Welcome to Project EQUIP

Title of Research:
Project EQUIP: Enhancing QUality In Protective strategies

Principal Investigator:
Melissa A. Lewis, Ph.D., melissa.lewis@unthsc.edu, 817-735-5136

Collaborative Investigators:
Dana Litt, Ph.D., dana.litt@unthsc.edu
Anne Fairlie, Ph.D., afairlie@uw.edu
Jason Kilmer, Ph.D., jkilmer@uw.edu

Research Staff:
Allison Cross, MS, Graduate Student Research Assistant, allisoncross@my.unthsc.edu
Haleigh Hicks, BS, Research Assistant, haleigh.hicks@unthsc.edu
Delaney Miller, BS, Research Assistant, delaney.miller@unthsc.edu
Katherine Vrotsos, MA, Graduate Student Research Assistant, katherinevrotsos@my.unthsc.edu

Collaborating Research Institutions:
University of North Texas Health Science Center
University of Washington

This study is funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Key Information for Project EQUIP:

We are inviting you to take part in a research study. Your participation in this study is voluntary, and you do not have to participate.

What is the purpose, procedures, and duration of this study?

What are reasons you might choose not to volunteer for this study?

This research study involves foreseeable risks and discomforts, which are summarized below:

• The risks associated with participation in the study are primarily related to the possibility of hacking during the online training session and the sensitivity of some of the questions. Due to the online nature of the training session, there exists a possibility that the session could be hacked, which would result in loss of confidentiality. You will be asked about thoughts, feelings, and personal difficulties that may be private, and about personal behaviors such as alcohol use and drug use in the surveys. These questions may make you feel uncomfortable or may seem intrusive, or you may become concerned about your own drinking or other health behaviors as you answer the questions.
• In addition, you are asked to report on illegal behaviors, such as drinking under the legal age, or using controlled substances such as cannabis.
• There is a risk of loss of confidentiality, which means that the information we collect about you could possibly be accessed by someone who is not authorized to see it. However, all of your data will be kept confidential and data will be identified only by a PIN (personalized identification number) randomly generated for research purposes, and will not be directly identified by your name.

What are reasons you might choose to volunteer for this study?

Your participation in this study may not directly benefit you. However, you may benefit from the online program in that preliminary data suggest that programs such as these can reduce alcohol and cannabis use. Additionally, your participation in the study may help the clinical and scientific communities gain a greater understanding about the potential that this research has for reducing the serious public health problem of high-risk drinking and cannabis use in young adults. Given the high rates of hazardous alcohol and cannabis use, risk for future use, and consequences in this population, development and dissemination of efficacious brief prevention strategies has the potential for significant societal benefits. In light of these potential individual and societal benefits, we believe the risks of participation are outweighed.

What are alternatives to participating in this study?

This research project does not involve treatment. You may choose not to participate in this study. If you choose not to participate in the study but have questions about alcohol or cannabis use, we can provide you with a list of information and referrals within the community.

Main Consent Form

I. Introduction

You are invited to participate in a research study. Your participation in this study is entirely voluntary. This consent form contains information to help you decide whether or not you wish to participate. Please read this consent form at your own pace. It is important that you read what is written below and ask questions about anything you do not understand. You may want to talk with your family, friends, or others to help you decide if you want to be part of this study. When you feel that your questions have been answered, you will be asked if you agree to be part of the study. If you agree, you will be asked to sign this consent form. You will be emailed a copy of this form to keep.

If you are a student or employee at the University of North Texas Health Science Center, your participation (or non-participation) will in no way affect your academic standing or employment status.

II. Study Purpose

The purpose of this study is to explore the effects of an online and text message program for use and non-use of alcohol and cannabis protective behavioral strategies among young adults ages 18-24. The findings of this study could improve health practices in these areas. Approximately 240 participants will be involved in this study.

