Twin Spectrum Study Information

Your participation will help researchers learn more about cognitive development!

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FYI - go.vcu.edu/TBD will take PTs to this "survey"

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Twin Spectrum Study Consent Language

Twin Spectrum Study Info Sheet

Study Title: The Twin Spectrum Study - Exploring Cognitive Spectrums through Twins

Protocol No.: HM20026116

Principal Investigators: Elizabeth Prom-Wormley, PhD, MPH

Contact Info: Email: matr@vcu.edu Phone: 800-872-8946 Address: MATR, Box 980617, Richmond VA 23298

Twin Spectrum Study ~ Exploring Cognitive Spectrums through Twins ~ Consent

As the parent or legal guardian of twins, ages 6 through 17 years old, you are being invited to take part in the Twin Spectrum study survey.

Participation in this is voluntary. You can choose not to participate at all and even if you start the study, you can change your mind later. There is no loss of benefits to which you otherwise might entitled to if you choose not to participate in this study.

Please think carefully about whether or not you want to complete this research study and only continue if you understand this consent. If you have questions, please contact the MATR and have your questions answered before continuing.

Purpose & Background Information. Prior research has shown that a number of genetic and environmental factors impact human cognitive development. This study uses a survey which aims to help the researchers learn more about these factors in order to better support people across the spectrum of development. While the study is particularly interested in those who fall within the autism spectrum (ASD) and related conditions (attention deficit, mood disorders, anxiety, etc), they need participants that represent the whole population. The best way for them to learn more is to compare the similarities and differences across the range of developmental characteristics in identical and fraternal twin pairs, which will be done in this study's survey. The survey will also help the researchers determine if they can carryout a larger study on this topic. If the researchers decide that a larger study is feasible, then they may wish to contact you at a later date regarding this.

Your Involvement. Your participation is vital because each twin family that takes part adds value to the conclusions that can be made using the data - it is particularly helpful to have twin participants that represent the entire range of cognitive development. In addition to this consent, your involvement includes completing a survey (approx. 50 min). Most of the survey questions will be about your twins and include topics such as: zygosity; gestational health, birth weight, developmental milestones (first steps, first words, etc); health issues; mental health; education; gender identity and biological sex; social awareness, cognition, communication, interests, peer groups; sleep, conduct disorders, moods & feelings; worries; behaviors & interests as well as the number of and sex of their siblings. Questions for or about the twin's parent(s) include demographic items (marital status, race, education, income, etc) and prenatal health during twin pregnancy. We will also ask you for your current contact information as well as whether you would be willing for researchers to contact you directly, if a larger study begins as a result of this survey. Included in the study is a $50 e-gift card of your choice of Amazon, MasterCard, Walmart, Lowe's as compensation for your time.

What's likely to happen with the information you provide. The information you provide during this study (full and partial survey responses) are all considered "data." The data you provide:

will be de-identified (which means a coded identifier will be used rather than your name or other identifying information) and shared with Dr. White and her research team and colleagues. The research team will not be given your name or other identifying information unless you give permission.
will be kept indefinitely for research purposes.
may be matched with information about your family that is in the MATR database, such as your date of birth, sex, zygosity, ethnicity/race.
may be matched with data collected in previous studies or future studies following IRB guidelines (The IRB or Institutional Review Board is the organization that governs human subjects research and ensures that research is being done ethically).
may be matched with data in other databases that the MATR has working relationships with or that are publicly available. Data matching examples include:
- Birth record data (which could include parent behaviors, birth issues, gestational health, etc) available through the Office of Vital Statistics.
- Virginia Health Information - VHI (which could include information about healthcare).
- Environmental risk data (which could include data about air & water quality, industrial hazards, toxins, etc) available through the Environmental Protection Agency (EPA).
- Data provided to the research team from data matching will be fully de-identified and will not have your name or other personally identifying information.
may be included in scientific presentations or publications; however, your identity will not be disclosed.
will be retained by the MATR and may be used:
- to determine how many members within our registry have a certain health condition or trait, or to answer basic research questions.
- may be used to determine whether you are eligible for an invitation to participate in other MATR studies. You can always decline these requests.
- may be matched to DNA and/or other samples you provide for this study, may someday provide, or have already provided to the MATR Repository for future research following IRB guidelines.
- in the unlikely event the MATR ceased to exist, the data could continue to be used as part of anonymized or de-identified datasets for continued analysis.

