will be provided for the optional blood draw. For example, if during your visit you complete a skin biopsy and a blood draw, you will receive a total compensation of $75 ($50 for the skin biopsy + $25 for the blood draw). Any additional blood draws will receive an additional $25 compensation.
Please note that these compensations are intended to acknowledge your time and effort and are not intended to act as an inducement to participate. Your decision to participate should be based on your interest in contributing to dermatitis research and your comfort with the study procedures.
For your participation in the MAADO sub-study, you will receive monetary compensation. The compensation details for the MAADO sub-study are as follows:
- Completion of Online Questionnaires: Participants will receive $30 for completing the online questionnaires.
- Focus Group Participation: An additional $30 will be provided for participating in the focus group.
Participants will take part in one (1) to three (3) rounds of the study, and their compensation will be adjusted accordingly. If you withdraw from the study before it is completed, your compensation will be proportional to the length of your participation.
Please note that the compensations offered are meant to acknowledge your time and effort, and are not intended as inducements to participate. Your decision to participate should be based on your interest in contributing to dermatitis research and your comfort with the study procedures.
Funding and Sponsorship
The Dermatitis Biobank Registry and its sub-studies are funded through various resources to ensure their sustainability. The funding sources include peer-reviewed grants from organizations such as the Canadian Institutes of Health Research (CIHR), the Canadian Dermatology Foundation, and the McGill Department of Medicine. Additionally, funding has been secured from the Eczema Society of Canada and multiple industry sponsors. The financial standing of the project is currently secure, and future funding may come from internal sources, research grants, or access fees for data and sample retrieval by researchers.
It is important to note that the funding organizations do not have the right to access the data collected from participants, nor do they have any influence over the study’s design, execution, or reporting.
Voluntary participation and right to withdrawal
Your participation in the Dermatitis Biobank Registry and its sub-studies is voluntary. You have the right to refuse participation or withdraw from any of the sub-studies at any time without providing an explanation. There will be no penalty or loss of benefits if you choose not to participate or decide to discontinue your participation. Your decision to participate or withdraw will have no impact on the quality of care and services you receive outside of the study.
If you decide to withdraw from the Dermatitis Biobank Registry and its sub-studies, any biological material that remains in the bank will be destroyed, and you will receive a written confirmation of the destruction. However, it’s important to note that if your biological material and data have already been distributed for research purposes or if information has been generated from previously distributed material and data, it may not be possible to destroy them.
Withdrawing from the study also gives you the option to request the removal of any data collected about you. If you choose to exercise this option, any identifiable information collected will be destroyed.
Can I withdraw blood, skin, and/or swab samples?
If you provided blood, skin, and/or swab samples and no longer want your samples to contribute to this research study, you should inform our research coordinator. The research coordinator will ensure that your samples are destroyed. However, if testing has already started with your samples, it will not be possible to withdraw those results. No further testing will be done on your samples. You can request the withdrawal of your specimens until 5 years after the study ends when the samples will be made anonymous. After this point, it won’t be possible to return samples because the researchers will not know which sample is yours.
Please note that even if you withdraw from skin or blood tests or the use of your samples, you may still choose to continue participating in other parts of the study.
If you have any concerns or questions about participation or withdrawal, please feel free to discuss them with the research team.
If you have any questions, concerns, or if you encounter any issues related to your participation in these research studies, or if you wish to withdraw, you may reach out to the respective researcher or research team in charge of each sub-study.
For the McGill Adult Atopic Dermatitis Digital Outcomes Study (MAADO):
You may communicate with the researcher in charge of this research study or with someone on the research team at the following number: (514) 934-1934 (ext. 38809) or 514-813-9651. If you have any questions concerning your rights as a research participant in this study, or if you have comments or wish to file a complaint, you may communicate with the Ombudsman of the McGill University Health Centre at the following phone number: (514) 934-1934, ex. 44285. The office of the Ombudsman can also be reached by email: firstname.lastname@example.org
For the Dermatitis BioBank (DBB):
If you have any questions regarding the study, or wish to withdraw, please contact Dr. Carolyn Jack at 514 345-3511, 3377 or email@example.com. If you have any questions regarding your rights as a research participant, or if you have comments, or wish to file a complaint, please contact the MUHC ombudsman at: tel. 514-934-1934, ext. 48306. firstname.lastname@example.org. The MUHC Office of the Ombudsman is located at 1650 Cedar Room E6.164, Montreal, Qc, H3G 1A4.
For the Canadian Atopic Dermatitis Cohort for Translational Immunology and Imaging (CACTI):
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 Melissa Sidhu, WCH Research Ethics Coordinator (416-351-3732 x2723). If you have questions about taking part in this study, or if you suffer a research-related injury, you can talk to your study doctor. That person is Dr. Aaron Drucker, Scientist (416-323-6400 x5118).
Please remember that your participation in these studies is voluntary, and you can choose to withdraw at any time. Your decision will not affect your usual medical care.
Your participation in this research study is entirely voluntary. By providing your consent, you are agreeing to the following:
- Understanding of the Study: You have read and understood the information provided about the research study, including the purpose, procedures, potential risks and benefits, and your rights as a participant.
- Voluntary Participation: You understand that your participation is voluntary, and you can choose to opt in or out of specific study procedures. You have the right to withdraw from the study at any time without any negative consequences.
- Data and Privacy: You understand that your personal and health information will be used for the purposes of this study, and you authorize the research team to access your medical records as needed. All your information will be kept confidential and used in accordance with applicable laws and regulations.
- Consent to Procedures: You agree to participate in the procedures that you have checked in the table below. You understand what each procedure involves and any potential risks associated with it.
- Future Contact: If you have indicated so, you agree to be contacted for future research projects or to receive updates on the results of this study.
By signing this consent form, you are not waiving any of your legal rights as a research participant. If you have any questions or concerns about your rights or welfare as a research participant, please feel free to contact the appropriate person listed in the Contact Information section.
Please take your time to review this consent form and discuss it with family, friends, and your healthcare provider if you wish. Do not sign this form unless you understand what it means and agree to it.
In this section, you can choose which parts of the study you would like to participate in. This is called “staged consent”. You can opt in or out of specific study procedures. Please review the tables below and check the boxes for the procedures you agree to participate in.
Table 1: Common Procedures for All Studies
|All||All||Questionnaire and clinical data|
Table 2: Procedures for DBB, CACTI, CTTB-DBB Studies
|DBB, CACTI, CTTB-DBB||Baseline||Blood sampling (+/- 40mL)RNA collection (+/- 5mL)Skin biopsy of affected skinSkin biopsy of unaffected skinNares swabsSkin swabs of affected skinSkin swabs on unaffected skin|
|DBB, CACTI, CTTB-DBB||Follow Up||Blood sampling (+/- 40mL)RNA collection (+/- 5mL)Skin biopsy of affected skinSkin biopsy of unaffected skinNares swabsSkin swabs of affected skinSkin swabs on unaffected skin|
Table 3: Procedures for MAADO Study
|MAADO||Other||Online questionnaires onlyOnline questionnaires and focus groupOnline questionnaires and several (2-3) focus groupsVideorecording of sessionsContact to check transcript|
Table 4: Future Contact and Study Updates
|All||All||Agree to be re-contacted for future specific research projectsReceive an update on the results of this project via e-mailContacted regarding potential participation in other research studies|
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