A clinical data registry is a collection of health information on a large number of participants. The type of health information that is collected depends on the purpose of the registry. The Nexus Clinical Data Registry collects and stores a wide range of health information on participants who have conditions that affect their cognitive abilities or development. This information is collected from doctor and clinic visits and is stored in a secure and searchable database. This de-identified health information can be shared with Researchers for approved studies. 1
A biobank is a collection of biological samples (blood, serum/plasma, tissues, and/or cells) that are stored in a secure facility. These samples are used for research, along with the health information connected to the samples. The Nexus Biobank is a specific collection of biological samples from individuals who have a condition that affects their cognitive abilities and/or development. We also store samples from family members of enrolled individuals. These samples can be obtained at the same time as clinical labs or other procedures a child may need. Once the samples are obtained, they are processed in the Biorepository Core Facility and stored in their secure facility. Only a unique Subject ID number is attached to the samples so that your privacy can be maintained. 2
Contributing data and samples facilitates and speeds research by giving researchers access to a ready pool of participants with specific conditions, demographics, and other characteristics that they need. The Nexus allows researchers to concentrate on their studies rather than spending time trying to recruit participants.
The Biobank uses a blood sample. Once we obtain a blood sample, we process the samples in our lab and then store them in a very cold freezer for use at a later date. First, we separate out the liquid portion of the blood (serum and plasma) for biochemical and protein studies. Then, from other parts of the blood, we extract DNA. Lastly, we grow your cells and then cryopreserve (preserve by freezing at very low temperatures) them so that we can continue to obtain DNA for future research.
Your data and samples that are in the Nexus have no expiration date. We will continue to use them into the future for approved research protocols unless you withdraw from the study.
Because most studies using samples from the Nexus are done on de-identified samples, we will not be able to connect research results to individual participants.
If you qualify for a study that requires identifying information and you choose to participate in that study, results or other benefits may be available to you. You may discuss this with the researcher when he contacts you to ask if you’d like to be in his study.
When your child turns 18, we will make an effort to re-contact you to see if your child is able to consent and would like to continue participating in the Nexus project. If interested, we’ll explain the project to him or her and re-obtain consent directly.
If your child is unable to consent and you are the legal guardian and want your child to continue with the study, you can provide consent.
If, after your child turns 18, he or she is no longer interested in participating in the Nexus, we will no longer access his medical records or contact you to participate in qualifying studies. The biological sample will remain in the Biobank and may continue to be used on a de-identified basis.
Researchers at the University of Colorado Anschutz Medical Campus , including those at Children’s Hospital, University Hospital and research centers on campus, will be able to use de-indentified data and samples that are stored in the Nexus. All studies wanting to use samples from the Nexus Biobank must have COMIRB approval. Identifying information is given to researchers only with your permission.8
The Colorado Multiple Institutional Review Board (COMIRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the University of Colorado Denver and its affiliates: Children's Hospital Colorado, Denver Health Medical Center, University of Colorado Hospital, VA Eastern Colorado Health Care System, and Colorado Prevention Center.
When you enroll, we will ask if you would like to be contacted for future studies. We will then obtain contact information from you to put in the registry. If your child or family qualifies for a study, we will either call you or send you a letter to let you know that there is an investigator interested in getting in touch with you. We’ll ask you for permission to give him your contact information. If you are not interested we will not give your contact information to the investigator.
If you move, we ask that you let us know of your new address, phone number, and email so we can still get in touch with you if your child or family qualifies for a study. Our contact information is:
IDDRC Nexus Study Coordinator
13121 E. 17th Ave, C-234
Aurora, CO 80045
All of the clinical information that we collect is stored in a password secure database accessed only by Nexus study personnel. All personnel have had the appropriate privacy training and will not release any identifying information about you or your child to investigators without your permission.
Information for the clinical data registry comes from your child’s medical and research records at Children’s Hospital Colorado, JFK Partners, and the University of Colorado Anschutz medical Campus. In addition, if you have medical records or information relevant to your child’s medical condition that are not on our campus you may be asked to provide those as well.
Oversight for the Nexus Clinical Data Registry and Biobank is provided for by the Nexus Steering Committee, which sets goals for the Nexus and makes sure all policies and procedures are followed. The membership of the Nexus Steering Committee is comprised of patient representatives, referring clinicians, a medical ethics representative, the director and co-directors of the Nexus, and the director of the Intellectual and Developmental Disabilities Resource Center.
If your child isn’t a regular patient at Children’s Hospital Colorado, we may ask you to provide us with clinical information that you have in your records, or we may ask for access to clinical information from his/her regular doctor.
You may participate only in the Clinical Data Registry portion of The Nexus. By allowing us access to your/your child’s clinical information, important research can still be done by investigators.
Your participation is strictly voluntary, and you may withdraw at any time. You would just have to let us know by writing to us. If you decide to withdraw, we lock down the clinical information in our registry and destroy all the samples with the exception of the cells. These cells are stripped of all registry numbers and become anonymous (not able to be linked to the donor in any way) samples. Our contact information is:
IDDRC Nexus Study Coordinator
13121 E. 17th Ave, C-234
Aurora, CO 80045
Your child may have been referred to us by his/her clinician. Many clinicians are interested in helping patients and families not only in the clinical setting, but also in the research setting. Researchers are becoming increasingly interested in developing a more complete understanding of complex cases of conditions that affect development in children and adults. This includes not only the understanding the genetic and biological factors that contribute to these conditions, but also the clinical, behavioral and cognitive characteristics of them.
The Nexus welcomes your enrollment as a healthy control. Some study designs incorporate the use of healthy control samples and data to improve the scientific validity of their research. They do this by comparing those controls to the condition being studied.
Yes. Sometimes investigators are interested in the genetic differences between family members and how these differences interact to contribute to the variability or expression of a condition. Having family members enrolled in the Nexus will make this type of research possible.
You can volunteer to be part of the Nexus Clinical Data Registry and Biobank or the Data Registry alone.
A study coordinator will explain the project, answer any questions you have, and help you get enrolled.
Please call 303-724-2349 or use this link to have a Study Coordinator contact you. Nexus Self-Referral