Ohio Study Consent and Assent Information

Body

Youth Consent | Youth Assent

 

 

Just as we previously asked you about where you went, about your family, and your health, we’re interested now in where caregivers and their adolescents are going during the COVID-19 pandemic.

We want to study how families are connected with each other and their friends during this time.

We also want to study how families are coping with the COVID-19 pandemic, and their wellbeing during this time.

The information scientists learn from this study may not benefit you directly, but may be used for planning programs and policy to help improve children’s health and well-being during and after the COVID-19 pandemic.

The interview will take about an hour of your time on the phone, and will ask you questions about where you go, your health, family well-being, substance use, and your perceptions of COVID-19 risks and social distancing behaviors. We will give each participant who has completed $50 in appreciation of your help.

There is a follow-up survey online that you can participate in, which includes questions on mental health, substance use, and family relationships, and will take approximately one hour.

You can also participate in mini-surveys on your phone, like in previous years. This time, you will be asked to download a free app, named MetricWire, on your phone to complete the mini-surveys. The app will use the GPS on the phone to track where you go and how much time you spend at places. You will receive $25 for completing the online follow-up survey, and $1 for each mini-survey completed. There will be 35 of them over the week. In addition, you can earn a $5 bonus if you complete 20 of the mini-surveys and $10 bonus if you do 30 of the mini-surveys. You can also earn $5 for doing a follow-up survey. To summarize, this is $50 for the phone interview, $25 for the online questionnaire, and as much as $55 for the mini-surveys. If you do not want to use your own phone, or you do not have a phone to use, we can provide you with a phone to use for the study period.

Participation is voluntary. If you decide not to participate, there will be no penalty or loss of benefits to which you are otherwise entitled. You can, of course, decline to answer any question if it makes you uncomfortable, as well as to stop participating at any time, without any penalty or loss of benefits to which you are otherwise entitled. If you would prefer not to answer a question, you can say ‘I’d like to skip that question.’

Efforts will be made to keep your study-related information confidential. The information collected in this study will be used only for research purposes and in ways that will not reveal who you are. To help us protect your privacy, we have obtained a Certificate of Confidentiality from the National Institute of Drug Abuse. This Certificate provides extra protection for you and your study information, documents, or samples (blood, tissue, etc.). The Certificates are issued so that we cannot be required to disclose any identifiable, sensitive information collected about you as a part of this study in a lawsuit or legal proceeding. We are also prevented from releasing your study information without your consent. This is a layer of protection over and above the already existing protections in place for you and your information.

However, these protections do not apply in some situations. For example, we may have to release your information if a law requires us to do so, the Agency that is funding this study requests the information, or if the FDA tells us to release this information. We may also use your information to conduct other scientific research as allowed by federal regulations.

Please talk to your study team, or contact the Office of Responsible Research Practices at 614-688-8641, if you have questions. You may also visit the NIH website at https://humansubjects.nih.gov/coc/faqs to learn more.

Some of your information might also be placed into one or more external scientific databases. Any personal information that could directly identify you, such as your name and phone number, will be removed, and other information that could identify you may be changed – such as removing the exact day of birth – before files are shared with other researchers or results are made public. Other information that may identify you (such as activity locations) will only be made available to authorized researchers who have approved plans to maintain respondent privacy.

Metricwire, the app we use for the mini-surveys, is committed to protecting your privacy. The Ohio Study research team determines the types of information collected from you through the Metricwire app, and that information is owned and controlled by the Research Team. Metricwire applies the highest level of security controls & safeguards to all data and information collected from you through the Metricwire app. You can review MetricWire’s privacy policies at https://metricwire.com/privacy-policy/.

When you submit response data using the Metricwire App or sensor data is passively logged and your mobile device is connected to the internet, your data are immediately synced using encryption to secure servers located in the United States and removed from your mobile device.

If you are not connected to the internet, the data are temporarily stored on your mobile device until the next time you are connected to the internet. The Metricwire app stores your response and sensor data in an encrypted format without any additional identifying information. The data cannot be accessed by the device’s users. When the Metricwire app detects an internet connection, your encrypted data are securely transmitted to Metricwire servers and removed from your device.

When the study is over, the Research Team will delete your data from the Metricwire servers. Metricwire does not retain any additional copies of your data on our servers or in the Metricwire app.

GPS data is collected as in prior years of the study, to provide more detailed location tracking than what is available in the survey measures. This will help us more completely assess the places you go and how you spend your time. Non-identifiable sensor data on your phone such as accelerometer and gyroscope data may be collected to aid in detecting and tracking movement during the week. As with all other data collected during the Ohio Study project, location data is kept confidential and secure, and is protected by the NIH Certificate of Confidentiality from being disclosed.

Although there is always some risk of exposure if there is a data breach at MetricWire, their security protocols are designed to minimize this risk as much as possible and safeguard all data collected during this research project.

For questions about your rights as someone taking part in this study, you may contact Ms. Sandra Meadows in the Office of Responsible Research Practices at 1-614-688-4792 or 1-800-678-6251. You
may call this number to discuss concerns or complaints about the study with someone who is not part of the research team.

For questions, concerns, complaints, or if you feel you or your child have been harmed as a result of study participation, you may contact the research team of Dr. Christopher R. Browning, Professor of Sociology at The Ohio State University, 614-962-OHIO (6446).


