These questions and answers are meant for educational purposes only. This information is provided by the NJ-WRIISC and is not intended to replace the medical advice of your doctor or health care provider. Please consult your health care provider for advice about a specific medical condition.
Frequently Asked Questions and Answers
Medically Unexplained Symptoms (MUS) related questions
Mental Health and Stress Management related questions
Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) specific questions
General Health related questions
Medically Unexplained Symptoms
What are Medically Unexplained Physical Symptoms?
If you have been told by a doctor that your symptoms are medically unexplained, it means that a medical cause for your symptoms can not be identified. Having unexplained symptoms can be frustrating and confusing, but it is not uncommon.
It is important to keep in mind that almost all life threatening diseases would become apparent after a physician completes a careful history, exam and testing. So while having unexplained symptoms is distressing, you are unlikely to have a life threatening disease and there are a number of things that can be done to improve your symptoms and quality of life.
Chronic Fatigue Syndrome (CFS), Irritable Bowel Syndrome (IBS) and Fibromyalgia (FM) are among the most common medically unexplained illnesses.
What is Chronic Fatigue Syndrome?
Chronic Fatigue Syndrome (CFS) is a label given to people with unexplained severe fatigue and other symptoms including achiness, sore throat, unrefreshing sleep and cognitive problems. Treatment of CFS includes cognitive behavioral therapy which involves increasing physical activity and managing pain.
Patients with CFS often experience both good periods and some bad periods. On the positive side, clinical experience shows that with appropriate treatment, some patients improve. If you have fatigue, you should know what your normal range is. If symptoms get much worse, you should talk about them with your primary care doctor.
For more information on CFS, please click here.
What is Irritable Bowel Syndrome?
Irritable bowel syndrome (IBS) is a disorder that interferes with the normal functions of the large intestine. It is defined by a group of symptoms which include abdominal pain, bloating, constipation, and diarrhea. IBS causes discomfort, but it does not permanently harm the intestines and does not lead to intestinal bleeding or to any serious disease such as cancer. Most people can control their symptoms with diet, stress management, and medications prescribed by their physician.
For more information on Irritable Bowel Syndrome, please click here.
What is Fibromyalgia?
Fibromyalgia is characterized by fatigue, diffuse pain and/or stiffness, and multiple areas of the body that are tender following relatively mild pressure. Diagnosis is based on subjective complaint of widespread pain persisting for greater than three months in addition to a positive tender point examination. Fibromyalgia (FM) is a common ailment affecting approximately 5% of the population affecting women more often than men.
Like chronic fatigue syndrome, patients will often experience both good periods and some bad periods. Treatment is generally focused on improving sleep and reducing pain. Graded exercise, which involves gradually increasing aerobic activity such as walking or biking, is recommended for this condition and has been shown to improve symptoms for both fibromyalgia and chronic fatigue.
For more information on Fibromyalgia, please click here.
Please click here for WRIISC fact sheet on graded exercise.
I've been feeling fatigued and suffering from memory loss since I left the military service. My doctor can't seem to find what is wrong with me. Could I have a medically unexplained illness?
Fatigue is a feeling of extreme tiredness or weakness, making it difficult for you to go about your normal routine, and can be caused by not getting enough sleep, chronic disease or side effects of certain medications, or perhaps even stress or anxiety. If you've gone to your doctor to discuss your symptoms and had a thorough physical exam and it is still unknown what is going on with you, you may be experiencing medically unexplained physical symptoms. Having medically unexplained physical symptoms is not that uncommon. And the good news is that by having had a work up by your doctor, most life-threatening diseases were probably ruled out. Our War-Related Illness and Injury Study Center may be able to fully evaluate you to determine possible cause.
What type of research is being done on unexplained medical symptoms related to veterans?
Research being conducted at the WRIISC falls in three areas: 1) physiology of unexplained illness, including sleep, pain, stress and balance, 2) perception of symptoms, both by patients and by providers, and 3) health services and systems and how well they deal with unexplained illnesses.
For more information on current research studies at WRIISC, please click here.
