Welcome to the Health for Every Veteran Study! Thank you for taking the time to learn more about this study. Before continuing, please read this Information Statement. If you have any questions about the study purpose, procedures, risks, discomforts, possible benefit, choices available to you, or your rights as a research subject after reading this Information Statement, please contact the study office prior to agreeing to participate in this research activity. Please be sure to click either “Yes” or No” at the end of this Information Statement as to whether you agree to participate in this study.
Study Office Phone Number: (206) 277-4328 or toll-free at 1-800-329-8387, extension 64328
Keren Lehavot, PhD, Principal Investigator
Tracy Simpson, PhD, Co-Investigator
Michelle Upham, MSW, Study Coordinator
We are inviting you to participate in a research study. The purpose of this Information Statement is to give you information you will need to help you decide whether to be in the study. Please read this form carefully. You may ask questions about the purpose of the research, what we are asking you to do, the possible risks and benefits, your rights, as a volunteer, and anything else about the research or this form that is not clear. Please contact our study office at (206) 277-4328 or toll-free at 1-800-329-8387, extension 64328
if you have any questions. When we have answered all your questions, you can decide if you want to be in the study or not.
PURPOSE OF THE STUDY
The purpose of this study is to learn more about the health and life experiences of different groups of Veterans from all backgrounds. Veterans are individuals who have served on active duty in the U.S. military but no longer do so. Veterans may or may not currently serve in the in the National Guard/Reserves. We are interested in understanding how Veterans’ identities, stressors, and experiences may affect their day-to-day life over time, including their mental, physical, and social health.
We will be approaching up to 6,500 Veterans to take part in this study. If you decide to participate, you will first need to complete screening questions to see if you are eligible to take part in this study. If you are eligible, you will be asked to complete an online questionnaire every 9 months for a 27-month period (total of four questionnaires). Each questionnaire will take approximately 60-90 minutes to complete.
To be sure you are eligible for this study, you will first need to complete online screening questions, which will take 5-10 minutes to complete. These include questions about your willingness to answer key demographic questions (such as your age, gender, race/ethnicity, sexual orientation), questions about your Veteran status, and whether you have access to the internet. You may also be asked for your name, date of birth, and email address so that study staff can get in touch with you to let you know if the study is right for you. All screening questions must be answered to determine eligibility for the study. After completing the screening questions, you will either be immediately alerted as to your eligibility or you will receive an email from study staff with this information within one week.
If you are eligible for the study, you will receive an email with instructions on how to access and complete the Baseline Questionnaire, which will take approximately 60-90 minutes to complete. The Baseline Questionnaire will include questions about your general feelings and emotions, stressful events you may have experienced and reactions to those events, and your healthcare experiences. Some of the most sensitive questions involve sexual behaviors and sexually transmitted infections, whether you are feeling depressed or anxious, alcohol and/or drug use, and whether you experienced verbal, physical, or sexual victimization as a child and as an adult. You are free to not answer any questions that you do not want to.
At the completion of this Baseline Questionnaire, we will ask for your complete contact information (including name, address, telephone number, and social security number). This information is needed for payment to be processed to you, and it will be kept separately from all your other data. In addition, you have the option of providing us with the name and contact information of up to two people who are likely to know where you are if we are unable to reach you over the course of the study.
After completing the Baseline Questionnaire, you will receive an email with instructions on how to access and complete a Follow-up Questionnaire every 9 months for approximately 2 years (at 9, 18, and 27 months). The Follow-up Questionnaires will be very similar to the Baseline Questionnaire. Each will take approximately 60-90 minutes to complete.
If you agree to participate in this study and you are due to complete a survey, we will contact you to provide reminders by email as well as by phone, letter, and contacting an emergency contact (if you choose to provide one) if we are unable to reach you.
POTENTIAL RISKS AND DISCOMFORTS
The risks associated with participation in this study are primarily related to the sensitivity of some of the questions. You will be asked about thoughts, feelings, and personal difficulties that may be private, personal behavior such as sexual history, trauma exposure, and health behaviors. These questions may make you feel uncomfortable, bring back stressful or upsetting memories, or seem intrusive. The questions may make you think about how you are coping with stressful events you have experienced or other health behaviors as you answer them. While we will provide you with resources for hotlines, websites, and services that you can access, please note that this study does not provide treatment services.
Answers to the questions could pose a risk if the information were known and linked to identifiable individuals. Note that we have taken several steps to protect you from these risks, as described in the CONFIDENTIALITY section below.Resources
Please see the “Resources” page for a variety of mental health and health-related resources for Veterans. If you experience distress or discomfort during any of the online questionnaires or because of your participation, you can contact any of the investigators listed above to discuss your concerns. Should your discomfort become severe, please contact 1-800-273-TALK (8255) and press “1” for the Veterans Crisis Line’s toll-free number for further assistance. You can also visit http://www.veteranscrisisline.net, which provides resources and live chat. The Veterans Crisis Line connects Veterans with qualified, caring VA responders through confidential support 24 hours a day, 7 days a week
. In addition, you are free to participate in other health-related programs such as support groups, treatment, or therapy while involved in the study.