Youth Assent

 

Just as we previously asked you about where you went, about your family, and your health, we’re interested now in where caregivers and their adolescents are going during the COVID-19 pandemic.

We want to study how families are connected with each other and their friends during this time.

We also want to study how families are coping with the COVID-19 pandemic, and their wellbeing during this time.

The information scientists learn from this study may not benefit you directly, but may be used for planning programs and policy to help improve children’s health and well-being during and after the COVID-19 pandemic.

The interview will take about an hour of your time on the phone, and will ask you questions about where you go, your health, family well-being, substance use, and your perceptions of Covid-19 risks and social distancing behaviors. We will give each participant who has completed the interview $50 in appreciation of your help.

There is a follow-up survey online that you can participate in, which includes questions on mental health, substance use, and family relationships, and will take approximately one hour.

You can also participate in mini-surveys on your phone, like in previous years. This time, you will be asked download a free app, named MetricWire, on your phone to complete the mini-surveys. The app will use the GPS on the phone to track where you go and how much time you spend at places. You will receive $25 for completing the online follow-up survey, and $1 for each mini-survey completed. There will be 35 of them over the week. In addition, you can earn a $5 bonus if you complete 20 of the mini-surveys and $10 bonus if you do 30 of the mini-surveys. You can also earn $5 for doing a follow-up survey. To summarize, this is $50 for the phone interview, $25 for the online questionnaire, and as much as $55 for the mini-surveys. If you do not want to use your own phone, or you do not have a phone to use, we can provide you with a phone to use for the study period.

Participation is voluntary. If you decide not to participate, there will be no penalty or loss of benefits to which you are otherwise entitled. You can, of course, decline to answer any question if it makes you uncomfortable, as well as to stop participating at any time, without any penalty or loss of benefits to which you are otherwise entitled. If you would prefer not to answer a question, you can say ‘I’d like to skip that question.’

Efforts will be made to keep your study-related information confidential. The information collected in this study will be used only for research purposes and in ways that will not reveal who you are. To help us protect your privacy, we have obtained a Certificate of Confidentiality from the National Institute of Drug Abuse. This Certificate provides extra protection for you and your study information, documents, or samples (blood, tissue, etc.). The Certificates are issued so that we cannot be required to disclose any identifiable, sensitive information collected about you as a part of this study in a lawsuit or legal proceeding. We are also prevented from releasing your study information without your consent. This is a layer of protection over and above the already existing protections in place for you and your information.

However, these protections do not apply in some situations. For example, we may have to release your information if a law requires us to do so, the Agency that is funding this study requests the information, or if the FDA tells us to release this information. We may also use your information to conduct other scientific research as allowed by federal regulations.

Please talk to your study team, or contact the Office of Responsible Research Practices at 614-688-8641, if you have questions. You may also visit the NIH website at https://humansubjects.nih.gov/coc/faqs to learn more.

Some of your information might also be placed into one or more external scientific databases. Any personal information that could directly identify you, such as name and phone number, will be removed, and other information that could identify you may be changed – such as removing the exact day of birth – before files are shared with other researchers or results are made public. Other information that may identify you (such as activity locations) will only be made available to authorized researchers who have approved plans to maintain respondent privacy.

Metricwire, the app we use for the mini-surveys, is committed to protecting your privacy. The Ohio Study research team determines the types of information collected from you through the Metricwire app, and that information is owned and controlled by the Research Team. Metricwire applies the highest level of security controls & safeguards to all data and information collected from you through the Metricwire app. You can review MetricWire’s privacy policies at https://metricwire.com/privacy-policy/.

When you submit response data using the Metricwire App or sensor data is passively logged and your mobile device is connected to the internet, your data are immediately synced using encryption to secure servers located in the United States and removed from your mobile device.

If you are not connected to the internet, the data are temporarily stored on your mobile device until the next time you are connected to the internet. The Metricwire app stores your response and sensor data in an encrypted format without any additional identifying information. The data cannot be accessed by the device’s users. When the Metricwire app detects an internet connection, your encrypted data are securely transmitted to Metricwire servers and removed from your device.

When the study is over, the Research Team will delete your data from the Metricwire servers. Metricwire does not retain any additional copies of your data on our servers or in the Metricwire app.

GPS data is collected as in prior years of the study, to provide more detailed location tracking than what is available in the survey measures. This will help us more completely assess the places you go and how you spend your time. Non-identifiable sensor data on your phone such as accelerometer and gyroscope data may be collected to aid in detecting and tracking movement during the week. As with all other data collected during the Ohio Study project, location data is kept confidential and secure, and is protected by the NIH Certificate of Confidentiality from being disclosed.

Although there is always some risk of exposure if there is a data breach at MetricWire, their security protocols are designed to minimize this risk as much as possible and safeguard all data collected during this research project.

For questions about your rights as someone taking part in this study, you may contact Ms. Sandra Meadows in the Office of Responsible Research Practices at 1-614-688-4792 or 1-800-678-6251. You may call this number to discuss concerns or complaints about the study with someone who is not part of the research team.

For questions, concerns, complaints, or if you feel you have been harmed as a result of study participation, you may contact the research team of Dr. Christopher R. Browning, Professor of Sociology at The Ohio State University, 614-962-OHIO (6446).