Why are we doing this research?
SPARK: Simons Foundation Powering Autism Research for Knowledge
Cincinnati Children’s is recruiting for a research study, sometimes known as a clinical trial or clinical study, to build a research community of individuals with autism and their families. SPARK aims to build a research community of tens of thousands of individuals with autism and their families, who will be asked to share medical and genetic information with scientists and to agree to be contacted about future research studies. The data shared with SPARK researchers will power important new autism research that aims to advance the understanding of autism and provide meaningful information and resources to participants.
Who can participate?
Individuals of all ages with a professional diagnosis of autism, together with their biological parents and siblings, can participate if they live in the United States and can read and understand English in order to complete consent forms and online questionnaires.
What will happen in the study?
To learn more about SPARK and register online via a secure portal, visit www.SPARKforAutism.org/CincinnatiChildrens. All data provided to SPARK will be stored without any identifying information and kept confidential.
An important part of SPARK is the collection of DNA so it can be analyzed to expand our understanding of the role of specific genes in the development of autism. SPARK will ask you to share basic information about your medical and family history, and if you choose, a DNA sample using a saliva collection kit.
After you register, a saliva kit will be shipped directly to your home with clear instructions for collection and return shipping. The kit includes a tube for collecting saliva, as well as an absorbent sponge that can be used for any child who is not able to spit. If you prefer, you can provide a saliva sample in-person by scheduling an appointment at your local clinical site or hospital participating in SPARK.
Participants will agree to be recontacted about taking part in other research projects but are not required to join additional studies.
What are the good things that can happen from this research?
You could find out there is a change in your DNA that might cause autism. A major benefit will also be to the larger community of individuals with autism as we learn more about the causes of autism and try to develop better treatments and supports.
By giving saliva to SPARK, you may benefit from hearing about other research studies. Some of these studies may have their own incentives/benefits.
What are the bad things that can happen from this research?
There are no major risks to giving saliva. Your genetic information will be shared with other scientists, but it will not be linked with your name. One possible risk is that someone could see your information but they are not allowed to. Sometimes people feel worried or are upset when they get results that are a cause of autism. If you agree and consent for us to send your genetic results to your doctor, those results will become part of your medical record. Given this, there may be insurance implications you should be aware of. A federal law called the Genetic Information Nondiscrimination Act (GINA) makes it illegal for employers, health insurers and group health plans to discriminate against individuals based on their genetic information. Genetic discrimination is when someone is treated unfairly because of their genetic results.
You and your child’s personal data will be protected, but loss of confidentiality is possible. Loss of confidentiality means that personal information is unintentionally seen by someone who is not on the study team and was not supposed to see or know about your information.
It is possible a question on the questionnaire or results from a survey may make you feel uncomfortable or upset. You can choose not to answer any question or you should call your doctor or mental health provider to discuss your concerns.
Will you/your child be paid to be in this research study?
There is no cost to families to participate in SPARK. Families that participate with 2 biological parents and complete all of the required registration tasks (including surveys and the submission of a sufficient saliva sample) will receive $50 for their time and effort.