PTSD and Vagus Nerve Stimulation Research Study


Invitation to be Part of a Research Survey

Researchers from TxBDC, The University of Texas at Dallas, The University of Texas at Austin, and Baylor Scott & White Research Institute have teamed up to assess if implanted vagus nerve stimulation (VNS) can make Prolonged Exposure Therapy (PE, a psychological treatment) more tolerable and effective for reducing symptom severity in individuals with post-traumatic stress disorder (PTSD). You are invited to take part in a screening survey to see if you are eligible for this research study. Before you decide if you would like to participate, it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully. Feel free to ask if anything is not clear in this consent form

Your Participation is Voluntary

It is totally up to you to decide to be in this screening survey. Participating in this survey is voluntary. Even if you decide to be part of the screening now, you may change your mind and stop at any time. You do not have to answer any questions you do not want to answer. Your decision not to take part or to withdraw will involve no penalty or loss of benefits to which you are otherwise entitled.

What will happen if you take part?

The screening survey includes general questions about you including demographic information, questions about your PTSD diagnosis, attempted PTSD treatments, current involvement in other medical treatments or interventions, and questions about past injuries and stimulation of the vagus nerve. Please complete this information. If you may be eligible to participate in our study, a research team member will contact you. Please note that you may not be contacted if you are not eligible to participate. By completing this survey, you are consenting to provide the information below and for research staff to contact you about participation in this study.

It will take approximately 5 minutes to complete this screening survey

What risks and discomforts might you experience?

There are some risks and discomforts you might experience from participating in this screening survey.

You may be uncomfortable while answering the survey questions. You can skip any questions that make you uncomfortable or that you do not want to answer.

Participation in research might involve some loss of privacy. There is a risk that someone outside the research study could see and misuse information about you. More information about how we will protect your information to reduce this risk can be found below.

How could you benefit?

Participating in this screening survey is not likely to help you. If you are found to be eligible, the information you provide may help the investigators learn things that may help other people in the future.

How will information about you be protected?

UT Dallas has established secure research databases and computer systems to store information and to help with monitoring and oversight of research. Your information may be kept in these databases but are only accessible to individuals working on this study or authorized individuals who have access for specific research related tasks.

Identifiable information in these databases is not released outside of UT Austin, UT Dallas, or Baylor Scott and White Research Institute, unless stated in this consent or required by law. Although results of this research may be presented at meetings or in publications, identifiable personal information about participants will not be disclosed.

Personal information about you might be shared with or copied by authorized representatives from the following organizations for the purposes of managing, monitoring, and overseeing this study:

● The study sponsor and/or representative of the sponsor (Department of Defense)

● Representatives of UT Austin and the UT Austin Institutional Review Board

● Representatives of UT Dallas and the UT Dallas Institutional Review Board

● Representatives of Baylor Scott and White Research Institute

● Officials of the Department of Health and Human Services or the Federal Food and Drug Administration.

To help protect your privacy, this research is covered by a Certificate of Confidentiality from the National Institutes of Health. This means that researchers cannot release or use information, documents, or samples that may identify you in any action or suit unless you say it is okay. They also cannot provide information, documents, or samples that may identify you as evidence unless you have agreed. This protection includes federal, state, or local civil, criminal, administrative, legislative, or other proceedings. An example would be a court subpoena.

There are some important things that you need to know. The Certificate DOES NOT stop reporting that federal, state, or local laws require. Some examples are laws that require reporting of child or elder abuse, some communicable diseases, and threats to harm yourself or others. The Certificate CANNOT BE USED to stop sponsoring United States federal or state government agency from checking records or evaluating programs. The Certificate DOES NOT stop disclosures required by the federal Food and Drug Administration (FDA). The Certificate also DOES NOT prevent your information from being used for other research if allowed by federal regulations.

Researchers may release information about you when you say it is okay. For example, you may give them permission to release information to insurers, medical providers, or any other persons not connected with the research. The Certificate of Confidentiality does not stop you from willingly releasing information about your involvement in this research. It also does not prevent you from having access to your own information.

What will happen to the information we collect about you after the study is over?

Only if your responses indicate you may be eligible for the greater research study will your responses be included in the research database. Research data will be kept for at least 3 years after study completion. During this time, your name and other information that can directly identify you will be kept secure and stored separately from the research data collected as part of the project.

In the future, identifiers might be removed from the information you provide in this study, and after that removal, the information could be used for other research studies by this study team or another researcher without asking you for additional consent.

How will we compensate you?

You will not receive any type of payment for your participation.

Can you stop being in the study?

You can stop being in this research study at any time. Leaving the study will not affect your medical care, employment status, or academic standing at UT Dallas, UT Austin, or Baylor Scott and White Medical Institute. Tell the study staff if you are thinking about stopping or decide to stop.

If you withdraw from the study, data that has already been collected about you will remain part of the study database and may not be removed.

Contact Information for the Study Team

If you have any questions about this research, you may contact:

If you have questions about your rights as a research participant, or wish to obtain information, ask questions, or discuss any concerns about this study with someone other than the researcher(s), please contact the following:

YOUR CONSENT

Before agreeing to be part of the research, please be sure that you understand what the study is about. We will give you a copy of this document for your records [or you can print a copy of the document for your records]. If you have any questions about the study later, you can contact the study team using the information provided above.

By clicking “I Consent” below, you confirm that:

  • You have read and understood the information above.

  • You voluntarily agree to complete the screening survey.

  • You understand that participation is voluntary and you may withdraw at any time.

I Consent
I Do Not Consent
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