Serving Veterans Through Integrity and Accountability in VA 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 research 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 trail is a specific type of medical research study that tries to determine whether medicines, new therapies or new devices are safe and effective when used. In clinical trials, drugs or treatments are often compared with placebos (see definition below) to check the effectiveness of that drug or treatment on the persons receiving them.
What is a placebo?
A placebo is an inactive substance which may resemble an active substance but typically has no value to treat or prevent an illness.
Why volunteer for a study?
There are many reasons to participate in research. You may want to:
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 benefits to being in a research study?
There may or may not be a direct medical benefit to you if you take part in a research study. For example, your health or a health condition you have may get better as a result or your participation in the study, but 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.
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.
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. The research staff will assist 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.
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 you do understand. If English isn't your native language, ask for an interpreter to be present when you are discussing the study with the research staff. The written and verbal informed consent information should 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, 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, or at any 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 ay 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, to other researchers if you give permission, 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) (see definition below), the company or group funding the study, and the 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.
What is an 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 the medical center serves to protect your rights and your welfare before and during the research study and to ensure that any risks are reasonable and justified. 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 is the VA's way of assuring YOU that any study you are asked to take part in has been thoroughly reviewed.
What questions should I ask before I agree to take part in a research 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. The following are a list of sample questions. Not every question will apply to every study.
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 answer to the questions during the study, just ask them again.
What if do not want to take part in a research study?
If anyone ask you to take part in a research study, you have the right to say "no." Remember: