POZ Community Forums
Main Forums => Pre-HAART Long-Term Survivors => Topic started by: J.R.E. on December 27, 2011, 07:42:07 am
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So I received a letter last week from the VA. Seems, I've been invited ( As I am sure many vets have) to partake in a research study.
I filled out the 7 page survey the other day and mailed it in. I figured what the heck, I don't mind. Did any of my other fellow vets, get this in the mail?
Here's a little of what it is all about. The next step for me, is waiting for them to contact me, so I can give some blood and meet with those doing the research.
http://www.research.va.gov/mvp/veterans.cfm#1
Overview
The Veterans Affairs (VA) Office of Research and Development is launching the Million Veteran Program (MVP), an important partnership between VA and Veterans. The goal of MVP is to better understand how genes affect health and illness in order to improve health care for Veterans. Participation in MVP is entirely voluntary and will not in any way affect Veterans' access to health care or benefits. MVP has extensive safeguards in-place to ensure information security and patient confidentiality are top priorities. MVP is a research program that could allow current Veterans to help transform health care, not only for themselves, but for future generations of Veterans.
What is the purpose of the Million Veteran Program?
The Veterans Affairs (VA) Research and Development program is launching the Million Veteran Program (MVP), an important partnership between VA and Veterans to learn more about how genes affect health, to improve health care for Veterans. In order to do this, MVP will establish one of the largest databases of genetic, military exposure, lifestyle, and health information. Research findings based on MVP may lead to new ways of preventing and treating illnesses in Veterans. Such findings may help answer questions like "Why does a treatment work well for some Veterans but not for others?"; "Why are some Veterans at a greater risk for developing an illness?"; and "How can we prevent certain illnesses in the first place?" With the expected enrollment of one million Veterans over the next five to seven years, MVP aims to be one of the largest databases of its kind in the United States.
What are genes and how do they affect health?
Genes determine the color of our eyes and hair, our height, and other personal traits. Through interactions with our environment and various lifestyle factors, genes may also contribute to our risk for disease, including common illnesses such as heart disease, diabetes, and cancer. In fact, genes may be a critical part of why some people get diseases and others do not. Genes may also affect how we respond to certain medications. Because of their genetic make-up, some people may respond better than others to a particular treatment, or experience different side effects. Overall, a better understanding of how genes work may help to prevent, and improve treatment of, disease. An increasingly common way to gain knowledge about genes and health is to collect genetic samples and health information from large groups of people, and compare which genes are linked to which health traits.
How does this important research help Veterans?
Veterans—and in fact all Americans—stand to benefit greatly as researchers learn more about the effects of genes on health. Screening, diagnosis, and treatment for some illnesses—such as some forms of cancer—have already been improved through knowledge about the effects of certain genes. MVP will lead to new knowledge about which genes put people at risk for certain diseases, and which ones affect how people respond to treatment. This knowledge may eventually lead to better treatments and preventive measures for many diseases, including common illnesses such as heart disease, diabetes, and cancer.
What does participation involve?
The goal of MVP is to partner with Veterans receiving services in the VA health care system who volunteer to share their health information, as well as genetic material.
Active involvement in this program includes:
Filling out surveys about health and health-related behaviors;
Providing a blood sample (containing DNA and other substances) that will be stored for future research;
Completing an optional health assessment;
Allowing secure access to VA and VA-linked medical and health information, including past and future health records; and
Allowing future contact
Why is it important that so many Veterans participate in the study?
In order to learn about the role of genes, health researchers compare genetic and health information from many thousands of people. With such large amounts of information, researchers are better able to gain valuable knowledge to improve health care.
Are there risks involved in participation?
Any procedure has possible risks. Besides the risks associated with having blood drawn, there is the possibility that filling out the survey may result in distress if participants find out, through their own questioning, about family health conditions they may not have been previously aware of. Family members will NOT be contacted as part of MVP.
If participants choose to have a health assessment as part of their participation in MVP, there are no risks associated with routine measurements such as height, weight, blood pressure, body composition, and grip strength. The lung function test does involve forceful and rapid breathing. Some people may experience shortness of breath or dizziness. Participants will be monitored throughout the procedure.
Will results from my blood tests be forwarded to me?
