Central Alabama Research

What is clinical research?


What is research?

Research is an organized way to learn more about almost anything. Research is done in many areas, such as engineering, basic science, psychology, and medicine. When research involves people as subjects, it is called human subject research.


Why do people join research studies?


There are many reasons why a person may choose to be in a research study. If you are considering joining a research study, you should think about what your reasons and goals are for joining and discuss them with friends, family, a trusted health care provider and with the principal investigator or other study personnel. Talking with these people should help you determine if your reason(s) for joining the study agrees with what may happen as a result of your participation and the question the research is trying to answer. The following are examples of reasons why people join research studies:

  • Some healthy people decide to join a study because they want to help in developing a cure for a particular disease.
  • Some people decide to join a research study because they have a disease or condition and they want to help find a cure.
  • Some people decide to join because they have a disease or condition that has not responded to any of the medications available to treat the condition.
  • Some people decide to join because they have a very advanced stage of disease and no treatment option is available.
  • Some people decide to join because they have a disease or condition and they have had bad reactions to the available treatments and they are looking for something with fewer side effects.
  • Some people decide to join a study because they want the money that is paid to subjects.

Whatever your reason, you need to know that there can never be any guarantee given to you that the research drug, device or procedure will work for you or will ever work well enough to be approved for general use. A doctor may tell you about a research study because he or she thinks you may meet the requirements for enrolling. Just because a research study is suggested to you does not mean that you have to join it.


Are there risks in research?

Joining a research study will usually involve risks. Those risks vary from study to study. You should understand what risks are anticipated in the particular study you are considering and remember that there can always be unanticipated risks for research subjects. The risks should be clearly explained in the consent form.

Will I benefit if I participate in research?

Sometimes the person (subject) who joins a research study will benefit directly, and their disease or problem will be helped. However, the possibility of receiving benefit varies from study to study, just like the risks. It is important to remember that the main goal of research is to collect information that may help future patients, not the subject participating in the research study. You should always ask questions and keep asking until you understand how the research study is different from the treatment you would get outside of the research study.

What do I have to do if I join a research study?

As a participant in a research study you will have responsibilities too. For example, you will be expected to show up for all scheduled appointments, call the study personnel if you have a bad reaction, and follow the study related instructions given to you. You may also be expected to go in for many more visits than you would have with regular care. Therefore, you may have extra costs, such as parking, babysitting and time off work.

What are my rights as a research subject?

You have several rights as a research subject:

  • You have the right to decide not to participate in the research, and there will be no penalty or loss of benefits.
  • If you decide to participate, you have the right to quit at any time. Again, there will be no penalty or loss of benefits.
  • You have the right to be informed about the research study, without any coercion, undue influence, or pressure. Your main source of information about the research study is usually the consent form.
  • You have the right to ask questions about the research study.
  • You have the right to get a copy of the consent form.
  • You do not waive any of your legal rights by joining a research study or signing a consent form.

 

Deciding to be in a research study is an important decision and requires that you understand what your expectations are. You should talk about your expectations with the study staff before you agree to be in a research study.