III. Eligibility to Participate

• You will be asked to complete demographic questions (e.g., age, birth sex, race, ethnicity, pregnancy status [i.e., if female, you cannot enroll in the research study if you are pregnant or trying to get pregnant]), as well as questions about your alcohol and cannabis use (e.g., “On average, over the past month, how often have you consumed alcohol?”; “On average, during the past month, how often have you used cannabis?”) to see if you fit our study needs. We also ask for your contact information and whether you would like to be contacted for future or additional research opportunities. The re-contact provision clause will be found in the screening survey. This information will be confidential.
• This short survey takes approximately 5 minutes. The overall purpose of this initial screening survey is to determine if you are eligible to participate in the main study where you may be invited to complete an interactive online and text message program. You will not be compensated for this short eligibility survey.
• If you are a potential fit for our study, you will be invited to schedule a one-time 30-minute online training session via Zoom Video Communications with a study staff member.
• If you do not meet the requirements to participate in our study, you will receive an email following the completion of this initial screening survey notifying you that you are ineligible for the study.
• The information that is collected about you during the screening process will be used for research purposes. Please note that you may be deemed ineligible for further participation in this study based on the information that is obtained about you during the screening process.
• If a minor under the age of 18 completes screening, they will automatically be deemed ineligible upon providing their age and date of birth. Screening information provided by minors under the age of 18 will not be retained and will be deleted 120 days after the study has ended.

IV. Study Procedures

• After completing this initial screening survey, if you meet the initial requirements for participation, you will be invited to schedule an online training session (hosted via Zoom Video Communications) regarding the daily survey portion of the study (see below). You will then be asked to download and install the Zoom application on your personal device. You will not be asked to sign up for a Zoom account in order to participate in the online training session. In order to download and run Zoom on your personal device, you will need an iPhone (iOS 7.0 or later), an Android cell phone (Android 4.0x or later), a PC/laptop (with Windows XP, Vista, 7, 8, or 10) or a Mac computer/laptop (MACOS 10.7 or later). You will need a stable internet connection during your participation in the online training session. The digital recording feature in Zoom will not be used by the facilitator and participants will not have access to it. Once you join the online session, the session will be locked and no one else will be allowed to join. You will be asked to show a picture ID (current driver’s license, passport, state or government issued ID, etc.) at the beginning of your online session to verify your age and identity. During this online session, you will review the consent form with a trained facilitator and verify that you continue to agree to be in the study. You will be shown how survey links will be sent to you via text message and email and will be shown a test survey. Use of your phone during the entire study may contribute to your data use/data plan. The survey links have security features that ensure that all data is kept confidential. The session will last approximately 30 minutes and you will be paid $20 to compensate for your time loaded onto a Greenphire Mastercard, which will be mailed to you after you complete the online baseline survey (see below). After you receive your card, you will be asked to contact us via email or phone so we can load your card with a total of $40 ($20 for the online session, and $20 for completing the online baseline survey). You will also be provided with information about how the Greenphire Mastercard works during your online session.
• If you are eligible and agree to be in our study during the online training session, you will then be invited to complete an online baseline survey, which will take approximately 30 minutes to complete. The confidential online survey asks about your basic demographics, alcohol and cannabis use and related consequences, motivations for use or non-use of protective behavioral strategies, other potential drug use, family history or alcohol use, and eating patterns. You will be paid $20 that will be loaded onto your Greenphire Mastercard to compensate you for your time.
• Immediately following the completion of the baseline survey, you will be randomly assigned into one of two groups: either the online program group, which contains both an interactive online component and daily personalized protective behavioral strategy text messages; or a group which will not receive this additional component of the interactive online program and daily text messages, and will only complete the survey component of the study.
• This assignment will be made completely at random, and none of the responses you provide in the screening or baseline survey will influence which group you will be assigned to. You will be alerted as to which group you have been randomly assigned to via email upon completion of the baseline survey.
• If randomly assigned to the online program group, after completion of the baseline survey you will receive a brief interactive online program focusing on self-selected alcohol and cannabis protective behavioral strategy messages and motives for using alcohol- and cannabis-related protective behavioral strategies. You will be asked to complete and provide feedback on the content of the interactive online program. The personalized online program content will be delivered via text messages three days a week (random day, Friday, Saturday) over eight consecutive weeks.
• All participants, regardless of which group they are randomly assigned to, will be asked to complete short online daily surveys reporting on protective behavioral strategy use, including motivations for use (or non-use) and quality, alcohol and cannabis use, and related risk behaviors, such as sexual behavior and other substance use. These surveys will be sent three days a week (random day, Saturday, Sunday), for a total of 24 surveys over 8 consecutive weeks.
• If randomly assigned to the group that will not be receiving the interactive online program or daily text messages, you will not receive any online program content after completing the baseline survey, but will be invited to complete the daily surveys and 2-month follow-up survey according to the same schedule as the online program group in order to assess daily-level protective behavioral strategy use and non-use, alcohol and cannabis use, and related consequences for 24 days over an 8-week period.
• The 8-week period for daily surveys (both groups) and text message online program content (online program group) will begin the first weekend after completion of the interactive online program (online program group) or the baseline survey.
• For each survey window, you will receive a text message and email indicating the beginning of the 4-hour survey period and a hyperlink to the survey. If you do not complete the assessment, you will be emailed and sent a text message reminder 2 hours before the close of the window, and again 30 minutes before the close of the window.
• Each daily survey will take approximately 9-10 minutes to complete, and you will be paid $4 for each daily survey that you complete, with a $10 bonus for completing at least 90% of the surveys, for a total of up to $106 as compensation for the daily surveys. The payments for the daily surveys will be uploaded to your Greenphire Mastercard at the end of the study after you complete the 2-month follow-up survey.
• All participants will also be asked to complete a 2-month follow-up survey after the completion of the daily assessment portion of the study. The confidential online survey will take about 30 minutes to complete and ask questions about your alcohol and cannabis use, related consequences, and other health and risk behaviors. You will receive $30 loaded onto your Greenphire Mastercard for completing this survey.
• The use of the text message links to complete study surveys may contribute to your text messaging data use/data plan.
• In total, you can earn up to $176 loaded onto your Greenphire Mastercard throughout the course of the study. You will also receive additional information about how the Greenphire Mastercard works. When you receive your card in the mail, you will be asked to contact us via email or phone so we can load it with your payment.

