Frequently Asked Questions

A registry is a place to store detailed information about a person with a specific condition. In this case, DS-Connect is for people with Down syndrome. We hope that DS-Connect will answer two important needs. First, doctors taking care of people with Down syndrome and scientists studying Down syndrome need first-hand information to understand how Down syndrome affects people. Second, they need to find new educational, behavioral, and drug treatments and study whether they are effective in people with Down syndrome. This registry will help to find those people who might be eligible to take part in these studies. All studies will be reviewed by the DS-Connect Research Review Committee before contacting any eligible participants who may qualify. Scientists will not be able to contact families directly. 

A research study is a scientific project designed to learn more about a specific topic. Many research studies collect information about health, medical care, or treatments for people. One type of research study is a clinical trial, which tests whether a treatment such as a drug or an educational program improves the participants' health and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with certain conditions.

There are several ways DS-Connect can help people with Down syndrome and their families and caregivers. The Registry can connect its members with information about the larger Down syndrome community, including Down syndrome family organizations. DS-Connect can provide information about Down syndrome to the registry members. It can also provide yearly updates about the medical care that is recommended at the current age of the person with Down syndrome. DS-Connect can give people with Down syndrome and their family members information about new findings and treatments for Down syndrome. It can provide a list of specialty-care doctors and other healthcare providers in their local community. In addition, DS-Connect can let people with Down syndrome (or their family members) know when they may be eligible for new research studies. Any DS-Connect participant can look at the grouped results to learn how often a response is given by other members of the Registry. Finally, DS-Connect can be a useful way to store medical information about the person with Down syndrome, including growth charts and summary reports that can be shared with doctors.

By collecting information about people with Down syndrome, the registry may be a catalyst for research that benefits people with Down syndrome. A registry can:

• Help connect people with Down syndrome who may be interested in participating in research to scientists who study Down syndrome.
• Speed up research in Down syndrome by collecting information that scientists can use.
• Help scientists learn why people with Down syndrome have different symptoms.
• Help healthcare providers improve how they treat people with Down syndrome.
• Advance our understanding of how and why certain treatments work or don't work by quickly publicizing the results of studies on Down syndrome.
• Help scientists develop and test new treatments for people with Down syndrome.
• Encourage new scientists to conduct research on Down syndrome.

The DS-Connect project is funded by the Other Transaction Award (OTA) and is a collaboration between The University of Colorado and the National Institutes of Health (NIH). The University of Colorado operates the DS-Connect Registry with oversight by NIH’s program team. 

All pages within the DS-Connect website are owned and operated by The University of Colorado. The NIH program team reports back to the NIH Down Syndrome Consortium with updates about the Registry.

DS-Connect is for people living with a diagnosis of Down syndrome, including people with mosaic Down syndrome and partial trisomy 21. All of the health data collected by DS-Connect are related to the health issues of people with Down syndrome.

To join the registry, please click the "Join" button at the top of this page. You will be prompted to:

1. Provide basic contact and demographic information.
2. Create an account by providing a username and password.
3. Consent to participation in the registry.
4. Begin completing the health history surveys!

1. For children younger than 18 years old, a parent, family member, or caregiver can sign the consent.
2. For children seven years and older, verbal assent is requested before signing the consent form. (The person with Down syndrome is asked if they want to be part of the Registry. If they say yes, the adult signs both the consent and the assent.)
3. When the person with Down syndrome turns 18, they will need to provide assent or consent to continue being in the Registry. Adults with Down syndrome 18 years or older who understand the consent form and do not have a legal guardian can sign for themselves.
4. The legal guardian, parent or authorized representative of the person with Down syndrome must sign the consent form for adults with Down syndrome 18 years or older who cannot sign it themselves.

Yes, we hope so! DS-Connect is most valuable for you and for scientific research when it is kept up to date. We will ask you to update your information at least once a year by sending out annual notices to remind you. You can also update your information whenever there is a change in any condition, change in medication, or any new symptom. We may also ask you to send a copy of your test results (such as genetic or diagnostic test results) or other medical reports, if available.

The risks of taking part in DS-Connect are very low. If you are not comfortable answering or do not want to answer a question in the Registry, you do not have to answer. Loss of private or confidential information is also a risk, but that risk is very low. To keep this risk low, we will store your information in a secure computer database. This database uses a security system with many safeguards and protections (see next question). In the unlikely situation where there is a loss of security, we will let you know right away.

DS-Connect is being managed by the University of Colorado with the support of the NIH. DS-Connect is maintained using standards outlined in the Federal Information Security Management Act (FISMA). FISMA sets out a comprehensive set of rules and procedures to follow to protect information and operations from threats. FISMA requires that systems use a set of best practices based on the National Institute of Standards and Technology (NIST) security standards. DS-Connect collects and maintains required security documentation and undergoes a thorough internal review process which includes yearly testing of the security controls. These controls are reviewed annually for compliance and accuracy. FISMA also requires continuous monitoring of the system to look for any vulnerabilities so that we can quickly identify potential security threats and respond. Procedures also have been established for detecting, reporting, and responding to any incidents. To ensure that all of these protections are kept intact, we feel that it is best for DS-Connect to continue to be housed in a secure cloud environment maintained by the University of Colorado, rather than dispersed across local sites. 