Mental Health and Stress Management
What is post-traumatic stress disorder (PTSD) and how many Vietnam veterans suffer from this illness?
Posttraumatic Stress Disorder, or PTSD, is the name given to a set of symptoms that sometimes occur in people after they experience life-threatening events such as military combat, natural disasters, terrorist incidents, serious accidents, or violent personal assaults like rape or other sexual assault. After tragic and threatening events like these it is normal to feel upset, sad, and anxious. Most people have symptoms like these after experiencing a traumatic event and for many people these symptoms go away by themselves within a few weeks or months. For others, these symptoms continue and interfere with their daily work, family, and social life. That's often when people look for help from their doctor and are diagnosed with PTSD. Some of the symptoms of PTSD include difficulty sleeping, feeling detached or distanced from family and friends, reliving experiences through nightmares or unwanted thoughts and images of the traumatic event/s.
People with PTSD sometimes also have related disorders such as depression, substance abuse, memory or concentration problems, and physical symptoms such as gastrointestinal problems or headaches. Taken together, all of these problems can result in a decrease in the person's ability to function in social or family life including occupational instability, marital or relationship problems and divorces, family discord, and difficulties in parenting.
Community studies estimate that about 5% of men and 10% of women meet diagnostic definitions of PTSD at some point in their lifetime. In contrast, about 30% of Vietnam veterans (mostly men) had enough symptoms to be diagnosed with PTSD at some point in their lives, and another 20% did not meet full diagnostic criteria but had significant symptoms of distress after trauma. For some of these veterans these problems persist. Approximately 15% of those veterans who experienced PTSD symptoms had long-term problems (or about 7.5% of all the veterans in the study).
Among Persian Gulf veterans who experienced combat, approximately 10% have been diagnosed with PTSD. Follow-up studies of these vets found that National Reserve and Guard units had higher levels of symptoms than Active duty personnel and rates among female veterans were higher than for men. Estimates of PTSD among veterans who are currently returning from Operation Iraqi Freedom and Operation Enduring Freedom (in Iraq and Afghanistan, respectively) are about 15%.
For more information on PTSD, please click here.
My doctor told me that my illnesses are "all in my head" and that is why I am sick. Is it possible that a mental illness is the cause of my physical illness?
Causes for physical illness are sometimes not easy to determine - even for the most highly trained physicians. Part of the complexity comes from the fact that our physical and emotional health are interrelated - in other words, they affect one another rather than functioning separately. There are several ways that negative psychological states such as depression and anxiety affect your physical health (even if they are severe enough to be considered a "mental illness"). Constant anxiety and worry can lead to a variety of physical changes such as muscle tension and aching, grinding teeth and jaw pain, stomach problems, and tension headaches. When anxious, some people feel that their heart is beating too fast, experience chest pain, or find that they have difficulty catching their breath. Other people have difficulty sleeping and so are tired during the day and feel "run down." You might hear people say that someone was "worried sick" about something - this common phrase captures the phenomenon of becoming physically unwell because of excessive anxiety or worry. Depression can also result in lack of energy, difficulty sleeping and general feelings of malaise. People with depression may neglect to take care of their bodies and do such things as not eating well, smoking more, and drinking alcohol excessively. In extreme cases, depressed individuals might have thoughts of hurting themselves and inflict physical injury on themselves. In these latter examples it is easier to accept that the behaviors associated with psychological distress might have "caused" the physical illness - lung disease from smoking, diabetes from over-eating, etc. In most cases, however, the picture is quite complicated with the physical and psychological health intertwined. The effects of anxiety and depression are even seen in patients with widely accepted "real" diseases such as cancer. Higher levels of distress are associated with poorer immune functioning in a variety of disorders.
If you are having physical symptoms and are also feeling more worried, anxious, or depressed than you would like, referral to a psychologist or other mental health professional may be helpful for you. Ideally, your physician and psychologist will collaborate to alleviate your symptoms as much as possible to improve both you physical and emotional health.