We understand our participants have busy lives. Participants will receive a number of invitations and reminders (via phone, email, and text message). These include the following: scheduling online session invitation and reminders (up to 8 emails, up to 8 text messages, up to 5 phone calls), baseline survey invitation and reminders (up to 8 emails, up to 8 text messages, up to 5 phone calls), online program invitation and reminders if selected for the program group (up to 7 emails, up to 7 text messages, up to 5 phone calls), monthly summary invitations if selected for the program group (up to 2 emails, up to 2 text messages), daily survey invitation and reminders (up to 3 emails per day, up to 3 text messages per day), check-in phone calls (up to 2), and payment notifications (up to 4 emails, up to 4 text messages). Participants who consent but do not complete the online screening survey may receive up to 3 reminder email notifications. Participants who do not confirm receipt of their Greenphire Mastercard within 10 business days of it being mailed will receive 1 text message and 1 email reminder to confirm receipt of their card. We will also periodically contact you over the phone to confirm receipt of your card. Participants who miss several daily surveys will receive additional reminders via email, text, and phone calls. You will also receive an email reminder when the 2-Month Follow-Up survey date approaches. You will then receive reminders to complete the 2-Month Follow-Up survey (up to 8 emails, up to 8 text messages, up to 5 phone calls). At any point during this time, you can complete the survey or contact us to be removed from the study, at which point reminder contacts will stop. Additionally, if you choose to “like” our Facebook Fan Page and/or “follow” our Instagram profile or Twitter feed, you may see more posts from us about our latest projects/activities, general updates, and other fun things.

