1. Before clinical research begins
Clinical research relies on people who join. People who are thinking about joining a study get information about the study to help them decide. Research staff are available to answer their questions. This process is called informed consent. It’s the main way people get study information before deciding whether or not to join a study.
Informed consent is a process that includes a document that has important information about taking part in the study, including:
- A description of what will happen during the study
- Who can join the study
- How much of participants’ time the study will take
- Any payments and costs, such as payment participants get from taking part and any costs participants may need to pay
- The known benefits and risks of taking part in the study
Other ways people can get information about a study may include:
- Asking the research study staff questions
- Reading brochures or websites
- Watching videos about the study
If someone has discussed the study with the research staff, has had their questions answered, and agrees to join the study, they sign the informed consent form. Even if they sign the informed consent, they can leave the study at any time and for any reason. If they decide to leave, they can talk to the research staff to do so safely.
2. During clinical research
Clinical research happens in many ways, depending on the type of study. Studies can take place at hospitals, clinics, research centers, universities, over the phone, or on the internet. They may take a few days, weeks, or even years.
Researchers may assign participants into different groups. This happens in studies that compare an intervention to something else. For example, researchers may:
- Compare two drugs to see which works better or has fewer unwanted side effects
- Compare a drug to a placebo (a substance or treatment that looks like the drug, and is given in the same way, but has no active drug)
- Compare getting a treatment to no treatment
Often in clinical trials, researchers assign participants into the groups at random (by chance). These participants may not know what group (or intervention) they have been assigned, and the staff may not know either. This is called "masking" or "blinding." This ensures that participants and research staff do not know what intervention each participant receives to help make sure the results are looked at fairly.
In other types of clinical trials, all the participants get the intervention being studied.