There may be no direct benefit to you for participating in this research; however, you may benefit by learning more about yourself through participation in the study. You may gain greater self-knowledge or understanding of your coping behavior. Benefits to society include the opportunity to contribute to the development of programs intended to improve the health and wellness of every Veteran.
You do not have to take part in this study. If you are in this study, you can withdraw at any time. You are free not to answer any questions that you do not want to answer. If you decide not to participate or to withdraw, no action will be taken against you; for instance, you will not lose your VA benefits.
If you decide to participate and the study is right for you, you will receive payment for your participation in the study as follows:
There will be no compensation for completion of the initial online screening questions. Payment will be made in the form of a check, which will be mailed to you within 8 weeks after completing each questionnaire. Per the Stolen Valor Act of 2013, it is a federal crime to obtain money or other benefits by falsely representing prior military service.
Your complete contact information (including name, address, telephone number, and social security number) is required for payment to be processed to you. As mentioned above, this information will be kept separately from all other study data. We will collect your social security number to comply with Internal Revenue Service (IRS) guidelines. You may receive an IRS Form 1099. While you are free to not answer any question, in order to receive payment, we will check to ensure that you have completed at least two-thirds of each questionnaire and that responses are consistent.
Your research information will be kept confidential. However, some data will be shared, communicated, or stored during or after this research study.
The following list of people or groups may know that you are in this study. They may have access to your research records:
- Research team members
- Austin Data Center, the questionnaire database portal
- Other federal agencies including, but not limited to, the Food and Drug Administration (FDA), the Office for Human Research Protection (OHRP), the VA Office of Research Oversight (ORO), the VA Office of the Inspector General (OIG), and the Government Accountability Office (GAO)
- The VA committees that oversee research
- The VA Puget Sound Fiscal Department and U.S. Department of the Treasury will be provided with your full name, address, phone number, and social security number in order to authorize payment for your participation in this study
You will be using the website QuestionPro to complete the screening questions for this study (https://www.questionpro.com
Your name, email address, and date of birth will be collected on QuestionPro, but this information will not be linked to your screening questions. On a weekly basis, research staff will log into the administrator side of QuestionPro to extract this personally identifying information. That extract will be collected via a secure internet connection, saved to the secure VA network, and removed from the QuestionPro server. At the end of the research project, all screening question data will be extracted onto the secure VA network and removed from QuestionPro.
The baseline and follow-up questionnaires will be completed using a secure VA server. All your study data, meaning the information that you provide the researchers in the online questionnaires, will be saved at VA Puget Sound using transmission and storage procedures that meet VA standards for information security.
Your identity will be strictly confidential. Only study personnel will have access to the identifiable information that we collect from you. We will not place any identifiable information (such as your name or social security number) on any research data. Instead, we will assign a unique Study ID number to identify your information.
We will keep the master list that links your name to your Study ID in a secure-access computer specifically for research data. The master list will be stored in a password-protected folder and will only be accessed by the authorized study staff members.
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 to a federal institution. The researchers will use the Certificate to resist any demands, even by a court of law, for information that would identify you. You may still share information about yourself or your part in this research as you see fit.
The Certificate of Confidentiality does not protect us from:
- Disclosing information to law enforcement authorities if we get any information that suggests the occurrence of child abuse, elder abuse, or your intent to immediately and substantially harm yourself or others.
- Giving the VA Puget Sound office that manages payments to subjects your name, social security number, address, and the name of this study.
- Giving your name to state, federal, and institutional offices involved in auditing or compliance of research, risk management, patient safety, and financial controls.
Once this study is completed, we will not use the Study ID linking you to your data for any additional research. We will store the code linking you to your data in a secure database or in a locked filing cabinet in accordance with the VA records retention policy (which will be a minimum of 6 years after the study has been completed). We will keep your coded data indefinitely.
In the future, researchers may write about the information collected from this research study. Any future publications or articles will not include any identifying information about you without your approval in writing. We will use the information that we collect for this study only for research purposes, not for profit. However, in the future, researchers may use this research information for the development of new ways to diagnose or treat diseases. Neither you nor your family will gain financially from discoveries made using the information you provide.
QUESTIONS OR CONCERNS RELATED TO THE STUDY
If you have any questions about the study, you may contact the VA Institutional Review Board (IRB) Office at 206-277-1715 if you:
- Would like to speak with a neutral party who is not involved with this study.
- Have questions, concerns, or complaints about the research.
- Would like to verify the validity of the study.
- Have questions about your rights as a research subject.
An IRB is an independent body made up of medical, scientific, and non-scientific members, who ensures the protection of the rights, safety, and well-being of subjects involved in research.
RESEARCH SUBJECT’S RIGHTS
After reading this Information Statement, if you have any questions about the study purpose, procedures, risks, discomfort, possible benefit, choices available to you, or your rights as a research subject, please discuss them with the study team at (206) 277-4328 or toll-free at 1-800-329-8387, extension 64328 prior to agreeing to participate in this research activity.