March 16, 2006
Ref#:
THE INSTITUTE OF MEDICINE’S VIETNAM ERA SHIPBOARD HEALTH STUDY
Dear Sir:
You are asked to participate in a research study conducted at the Institute of Medicine William F. Page, Ph.D., Study Director. Your participation in this study is voluntary. You should read the information below and ask questions about anything you do not understand before deciding whether or not to participate.
The Institute of Medicine (IOM) is part of the National Academies, a private, nongovernmental research organization chartered by Congress during Abraham Lincol1>s presidency. We have been asked to conduct a survey of the health status of Vietnam era military service personnel such as yourself, most of whom served in the Navy and also participated in Project SHAD (Shipboard Hazard and Defense) tests, between 1963 and 1970. The Department of Veterans Affairs has funded IOM to do this survey to determine the present health of Project SHAD participants and a comparable group of non-participants. It is important for us to hear from you because our records indicate that you were a participant in tests in which active chemical or biological warfare agents were used, and your response is the only way we can get accurate and complete information about the current health of these participants.
If you volunteer to participate in this study, we would like you to complete the enclosed mail survey, which contains some questions about your current and past physical and emotional health. If you would prefer, we can also have someone contact you and ask you these questions over the telephone. Either way, the survey should take no more than 20 minutes of your time. The data collection procedures are not expected to involve any health risk or discomfort to you. The principal risk for you is problems that could occur if the data you provide were disclosed inappropriately. However, our research group has collected similar information from participants in dozens of studies without any cases of inappropriate disclosure.
We will keep the information we collect confidential and not share it outside our agency. All the data we collect will be kept in locked file cabinets or password-protected computer files to prevent access by unauthorized persons. When the results of the research are published or discussed in conferences, no information will be included that would reveal your identity.
This study is not being done to improve your health or condition. Again, your participation in this research is voluntary. If you choose not to participate, that will not affect your relationship with the Department of Veterans Affairs or your right to health care or other services to which you are otherwise entitled. If you decide to participate, you are free to withdraw your consent and discontinue participation at any time without prejudice. You will not be paid for your participation.
I am enclosing a copy of the questionnaire to be filled out and returned using the postage-paid envelope. As a gift, I am including a pen with the National Academies logo which can be used to fill out the questionnaire, and is also yours to keep in appreciation for your assistance. There is an extra copy of the consent form to keep for your files. If we do not hear from you within the next several weeks, you may receive a telephone call about participation in the survey. If at that time you haven’t sent in the consent form by mail, the interviewer will ask for your consent to be interviewed over the telephone before proceeding with any questions.
You may withdraw your consent at any time and discontinue participation without penalty. You are not waiving any legal claims, rights, or remedies because of your participation in this research study. If you have any questions about the study or regarding your rights as a research subject, you may call me toll-free at 1-800-556-9896. I hope that you will be able to participate in our health survey, and I thank you for your attention to this matter.
Dear Veteran:
The Department of Veterans Affairs (VA) has asked the Institute of Medicine, part of the National Academies (a private, non-governmental research organization), to conduct a survey of the health status of veterans, some of who may have participated in Project Shipboard Hazard and Defense (SHAD) tests between 1963 and 1970. The VA has funded this survey and the Department of Defense (DoD) has provided information to identify study participants and to specify the kinds of health hazards Project SHAD participants may have encountered.
The goal of the study is to determine the present health of Project SHAD participants and a comparable group of non-participants. It is important for you to participate in this study so that accurate and complete information can be obtained. Both the VA and DoD have great interest in obtaining the best, most accurate picture possible of the potential adverse health effects that amy have resulted from Project SHAD participation. The Institute of Medicine has been chosen to do this health survey because fo their history of independent research regarding the health of military veterans.
I hope that you will agree to the Institute of Medicine’s request to participate in this very important health survey, regardless of your participation status in Project SHAD. If you know that you were a participant, you should not have any misgivings about answering the questions in the survey. Much has been declassigied about the SHAD tests, so answering these questions will not constitute a violation of your previous agreement not to disclose classified information. Also, whether or not you choose to participate, your relationship with the Departments of Defense and Veterans Affairs, and your right to health care or other services to which you are otherwise entitled will not be affected.
This is an important endeavor, and we appreciate your support.
October 24, 2005
William F. Page, Ph.D.
Senior Program Officer
Medical Follow-up Agency
Institute of Medicine
TNA 776
500 Fifth Street, N.W.
Washington, D.C. 20001
Dear Dr. Page:
We, the undersigned veterans service organizations and military service organizations, support fully the Institute of Medicine (IOM) study of the health effects of SHAD (Shipboard Hazard and Defense) testing in the 1960s and early 1970s. We believe that the data obtained from this study can go a long way towards answering many of the questions SHAD veterans have regarding health effects that may have been associated with their unwitting participation in SHAD tests while they were serving our nation.
We urge all veterans who receive a questionnaire from the IOM to take the time to fill it out and return it to the IOM. Their cooperation is essential if the study is to have the integrity and substance it needs for the IOM to make some definitive determinations about the health of SHAD veterans. Study results may compel the Department of Veterans Affairs (VA) to grant compensation and provide treatment for illnesses associated with exposure to the chemical and/or biological agents and decontaminants used in the SHAD project
Thank you for your cooperation.
Sincerely,
PETER S. GAYTAN
Director,
Veterans Affairs and Rehabilitation Division
The American Legion
JAMES B. KING
National Executive Director
AMVETS (American Veterans)
THOMAS ZAMPIERI
Director of Government Relations
Blinded Veterans Association
JOSEPH A. VIOLANTE
National Legislative Director
Disabled American Veterans
RICK JONES
Legislative Director
National Association for Uniformed Services
VADM NORB RYAN, JR. (USN - RET.)
President
Military Officers Association of America
HERSHEL GOBER
National Legislative Director
Military Order of the Purple Heart of the U.S.A., Inc.
RICHARD B. FULLER
National Legislative Director
Paralyzed Veterans of America
DENNIS CULLINAN
Legislative Director
Veterans of Foreign Wars of the United States
RICK WEIDMAN
Director of Government Relations
Vietnam Veterans of America, Inc.
THE INSTITUTE OF MEDICINE’S VIETNAM ERA SHIPBOARD HEALTH STUDY
Consent Form
What is this study about?
You are being asked to volunteer in a research study called “The Vietnam Era Shipboard Health Study.” This purpose of the study is to assess the current health of veterans, many of whom were in the Navy during the Vietnam era. You are included in this study because, according to our records, you participated in tests in which chemical and biological agents were used. The results of the study will help in understanding if there were any long-term effects of those tests on the health of participants. This study is being conducted for the Department of Veterans Affairs by the National Academies, a respected, private, non-governmental research organization.
What will participation involve?
You are being asked to complete the attached questionnaire today. The questionnaire asks about your physical and mental health. The questions are similar to what a doctor or mental health professional might ask you on your first visit. Some questions are related to specific experiences of military service. Filling out the questionnaire will take about 20 minutes.
What are the risks involved in the study?
The data collection procedures are not expected to involve any health risk or discomfort to you. The principal risk for you is problems that could occur if the data you provide were disclosed inappropriately. However, this research group has collected similar information from participants in dozens of studies without any cases of inappropriate disclosure.
How will your data be protected?
All questionnaires will be kept in locked files. When your data are entered into computer files for analysis, your answers will be identified only by a special study identification number known to you and research team members. Your social security number and any other personal identification information will be removed from your questionnaire and data file upon return to the researchers. Even if someone outside the research team broke into the files, it would be impossible for them to identify your data. To minimize the risk of anyone breaking into the data files, those files will be maintained on computers protected by computer security measures. All members of the research team with access to the data files will be trained on computer security procedures specifically designed to protect sensitive data. Reports of the study findings will contain only group data, so that no individual study participant can be identified.
What are the benefits of participating in the study?
Your participation in this study will not directly benefit you; however, your participation will greatly assist us in better understanding the health and health care needs of present and future veterans involved in similar tests.
Will you be provided medical care based on your responses?
No. This is a population-based study and the 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 the appropriate health care personnel.
Do you have to participate?
No, you do not. 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 if you later drop out of the study, you will not lose any rights or benefits to which you are otherwise entitled.
Who can provide additional information if you need it?
Questions about the research (science) aspects of the study, or questions about the ethical aspects of the study, your rights as a volunteer, or any problem related to the protection of research volunteers should be directed to Dr. William F. Page, toll-free telephone number 1-800-556-9896.