Research and Clinical Trials
Joining a research study may involve risks. Those risks vary from study to study. You should understand what risks are anticipated in the study you are considering and remember that there can be unanticipated risks. The risks should be clearly explained in the consent form.
Sometimes the person 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 you and future patients. 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.
Before research studies can start, they must be approved by a committee called an Institutional Review Board (IRB). IRBs are made up of scientists, doctors, non-scientists and community members. The IRB reviews the research to make sure it is well designed, that the risks are as low as possible, and that these risks are reasonable when compared to the possible benefits of the research. The IRB also reviews the study's consent form to make sure that it is accurate. The IRB continues to review approved research to ensure that it is properly conducted.
It is important to know that IRB approval does not mean that a research project is right for everyone. When an IRB approves research, it means that the members of the IRB believe that the research is acceptable to present to participants for consideration. You need to carefully look at the details of the research and decide whether it is right for your particular needs.
As a participant in a research study you will have responsibilities. 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 also might be expected to go in for many more visits than non-participants. Therefore, you may have extra costs, such as parking, babysitting and time off work.
Before you decide to become a research volunteer, get the facts. Know what you're getting into and the pros and cons. There are a number of resources available online to help you find out more.
Here are some examples of questions that you may want to ask the research staff about the study:
- Why is the research being done?
- What exactly will happen to me as part of the research?
- Will there be any unpleasant side effects?
- Will the research help me personally?
- What other options do I have?
- How long will the study last?