Division of Developmental and Behavioral Pediatrics Research Contact Database

This form describes a research study that is being conducted by Emily Knight, MD, PhD from the University of Rochester's Department of Pediatrics.

The purpose of this study is to establish a database of subjects interested in participating in autism research or research involving other developmental disabilities at the University of Rochester. The research group in the Division of Developmental and Behavioral Pediatrics at the University of Rochester Medical Center is often looking for children with and without autism or other developmental disabilities and their families to participate in a variety of research projects. 

We maintain a secure database in which caregivers can choose to provide their contact information. This database is a place for Research Coordinators at the University of Rochester to find potential participants with or without autism or developmental disabilities that may be eligible for a new study. 

If you decide to take part in this study, you will be asked to enter you/your child's name, contact information, as well as optional additional details about your child into the database. Being included in the database does not commit you/your child to any study. You/your child are agreeing only to be contacted by a research staff person from the University of Rochester to provide you with information about possible research activity participation opportunities. The information you choose to provide will be shared only with researchers conducting research that has been approved by the University Institutional Review Board and the Developmental and Behavioral Pediatrics Research Committee. 

There will be no limit on the number of subjects who will take part in this database.

You will not be paid for participating in this database. There will be no cost to you to participate in this database.

All of the information you submit will be strictly confidential. However, the one risk to participating in this database is the potential for a breach in confidentiality. We will try to keep what we learn about you/your child private, but we may have to share this information with the University of Rochester and the Department of Health and Human Services. While they normally protect the privacy of this information, they may not be required to do so by law.

The University of Rochester makes every effort to keep the information collected from you private. In order to do so, all subject information is being hosted on a data capture system called REDCap. Through the national Clinical and Translational Science Award Consortium, the University of Rochester Clinical and Translational Science Institute (CTSI) is a member of the REDCap Consortium, and makes the system available to research groups affiliated with the Medical Center. The CTSI maintains the hardware necessary to operate the system, manages software deployment and upgrades, and ensures data security. REDCap servers are housed in a local data center and all web-based information transmission is encrypted. REDCap was developed in a manner consistent with HIPAA security requirements and is recommended to University of Rochester researchers by the URMC Research Privacy Officer and Office for Human Subject Protection.

Sometimes, however, researchers need to share information that may identify you with people that work for the University. If this does happen we will take precautions to protect the information you have provided. Results of research you agree to may be presented at meetings or in publications, but you/your child's name will not be used.

Transmitting your information by e-mail has a number of risks that you should consider. These include, but are not limited to, the following:

1. E-mail can be circulated, forwarded, stored electronically and on paper, and broadcast to unintended recipients.
2. E-mail senders can easily misaddress an e-mail.
3. Backup copies of e-mail may exist even after the sender or the recipient has deleted his or her copy.
4. Employers an on-line services have a right to inspect e-mail transmitted through their systems.
5. E-mail can be intercepted, altered, forwarded, or used without authorization or detection.
6. 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 confidentiality of e-mail information sent and received. You and researcher must consent to the following conditions:

1. E-mail is not appropriate for urgent or emergency situations. The researcher cannot guarantee that any particular e-mail will be read and responded to.
2. E-mail must be concise. You should schedule an appointment if the issue is too complex or sensitive to discuss via e-mail.
3. E-mail communications between you and the researcher will be filed in your research record.
4. Your messages may also be delegated to any member of the study team for response.
5. 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.
6. You should not use e-mail for communication regarding sensitive medical information.
7. It is your responsibility to follow up and/or schedule an appointment if warranted.

E-mail Instructions

1. Avoid use of your employer's computer.
2. Put your name in the body of the e-mail.
3. Put the topic (e.g., study question) in the subject line.
4. Inform the researcher of changes in your e-mail address.
5. Take precautions to preserve the confidentiality of e-mail.
6. Contact the researcher's office via conventional communication modes (phone, fax, etc.) if you do not receive a reply within a reasonable period of time.

In order to collect study information, we have to get your permission to use and give out your personal health information. We will use information you enter into the database, your research record, related information from your medical records, and both clinical and research observations made while you take part in the research, screening logs, case report forms, survey forms, and questionnaires to maintain the database. This information may be audited to make sure we are following regulations, policies, and study plans.

In order to maintain accurate information, you may be contacted once a year by research staff in order to update your record. 

If your child receives ongoing care at the Developmental and Behavioral Pediatrics Clinic, study staff may review your child's medical record to ensure up-to-date diagnosis information is kept in your database record, so that you are only contacted about studies your child may be eligible for.

Outside of updating your record, you may also receive communications from the research team informing you of ongoing research studies in the Division and the University a few times a year. 

Your permission to use your health information for this study will not expire unless you tell us you no longer want to participate. We will keep information we collect until your child turns 18. Once they turn 18, their record will be made inactive and they will be contacted to see if they would like to remain in the database or if they would prefer not to be contacted about research projects. If you cancel your permission, you/your child's record will be removed from the database.

Your participation in this study is completely voluntary. You are free not to participate or to withdraw at any time, for whatever reason. No matter what decision you make, there will be no penalty or loss of benefits to which you are otherwise entitled.

For more information or questions about this research you may call Claudia Perez, Project Manager, at (585) 273-3073 or Dr. Emily Knight at (585) 275-8749. You may also send an email to Developmental_Research@urmc.rochester.edu.  Please contact the University of Rochester Research Subjects Review Board at 265 Crittenden Blvd., CU 420628, Rochester, NY 14642, Telephone (585) 276-0005 or (877) 449-4441 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.