V. Expected Time or Duration of Participation

• You will be asked to complete a 5-minute online screening survey.
• If you meet the initial requirements to participate in the study, you will be invited to schedule a one-time 30-minute online training session via Zoom Video Communications with a study staff member.
• Once you complete the online training session and agree to participate, you will receive an email and text message invitation to complete a 30-minute online baseline survey.
• You will then be asked to fill out short daily surveys through links sent to you via email and text message over the course of 8 weeks; you will receive 3 daily surveys per week, to be sent to you on Saturday morning, Sunday morning, and a random day morning each week, for a total of 24 daily surveys over the course of the 8 consecutive weeks. The surveys will take approximately 9-10 minutes to complete.
• You may also be asked to view and provide feedback on a brief 20–30-minute interactive online alcohol and cannabis program and may receive content related to the program via text message over the course of 8 weeks.
• Approximately 2 months after you complete the online baseline survey, you will receive an email and text message invitation to complete a 30-minute online follow-up survey.
• In total, the study will take approximately 8 weeks to be completed.

VI. Risks and Discomforts of the Study

There is a certain amount of risk that is involved with participating in a research study. Every precaution will be taken by the research team to minimize these risks and ensure your safety. Please remember that if you feel uncomfortable about any of these risks, discuss your concerns with the research team. You do not have to enroll in this study. If you decide to enroll in this study, you are free to withdraw from the study at any time.

This study involves informational risks (such as breach of confidentiality). The risks associated with participation in this short online survey and the main study are primarily related to the possibility of hacking during the online training session and the sensitivity of some of the questions in the surveys, including alcohol and drug use. These questions may make you feel uncomfortable or may seem intrusive, or you may become concerned about your drinking or other health behaviors as you answer the questions. You are asked to report on illegal behaviors, such as using controlled substances. Answers to these questions could pose a risk if the information were known and linked to identifiable individuals. It is possible that you will feel uncomfortable while taking the surveys, or feel as if you should share information that you don’t want to share. Additionally, there is informational risk since your contact information will be maintained at least until the end of the study to monitor study enrollment. However, we have taken steps to protect you from this risk. To ensure that online training sessions are not hacked, online connection to the sessions via Zoom will be encrypted and the training session facilitator will lock the online session once the participant has joined. This will minimize the potential for loss of confidentiality if an attempt to hack the online training session was made. All of your data will be kept confidential and data will be identified only by a PIN (personalized identification number) randomly generated for research purposes, and will not be identified by participants’ names. The PIN is always embedded in survey links, meaning the link is specific to you and your survey data. Thus, you will not ever need to enter your PIN to complete study surveys. Additionally, you are not required to respond to any questions that you do not feel comfortable responding to, and you may withdraw participation from the study at any time.

In addition to the potential risks (described above), the research procedures may involve risks to you that are currently unforeseeable at this time. Significant new findings that are developed during the course of the research that may relate to your willingness to continue participation will be provided to you.

VII. Benefits

You are not expected to directly benefit from this study. However, for those who receive the online program, you may potentially benefit from the online program in that preliminary data suggest that programs such as these can reduce alcohol and cannabis use. In addition, benefits to society include the potential that this research has for reducing the serious public health problem of high-risk drinking and cannabis use in young adults. Given the high rates of hazardous alcohol and cannabis use, risk for future use, and consequences in this population, development and dissemination of efficacious brief prevention strategies has the potential for significant societal benefits. Finally, participants who report a potentially lethal doses of alcohol (estimated Blood Alcohol Concentrations above 0.35%) and hazardous alcohol or cannabis use as measured on the Alcohol Use Disorder Identification Test or on the Cannabis Use Disorder Identification Test will be emailed referral information following the baseline survey. All participants will be emailed resource information following the completion of the study (after the 2 month survey is completed). Thus, there are potential direct benefits for everyone participating in this study.

VIII. Contacts

If you have any questions about the research, concerns about your participation in this study, and/or if you have a research-related injury, please contact Dr. Melissa Lewis via email at melissa.lewis@unthsc.edu, or via phone at 817-735-5136. If you have questions about your rights as a research subject, you should contact the North Texas Regional Institutional Review Board by phone at 817-735-0409.

