- Purpose of this document
- What is clinical research?
- Why do people choose to participate in research?
- What are the different types of clinical research?
- What are the risks and benefits of participating in research?
- What rights do I have?
- What are the possible financial costs?
- Who can participate in clinical research?
- What is randomization?
- What is informed consent?
- What else should I consider?
- How do researchers make sure that participants are safe?
- What kinds of results will come from the research?
- How can I enroll in clinical research?
- What kinds of questions should I ask the researcher?
- For more information on clinical research and clinical trials
What is clinical research?
Clinical research refers to studies in which people participate as patients or volunteers. Different terms are used to describe clinical research, including clinical studies, clinical trials, studies, research, trials, and protocols. Clinical research may have a number of goals, such as developing new treatments or medications, identifying causes of illness, studying trends, or evaluating ways in which genetics may be related to an illness.
Strict rules for clinical studies have been put in place by NIH and the U.S. Food and Drug Administration (FDA). Some studies involve promising new treatments that may directly benefit participants. Others do not directly benefit participants, but may help scientists learn better ways to help people.
Confidentiality is an important part of clinical research and ensures that personal information is seen only by those authorized to have access. It also means that the personal identity and all medical information of clinical trial participants is known only to the individual patient and researchers. Results from a study will usually be presented only in terms of trends or overall findings and will not mention specific participants.
People sometimes think that participating in a study will require changes to their current treatment, but this is not always the case. Though some studies may require participants to try new medications or treatments, other studies use techniques such as brain scans, psychological tests, behavioral observation, or blood tests for genetic evaluation. Such studies may not require any change in treatment.