My physician suggested I do cognitive behavioral therapy (CBT) to help with my illness. What is CBT and how does it work?
Cognitive Behavioral Therapy (CBT) is a form of psychotherapy used to treat many psychiatric disorders such as PTSD, Depression, and Anxiety. CBT is often used to help people who are experiencing physical symptoms (for example, pain management). As its name suggests, this form of therapy has a cognitive (thinking) and behavioral component. The cognitive portion will help you identify and change thinking patterns that can lead to intensification of symptoms. For example, imagine that your heart begins to beat faster. If you think, "I'm having a heart attack" then you are likely to become anxious, causing a further increase in your heart rate and maybe you would go to an emergency room. However, if you think, "I walked up the stairs too fast" then you will probably assume that your heart rate will return to normal and you will continue your day. We all make mistakes in our thinking at times. An example might be if I jumped to the conclusion that I probably have a brain tumor because I've had headaches recently. This thought would likely lead to unnecessary worrying about my health. CBT can help by identifying the kind of thoughts that are upsetting us and teaching us to change those maladaptive thinking patterns. Together with targeting these thoughts, the behavioral part of CBT will help you take actions that will get the results you desire. For example, you could be taught a relaxation technique to help you reduce your anxiety.
When people hear that CBT is psychotherapy, they sometimes imagine that they will be lying on a couch, talking about their childhood, and the doctor will simply nod and take notes. Do not expect that! CBT is an active form of therapy and will require you to engage with your therapist in problem-solving about current issues and problems. It is a structured approach to treatment and you and your therapist will set goals for you to make sure that you are making improvements in your life. If you try therapy and do not think you are making progress, rather than saying "therapy doesn't work" you would be better to look for a different therapist.
My post-traumatic stress disorder (PTSD) and depression are beginning to affect my family, friends, and social life. What can we (myself, family, and friends) do to cope with my illness?
You should seek a therapist who specializes in PTSD and can help you cope with your symptoms. Your therapist can help you to understand and explain your illness to your loved ones as well as provide treatments that will improve your symptoms. Research has shown that PTSD and depression can both be treated in individual treatment (one-on-one with a therapist) and sometimes in groups of people who have had similar experiences. While family and friends may be concerned about you, ultimately you are the only person who can make the decision to seek help for yourself.
For more information on PTSD, please click here.
For more information on Depression, please click here.
My post-traumatic stress disorder (PTSD) and depression are beginning to affect my family, friends, and social life. What can we (myself, family, and friends) do to cope with my illness?
You should seek a therapist who specializes in PTSD and can help you cope with your symptoms. Your therapist can help you to understand and explain your illness to your loved ones as well as provide treatments that will improve your symptoms. Research has shown that PTSD and depression can both be treated in individual treatment (one-on-one with a therapist) and sometimes in groups of people who have had similar experiences. While family and friends may be concerned about you, ultimately you are the only person who can make the decision to seek help for yourself.
For more information on PTSD, please click here.
At what point should someone seek medical attention for a mental illness?
Someone should seek treatment whenever they feel up set by their thoughts, behavior or emotions and/or when they are having problems performing normal tasks at home, work, school or in other areas. If you notice these changes, you can ask your primary care doctor to provide you with a referral. Sometimes people who are close to you may notice a problem before you do. If other people (family, friends) tell you that your behavior is changing or suggest that you may have a problem, you should consider seeing your doctor and asking him or her to refer you to a psychologist.
Have studies been done on the effect Post-Traumatic Stress Disorder (PTSD) has on heart disease, diabetes and hypothyroidism?
There are very few studies on PTSD and its specific effects on development of other diseases. Schnurr (2000) looked at combat veterans of WWII and Korea and found an increase in arterial, lower gastrointestinal, dermatologic and musculoskeletal factors in those who were diagnosed with PTSD, but the PTSD diagnosis was made many years after the conflict.
The body's reaction to stress is controlled by complex systems. In particular, when the sympathetic-adrenal system and the hypothalamus - pituitary - adrenal system are disturbed by chronic stress, they contribute to the development of a number of diseases including hypertension, atherosclerosis, and insulin resistance/ abnormal blood lipids.
