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Canadian Retinoblastoma Research Community
Consent Form
Study Title: Canadian Retinoblastoma Research Community
Principal Investigator:
Helen Dimaras, PhD, Department of Ophthalmology and Vision Sciences, helen.dimaras@sickkids.ca, 416.813.7654, Extension: 201876
Research Contact:
Kaitlyn Flegg, MSc, Department of Ophthalmology and Vision Sciences, kaitlyn.flegg@sickkids.ca, 416.813.7654, Extension: 203287
Study Sponsor:
The Hospital for Sick Children
Conflict of Interest:
There are no conflicts of interest to declare related to this study.
Introduction
Throughout this form, “we” represents the SickKids researchers.
You are being invited to take part in our research study. This consent form describes the research study and what it means to participate. Please ask the study staff to explain anything that you do not understand. Please take as much time as you need to think about your decision to participate or not.
All participation in a research study is voluntary and you are not under any obligation to participate.
Why am I being asked to participate?
You are being invited to participate in this study because you are:
• 18 years of age or older or considered an emancipated minor (i.e. are married and/or parents);
And one or more of the following:
• Someone with lived experience of retinoblastoma (i.e., patient, survivor, family member, caregiver);
• Health care professional with experience relevant to retinoblastoma;
• Researcher with interest in retinoblastoma research;
• Advocate engaged in supporting the retinoblastoma community.
Why is this study being done?
The purpose of this study is to create a list of people interested in retinoblastoma research called the Canadian Retinoblastoma Research Community. These people include retinoblastoma patients (i.e., those with lived experience of retinoblastoma including survivors, family members and caregivers), advocates, researchers, and health care professionals. The development of this Research Community list will allow us to:
1. Share research results with those interested in retinoblastoma;
2. Include a large and diverse group of patients, researchers, healthcare professionals, and advocates in research; and
3. Promote research that is created and lead by retinoblastoma patients.
How long will the study take?
Your participation in this study will include a survey that will take approximately ten minutes to complete. We estimate that the Research Community list will be developed for ten years.
How many participants will be in this study?
This study is open worldwide. We expect to enroll up 460 members in the initial ten year period of the study.
What will happen in this research study?
This study is a long-term registry. Your participation in the Canadian Retinoblastoma Research Community will involve the completion of a survey.
The survey will invite you to give us permission to any (or none) of the following:
1. Email you information about retinoblastoma, including research results and updates about the Canadian Retinoblastoma Research Community.
2. Contact you if:
• You (or your child, if applicable) appears to fit a research study that is seeking participants. (This is only for permission to contact you. You would later decide whether or not to participate in the research study); or
• There is a position available on a research study team.
3. Share your contact and personal information with other researchers so that these researchers can also contact you if:
• You (or your child, if applicable) appears to fit a research study that is seeking participants. This is only for permission to contact you. You would later decide whether or not to participate in the research study; or
• There is a position available on a research study team.
The survey will also collect your contact and personal information. This information will be added to the Research Community list.
We might contact you to clarify the information that you provide in the survey.
What are the risks, harms or discomforts of the study?
The potential harm associated with participation in the Canadian Retinoblastoma Research Community is the possible inconvenience of being contacted.
Are there benefits from being in the study?
You are not guaranteed to obtain any direct benefit from participating in the Canadian Retinoblastoma Research Community. However, you may benefit from the satisfaction of knowing that you are contributing to a patient engagement strategy for retinoblastoma research.
You may benefit by being made aware of retinoblastoma research results, news, community events and opportunities.
The Canadian Retinoblastoma Research Community may lead to increased patient oriented retinoblastoma research and better translation of research findings to those affected by retinoblastoma. In this way, these results may ultimately strengthen retinoblastoma research and, in turn, improve outcomes.
What are my responsibilities in this study?
If you choose to participate in this study, you will be expected to:
• Ask your study team about anything that worries you.
• Tell the study staff if you change your mind about being in this study.
Can I choose to leave the study?
It is your choice to decide to take part in this study, and participation is voluntary. You can change your mind at any time during the research study. If you decide to leave the study, you can contact a member of the study team to let them know. The study team may ask why you are withdrawing for reporting purposes, but you do not need to give a reason to withdraw from the study if you do not want to.
Will it cost me or my family anything to be in this study?
There are no anticipated costs associated to participation in this study.
Will I be paid if I join this study?
You will not be paid to be part of this study.
What personal health information will be collected about me as part of this study?
Personal health information (PHI) includes any information collected from you during the study survey.
Some of the data collected for this study includes identifiable information about you, including: name and contact information. This information is needed to contact you to share/engage in retinoblastoma research.
How will my privacy be protected?
Your rights to privacy are legally protected by federal and provincial laws that require safeguards to ensure that your privacy is respected. We will respect your privacy. No information about you will be given to anyone or be published without your permission, unless the law requires us to do this.
SickKids guidelines include the following privacy protection measures:
- All information that identifies you, will be kept confidential and stored and locked in a secure place that only the study staff will be able to access.
- Electronic files will be stored securely on hospital networks.
- No information identifying you will be allowed off site without your consent.
The following people may look at your original (identifiable) study records to check that the information collected for the study followed the required laws and guidelines:
• Representatives of SickKids Research Ethics Board and other SickKids staff who oversee the conduct of research at SickKids.
Access to your personal health information will take place under the supervision of the Principal Investigator. You have the right to access, review and request changes to your personal health information. The study staff and the others listed above will keep the information about you confidential. Even though the risk of identifying you from the study data is very small, it can never be completely eliminated.
The study staff will keep any PHI about you in a secure and confidential location for seven years following the closure of this study and then destroy it according to SickKids policy.
This study includes the option for the transfer of identifiable study data to external investigators for the purposes of research development. The following information may be transferred (if you have selected this optional component): name, contact information.
Any information sent outside of Canadian borders may increase the risk of disclosure of information. Any information will be transferred in compliance with all relevant Canadian privacy laws.
If you have any concerns about the way your information is being kept private, you can contact the SickKids Research Ethics Board or the SickKids Privacy Office.
Will information about this study be available online?
A description of this study is available on lab.research.sickkids.ca/dimaras/. This website will not include information that can identify you.
Will I receive study results?
Research results will be shared through journal publications, conferences, and the study website. When the results of this study are shared, your identity will not be disclosed.
What are my rights when participating in a research study?
You have the right to receive all information that could help you make a decision about participating in this study. You also have the right to ask questions about this study at any time and to have them answered to your satisfaction. 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 Principal Investigator, or involved institutions for compensation, nor does this form relieve the Principal Investigator or their agents of their legal and professional responsibilities.
You will be able to download a copy of this consent form prior to your participating in this study.
Who can I call if I have questions about the study?
If you have any questions during your participation in this research study you can contact any research team member listed at the beginning of this consent form.
Research Ethics Board Contact Information
The study protocol and consent form have been reviewed by the SickKids Research Ethics Board. If you have any questions regarding your rights as a research participant, you may contact the Office of the Research Ethics Board at 416-813-8279 during business hours.
Consent to Participate in a Research Study
By enrolling in the Canadian Retinoblastoma Research Community, I understand and confirm that:
1. All of my questions have been answered.
2. I understand the information within this informed consent form.
3. I allow access to my Personal Health Information as explained in this consent form.
4. I do not give up any of my legal rights by signing this consent form.
5. I understand I will be able to download a copy of completed consent form.