It will not be possible to give participants results of the blood tests. Due to regulations under the Clinical Laboratory Improvement Ammendments (CLIA), we are legally unable to return research results to participants. Results from the blood tests will not be placed in participants' electronic health record. Participants should discuss any health concerns with their doctor or other health care provider, who can arrange any necessary and appropriate tests.
What will happen to the health information and blood samples that are collected?
Samples and health information will be available to researchers with VA, other federal health agencies, and academic institutions within the U.S. for future research projects approved by appropriate VA oversight committees. Researchers who are approved access to analyze samples and data will not receive the name, address, date of birth, or social security number of participating Veterans.
How will medical records be accessed?
If consent is given to participate, MVP will access health information from VA medical health records as needed and add that information to the VA Central Research Database so that participants' health status and health care can be followed over time. All information will be labeled with a code that does not identify participants directly.
How are the VA researchers who will handle this data being vetted by VA?
VA researchers go through an extensive recruitment process before being hired. Each researcher undergoes a criminal background investigation conducted by the federal government. Researchers are fingerprinted, and other data (such as college degrees earned) must be confirmed before the researcher is hired. Additionally, researchers undergo annual ethics training. They meet regularly with the VA's National Center for Ethics in Health Care.
How will confidentiality and privacy be protected?
The security and confidentiality of data are MVP's top priorities. Researchers will use stringent security measures, including restricted computer and building access. Confidentiality will be protected through a variety of methods. DNA samples and health information will be stored in the VA Central Research Database without name, address, date of birth, and social security numbers. Rather, samples and data will be labeled with a code. Only a few authorized VA staff will have access to the key for the code. It is necessary to keep the key for the code to connect participants with their information and samples in order to track medical records, contact participants again, or destroy the samples if a participant withdraws.
Researchers who are approved access to analyze samples and data will not receive name, address, date of birth, or social security number of participating Veterans.
What is a Certificate of Confidentiality?
To further protect privacy, MVP has applied for a Certificate of Confidentiality from the National Institutes of Health (NIH). With this Certificate, MVP researchers can avoid being forced to disclose information that may identify participants, even by a court subpoena or in any civil, criminal, administrative, legislative, or other proceeding at the federal, state, or local level.
Researchers can rely on the Certificate to deny requests for information that would identify participants, except in the following situation: In the unlikely event of an audit by NIH, personnel with MVP would potentially have to reveal a name, but only to NIH's authorized representatives. The Certificate does not prevent participants or their family members from voluntarily releasing information. The Certificate also does not prevent VA from taking steps, including reporting to authorities, to prevent serious harm to participants or others. The Certificate of Confidentiality is not an endorsement of this research by the Department of Health and Human Services or the NIH.
Will any other organization have access to the results of research conducted through MVP?
Samples and health information will be available to researchers at VA, other federal health agencies, and academic institutions within the U.S. for future research projects approved by appropriate VA oversight committees. Researchers will be granted access to coded samples and data for only those research studies into the causes and treatment of disease that meet all ethical, scientific, and regulatory criteria for approval by VA and other overseeing agencies and institutions. Researchers who are approved access to analyze samples and data will not receive the name, address, date of birth, or social security number of participating Veterans.
What is the Genetic Information Non-discrimination Act (GINA)?
The Genetic Information Non-discrimination Act (GINA) is a federal law that makes it illegal for health insurance companies, group health plans, and most employers to discriminate based on genetic information. This law will protect participants in the following ways:
Health insurance companies and group health plans may not request genetic information obtained from this research.
Health insurance companies and group health plans may not use genetic information obtained from this research when making decisions regarding eligibility or premiums.
Employers with 15 or more employees may not use genetic information obtained from this research when making decisions to hire, promote, or fire a person or when setting the terms of employment.
What is the Genetic Information Non-discrimination Act (GINA) Continued?
All health insurance companies and group health plans were required to follow this law starting May 21, 2010. All employers with 15 or more employees were required to follow the law as of May 21, 2009. Be aware that this federal law does not protect against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance.
What is a biorepository?
A biorepository is a facility that collects, processes, and stores specimens (such as blood, tissue, and other bodily fluids). These specimens are made available to approved investigators for research purposes.
How long will the researchers keep the DNA/blood samples in the biorepository?
Upon receipt, the blood samples will be processed to obtain DNA and other materials that may be stored indefinitely until they are used up for research studies or they are no longer of scientific value. If a Veteran decides to withdraw from MVP and notifies the VA as instructed during the consenting process, the DNA and other samples will be destroyed so that they cannot be used in any further research.