IX. Alternatives

There are no alternative treatments or interventions involved in this study, other than what has been described. Therefore, the only alternative is that you may choose not to participate in this study.

X. Confidentiality

All of your records will be kept as confidential as possible under current local, state and federal laws. You will not be identified in the analysis or presentation of the data in subsequent publications and presentations at local, national and/or international academic conferences.

We have taken steps to protect you from the risks mentioned above. Participating in this study is voluntary. You may refuse to answer any question and still submit your survey without penalty or loss of benefits to which you are otherwise entitled. You are free to withdraw at any time without penalty or loss of benefits to which you are otherwise entitled. To withdraw from the study at any time, please contact the researchers using the phone number 817-735-2371 or by emailing equip@unthsc.edu.

You can still submit a survey with unanswered questions and will still receive full compensation when submitting a survey with unanswered questions. All of your data will be kept confidential. Your survey answers are kept separate from your personal information, so that none of your answers can be directly linked to anything that might identify you. Data will be identified only by a PIN (personalized identification number) randomly generated for research purposes, and will not be identified by participants’ names. Only the researchers will know the PIN. The PIN is embedded in all links that we send you. You do not need to know the PIN or enter the PIN for this study. You will not be identified in any research reports, data sharing/online research, databases, or presentations of this research. Your name and contact information will be accessible only to research staff for the purposes of contacting you to complete the study, and will be stored separately from your data on computers with password protection until the end of the study. Your name, contact and demographic (age, sex, and date of birth) information may be retained indefinitely if you consent to being contacted for future or additional research opportunities. The daily survey data/study information is immediately sent to the secure, HIPAA compliant server via the internet. All survey links have security features to keep all data confidential. Identifiers might be removed from the identifiable private information and after such removal, the de-identified information could be used for future research opportunities or distributed to another investigator for future research opportunities without additional informed consent from you.

Authorized representatives from the following organizations may need to review your research information as part of their responsibilities to protect research participants:

• University of North Texas Health Science Center Office of Research Compliance
• North Texas Regional Institutional Review Board
• Other federal regulatory agencies, as required

A description of this clinical trial will be available on http://www.clinicaltrials.gov, as required by US law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time using the following ID: NCT04978129.

This research is covered by a Certificate of Confidentiality from the National Institutes of Health. With this Certificate, the researchers cannot be forced to disclose or use information that may identify you, even by 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 federal agencies. A Certificate of Confidentiality does not prevent you 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. The protection offered by the Certificate does not stop us from voluntarily reporting information about suspected or known sexual, physical, or other abuse of a child or older person, or a subject’s threat of violence to self or others. If any member of the research team is given such information, he or she will make a report to the appropriate authorities, and will do so without disclosing your participation in this study. Please note that information collected from this study will not be reported to authorities, unless a situation arises in which research staff is legally required to report (i.e., suspected/known child abuse or neglect, or threat of harm to self or others). The Certificate of Confidentiality will not be used to prevent disclosure for any purpose you have consented to in this informed consent document.

XI. Payments of the Study

You can earn up to $176 loaded onto a Greenphire Mastercard over the course of the study.

XII. Leaving the Study

You may refuse to participate or stop participating in this study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled. To withdraw from the study at any time, please contact the researchers using phone number 817-735-2371 or email equip@unthsc.edu.

Research information that was collected about you prior to your withdrawal or termination may be retained and used for research purposes. The researchers can continue to use or share your de-identified (no identifiers) information indefinitely. De-identified data could be used for future research opportunities or distributed to another investigator for future research opportunities without additional informed consent from the subject or the legally authorized representative. The researchers will be publishing articles about the project and presenting de-identified data at conferences and through other platforms such as online databases. Data will be de-identified (no identifiers) by the end of the study.