For more information on PTSD, please click here.
Have links been established (cause and effect) between PTSD and disease?
Diseases take many years to develop and can come from a number of causes. This makes it very difficult to establish a cause and effect link with any specific factor such as PTSD. One of the biggest difficulties in establishing cause and effect relationships is that most studies do not look at people before they are exposed to the event which may have resulted in the PTSD. Since many people exposed to stress do NOT develop PTSD, researchers now are looking to see whether those who develop PTSD may have some underlying difference in the way they react to stress, compared to those who do not develop PTSD. This underlying difference, rather than the PTSD itself, may be what contributes to the development of other medical conditions. True cause and effect studies require measurement of the subject before they are exposed to the specific condition of interest, and also require a control population, that is subjects who are NOT exposed. Researchers are only just beginning these kinds of studies, which can take many years. This can be frustrating both to the patient and to their doctor, who must make treatment decisions based on studies, which are not as definitive as we would like.
For more information on PTSD, please click here.
Exposure
Is there a link between exposure to sarin gas and brain cancer?
Because of the concern over exposure to sarin gas, the Veterans Health Administration asked the Institute of Medicine (IOM) to conduct a literature review about the long-term health effects of chemical agents that Gulf War veterans may have been exposed to. This 2004 report and a congressionally mandated report in the year 2000 revealed there was no scientific evidence of any health effects following exposures at levels that failed to cause symptoms at the time of exposure.
A recent research study by Bullman et al (2005) revealed that there is a possible link between brain cancer and sarin. This study suggested that there was a higher incidence of brain cancer and death as a result of brain cancer in Gulf War Veterans thought to be exposed to low levels of chemical warfare nerve agents during March 2001 weapons demolitions at Khamisiyah, Iraq based on computer modeled exposure estimates by the Department of Defense (DoD). Other scientists have noted there were several limitations to the study. Additional research is required to confirm these findings.
For more information on Exposure, please click here.
Does exposure to Depleted Uranium pose health concerns for veterans?
Uranium is a metal that occurs naturally in the earth's crust and is found in air, water, soil and food. It is a weakly radioactive substance. Depleted Uranium (DU) is what is left over after Uranium is processed. DU has most of its radioactivity taken out during processing. DU is 40% less radioactive than natural uranium. Because of its density and low cost, DU is used by the U.S. to make armor on tanks and other supplies stronger. DU is the best metal to use in armor to protect service men and women. The first time DU was used by the US on a large scale was during the Persian Gulf War in the early 1990's.
DU cannot cause harm as long as it stays out of the body. Just being in the area of tanks or supplies made with DU will not result in exposure. Exposure to DU is the highest for service members who are near fires or explosions involving DU munitions or supplies. If DU shrapnel enters the body, it could remain in the body. DU particles can also be inhaled and taken into the body through smoke from burning DU-armored vehicles or exploded DU munitions. Current research shows that most service men and women who work with DU will not have harmful health effects. However, veterans have still had concerns about the possible effects of exposure. In part, it is often not clear whether or how much exposure a person may have had. In general, most services members have not taken enough DU into their bodies to need testing. It is important to remember that just being in the vicinity of tanks or munitions that have DU does not mean you were exposed.
It is still important to talk about any concerns you might have about exposure to DU with your primary care provider. He or she can look at the type and length of your exposure to DU and the chance that you might still carry DU in your body. You can work as a team to see if any follow up is appropriate.
Please click here for WRIISC fact sheet on DU.
For more information on Exposure, please click here.
I have been taking medication for numbness, tingling, and pain in both arms and legs since Vietnam; I also have Agent Orange Exposure. Can this be linked with peripheral neuropathy?
These symptoms are clearly consistent with the diagnosis of peripheral neuropathy but definitive diagnosis requires laboratory testing. A relationship between Agent Orange exposure and development of peripheral neuropathy is not known.
For more information on Exposure, please click here.
What types of medical problems are being reported due to Agent Orange?
