Should I Participate in Research?
Someday, you or a family member may want to take part in a research study. If this happens, the information here may help you make the right decision.
What Is Research?
Research is a study that is done to answer a question. Scientists do research because they don’t know for sure what works best to help. Some other words that describe research are clinical trial, protocol, survey, or experiment. Research is not the same as treatment.
Why Is Research Important?
Research has led to important discoveries that make our lives better. Some examples are:
- New medications to treat diseases
- Improved medical procedures
- New or improved tests (like ultrasounds, X-ray machines, etc.)
- Vaccines
- Ways to stop smoking
What is an IRB?
The Institutional Review Board (IRB) is a group of people who review and approve human research. The IRB includes medical people, scientists, and people from the local community. They review human research to make sure it is well-planned and ethical. The IRB serves to protect your rights and your welfare before and during the research study. For example, the IRB makes sure that any risks are as small as possible. The IRB does not make a decision about whether you should participate. The IRB decides whether it is right to ask people whether they want to take part in a research study. The IRB also reviews each research study while it is going on to make sure volunteers are protected.
Should I take part in a research study?
Thousands of research studies are being conducted each year. These research studies have contributed to health improvements for many people from every walk of life.
The advances in health care would not be possible without people willing to volunteer to take part in a research study. You may be asked to volunteer for a research study approved by our local IRB.
Who will see my records?
Like your medical record, the information in your research study record will be confidential. Information will be given only to the people who need it. This includes researchers and staff who carry out the research study. This includes the Institutional Review Board (IRB), the company or group funding the research 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 research study is conducted using acceptable research practices. It is important for you to fully read the informed consent form provided to you so that you may understand who will have access to your records.
Who will see my records?
A research study is an organized activity to learn more about a problem or answer questions. Scientists conduct many different kinds of studies. For example, a research study may test if a drug is safe and effective. A research study may be done to find out what health care practices work best. A research study may be done to determine the best way to prevent an illness. A research study may use a survey or an interview to understand feelings people have about their health. One type of research study is a clinical trial. A clinical trial is a research study that will try to decide whether new treatments 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.
Who will answer my questions?
The research team will explain the research study to you. The informed consent form includes this explanation. 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. The information will be given to you in a language that you know.
Depending on the study type, you may have time to take the information home. You can always discuss it with your family, friends, a health care provider, or others before you decide whether or not to take part in the research study. If you decide to take part in the research study, you will be asked to sign the informed consent form.
The informed consent process is more than just signing a piece of paper. It is a process that goes on throughout the research study. During the course of the research study, you may be told of new findings, benefits or risks. At that time, you can decide whether or not to continue to take part in the research study. You may decide not to take part. You may change your mind and leave the research study before it starts. You may also leave at any time during the research study or the follow-up period.
Why should I volunteer for a research study?
There are many reasons to participate in research study. You may want to:
- Help find a cure for an 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 research 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.
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 knowing what will take place in the research 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 research study. These facts include details about the research 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, your health or a health condition you have may get better as a result of your participation in the research study. It may stay the same. It may get worse. No one can predict what will happen with a research study or how it might affect you. The research study may not help you personally. The research 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 bad side effects. The questions being asked could make you uncomfortable. The risks and side effects of the research study may not be known completely when you start the research 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 research study for as long as you take part in the research study.
What if I do not want to take part in a research study?
If anyone asks you to take part in a research study, you have the right to say “no.”
Who will answer my questions?
If you have questions about research at VA Pittsburgh, please contact:
VA Pittsburgh Healthcare System Research and Development Office
Phone: +14123602390
Please call this number if you have concerns or complaints, or just want to talk to someone about VAPHS research.
Remember:
- Your decision will not affect how we treat you.
- You need to weigh both the risks of the research study and the benefits.
- It may be helpful to talk with family members, friends, or your health care providers.
- If you decide to volunteer for a research study, you can change your mind and stop or leave the research study at any time. Your decision will not affect how we treat you.