How will the survey completed by participants be stored?
The information will be stored in a secure VA Central Research Database without name, address, date of birth, and social security numbers. Rather, the information will be labeled with a code. Only few authorized VA staff will have access to the key for the code.
Your privacy will be further protected by a Certificate of Confidentiality issued from the National Institutes of Health. With this Certificate, the researchers cannot be forced to disclose information that may identify you, even by a 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 in situations as follows: in the unlikely event of an audit by the government agency that gave us this Certificate, we may have to reveal your name, but only to the agency's authorized representatives.
How long will the data from the surveys and medical records be stored?
The data gathered from MVP will be stored indefinitely and will be used for future medical research.
Contact Information
Whom do I contact for more information about participation in MVP?
For more information about MVP, visit www.research.va.gov/mvp. Or call, toll-free, (866) 441-6075.
Ray 8)
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Ray , unfortunately I'm not a Vietnam Era Veteran my 8 yr. service was (DEC 77 to DEC 85) so, I don't qualify for any VA benefits that I know of, I'm on Medicare and have been on that as well as SSDI for the last 12yrs. Good Luck Ray, if your accepted, it sounds very promising ;)
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I agree, it does sound promising.
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Thanks guys,
I'll update this thread , when I learn more about it, and get contacted !
Ray
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Hey Ray,
It does sound interesting. Keep us posted on how it goes.
HUGS,
Mark
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8)
It looks as though, everything is in motion, for this research study. I received the letter in the mail yesterday, informing me that I have been accepted. My first appointment is March 5th, 12 @ 12:40 pm.
This is the letter I received: ( or at least part of it)
(http://i1047.photobucket.com/albums/b473/exrrje/002-1.jpg)
(http://i1047.photobucket.com/albums/b473/exrrje/001-1.jpg)
This is the 6 page consent form:
(http://i1047.photobucket.com/albums/b473/exrrje/003-1.jpg)
This is the brochure, explaining more about the study:
(http://i1047.photobucket.com/albums/b473/exrrje/004-1.jpg)
(http://i1047.photobucket.com/albums/b473/exrrje/005-1.jpg)
This brochure can also be found here: ( the brochure is a little more detailed)
http://www.research.va.gov/programs/PRIDE/veterans/tri-fold.pdf
All is set to go !!-------Ray 8)
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Ps,
Ed's a little nervous about my involvement with this. He said " I don't want them injecting you with experimental drugs! "
I tried to calm him a little , by stating no one said that this would take place. But I let him know that I am more than comfortable, and at ease getting involved, and doing my part.
Ray
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Good luck ,and if Ed wants to work out his fears it could be good beginning to a movie , who will play who?
Can I please please be the villainous Euro/English Lord with a pack off highly trained Jack Russell assassin dogs, and the ability to perfectly pronounce Russian.
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UPDATE ----3/5/12
In a few minutes, Ed and I will be heading out the door. Today is my appointment, with the research people, down at the VA. The appointment time, is at 12:40.
Wish me luck, I'll tell you all about it later this evening ! 8)
Ray
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:) Well, that was easy enough. We didn't spend more than about thirty minutes there today. The consent form was about 8 pages, and I can opt out at any time. Both Ed and myself asked quite a few questions.
We met with the research coordinator, she explained that they would be taking one blood sample, to analyze for DNA , and store in their database.
There is nothing additional that I have to do at this point. Confidentiality was assured. ( Not that I am concerned about that anyway)
I will not be a guinea pig, and won't be testing anything, :P the blood sample will be used to research different diseases, and similarities in medical backgrounds.
She informed me that so far, they have over 30,000 vets enrolled, and their projection is to have 1,000,000 vets enrolled in the next 5 -7 years.
Oh, and they gave me a pin for enrolling: 8) Hopefully they will find some good use, from my blood ! One more thing, the pin was made in China ! >:(
(http://i1047.photobucket.com/albums/b473/exrrje/HPIM0809.jpg)
Ray
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:o Now I got to try to get about 4 hours of sleep, before going into work tonight!!
Ray---- Nighty-nite ! :)
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Ray, you are a inspiration, and your DNA will be used to fight many diseases, and could possibly help cure many, thanks for sharing this info with us all ;) now get some rest, so you can go to work tonight :)