Infosheet |
INFORMATION SHEET
Autism Care Network (ACNet)
Principal Investigator: Lynn Cole, DNP
Sub-Investigator: Susan Hyman, MD
This form describes a research study and learning network that is being conducted by Lynn Cole, DNP and Susan Hyman, MD. They are a part of the University of Rochester's Division of Developmental and Behavioral Pediatrics.
The purpose of this study is to create a learning health system focused on the care of children with Autism Spectrum Disorder (ASD). A learning health system is a network of clinicians, families, patients, and scientists who want to learn how to improve patient care and outcomes. The Autism Care Network (ACNet) includes teams from sites across the US and Canada. They use both quality improvement methods (small changes in clinical care) and research to do this.
The long-term goals of the ACNet are to:
- Learn what aspects of behavioral and medical care help children with autism
- Find aspects of care that need to be improved
- Identify areas of care in need of more research
Right now, our teams want to improve:
- Health and quality of life for children with ASD.
- How we find and treat problems that often go along with ASD. These include attention deficit hyperactivity disorder (ADHD), anxiety and irritability.
The ACNet is a registry. This registry will collect past, current, and future information on each enrolled child. If you decide to take part in this study, it will be important for you to know:
- No experimental treatment is involved.
- Most information will be collected from your child's regular clinic visits. You will not need to come to extra research visits.
- Your child will continue to receive normal care as a patient in the Developmental and Behavior Pediatric Clinic (Kirch/Levine).
- You may be asked extra questions about your child and your family, to add to routine care.
- Most parent forms will be done on My Chart (EMR patient portal). They can be completed before or during clinic visits. If you do not have My Chart, you can complete the parent forms online on a secure web application known as REDCap.
- Paper forms can be provided if needed.
- You may refuse to answer any questions you do not wish to answer.
Data collection:
For this study, we need your permission to gather and share your child's health information. Most data about your child will come from your child's electronic medical record (EMR). The protected health information (PHI) that study staff would have access to include some or all of your child's health records. This includes, but is not limited to:
- Your child's name, medical record number, date of birth, zip code and visit dates
- Hospital records and reports
- Admission histories and exams
- X-ray films and reports
- Laboratory reports
- Treatment and test results
- Immunizations
- Allergy reports
- Prescriptions
- Consultations and clinic notes
- Other records collected by the clinical service to care for your child
- Parent forms completed by My Chart, REDCap, or on paper
Data that will be collected from your child's health record and put into the ACNet registry include:
- Your child's first and last name (optional), medical record number, date of birth, zip code and visit dates
- Confirmation of ASD diagnosis and assessment used
- Medications and prescriptions
- Information on frequency and severity of behaviors or behavioral challenges
- Common conditions that go along with ASD (such as anxiety or ADHD, sleep problems among others)
- Confirmation of other diagnoses
- Clinician's impression of your child's behaviors and skill levels
- Types and amounts of behavioral and educational interventions your child receives
- Parent completed forms in My Chart
- Cognitive testing scores
- Adaptive functioning testing scores
- Communication testing scores
- Information provided by you directly to the ACNet team
We may also collect data from you in other ways. The other ways might include paper forms, electronic forms, and by phone, if needed.
You can decide whether or not to include your child's first and last name into the registry. This is entirely optional. Whether or not you decide to include your child's name, they will be assigned a unique ATN study ID. Further details are provided below.
Where does the data go?
Data collected will be sent to ACNet through a secure Internet data capture system. The ACNet data registry is an electronic database registry housed at Cincinnati Children's Hospital Medical Center (CCHMC). Data will be shared securely between University of Rochester, CCHMC and the Massachusetts General Hospital Data Coordinating Center (DCC) as needed.
If review of your child's data identifies any new concerns, you will be contacted.
Privacy:
All information that identifies your child will be kept strictly confidential. Your child's PHI, including name (optional), medical record number, birth date, zip code and visit dates, will be stored in the ACNet registry housed in CCHMC. However, this information will not be linked to the clinical data collected into the registry. Instead, your child will be assigned a unique study ID within the registry called an ATN number and will only be referred to by that ID. This will allow your child's identity to be kept private when the data is analyzed.
You may choose whether to submit your child's name to the registry. Whatever you choose will not impact your child's care or participation in the ACNet registry.
Only UR and CCHMC staff will be able to see identifying information. Other members of the Learning Network, including the other participating centers, will only see anonymous data. Staff at the CCHMC will not share identifying information. They are strictly responsible for keeping the registry and the integrity of the data stored in it. They are required to follow research best practices to keep the data secure.
