Ciitizen Heart, Brain, and Rare Disorders Research Databank
Ciitizen is creating a databank of medical and survey data collected from children and adults living with heart, brain, or rare disorders, to be used for future research needs in collaboration with academic and pharmaceutical researchers (the “Databank”).
Ciitizen is a novel, patient-mediated online platform that allows patients to collect and store their medical records. Ciitizen turns these medical records into structured, longitudinal data that can be shared by patients (or their parents) with whomever they want - including for the patient’s medical treatment or for observational research and clinical trials.
Through this Databank, Ciitizen will enable patients with heart, brain, or rare disorders (or their parents/guardians, in the case of a child; or a representative for adults who have a legally authorized representative for making medical decisions) to become users of the Ciitizen platform. Through this partnership, Ciitizen will gather the patient’s medical records from their providers for population in the patient’s Ciitizen profile. Patients (or their parents/guardians) also have the opportunity to consent to share information from their medical records, as well as survey data and data maintained for research purposes, with the Databank.
Below is the informed consent to share information (including medical record information in the Ciitizen profile, as well as survey data and data maintained for research purposes) with the Databank. Please read it carefully. If you have any questions about this research, please contact firstname.lastname@example.org.
What type of research will be conducted with my data?
This consent is intended to allow you to consent broadly and in advance to any research that has the potential to improve the understanding and treatment of heart, brain, or rare disorders. For example, such research could include (but is not limited to) informing the natural history of rare disorders, serving as the control arm of a clinical trial, and studies looking for treatment and outcome patterns in certain subgroups of patients or subgroups of treatments.
Note: because you are broadly consenting in advance to the sharing of your (or your child’s) medical information with heart, brain, and/or rare disease researchers, you will not receive advance notice of the specific research projects being conducted with your (or your child’s) data. Although providing this broad consent does not give you the chance to vet research opportunities individually, it does give you the advantage of assuring that your data (or the data of your child) will be part of a broad range of research initiatives into your or your child’s condition.
What types of researchers will have access to my data and what type of information is shared?
Researchers at Ciitizen will have access to information in the Databank. In addition, Ciitizen may partner with other external researchers who are committed to developing knowledge about and advancing treatments and cures for heart, brain, and rare disorders. Such external researchers may include academic medical centers, nonprofit research institutions, pharmaceutical companies, and independent clinical research organizations. In some cases, information about you (or your child) in the Databank may be submitted to the U.S. Food and Drug Administration (FDA) and other pharmaceutical product regulatory authorities, to help them evaluate potential therapies and therapeutic approaches for heart, brain, and rare disorders.
The information to be shared with external research partners (and potentially with the FDA and other pharmaceutical product regulatory authorities) is information from your (or your child’s) Ciitizen profile, which will include demographic information and all of the clinical information and medical records gathered from your (or your child’s) treating providers. It also includes data from any surveys that you may have completed, for yourself or for your child, that were included in other studies prior to being shared with the Databank.
If you (or your child) learn about the Ciitizen Heart, Brain, and Rare Disorders Databank through an advocacy group, and if you provide consent to do so, Ciitizen will share contact information and identifiable information about your participation (or the participation of your child) in the Databank - for example, whether you have completed surveys, or whether relevant medical information about you or your child has been included in the Databank - to enable the advocacy group to help you maximize opportunities to contribute information about you or your child to the Databank.
Are there any risks to participating?
Because you are consenting to share your (or your child’s) information and images, there is no risk of bodily harm to you (or your child) from participating in this research. However, there is a risk of loss of privacy.
What are the benefits to participation?
It can take a long time for research to produce results, so participation in this research may not change your treatment options (or the options available for your child). But by participating, you will help power scientific discoveries about heart, brain, and rare disorders that could help others.
For some (but not all) research projects that include your data (or the data of your child), there may be an opportunity to have research results returned to you. We will notify you if this is the case and give you a chance to decide whether or not you want to receive those results.
How long will my information be made available to researchers?
Your (or your child’s) information will be available in the Databank indefinitely, until you withdraw your consent to participate (see below), or in the case of a child, when your child reaches the age of 18 years. When your child reaches the age of 18 years, he/she (or his/her legal representative) will have an opportunity to decide whether or not to continue to participate in the Databank.
Do I have alternatives? Can I withdraw from participation?
Your participation (or the participation of your child) in the Databank is completely voluntary. You can decide not to participate and still enjoy all of the benefits of having a Ciitizen profile for yourself or your child. If you are not comfortable providing advance consent to all research projects conducting research using information about you or your child from the Databank, we will contact you with opportunities for you (or your child) to share information on a per project basis.You can withdraw your consent to participate (or for your child to participate) in the Databank at any time by emailing email@example.com. It can take up to thirty (30) days for your withdrawal to take effect, and your withdrawal will be effective for researcher access occurring after this processing period. Information about you or your child that has already been shared with researchers as part of the Databank may not be recovered.
What if I have questions or concerns?
Please contact firstname.lastname@example.org if you have questions about this research, or if you believe you have experienced a research-related injury. If you have questions or concerns about this research and would like to contact the Institutional Review Board that approved this study, you may contact Pearl IRB from Monday through Friday 9-5 EST/EDT by writing, calling, or emailing the following:
29 East McCarty Street
Indianapolis, IN 46225