What to Know Before Participating in a NW MIRECC Research Study

What to Know Before Participating in a NW MIRECC Research Study

The U.S. Department of Veterans Affairs (VA) ranks as one of the nation's leaders in health research. Every year, thousands of research studies are conducted at VA medical centers, outpatient clinics, and nursing homes. NW MIRECC conducts research that seeks new ways to diagnose, treat, and prevent the following conditions in Veterans;

• Post-Traumatic Stress Disorder (PTSD)
• Mild Traumatic Brain Injury (mTBI), which is also called a concussion
• Chronic pain (post-concussive headaches) or other conditions that might start after an mTBI
• Gulf War Illness
• Drug abuse and dependence
• Dementia and neurodegeneration, including mild cognitive impairment (MCI) and Alzheimer’s disease (AD)
• Pandemic stress

Research studies may feature the following kinds of activities;

• Questionnaires, interviews, or assessments of physical and mental health
• Blood draws
• Talk therapies, which may include psychotherapy or cognitive rehabilitation interventions
• Tests that measure eye responses to light
• Lumbar punctures, which are used to obtain cerebrospinal fluid (CSF) and which have been safely performed in the NW MIRECC for more than two decades
• Scans of the brain, including diffusion tensor imaging (DTI), magnetic resonance imaging (MRI, fcMRI, or fMRI), and positron emission tomography (PET or FDG-PET) 
• Prescriptions for prazosin, a medication that may be useful for a number of conditions
• Wearing wristwatches or other devices that track physical activity or sleep patterns

VA Research Contributions

These research studies have significantly contributed to advancements in our understanding of medical problems and that have led to health improvements for Veterans and civilians alike. For example, the VA has:

• Developed artificial limbs that allow amputees to have more independence and better quality of life
• Invented the cardiac pacemaker
• Performed the first successful liver transplantation
• Developed the nicotine patch to help people stop smoking
• Played a major role in the development of the CT/CAT scan to view the inside of the body
• Tested new drugs and treatments for diseases such as AIDS, Diabetes, Alzheimer's and Osteoporosis

None of the advances in health care would be possible without individuals like you volunteering to participate in research studies.

What is a research study?

A research study is an organized activity to learn more about a problem or answer questions. 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. Another type of research study is a clinical trial. A clinical trial is a medical study with people that will 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 volunteer to participate in a research study?

There are many reasons to volunteer to participate in a research study. They include:

• to help find a cure for an illness
• to help other people who are sick
• to help find ways to provide better care
• to help scientists find out more about how the human body and mind work
• to 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, 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.

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 risks that they learn about during the study for as long as you participate in the study.

Before you decide to volunteer to take part in a 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 a list of questions. Not every question will apply to every study.

• Will I be told the results of the study?
• How do I end my participating in this study if I change my mind?
• Who will find out that I am taking part in this study?
• Whom do I contact for questions and information about this study?
• What will happen to any specimens that I give?
• Who is doing this study and what questions might it answer?
• Will this research help in understanding my condition? If so, how?
• What tests or procedures will be done?
• Will I have to make extra trips to the VA?
• What could happen to me, good and bad, if I take part in the study?
• How long will this study last?
• Who has reviewed and approved this study?
• Could my condition get worse during the study? What will happen if it does?
• Is it possible that I will receive a placebo (inactive substance)?
• What other options or choices do I have if I decide not to take part in this study?
• Who will be in charge or my care?
• Will I be able to continue to see my own doctor?
• Will I be charged anything or paid anything to be in this study?
• If I decide to participate in this study, how will it affect my daily life?
• What will happen to me at the end of the study?

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. If you forget the answers to the questions during the study, just ask them again.

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, your health or a health condition you have may get beter as a result of your participation in the study, it may stay the same, or it may even get worse. No one can completely predict the outcome of a research study or how it might affect you. The study may not help you personally, but your participation in the study may result in information that will help others in the future.

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 the research staff explains the facts to you about the research 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. The research staff will assist you with the "informed consent form" so you can decide whether or not you want to take part in the study.

You should take your time when you read the consent form. If you have any questions, ask the research staff. If you do not understand something, ask them to explain it in a way that would be more meaningful to you. If English is not your first language, you can ask for an interpreter to be present when you are discussing the study with the research staff. The written and verbal informed consent information will be given to you in a language that you know. You can take the information home with you and discuss it with your family, friends, 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.

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 to those 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 they can ensure that the study is conducted using acceptable research practices.

About the Institutional Review Board or IRB

The Institutional Review Board (IRB) is a group of people such as doctors, nurses, pharmacists, scientists, ethicists, and people from local community who ensure that human research is well-planned and ethical.

The IRB of this medical 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 a decision 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.

In the VA, there is another committee called the Research and Development (R&D) Committee. This committee reviews the work and recommendations of the IRB and must also approve the research before you can be asked to take part in a study. This the VA’s way of assuring YOU that any study you are asked to participate in has been thoroughly reviewed.

What if I do not want to participate in a research study?

Your participation in a research study is a strictly voluntary. You have the right to say “no.” Your decision to not participate will not affect your VA health care or other benefits.

Before you decide to participate, remember:

• Weigh both the risks and benefits of the research study
• It may be helpful to speak with your family members, friends, or health care providers
• If you decide to volunteer for a research study, you can change your mind and stop or leave the study at any time without losing any of your VA health care or other benefits.

For information about specific research, please contact the number listed on the research study.

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