This study has been issued a Certificate of Confidentiality from the federal government to help protect your privacy. The Certificate prohibits the researchers from disclosing your name, or any identifiable information, document or biospecimen from the research, with the exceptions listed below. A certificate provides protections against disclosing research information in federal, state, or local civil, criminal, administrative, legislative or other proceedings. These protections apply only to your research records. The protections do not apply to your medical records. The researchers may disclose your name or identifiable information, document or biospecimen, under the following circumstances: 

• To those connected with the research,
• If required by Federal, State or local laws,
• If necessary for your medical treatment, with your consent,
• For other scientific research conducted in compliance with Federal regulations,
• To comply with mandated reporting, such as a possible threat to harm yourself or others, reports of child abuse, and required communicable disease reporting, or
• Under other circumstances with your consent. 

A Certificate of Confidentiality does not protect information you or a member of your family voluntarily release.

The aim of DS-Connect is to share medical and other information with scientists, while still protecting your privacy. We will not share your name, address and other personal, "identifying" information with scientists or anyone else.

Information that has all personal identification removed is called "de-identified" or "de-coded" data. The registry will only share this de-identified data with approved scientists and clinicians through the INCLUDE Data Coordinator Center (DCC). Once people with Down syndrome and their families provide their consent and create their Registry account, they can look at their information in DS-Connect and compare it to de-identified information from other people in the Registry. Some of the de-identified information collected from the Registry may be shared with other registries and databases with your permission. Each Down syndrome-Connect participant will have a "Global Unique Identifier (GUID)" – a number created for each individual that does not have personal information attached to it. This can be used to link to other databases, registries and biobanks with your permission, without revealing personal information. The Registry is a knowledge base about Down syndrome and other conditions that we hope will lead to new research studies and new treatments.

DS-Connect follows all state and Federal rules to protect private information about you and the person with Down syndrome. Staff at The University of Colorado must complete training courses and receive certification in Human Subjects Protection and Information Privacy.

De-identified data is very useful for creating composite graphs and charts that anyone with a DS-Connect account may see. We believe that the de-identified data presented in this way belongs to the Down syndrome community without creating concerns about individuals' privacy.

DS-Connect is a registry where families and individuals control their data. We hope that the person who is the account holder is answering the questions to the best of their ability, because researchers will look at the data to help them design their studies around important health questions for people with Down syndrome.

No. Researchers interested in recruiting participants with Down syndrome for research studies will only be able to contact the DS-Connect Registry Coordinators, who will scan DS-Connect participants and identify who might be eligible for a particular study and contact those participants or their families.

No. DS-Connect will have a Research Review Committee to review proposals to use the Registry to recruit for research studies. The Research Review Committee is made up of experts from the University of Colorado, Down syndrome Consortium, and family members. It reviews requests from researchers who want to help in contacting individuals with Down syndrome who may be eligible for their proposed studies. Each study will need prior ethical approval from the Institutional Review Board (IRB) at the researcher's home academic institution, university, or company. The Research Review Committee will decide whether the researcher can proceed with the request that the Registry Coordinators contact families.

One of the main goals of DS-Connect is to make it easier for a person with Down syndrome to take part in research. If a researcher's proposed study has been approved by an Institutional Review Board and meets all of the criteria for data access by DS-Connect's Research Review Committee, that researcher will be able to use the registry to recruit. Interested and willing participants will be notified about the study and the participant (or their family) can decide whether they would like to contact the researcher or not. If we inform you about a new research study, this does not mean that you have to sign up for it. In order to take part in any research study, you or the person with Down syndrome will need to fill out a separate informed consent form. You should read and review any risks or benefits associated with participating in that research study before making a decision.

There is no guarantee that you or the person with Down syndrome will qualify for a research study. Even if the person is a good match for a research study based on the information in DS-Connect, that person will still need to go through another level of screening for that specific research study or clinical trial. It is possible that the person might not meet all the needs for that specific study after all.

Yes. We hope that you will still be willing to register, even if you don't want to take part in a study. Your information will still be useful to doctors and researchers who are trying to learn more about people with Down syndrome.

Your decision to take part in DS-Connect is always your choice. If you would like to remove your information from the Registry, you are free to do so without any explanation. Simply contact the DS-Connect Registry Coordinators at info@ds-connect.org. We will close your account, and all of your personal information will be removed from the DS-Connect database. However, any de-identified data (i.e., data that does not have your personal information) that was included in DS-Connect's graphs and charts, or provided to scientists or other registries before your request for removal cannot be retrieved.