Research is a way to answer a question and to gain knowledge. We use knowledge gained from research to come up with new treatments.

Clinical trial is the scientific term for a test or study of a drug or medical device in people. These tests are done to see if the product is safe and effective for people to use. Doctors and other health professionals run the tests according to strict rules set by the U.S. Food and Drug Administration (FDA). The FDA sets the rules to ensure that people who agree to be in the studies are treated as safely as possible.

By participating in a clinical trial, you can potentially try a new treatment that may or may not be better than those that already exist. You can also help others better understand how the treatment works in people of different races and genders.

A protocol describes the rules to follow during the research. For example, a protocol states why it is important to study the research question and how the research team will answer the research question. A protocol also states how the research team will protect the health and well being of the research volunteers. A protocol includes information on the study procedures, medications to be used, possible risks and benefits, possible adverse events, and data analysis methods.

Each research study is different. Each study tries to find answers to a specific question. Researchers must follow strict rules to decide who may take part in research. Not everyone with the disease or problem that is being studied can take part in a research study.

Informed consent is the process that gives information to people who are thinking about taking part in research. After learning about the research, you should understand:

• The purpose of the study
• The procedures involved in the study
• The possible benefits and risks of taking part in the study
• The rights of people who take part in research
• That taking part in research is your choice
• What you can do instead of taking part in the study
• How the research team will give you any new information that may be learned after you decide to take part in a study that might cause you to change your mind

Informed consent is a process that helps you learn about the research study. After learning about the study, you will be able to ask the researcher or his/her staff questions. You should only agree to take part after you clearly understand the study and feel comfortable. You should take time to talk over your decision with your doctors, family, and friends. If you agree to take part, you will be asked to sign an "informed consent form." The informed consent process goes on even after you are taking part in the study. If researchers learn new information after you begin the study, they must share this with you.

To help you decide if you want to be in a study, the FDA requires that you be given complete information about the study before you agree to participate. This is known as informed consent. Before you can be in the study, you must sign the informed consent form, showing that you have been given this information and understand it. The informed consent form is not a contract. You can leave the study at any time, for any reason.

Federal regulations require that a committee called the Institutional Review Board (IRB) review, approve and monitor all research involving human subjects. The IRB's goal is to protect the rights and welfare of human research participants. It monitors human subject research to determine that it is conducted ethically, and in compliance with federal regulations, state law and Texas Health Resources' policies and procedures.

IRB members include physicians, nurses, and community representatives.

Research studies include only people who choose to participate. You should take your time to make your decision and discuss it with your friends, family and/or physician prior to deciding to participate in a research study.

Participation in a clinical trial is your decision. You may refuse to be in the trial or you may stop participation in a trial at any time. If you decide not to participate, or you withdraw, you will not have any penalty or loss of benefits to which you are entitled and this will not affect your future medical care.

Clinical trials test new drugs, devices, or treatments. In some cases, taking part will not cost you or your insurance company anything. In other studies, the research team may bill your insurance company for drugs, devices, and services they provide. It is possible that your insurance company will not pay for some or all of the charges and you may receive a bill for those costs. The study informed consent form will describe any costs to you in detail. If the information in the consent form is not clear, you should ask the research team to explain any costs before you sign the consent form.

Some studies compensate participants for the time they spent participating in a trial; generally, this amount is given to cover expenses for parking, transportation, meals, and possibly for lost work time; however, payment may not be substantial enough to constitute inducement to participate for monetary gain.

A registry is a database comprised of information and/or tissues obtained from individuals. This information is collected in a standardized way so that it can be used in research; in this way, it is different from information collected typically by the patient's doctor. These registries are also called "banks." Registries are established for the purpose of collecting as much information as possible about a particular illness or a group of people. Some registries are very large and may include family members of people with specific illnesses. Agreeing to participate in a registry could be as simple as allowing a research study to collect tissues that would normally be thrown away after surgery; or a registry could be designed to collect blood, tissue specimens, and information from your medical records for many years. A registry could have information on 100 people or it could have information on 10,000 people. It is from registries and banks that many researchers develop new ideas for new research studies.

Randomized is used to describe a research study that hopes to compare two or more different treatments or procedures. Randomized means that you will be assigned to a study group by chance, like flipping a coin.

As part of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), which was originally passed as a means of maintaining healthcare coverage, Congress included Administrative Simplification provisions in HIPAA directed at standardizing how health care information and claims are processed and used. The privacy provisions (as well as the security provisions) were then added to HIPAA's Administrative Simplification provisions to protect how patient health information or "Protected Health Information" (PHI) is stored, transmitted and used.

"The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule establishes the conditions under which protected health information (PHI) may be used or disclosed by covered entities for research purposes. The Privacy Rule also defines the means by which individuals will be informed of uses and disclosures of their medical information for research purposes, and their rights to access information about them held by covered entities."