Many people have questions regarding the health effects associated with exposure to Agent Orange. Reports of health problems are based on an individual going to a health care provider and reporting specific concerns.
Problems that were reported within 1-2 years of contact with Agent Orange included skin conditions (diagnosed as chloracne and porphyria cutanea tarda) and neuropathy (nerve damage- tingling, burning, or numbness in the limbs, hands and feet). There is also significant evidence that the following conditions may be due to previous exposure: several types of cancer (including non-Hodgkin's lymphoma, soft tissue sarcoma, Hodgkin's disease, multiple myeloma, and respiratory cancers) and type 2 diabetes mellitus. Some evidence also exists that exposure to Agent Orange may increase the risk of having a child with a congenital birth defect called spina bifida. Unfortunately, there are no good data to determine how much contact with Agent Orange was required to increase the risk of the health conditions mentioned above.
A number of scientific review panels have examined the evidence and are convinced of a true association between Agent Orange and the skin conditions, neuropathy, the specific cancers, diabetes and spina bifida. Numerous other conditions have also been examined as possibly due to exposure to Agent Orange, such as prostate cancer, but there is no evidence to date that indicates a link between Agent Orange and prostate cancer or any other conditions.
If you or a loved one is experiencing any symptoms that are severe enough to worry you, it is important to see your regular health care provider and discuss these symptoms. It is also important to explain your concerns about the possible role of Agent Orange as a cause of those symptoms.
For more information, please see the Agent Orange General Information brochure (PDF file, save as... to download)
For more information on Exposure, please click here.
Gulf War
What types of medical problems are Persian Gulf veterans reporting?
A wide range of symptoms is being reported by Persian Gulf veterans since returning from the Persian Gulf. The most frequently reported symptoms are fatigue, muscle & joint pain, headache, difficulty concentrating, shortness of breath and skin rashes.
What are the possible causes for the medical problems veterans are reporting?
Troops may have been exposed to a variety of potentially harmful situations and/or substances during Operation Desert Shield/Storm. A list of some of these follows. Exposure to one or more of these factors could be responsible for the symptoms of the Gulf War veteran.
Veterans serving in Operation Desert Shield/Storm may have been exposed to Pyridostigmine Bromide, a medication used to counteract the effects of possible nerve gas attacks; pesticides that were used to control sand flies & scorpions; depleted uranium used to battle harden munitions; smoke from oil well fires and diesel fumes; nerve gas agent. These exposures are known to have health effects when the level of exposure is high enough. With regard to gulf war syndrome, however, there are a number of veterans who report symptoms but did not have significant exposure to any of these agents. Also, veterans of other conflicts, such as Bosnia, report similar unexplained symptoms.
One common denominator to the Gulf, Bosnia, and other combat zones is stress. Stress is known to make medical illness worse. For example, patients with diabetes or high blood pressure often need to have their medications adjusted when they are in stressful conditions. Stress also turns on bodily systems that can disturb sleep and lead to symptoms such as upset stomach and pain. If stress is found to play a role in your symptoms, the good news is that there are ways to help you reduce your stress "barometer."
Operation Enduring Freedom/Operation Iraqi Freedom
What kinds of problems are veteran's returning from Iraq and Afghanistan reporting?
Preliminary results of the health care needs for returning veterans from Iraq and Afghanistan show that about 20% have received care at a VA facility since coming home. The most frequent diagnosis documented concerns problems of the musculoskeletal system such as sprains and back pain. Other major diagnoses include gastrointestinal problems and possible mental disorders, such as readjustment distress and Post Traumatic Stress Syndrome (Kang & Hyams (2005). Mental health care needs among recent war veterans. New England Journal of Medicine. 352(13), 1289.
What types of health concerns do women veterans OIF/OEF experience?
Thus far, female veterans returning from Iraq and Afghanistan report a variety of concerns. The most frequent presenting problems documented for female soldiers are of the musculoskeletal system. The musculoskeletal problems generally cause pain and limit activity. Other top physical concerns involve the gastrointestinal system and genitourinary system, such as problems with diarrhea, constipation and menstruation. Common mental health concerns involve adjustment disorder, PTSD and depressive symptoms.
