Words to Know
The following
medical and technical words are used by researchers and other professionals
involved with clinical trials.
assent—when
a child agrees to be in a study.
blinding or masking—when
participants and usually study investigators do not know which medicine
or treatment participants are getting until the end of the trial
period.
informed consent—parents permission
for their child to join a research study after they have read an informed
consent form, spoken with the investigators, read other materials
about the study, and asked questions.
interventional
study—another name for a clinical trial.
investigators—people
doing the research study. People on the research team may include
doctors, nurses, research coordinators, social workers, and other
health care professionals. Each clinical study is led by a principal
investigator, who is often a medical doctor.
Institutional
Review Board (IRB)—an independent committee who
ensures that clinical trials are ethical and that the rights of
the people in the study are protected. Each clinical trial in the
United States must be approved and monitored by an IRB. Members
of an IRB include doctors, statisticians, and members of the community.
participants
or subjects—volunteers who enroll in a research
study.
placebo—a pill, liquid,
or powder without active medicine in it. Placebos are only given
to children when withholding treatment poses minimal risks.
protocol—detailed
plan of the research study.
randomization—a
way to choose what treatment each person in a study gets so that
there is less chance of bias. It's like flipping a coin
or rolling dice—the results are random and
are by chance, not choice.