Study Title: The Twin Voice Study
Protocol No.: HM20024813
Principal Investigators: Dr. Kenneth Kendler
Contact Info: Email: matr@vcu.edu Phone: 800-872-8946 Address: MATR, Box 980617, Richmond VA 23298
Twin Voice Study Consent
Participation in the Twin Voice Study 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 sophisticated voice analysis can be used to identify subtle differences in recordings of voices of women that are depressed vs those that are not depressed. The researchers ultimately want to understand the relationship between voice qualities and mental health. To do this, they must first identify factors that influence voice development. For example, is voice development highly influenced by a person's genetics? The best way to start answering that question is to compare the similarity of voice patterns in identical and fraternal twin pairs, which will be done in this study. Knowing the answer to questions like this can help the researchers determine the best way of using voice analysis as a tool to help learn more about a person's mental health.
Your Involvement. Your participation is vital because each twin that takes part adds value to the conclusions that can be made using the data (full pairs provide additional value). In addition to this consent, your involvement includes:
- Screener Survey: 2-5 minute survey asking about conditions that may impact your speech patterns to determine if you are eligible to complete the study.
- Interviewer-Guided Voice Recording: approximately 20 - 30 min recording session done by phone with a Research Interviewer. For this, you'll be asked to repeat sounds, sentences, answer a few easy questions (how's the weather) as well as share very brief memories of times that made you feel a certain way (e.g. happy, sad, proud, etc); includes a $20 e-gift card (your choice - MasterCard, Amazon, etc) for completion.
- Main Study Survey**: 5-10 minute survey that will contain zygosity questions as well as questions related to mental health, particularly depression; includes $20 e-gift card (your choice - MasterCard, Amazon, etc) for completion.
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- **The Voice Recording and Main Study Survey must be completed within one to two weeks (sooner is better) of each other. Meaning that if you complete one of those steps, the second one needs to be completed within a two-week period, or you may not be eligible to continue with the study.
Some items, like the surveys, have the option to complete online. Whereas, the voice recording must be completed by phone with a Research Interviewer guiding you through the voice recording steps. There may be some instances where we would need to recontact you. For example, to clarify or update your eligibility for the study or to request that the voice recording be completed again if there was a problem with the original recording.
What's likely to happen with the information you provide. The voice recordings and the answers you provide in the screener and survey (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. Kendler and his research team and colleagues. The research team will not be given your name or other identifying information.
- will be kept indefinitely for research purposes.
- may be matched with information about you that is in the Registry database, such as your date of birth, sex, zygosity, ethnicity/race.
- may be matched with data collected in previous studies (which may have collected data about physical & mental health, stressful life events, substance use, habits, health history, memory tasks, demographic data) 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 included in scientific presentations or publications; however, your identity will not be disclosed.
In addition to the above uses of your information, the MATR may also:
- retain a copy of the screener, voice recording, and survey data, which can be matched back to you and may be used:
- for all the uses listed in the section above, as well as:
- 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 screener 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.
General Risks and Discomforts.
- There is a possibility of feeling self-conscious during the voice recording. Generally, for most individuals this will not last long.
- The main study survey will ask questions about depression which may remind some individuals of their own experiences with depression. You do not have to answer questions you are not comfortable answering and you can stop participation at any time.
Risks Related to Confidentiality of Records & Privacy. 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.
- Be aware that since this study includes twins, although we will not share this information with your twin, they may figure out that you are likely a member of the MATR and possibly participating in this study.
This research looks at mental health/depression broadly, so the study is not intended for you to report about harm to yourself or others. However, if you do share information about harm to self or others during the study, your privacy cannot be guaranteed because the research staff are required by law to report this to the appropriate authorities.
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 all elements of the study, 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 voice development and its applications for identifying depression.
Compensation. Completing all elements of the study (and the VCU requirements described below) qualifies you to receive up to $40 in your choice of e-gift cards (MasterCard, Amazon, Walmart, &, Lowe's). ($20 for the voice recording plus another $20 for the main study survey). Even if you only complete one of the two elements, you would still qualify for the $20 payment for the element you did complete.
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. Judy Silberg, by emailing matr@vcu.edu or by calling our toll-free voicemail line at 1-800-URA-TWIN and referencing the Twin Voice Study.
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 Voice Stud
800 East Leigh Street, Suite 3000
Box 980568
Richmond, VA 23298
Telephone: (804) 827-2157