Researchers will retain your contact and demographic (age, sex, date of birth) information if you are eligible for this study or if you agree to be contacted for future or additional research opportunities. Demographic information will be retained for the purpose of sending more relevant future or additional research opportunity information to participants who agree to be contacted. If you are ineligible for this study and agree to be contacted for future research opportunities, your contact and demographic information will only be used for the purposes of contacting you about future research opportunities and we will retain your contact and demographic (age, sex, date of birth) information indefinitely. If you are eligible for this study and agree to be contacted for future research opportunities, your contact and demographic information will only be used for the purposes of contacting you about the study or future research opportunities and we will retain your contact and demographic (age, sex, date of birth) information indefinitely. If you are eligible for the study but do not agree to be contacted for future research opportunities, your contact information will only be used for the purposes of contacting you about the study and we will retain your contact information until the end of the study.

Who do I contact if I have questions about the study?
Project EQUIP Staff
equip@unthsc.edu, 817-735-2371

If you would like to participate in the screening survey and online text message program (if eligible), please indicate your consent below.

Melissa A. Lewis, Ph.D.
Principal Investigator
Melissa.Lewis@unthsc.edu, 817-735-5136

First, we will ask for you to provide consent for your own participation in the full research study (if eligible):

XIII. Consent

I voluntarily agree to participate in this study. All of the study procedures have been described to me, and all of the risks have been explained. I have been given an opportunity to ask questions, and all of my questions have been answered to my satisfaction. If I have questions about my rights as a research subject, I can call the North Texas Regional Institutional Review Board at 817-735-0409. I will receive a copy of this informed consent form.

Please answer the question below and hit “Next” (regardless of your answer).

Please sign and complete the information below if you checked “YES” above. This information will document your consent for the whole study. All of your responses will be kept confidential.

Please submit your completed consent form by pressing the ‘Next’ button below.

Study Title:
Project EQUIP: Enhancing QUality In Protective strategies

Principal Investigator Name:
Melissa A. Lewis

1. What is the purpose of this form?

   The purpose of this form is to give your permission to the research team at the University of North Texas Health Science Center (“UNTHSC”) to obtain, use or share your protected health information (PHI). This protected health information will be used to do the research named above. UNTHSC understands that information about you and your health is personal and we are committed to protecting the privacy of that information in accordance with state and federal privacy laws. Because of this commitment, we must obtain your written authorization before we may collect, use or share your protected health information for the research study listed above. This form provides authorization and helps us make sure you are properly informed of how this information will be used or disclosed. You do not have to sign this permission form. If you do not sign, UNTHSC will not obtain, use or share your protected health information for research. Please note though that you will not be able to participate in the research study. Your decision to not sign this permission will not affect any treatment, health care, enrollment in health plans or eligibility for benefits.

2. What is considered Protected Health Information (PHI)?

   In this form, “protected health information” (PHI) refers to any health information that identifies you, such as:

   • Your past, present, or future physical or mental health or condition (e.g., responses to surveys)
3. What Protected Health Information will be obtained, used or shared?

   If you sign this form, you give UNTHSC permission to obtain, use or share the following health information as part of this research study:

   • Alcohol use collected from surveys
   • Substance use collected from surveys
   • Sexual behavior information collected from surveys

   UNTHSC is required by law to protect your health information. By signing this form you authorize UNTHSC to obtain, use or share your health information for this research. Those persons who receive your health information may not be required by Federal privacy laws to protect it and may share your information with others without your permission, if permitted by laws governing them.

4. From whom, or where will you obtain my Protected Health Information?

   Health information about you created or generated during the course of this research study.

5. Who may obtain, use or share my Protected Health Information?

   Your protected health information may be obtained, used, or shared with these individuals or organizations for the following purposes:

   1. To the research team for the research described in the Research Consent Form
   2. To others with authority to oversee the research (i.e., Institutional Review Board (IRB), safety monitoring committee, oversight board, etc.)
   3. To others who are required by law to review the quality and safety of the research, including: U.S. government agencies, such as the Food and Drug Administration or the Office of Human Research Protections, the research sponsor National Institutes of Health, or the sponsor’s representatives including but not limited to the National Institutes on Alcohol Abuse and Alcoholism, other federal or state agencies, and government agencies in other countries.

