Database for Future Contact of Studies in Developmental and Behavioral Pediatrics and the Intellectual and Developmental Disabilities Research Center (Future Contact of Studies in DBP-IDDRC)

This form describes a research study that is being conducted by Emily Knight, MD, PhD from the University of Rochester's Department of Pediatrics and Heather Adams, PhD from the University of Rochester's IDDRC Human Phenotyping and Research Core. 

The purpose of this study is to establish a database of subjects interested in participating in autism or other intellectual and developmental disabilities (IDD) research at the University of Rochester. Researchers at the University of Rochester are often looking for children with and without autism or other IDDs, 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 other 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, date of birth and age, and your contact information, as well as optional additional details about your child into the database. Optional details include the following information about your child: their current age, gender, race and ethnicity, and information about their developmental diagnosis (e.g., autism or another IDD). If you want, you can also tell us how you learned about the DBP-IDDRC Research Contact Database. No more than once or twice annually, we may review your child's medical record to update database records appropriately to ensure accurate up to date information. More information about this is included further below.

Being included in the database does not commit you/your child to any study. You/your child are agreeing only to be contacted by study staff from the University of Rochester to give you information about possible research participation opportunities. You can then choose to contact those researchers if you so choose.

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 secure, encrypted data capture system called REDCap ("Research Data Capture". Your information will only be accessible in this system to approved study personnel.

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 or other information that could identify you/your child 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 through surveys, your research record, and related information from your medical records 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 contact information, you may be contacted once a year by research staff in order to update your record. 

If your child receives ongoing care at one of the following clinics (listed below), study staff who work in those clinics 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.

• Developmental and Behavioral Pediatrics
• Child Neurology and Neurogenetics clinics
• Complex Care Center clinic
• Golisano Children's Hospital

In addition to 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 for us to use your child's health information for this study will not expire unless you tell us you no longer want to participate. When you withdraw from the study, you/your child's record will be marked inactive and their contact information will be removed from the database. When your child turns 18, their record will become inactive. At this point, we will contact you again to re-affirm your interest in participating in the database. If the individual consents for themselves, they will be asked to provide consent.  If the individual has a legally authorized representative (LAR; e.g., legal guardian), then the representative will be asked to provide permission. If we are unable to contact you at this time, or if you choose not to continue participating, your/your child's record will be marked inactive and their contact information will be removed from the database.

Your participation in this study is completely voluntary. You/your child are free not to participate or to withdraw at any time, for whatever reason. To withdraw, you can contact the project manager or study PI at any point. 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.

RSRB Case Number: 00000208                                                                                                    Version Date: 06/17/2025