You are unlikely to be contacted for additional consent for the use of your data. In general, we will not give you any individual results from this study.

Risks and Discomforts. Some of the questions, like those about your twins' mental health or their gender identity, may cause you to feel uncomfortable. It may help to know that the survey provides methods to skip or optout of answering questions. Furthermore, although every reasonable effort has been taken to protect the information you provide, whenever sharing information about yourself there is always a risk of a loss of confidentiality and privacy.

What WE do to help protect your confidentiality:

Data is collected, de-identified, and stored using approved, secure data-collection methods and software. Data is stored on a secure VCU server that is encrypted, firewalled, and username and password protected.
Access to the secure databases, data-collection applications, and servers is limited to qualified, approved personnel and requires user accounts and passwords.
MATR and research staff undergo extensive training in policies to protect the confidentiality of our participants.

What YOU need to do to help protect your confidentiality:

Make sure you are in a location you are comfortable with when completing study elements.
If completing items online, make sure others cannot access the device you are using while you are completing items and that you exit browsers when finished.

In order to monitor the protection of study participants, research records which identify you and your consent may be looked at and/or copied by The Department of Health and Human Services (DHHS) agencies; Virginia Commonwealth University (VCU); and the VCU Institutional Review Board (IRB).

Withdrawal of consent. Even if you complete the survey, you retain your right to revoke your consent in the future. To do so, you will need to contact the MATR directly and express this change of willingness. Your withdrawal request will only pertain to future use of your data and cannot be applied to data that has already been shared or is part of scientific publications/presentations.

Costs. Other than your time, there are no costs to participate in this survey.

Benefits. Though you may not benefit directly from taking part, your participation could result in improving the generalized understanding of human cognitive development and improvements in understanding influences of autism spectrum and other brain developmental conditions.

Compensation. Completing the survey (and the VCU requirements described below) qualifies you to receive $50 in your choice of e-gift cards (MasterCard, Amazon, Walmart, &, Lowe's).

VCU Requirements for Compensation: VCU's financial offices require that compensation paid to research participants be tracked. This is needed on the off chance you were to receive six hundred or more dollars from VCU in a fiscal year for activities such as research, then that money would be considered taxable. The MATR is required to collect your full name and permanent mailing address to track the study payments. You might also be asked to provide your social security number, but that is optional. It is possible that VCU fiscal offices would request this information as documentation that a payment was made. If this request is made, no other details about you or your study data would be part of this information.

MATR Contact Information. If you have questions about the study specifically, you may contact the MATR or the MATR Scientific Director, Dr. Elizabeth Prom-Wormley, by emailing matr@vcu.edu or by calling our toll-free voicemail line at 1-800-URA-TWIN and referencing the Twin Spectrum Survey.

Other Questions. If you have general questions about your rights as a research participant in this or any other research, you may contact the IRB at the VCU Office of Research and Innovation and reference the Twin Spectrum Survey

800 East Leigh Street, Suite 3000
Box 980568
Richmond, VA 23298
Telephone: (804) 827-2157

Consent to participate.

If you select the "Yes, I consent/agree to participate..." option then you are indicating the following: You have read and you understand this consent and any questions you may have had were answered to your satisfaction. You freely consent to participate in this study and give your permission to have your data used as described in this consent.

Options provided online are:

YES, I consent/agree to participate in the Twin Spectrum Study (if you indicate yes to completing the survey, you will also be asked about sharing your contact information with this study - this is optional)
NO, I decline to participate in the Twin Spectrum Study

Please click the link below if you would like to download a consent copy for your records.

