Summary of Rights

What are some general things you should know about research studies?

You are being asked to take part in a research study. To join the study is voluntary. You may refuse to join, or you may withdraw your consent to be in the study, for any reason, without penalty.

Research studies are designed to obtain new knowledge. This new information may help people in the future. You may not receive any direct benefit from being in the research study. There also may be risks to being in research studies. Details about this study are discussed below. It is important that you understand this information so that you can make an informed choice about being in this research study.

What is the purpose of this study?

As a past participant in the National Longitudinal Study of Adolescent to Adult Health or Add Health (formerly the National Longitudinal Study of Adolescent Health), you are being asked to take part in the study’s fifth wave of surveys. This wave is being conducted by the Research Triangle Institute (RTI) for the Carolina Population Center at the University of North Carolina at Chapel Hill (UNC-CH). The Principal Investigator of this research study is Dr. Kathleen Mullan Harris. This research study is funded by the National Institutes of Health in Washington, DC.

Add Health was originally designed to help researchers understand the causes of adolescent health, and how they are affected by contexts such as schools, friends, and neighborhoods. Since that time, the study has followed participants into adulthood, and examined how adolescent experiences and health may affect your experiences and health as an adult. The purpose of Wave V of our research study is to collect updated information from our participants as they age further into adulthood. In this way, we are able to study health across the life course from the teenage years through young and mid adulthood. In Wave V we are also collecting information from participants about their births as well as their childhood health and experiences. This allows us to assess how biological, social, and environmental factors contribute to health over a long time span.

How many people will take part in this study?

If you decide to take part in the Wave V survey component, you will be one of almost 14,000 people who participate.

How long will your part in this study last?

Participation in the survey activities described in this consent form are expected to take approximately 55 minutes. If you are contacted for reminders, this may add another 5-10 minutes of time.

What will happen if you take part in the study?

Survey

If you agree to the survey component of the Add Health Wave V study, you will complete the survey alone by using a website or paper form. The survey contains questions about your current work experience, relationships with family, spouses/partners and children, and your general emotional and physical health. Many of these questions are similar to questions you have been asked before in Add Health interviews. You will also be asked about your daily activities, health-related behaviors, and health care access. Some of the questions are sensitive in nature, such as questions about romantic relationships and drug use. Because you will self-administer their own survey, you will have privacy in answering these items and can complete the survey at your own pace. You may skip any questions you do not want to answer and you may stop the survey at any time.

Information About Your Home Address and Prescription Medication Use

To better understand where Add Health participants live in relationship to community resources, we will also ask you to list your current home address. If you are taking the survey by web, you may be asked to verify your home address on a map that we provide. In addition, you may be asked to list the prescription medications that you are currently taking

Information About Your Birth Record

In order to better understand health over the life span, Add Health would like to obtain data from birth records for our participants. As part of the survey you will be asked to provide information about your state of birth as well as your biological parent’s name, date of birth and place of birth. We only use this information for finding your birth record, not as data for the study.

Opportunity to Participate in a Home Visit

After completing the survey, you will be given the opportunity to participate in the other half of our Wave V research which involves scheduling a home visit. During the home visit the study collects a blood sample and takes measurements such as height, weight and blood pressure. Agreeing to this home visit helps the research team to better understand the health of our Add Health participants. Upon completion of the home visit the study will pay you an additional incentive amount (on top of your payment for completing the survey part of the study) and also provide confidential results from your blood tests directly to you. You will be presented with a separate consent form explaining more about the home visit. We encourage you to review this form and consider taking part in the home visit component of Add Health Wave V. It is important for you to know that even if you agree to the consent for the home visit now, you can still refuse to participate in the home visit at any later time.

Add Health Study Communications and Opportunities

All participants eligible for Wave V of the Add Health study (regardless of Wave V participation) may be contacted over time so that the study team can track changes in home address, email address and phone numbers. If the study team obtains funding for future years of research, you may be approached for continued participation in Add Health research. You may also be contacted about other research studies that are associated with Add Health Wave V and approved by our investigative team.

What are the possible benefits from being in this study?

Research is designed to benefit society by gaining new knowledge. Information from previous Add Health interviews has made significant contributions to our understanding of the health and life experiences of adolescents and adults. Other than the monetary incentive, you will not benefit personally from being part of this study.

What are the possible risks or discomforts involved from being in this study?

The survey questions are expected to cause minimal risk or discomfort. There is a very small risk of breach of privacy for information you provide about your home address and verifying your home address on a map. There is a very unlikely risk of breaching privacy of the information collected from you and other respondents. Add Health’s strict privacy protections are described below.

What if we learn about new findings or information during the study?

You will be given any new information gained during the course of the study that might affect your willingness to continue your participation.

How will information about you be protected?

Add Health has always attempted to protect privacy to the greatest extent possible. Your answers will be held in strict privacy by the Add Health and RTI project staff and not given to unauthorized persons. Extensive security procedures are in place to make sure that participants’ answers are not linked to their names. Your name will not be reported with your responses or test results; these data are labeled only with an ID number.

After data collection and cleaning are completed, your identifying information will be electronically transmitted to the Add Health Security Manager in Canada, and your interview answers without identifying information will be sent to the Add Health project staff at the University of North Carolina at Chapel Hill. Storing different types of information in different places helps keep your identity confidential.

All analyses concern groups of persons, not specific individuals. No individuals will be identified in any report or publication that uses any data from Add Health.

Although every effort will be made to keep research records private, there may be times when federal or state law requires the disclosure of such records, including personal information. This is very unlikely, but if disclosure is ever required, UNC-Chapel Hill will take steps allowable by law to protect the privacy of personal information. In some cases, your information in this research study could be reviewed by representatives of the University, research sponsors, or government agencies (for example, the FDA) for purposes such as quality control or safety.

What is a Certificate of Confidentiality?

To help us protect your privacy, we have obtained a Certificate of Confidentiality from the National Institutes of Health. With this Certificate, the researchers cannot be forced to disclose information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings. The researchers will use the Certificate to resist any demands for information that would identify you, except as explained below.

The Certificate cannot be used to resist a demand for information from personnel of the United States Government that is used for auditing or evaluation of federally funded projects or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA).

You should understand that a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then the researchers may not use the Certificate to withhold that information.

What if you want to stop before your part in the study is complete?

You can skip any individual components of the study at any time. You can withdraw from this study at any time, without penalty. The investigators also have the right to stop your participation at any time. This could be because you have had an unexpected reaction, or have failed to follow instructions, or because the entire study has been stopped.

Will you receive anything for being in this study?

Some participants will receive the survey in full all at once. Others will receive the survey in two parts. If you complete one or both parts of the survey you will receive the monetary payment described in your consent form.

Will it cost you anything to be in this study?

It will not cost you anything to be in this study.

What if you have questions about this study?

You have the right to ask, and have answered, any questions you may have about this research. If you have questions about the study (including payments), complaints, concerns, or if a research-related injury occurs, you should contact the Principal Investigator of the study at 1-844-5-0-WAVE5 (1-844-509-2835).

What if you have questions about your rights as a research participant?

All research on human volunteers is reviewed by a committee that works to protect your rights and welfare. If you have questions or concerns about your rights as a research subject, or if you would like to obtain information or offer input, you may contact the Institutional Review Board at 919-966-3113 or by email to IRB_subjects@unc.edu.

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