Data that does not include personal health information collected for this study may be shared between the ACNet and all ACNet projects. The ACNet may share anonymous data with external investigators for other research, but only after a strict review of the qualifications of the investigator and the proposed research. These investigators will be asked to sign a data sharing document that details the conditions under which the data they receive can be used and published. Any shared data will not contain patient identifiers. The central coordinating center for ACNet will comply with any and all laws about the privacy of such information.
Privacy Risks:
Sometimes research records, including identifying information are inspected by the study sponsor (and/or) its agent. This happens during the study and is to make sure all staff are following protocol. If review occurs, ACNet staff will use their best efforts to protect the privacy of your child and the privacy of their health information.
The University of Rochester makes every effort to keep the information collected from you private. In order to do so, all study staff will follow approved research practices. They will use secure data transfer systems.
Study Plan:
We estimate that approximately 100 subjects per year from Rochester will participate in this study and, over 3 years 3,000 subjects network-wide will take part in this study. Your child's participation will last indefinitely or until you decide to withdraw.
Risks:
There should be no risk or discomfort for your child from taking part in this study. The only risk of being part of this network is the chance of health information being accessed by people not part of the study team. Use of best research practices will be in place to prevent this.
Benefits:
The potential benefit of this study is that pooled data (anonymous group data) will be reported back to ACNet centers often. This will help them make changes to improve care. This registry will also lead to future research which may help people with ASD and their families.
Other things you should know:
If you do not want your child to take part in this study, your child's care in the clinic will not be impacted.
You will not be paid for taking part in this study. There will be no cost to you to take part in this study.
The University of Rochester receives funds from the Autism Speaks - Autism Treatment Network for conducting this research study and learning network.
The information obtained for this study may be published in scientific journals or presented at scientific meetings; however, your child's identity will be kept strictly confidential.
E-Mail:
If you decide to participate in the learning network, you will be asked to provide your e-mail address. E-mail addresses may be used for recruitment and study-related communications. Information about your child's health care will NOT be sent by email. Sending information by e-mail has risks that you should consider. These include, but are not limited to:
a) E-mail can be circulated, forwarded, stored electronically and on paper, and sent to unintended recipients.
b) E-mail senders can easily misaddress an e-mail.
c) Backup copies of e-mail may exist even after the sender or the receiver has deleted his or her copy.
d) Employers and online services have a right to inspect e-mail sent through their systems.
e) E-mail can be intercepted, altered, forwarded, or used without authorization or detection.
f) E-mail can be used to introduce viruses into computer systems.
Conditions for the Use of E-mail
The researcher cannot guarantee but will use reasonable means to maintain security and privacy of e-mail information sent and received. You and the researcher must consent to the following conditions:
a) E-mail will not be used to conduct health care. This e-mail consent is for the purpose of research recruitment only.
b) E-mail should not be used for urgent or emergency situations. The researcher cannot guarantee that any particular e-mail will be read and responded to.
c) E-mail must be concise.
d) E-mail between you and the researcher will be filed in your research record.
e) Your messages may be sent to any member of the study team for response.
f) The researcher will not forward subject-identifiable e-mails outside of URMC and Affiliates without your prior written consent, except as authorized or required by law.
E-mail Instructions
a) Avoid use of your employer's computer.
b) Put your name in the body of the e-mail.
c) Put the topic (e.g., study question) in the subject line.
d) Inform the study team of changes in your e-mail address.
e) Take steps to preserve the privacy of e-mail.
f) Contact the researcher's office in other ways (phone, fax, etc.) if you do not receive a reply.
Ways we protect privacy:
The research team may share your child's PHI with the following persons or groups for the study: Institutional Review Board and the Cincinnati Children's Hospital Medical Center. Other centers in the network will receive anonymous data. Staff at Massachusetts General Hospital will receive a limited dataset containing date of the clinical visit, date of birth and ATN ID of your child.
Your permission for the ACNet to use your child's health information for this study will not expire unless you tell us you want to cancel it. We will keep the information we collect indefinitely. Taking part in this study is voluntary. Any information collected up until your withdrawal will be kept by the study, but no new information will be collected. If you decide to withdraw or cancel your permission, you will be removed from the study without any problems or changes to your child's care.
Taking part in this study is voluntary. You are free not to participate. You can withdraw at any time, for any reason. No matter what decision you make, there will be no penalty or loss of benefits to which you are otherwise entitled.
Contact Information:
For more information or questions about this research you may call Claudia Pérez at (585) 273-3073 or email her at claudia_perez@urmc.rochester.edu.
You may also contact the University of Rochester Research Subjects Review Board for the following reasons:
- You wish to talk to someone other than the research staff about your rights as a research subject;
- To voice concerns about the research;
- To provide input concerning the research process;
- In the event the study staff could not be reached.
Contact information: at 265 Crittenden Blvd., CU 420628, Rochester, NY 14642, Telephone (585) 276-0005 or (877) 449-4441
Version Date: 1/31/22