Why Clinical Research training is necessary? "A"

A clinical research study is an organized activity designed to learn more about a medical treatment or prevention. There are many kinds of studies.

Studies are done to:

• Test a product, such as a drug or device, for effectiveness, safety or to identify side effects
• Find out what health care practices work best
• Understand health needs, problems or feelings that people have about an illness
• Better understand what causes a particular disease

The study may not help you personally, but your participation may result in information that will help others in the future. Your involvement may help doctors learn how to prevent diseases or it may lead to new treatments for people with your condition. While you are in the study, your health may get better, 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.

All of the known risks associated with each study are explained in the study informed consent form. The study doctor or coordinator will discuss them with you. If you do volunteer, the researchers will tell you about any new risks discovered during the study.

Possible risks include:

• Being asked questions that could make you uncomfortable
• Discomfort or side effects* from the research procedures or drugs

*Not all of the risks or side effects may be known when you start a study, but any new findings will be reported to participants.

Informed consent is the process of learning the key facts about a research study before you decide whether or not to participate. To help you decide, the study doctors and coordinators explain the details of the study to you. Then they give you an informed consent document that describes things about the study, such as its purpose, risks, benefits, required procedures and contacts. You will get a copy of the informed consent document, and you may take as much time as you need to decide. You may want to talk over the study with your family, friends or doctor before you make a decision.

If you are injured or become ill as a result of your participation in a study, payment for any care you need may be covered by National Jewish Health, the study sponsor or by your health insurance company. In some cases, you could be personally responsible for paying for your medical care. It is important that you understand who is responsible for paying for any research-related injuries before you decide to participate in a study. Please discuss these concerns with the study doctor or coordinator.

It is important for you to know as much information as possible about a study before you decide to volunteer to participate. If there are any issues that concern you, ask questions. Most of the following questions are answered in the study informed consent document. But, the conversation with your study doctor should be equally as informative.

Here are some questions you should be able to answer after you talk with the research staff:

• What is the purpose of this study?
• How will this research help?
• What tests or procedures will be done?
• Will I be asked to take investigational drugs or undergo experimental procedures?
• Is it possible that I receive placebo (inactive ingredient) and not a drug?
• What are the potential risks and benefits of taking part of the study?
• What other options do I have if I decide not to participate?
• What will happen to the specimens (blood, tissue or genetic) that I give?
• Who has approved this research?
• What happens if my condition gets worse while I'm in study?
• Who will pay my medical bills if I become sick due to participating in the study?
• Will it cost me anything to be in the study?

Participating in medical research is always and completely voluntary. Choosing not to participate will never affect your care at National Jewish Health. If you decide to volunteer for a research study, you can change your mind and stop at any time. If you decide to stop participating in a study, it is always helpful to the researchers if you tell them why.

Overseeing organizations such as the Federal Drug Administration and the Department of Health & Human Services are always regulating medical research activities, but each research site also has its very own regulatory institutional review board (IRB). The IRB is a group of medical professionals, ethicists, and people from the community who protect the rights and welfare of research participants. The IRB reviews each study to make sure that the risks involved are as small as possible and that each volunteer is informed of those risks prior to their participation.

Clinical research is critical to understanding diseases and improving treatment therapies. Through the years, National Jewish Health has conducted research leading to new and improved treatments for a number of respiratory, allergic and immune diseases. We have helped bring such drugs as Advair, Claritin and Xolair to market.