General Health
Do I really need a primary care doctor?
A primary care provider is more than just your regular doctor. A primary care doctor can help put together all of your health information, make recommendations that are in your best interest and guide you in making decisions about your own healthcare. Having a primary care doctor that you trust and feel comfortable with is essential to overall health. It is also important that individuals take an active role in their healthcare and assist their primary care provider in providing the best care that leads to the best possible health outcomes. Working as a team is important, so that both you and your doctor are on the same page. There are things that individuals can do to take charge of their healthcare. These things include:
- Practicing strategies to improve patient physician communication (For more information click here for the WRIISC fact sheet on Talking to your doctor).
- Keeping a personal copy of medical records that includes visits with specialists.
- Keeping an up to date list of medications, including over the counter medications.
Could my health problems be due to all the vaccinations I was given before being deployed?
Military personnel often receive several vaccinations as they prepare for deployment. Some vaccinations are given routinely while other vaccinations are given to protect against diseases when going to high risk areas. Vaccines are designed to trick the body's immune system into thinking it is under attack. The system develops a protective response which it then remembers if the body ever truly comes under attack by the same or a closely related organism (virus, bacteria). That is why children get so many vaccinations, as do travelers to exotic places. Boosters are often used to increase the level of the recalled response. The effectiveness of the process is why vaccination is such a commonly used method to prevent serious diseases.
Some military personnel have concerns that getting multiple vaccinations may cause health problems. This is also a concern among several members of the general public. For example, some parents of infants are concerned that getting multiple vaccinations may overload their child's developing immune system. Recently, an Institute of Medicine committee (IOM) critically examined this issue and concluded that vaccination with multiple vaccines did not increase the risk of getting certain diseases or infections in children. IOM's report
As of the time this is being written, there are no studies that show that multiple vaccinations have resulted in any type of illness or symptom in service members. One of the handicaps in studying the issue is the lack of detailed information about which member received which vaccines in what time sequence. The IOM committee did acknowledge that more research is needed. For example, studies are needed to identify if certain individuals have a genetic susceptibility to adverse effects from vaccinations. The Department of Defense created the National Vaccine Healthcare Center to address growing concerns about the safety of vaccinations. This site is a resource for people with health concerns regarding immunizations in the military healthcare system/Tricare.
Exercise
I have multiple symptoms including fatigue and memory loss. Why does my healthcare provider want me to start an exercise plan?
Persons with fatigue find it difficult to do many types of strenuous activities, especially at times when their fatigue is highest. As a result, they tend to do less and less. As they become less physically active, they get out of shape. Moderate activities that formerly were not fatiguing become difficult once they are out of shape. Hence they feel as though their fatigue is increasing, when actually it is mostly just an increased muscle weakness and general loss of conditioning.
Regardless of whether your fatigue is due to lack of activity or due to some underlying disease, there is some benefit to have a stronger heart and muscles. Therefore your health provider will recommend an exercise plan - often this kind of plan is really no different from that which would be recommended for any person your age.
How do I know what type of exercise plan is right for me?
The kinds of programs are so numerous that it can be very confusing and difficult to choose. The first thing to consider is whether you like that type of exercise, have the equipment or can find a place that has the required equipment, and have the time it takes. If you don't actually do the exercise, it's certainly not the right program for you.
The second factor is whether you need specific exercises (for example, to strengthen your lower back). Your health care provider can advise you if you have special problem areas. People often see physicians who are specialists in physical medicine or in orthopedics, or see a physical therapist to get this advice.
Whatever exercise program you choose, it is a good idea to have a person knowledgeable in exercise actually observe you doing all of your exercises. If you are not doing some of the exercises properly, they will not be as beneficial to you and could even be causing harm.
Finally, if the program is right for you, you will notice some changes for the better. If you set a target performance, you should be able to see progress toward that goal. Some people find it helpful to actually chart their performance so they can watch it rise.
