Participants

Glossary

Biomedical: having to do with the life sciences, medicine, dentistry, nursing, and public health.

Clinical Research: medical research that involves patients and sometimes healthy volunteers. These research studies are designed to uncover better ways to treat, prevent, diagnose, and understand human disease. Sometimes they help patients feel or get better but sometimes they don’t. In rare cases, they studies can make patients worse.

Informed Consent: The dialogue between potential participants and researchers that takes place before anyone decides whether to take part in a study. This process of communication should be free of pressure or rushing, should include all key information and a chance to ask questions and have them answered. Informed consent can be more than just a one-time conversation. As a study goes on, participants can renew their agreement to be in the study, and they can also decide to quit without penalty. The important thing is open and clear communication.

Informed Consent Document (ICD): The form participants sign to agree to be in the study. The ICD includes details about the study, such as its purpose, duration, required procedures, risk, benefits, and who to contact for further information. Sometimes, a signature is not needed, but participants may still keep a copy of the ICD. In these cases it may be called an Information Sheet instead, but the contents are the same. The ICD is not a contract. Participants do not give up any legal rights by signing an ICD. Participants are free to withdraw at any time. 

Investigator: a scientist who is working on a research study to answer certain questions, test a theory, or explore a new area in hopes of designing a future study. Also called a researcher. The chief researcher on a study is called the “PI” or Principal Investigator. The PI is responsible for everything that takes place in a study.

Protocol: The scientific plan of the research study. A protocol describes the purpose of the study, who is eligible to participate, details about the research procedures, the length and steps of the study, and what information will be gathered.

Research: an organized way of finding out about something. Most scientists conduct research but not all research involves human volunteers. Most research is done with the hope of learning something valuable enough to share with others through publication. Research can turn up unexpected as well as expected results. Research usually involves some sort of risk-taking, whether small or great. As in other creative efforts, people have to take risks to learn and grow.

Sociobehavioral: involving the social sciences, the formal study of societies and human behavior. The areas of anthropology, sociology, psychology, religion, and political science are examples of disciplines that may conduct research of this kind. Common ways of collecting information include surveys, focus groups, interviews, and observing behavior in a specially designed setting.

Sponsor: The organization who pays for the study or provides in-kind support (like medications). This can be a single person, a charitable foundation, a medical institution, a drug-making company, or a federal agency like the National Institutes of Health or Department of Defense.