Health Status Evaluation of an Infantry Battalion Following Deployment iso Operation Iraqi Freedom (2004-2005)

INFORMED CONSENT DOCUMENT

Post-deployment Health Survey

Army Public Health Center

What is the survey about?

You are being invited to participate in a survey of post-deployment health conducted by the US Department of Defense. The data collected from the survey will be used to evaluate the health of current and former US Army personnel after deployment in support of Operation Iraqi Freedom. The purpose of the investigation is to assess the post-deployment health status of a unit of soldiers who operated in the vicinity of Mosul, Iraq in 2004.

Your participation will help the investigators quantify the health status of soldiers and veterans following military deployment to Iraq, define healthcare policy for future generations of service members, and guide future preventive health and medical service programs.

What will participating in the survey involve?

You are being asked to complete the attached questionnaire. We expect that completing the questionnaire will take less than 60 minutes. It contains questions on a broad range of health topics, including medical conditions, health behaviors, and exposures that may have affected your health. You are one of approximately 3,500 volunteers being asked to participate in this survey.

What risks are involved in participating in the survey?

The data collection procedures are not expected to involve any risk or discomfort to you. The main risks to you are those associated with inappropriate disclosure of data that we collect from or about you. Inappropriate disclosure on our part has the potential to impact your reputation, insurability, or employability. We have taken steps to ensure that inappropriate disclosures do not occur, and we summarize these steps in the next two sections.

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There is also the risk of possible discomfort from answering questions which you consider to be of a sensitive nature. Be aware that you may skip any question that makes you feel uncomfortable. If you feel that you might need medical care or counseling, you should make contact with the appropriate healthcare personnel.

How will your data be protected?

All paper copies of your completed survey will be kept in a locked file cabinet inside a secure room. Your personal identification information will be removed from hard copy files. Even if someone outside the investigation team broke into the files, it would be impossible for them to identify your data. When your data are entered into computer files for analysis, your answers will be identified only by a special study identification number known only to investigation team members. To minimize the risk of anyone breaking into the data files, those files will be maintained on Department of Defense computers protected by all the measures required by Department of Defense computer security regulations. They will be stored on a computer system that is designed specifically to store personal and health information. All members of the investigation team with access to data files will be trained in Department of Defense computer security procedures specifically designed to protect sensitive personal information and health data.

Reports of the study findings will contain only group data, so that no individual study participant can be identified. Similar procedures have been used to protect data in previous studies conducted within this organization.

Use and disclosures of this information shall comply with provisions of the Privacy Act and implementing regulations. According to US Department of Defense policy, the information you provide is for study purposes only, and may not be disclosed except for specifically authorized purposes or with your consent. If you indicate a desire to harm yourself or others, the Principal Investigator or Human Protections Administrator may be compelled to disclose this information in order to protect you or others from harm.

How is your information protected if you complete the questionnaire using the internet web application?

All information collected through the Internet questionnaire option is done by using Secure Sockets Layer data transmission lines. Secure Sockets Layer encrypts, or scrambles, all questionnaire data sent over the Internet. Information will only be understandable when it reaches the investigator database. The same methods of protection listed above will then be followed to further protect your information.

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What are the benefits of participating in the survey?

Participation in this survey will not directly benefit you. However, your participation will help investigators and senior leaders in the Department of Defense and the Department of Veterans Affairs better understand the health profile of soldiers and veterans who deployed to Iraq in support of Operation Iraqi Freedom, and may help define healthcare policy for future generations of military personnel and guide prevention and treatment programs.

Will you be provided with medical care based on your responses?

No. This is a population-based survey. Data collected will not be used to make decisions about treatment that any individual should receive. If you feel that you might need medical care or counseling, you should make contact with an appropriate healthcare provider.

Do you have to participate in the survey?

No. Your participation must be completely voluntary. If you decide to participate, you can stop at any time you wish or skip any question you choose. If you choose not to participate or to discontinue your participation, you will not lose any benefit to which you are otherwise entitled. You may change your mind and revoke your permission to further collect or use your health information at any time. If you revoke your permission, no new health information about you will be gathered after that date. However, unless specified otherwise, information that has already been gathered may still be used for analyses. Collected data will be maintained until all study questions are answered. To end participation, contact the principal investigator at [email protected], or (410) 436-2578. Your participation may also be ended by the investigators. While this is not anticipated, available funding or other logistical considerations could conceivably result in the early termination of this survey initiative.

Who can provide additional information if you need it?

Questions about the scientific aspects of this survey should be directed to the principal investigator at [email protected], or (410) 436-2578. Questions about ethical aspects of the study, including your rights as a volunteer, or any problem related to the protection of survey volunteers should be directed to the Human Protections Administrator of the US Army Public Health Center Public Health Review Board in the Office of Human Protections, by telephone at (410) 417-2611 or by email at [email protected].

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How can you receive a copy of your records if you wish to review them?

The principal investigator will be responsible for storing your consent form and other records related to this study. Paper records will be stored in a locked file cabinet at the US Army Public Health Center, 5158 Blackhawk Road, Aberdeen Proving Ground, MD 21010-5403. Electronic forms and responses will be stored on a secure server located at the US Army Public Health Center. You can review your survey responses until the study ends by contacting the principal investigator at [email protected], or (410) 436-2578.

Voluntary Consent

I consent to participate in the survey described above. My consent is completely voluntary. My consent is based solely on the information provided in this consent form.

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Volunteer’s Signature Date (MM/DD/YYYY)

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Volunteer’s printed name (First name, Middle initial, Last name)