I am always tired and I have pain in my muscles. My doctor tells me I need to exercise but the pain is preventing me from starting an exercise plan, what can I do?
First, your doctor has probably recommended exercise for you because pain and fatigue are common complaints that can be improved by exercise. Recent studies have shown that a gradual and progressive exercise program that lasts for a couple of months improves symptoms of pain and fatigue. The problem you described is a common one, many individuals find that one single bout of exercise is very tiring and painful and often results in feeling worse the following day/s. In your case, you may have to work with your doctor first to get your pain to a manageable level before attempting an exercise program. However, it is important to understand that even very short and light activities such as walking for 5 minutes can be considered exercise for someone suffering from pain and fatigue. Therefore, if you can tolerate it, you might want to try and start out with a small amount of activity (for example: walk around the block) and gradually increase the amount of activity when appropriate. Finally, it is important to remember that even if your symptoms don't immediately improve with exercise they should in the long run. In addition, you are receiving many other important health benefits such as a healthier heart and a decreased risk for the development of several diseases.
Benefits
What resources are available to veterans who are looking for information about benefits?
For more information on benefits, please click here.
Research
What is a research study?
A research study is an organized activity to learn more about a problem or answer questions. Many different kinds of studies are conducted. For example, a study may test if a product, such as a drug or equipment, is safe and effective. A study may be done to find out what health care practices work best. A study may be done to determine the best way to treat an illness, or how to prevent an illness. A study may use a survey or an interview to understand health needs, problems, or feelings people have about an illness or their general health.
What is a clinical trial?
A clinical trial is a specific type of medical research study where people try to determine whether medicines, new therapies or new devices are safe and effective. In clinical trials, drugs or treatments are often compared with placebos to check the effectiveness of that drug or treatment. A placebo is an inactive substance which may resemble an active substance. However, it typically has no value to treat or prevent an illness.
Why should I volunteer for a study?
There are many reasons to participate in research. You may want to:
- Help find a cure for illness
- Help other people who are sick
- Help find ways to provide better care
- Help scientists find out more about how the human body and mind work
- Take part in a study that is trying to find a better treatment for a condition that you have
If you decide to take part in a research study, it is important to remember that you do so as a VOLUNTEER. That means YOU decide whether or not you will take part. If you choose to do so, you have many important rights that will be explained to you as part of what is referred to as the informed consent process before you participate in any study.
What is informed consent?
Informed consent is the process of learning the key facts about a research study before you decide whether or not to volunteer. Your agreement to volunteer should be based upon a clear understanding of what will take place in the study and how it might affect you. Informed consent begins when research staff explains the facts to you about the research study.
The research staff will help you with the "informed consent form" that goes over these facts so you can decide whether or not you want to take part in the study. These facts include details about the study, tests or procedures you may receive, the benefits and risks that could result, and your rights as a research volunteer.
Are there benefits to being in a research study?
There may or may not be a direct benefit to you if you take part in a research study. For example, depending on the type of study it is, your health or a health condition you have may get better as a result of your participation in the study, it may stay the same, or it may get worse. No one can completely predict the outcome of a research study or how it might affect you. A study may not help you personally, but your participation in a study may result in information that will help others in the future.
Are there risks or side effects in a research study?
Sometimes research procedures and drugs may cause discomfort and/or side effects. The questions being asked could make you uncomfortable. The risks and side effects of the research may not be known completely when you start the study. The research staff will discuss with you known possible risks so you can decide if you want to volunteer. If you do volunteer, the research staff will tell you about any new risk that they learn about during the study for as long as you participate in the study.
What questions should I ask before I agree to take part in a research study?
Before you decide to volunteer to take part in research study, you need to know as much as possible about the research study. If there are any issues that concern you, be sure to ask questions. You might want to write your questions down in advance. The following are some questions you may want to ask. Not every question will apply to every study.
- Who is doing this study and what question might it answer?
- Who is doing this study and what question might it answer?
- Will this research help in understanding my condition?
- What tests or procedures will be done?