REMINDER - upload PDF once approved

The Twin Spectrum Study - Exploring Cognitive Spectrums through Twins Info Page

Thank you for your interest in learning more about this Study!

Despite advancements in science and our understanding of human cognitive development, there is still so much to be learned! For example, why do some individuals display what is often considered 'typical' development while others go on to show conditions such as autism spectrum disorders or related conditions?

Prior research has shown that a number of genetic and environmental factors impact human cognitive development. The study has developed a survey that is will help the researchers learn more about these factors in order to better support people across the spectrum of development. While the study is particularly interested in those who fall within the autism spectrum (ASD) and related conditions (attention deficit, mood disorders, anxiety, etc), they need participants that represent the whole population.

Since the study is looking at the impact of environmental and genetic factors, twin participants provide the best way to observe the influences of both of these types of factors. The study team will use the survey data to compare the similarities and differences across the range of developmental characteristics in identical and fraternal twin pairs. The survey will also help the researchers determine if they can carry out a larger study on this topic. If the researchers decide that a larger study is feasible, then they may wish to contact you at a later date regarding this. You can participate in this survey even if you do not agree to be contacted about the follow up study.

Why were you selected for participation?

Because you are the parent or legal guardian of twins that fall within the age range of 6 through 17 years old, you were selected for invitation in this study survey. Childhood and adolescence include active neurological and cognitive development, so that's why the researchers are seeking input from parents/legal guardians with twins that fall within these ages.

What's involved in study participation?

All the study procedures can be completed online or by phone.
There will be a consent to complete followed by a survey (approx. 50 min) that asks questions about each twin as well as items about the parent(s). The twins will NOT be asked to participate in the survey, but rather the parent/LG will be the one completing the survey.
- Topics covered include: zygosity; gestational health, birth weight, developmental milestones (first steps, first words, etc); health issues; mental health; education; gender identity and biological sex; social awareness, cognition, communication, interests, peer groups; sleep, conduct disorders, moods & feelings; worries; behaviors & interests as well as the number of and sex of their siblings.
- Questions for or about the twin's parent(s) include demographic items (marital status, race, education, income, etc) and prenatal health during twin pregnancy.
- Questions include your current contact information as well as whether you would be willing for researchers to contact you directly, if a larger study begins as a result of this survey. You can participate in this survey even if you do not agree to be contacted about the follow up study. You survey participation will still be helpful.

Will I get paid for being in the study & how do I receive payments?

Yes! If you complete the all the study elements (and provide info (name, address) that VCU requires us to collect to send payments, then you would qualify for a $50 e-gift card (Amazon, Mastercard, Walmart, Lowes - your choice!).

The e-gift cards are sent to you by email using an online vendor: Rybbon/BHN Rewards. The email will contain a link that takes you to your own compensation page where you can "claim" your choice of e-gift card. Generally, payments are made within one to two weeks of completing the survey but due to circumstances outside our control (e.g., delay in VCU fiscal offices providing approvals and payments to the vendor), it could take several weeks before you would receive compensation. IMPORTANT - Once the email is sent, you have approximately a year to "claim" the compensation if you select a retail card (like from Amazon). If you choose a MasterCard e-gift card, you may only have six months to claim the payment so please make sure you read the details provided on the emails and claim pages.

Who is in charge of this study?

The MATR is overseeing recruitment and the data collection on behalf of Dr. Tonya White (MD, PhD), Chief of the Section on Social and Cognitive Developmental Neuroscience at the National Institute of Mental Health (NIMH).

Who do I contact if I have questions? At this stage, if you have questions, it's best to contact the MATR by leaving a voicemail on our toll-free number (1-800-URA-TWIN) or emailing us at matr@vcu.edu.

Is there information out there that will help me learn more about my child's/children's learning, development, and mental health?

Yes! We've compiled some sources and shared them below.

Please click finish/exit when you are done reviewing this information or just exit your browser.

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