   Any protected health information disclosed pursuant to the authorization may be subject to re-disclosure by the recipient and is no longer protected.

6. How will my Protected Health Information be used or shared for the research?

   If you agree to be in this study, the research team may use or share your protected health information in the following ways:

   1. To perform the research
   2. Share it with researchers in the U.S. or other countries
   3. Use it to improve the design of future studies
7. Am I required to sign this document?

   No, you are not required to sign this document. If you decide not to sign this document, you will still receive the same clinical care, or any services you were already entitled to receive. However, if you do not sign the document, you will not be able to participate in this research study.

8. Does my permission expire?

   This permission to release your Protected Health Information expires when the research ends and all required study monitoring is over.

9. Can I cancel my permission?

   You can cancel your permission at any time.

   You can do this by writing to the researcher. Please send your written request to:

   Project EQUIP Staff
   Department of Health Behavior and Health Systems
   School of Public Health
   3500 Camp Bowie Blvd; EAD suite 708
   Fort Worth, TX 76107-2699
   Telephone: 817-735-2371
   Email: equip@unthsc.edu

   You have the right to take back your permission at any time, except to the extent that the research team has already taken action in reliance on your permission. If you cancel your permission, you may no longer be in the research study.

   If you cancel, no more health information about you will be collected. However, information that has already been collected and disclosed about you may continue to be used as necessary to maintain the integrity of the study (i.e., complete the research). Also, if the law requires it, the sponsor and government agencies may continue to look at your protected health information to review the quality or safety of the study.

10. QUESTIONS CONCERNING YOUR PRIVACY RIGHTS?

    Please call us at 817-735-2371 with any questions.

11. Authorization

    If you agree to the use and release of your Protected Health Information, please sign using your electronic signature below.

Consent for Specific Health Information and Use

The following information will only be released if you give your specific permission, which is required by Federal and state laws, by putting your initials on the line(s). The federal rules bar any use of the information to criminally investigate or prosecute any alcohol or drug abuse patient.

Required Signature for HIPAA Authorization:

Witness

If this form is being read to the subject because s/he cannot read the form, a witness must be present and is required to type his/her name and sign here:

If you provided your email, you will receive a copy of this statement for your records.

Please submit your completed HIPAA form by pressing the ‘Next’ button below.

NIH Data Sharing Consent Addendum

If you agree, your data from this study will be submitted to the National Institutes of Health (NIH) database. This large database is where deidentified study data from many NIH studies is stored and managed. If you participate in more than one NIH study, then your data from each of these studies may be combined. To do so, the researchers need to collect certain identifiable information about you (see bottom of page). However, the researchers will submit only deidentified data to the database. Deidentified study data means that all personal information about you (such as name, address, birthdate and phone number) is removed and replaced with a code number.

During and after the study, the study researchers will send deidentified study data about your health and behavior to the database. Other researchers across the world can then request your deidentified study data for other research. Every researcher (and institutions to which they belong) who requests your deidentified study data must promise to keep your data safe and promise not to try to learn your identity. Experts at the NIH who know how to keep your data safe will review each request carefully to reduce risks to your privacy. Sharing your study data does have some risks, although these risks are rare. Your study data could be accidentally shared with an unauthorized person who may attempt to learn your identity. The study researchers will make every attempt to protect your identity.

You may not benefit directly from allowing your study data to be shared with database. The study data provided to the database may help researchers around the world learn more about health. You will not be contacted directly about the study data contributed to the database.

It is your choice whether your data is added to the database. You may decide now or later that you do not want your study data to be added to the database. You can still participate in this research study even if you decide that you do not want your data to be added to the database. If you decide any time after today that you do not want your data to be added to the database, contact the study staff, and they will tell the database to stop sharing your study data. Once your data is part of the database, the study researchers cannot take back the study data that was shared with other researchers before they were notified that you changed your mind.

You will receive a copy of this document to keep.

Provide information as it appears on your birth certificate.