- Is it possible that I will receive a placebo (inactive substance)?
- Will I have to make extra trips to VA?
- What could happen to me, good and bad, if I take part in the study?
- How long will this study last?
- What will happen to any specimens that I give?
- Who has reviewed and approved the study?
- Could my condition get worse during the study? What will happen if it does?
- What other options or choices do I have if I decide not to take part in this study?
- Who will be in charge of my care? Will I be able to continue seeing my own doctor?
- Will I be charged anything or paid anything to be in study?
- Will I be paid anything to participate or be reimbursed?
- If I decide to participate in the study, how will it affect my daily life?
- What will happen to me at the end of study?
- Will I be told the results of the study?
- Who will find out that I am taking part in this study?
- How do I end my participation in this study if I change my mind?
- Whom do I contact for questions and information about the study?
- If I don't participate will it affect my care?
Remember, if you do not understand the answer to one of your questions, ask the question again and ask the person to explain the answer in a way you can understand it. If you forget the answers to the questions during the study, just ask them again.
Who will answer my questions about the informed consent form?
You should take your time when you read the consent form. If you have any questions, ask the research staff. If you don't understand something, ask them to explain it to you so that you can understand. You can take the information home with you and discuss it with your family, friends, a health care provider, or others before you decide whether or not to take part in the study.
If you decide to take part in the study, you will be asked to sign the informed consent form. However, the informed consent process is more than just signing a piece of paper. It is a process that goes on throughout the study. During the course of the study, you may be told of new findings, benefits or risks. At that time, you can decide whether or not to continue your participation in the study. You may change your mind and leave the study before it starts or leave at any time during the study or the follow-up period. The researcher should also ask you questions to be sure that you have understood everything.
What is IRB?
The Institutional Review Board (IRB) is a group of people such as doctors, nurses, pharmacists, scientists, ethicists, and people from the local community who ensure that human research is well-planned and ethical.
The IRB of this center serves to protect your rights and your welfare before and during the research study. For example, the IRB makes sure that any risks in the research study are as small as possible. The IRB does not make decisions for you. The IRB decides, when approving research studies, that it is reasonable to ask people whether they want to be involved in it. The IRB also reviews each study while it is going on to make sure volunteers are protected. A project must receive IRB approval before beginning and the IRB will monitor the progress of the study as well.
In the VA, there is another committee called the Research and Development (R&D) Committee. This committee reviews the work and recommendation of the IRB and must also approve research before you can be asked to take part in a study. This is the VA way of assuring YOU that any study you are asked to take part in has been thoroughly reviewed.
Who will see my records?
Like your medical record, the information in your research record will be confidential. Information will be given only to the researchers who carry out the study or who make sure that the study is safe and carried out the way it was planned. The groups of individuals who might look at your records are the research staff, the Institutional Review Board (IRB), the company or group funding the study, and various government oversight agencies. It is important for these groups to be able to look at your records so that they can ensure that the study is conducted using acceptable research practices. However, in this case, no data collected as part of the study will be put into your medical record, only the fact that you have participated.
How can I participate in research?
There are typically several studies going on in the WRIISC at any one time. On the research section of this website, you can check for studies that interest you. You can also call or e-mail us to get information on any of the studies for which we are currently recruiting volunteers. You can contact us at: 973-676-1000 * 1-2500.
Will I be compensated for my time as a research volunteer?
Each study provides different compensation for research volunteers. Some studies pay money for your time and effort, other studies may offer free treatment, yet others may offer small inducements such as a lottery ticket, refreshments, or information about your health status that may be useful to you. Finally, some studies may not offer any compensation. The researchers will be sure to indicate what the compensation is as part of the informed consent process.
Who do I contact about volunteering in a research study?
You can call or e-mail us to get information on any of the studies for which we are currently recruiting volunteers. You can contact us at: 973-676-1000 * 1-2500.
How do I find out about studies currently recruiting volunteers?
There are typically several studies going on in the WRIISC at any one time. On the research section of this website, you can check for studies that interest you.