Medical Research: A Consumer's Guide for Participation

APPENDIX A
GLOSSARY
There are many special words that are used to
describe and talk about research. To help you better
understand issues related to medical research, a glossary
of commonly used terms is provided below. While
not all of the words in this glossary appear in this
Guidebook, they are helpful to know as you decide
whether or not to participate in a clinical trial.
Assent: The process of obtaining one’s agreement to
participate in research.
Bench Research: General scientific research that
occurs in a laboratory.
Bias: Permitting expectations or hopes to influence
decisions or analysis of data.
Biologic: A substance made from a living organism
that is used to prevent, diagnose or treat a disease,
such as a vaccine.
Biomarker: A protein occurring in the blood that
indicates health or the presence of an illness.
Biorepository: A facility that collects and stores tissue
and body fluids for research, also referred to as a
tissue bank.
Blinded: A study design used to decrease bias. In a
single-blinded study, the research volunteer does not
know if she is receiving the study product. In a
double-blinded study, neither the research volunteer
nor the principal investigator knows who is receiving
the study product.
Case Reports: A research and teaching approach that
uses a detailed discussion of the clinical progress of
one person or several people (case series) and follows
the progress of the person’s disease or treatment.
Researchers hope to learn more about the disease
and its treatment by examining how the disease
progresses and what effect a given treatment has.
Case-Control Study: A research approach that
compares detailed information about two very similar
groups of people (one that has a disease and one that
doesn’t). Researchers use this technique to try to
identify what causes one group to be sick and the
other to be healthy.
Case Report Form (CRF): The form used to collect
and submit information and data about a research
study.
Cells: The basic functional units of the body. Groups
of cells that perform common functions create tissues.
Clinical Trial: Research into how a new medical
approach works in people. Clinical trials can study
prevention, diagnosis, and treatment options. Also
referred to as clinical research.
Cohort Study: A cohort is a group of people who have
common characteristics. A cohort study looks at
outcomes and compares groups of people who are
alike in many ways but have some differences.
Common Rule: The term used for the regulations
that were developed to guide research that is
supported by the federal government and involves
human volunteers as participants.
Compassionate Use Trial: A clinical trial that permits
use of a new, possibly helpful treatment by people
who have a serious disease but do not qualify to be
included in a clinical trial exploring the treatment.
Control Group (also control arm): The group of
people in a clinical trial that do not have the disease
or do not receive the experimental product. Control
group participants may receive a placebo, an alternate
treatment, or no treatment.
Controlled Clinical Trial (also controlled study): A
clinical trial that uses a control group as comparison
to the experimental product.
Cross-Over: A study design where the experimental
and control groups switch halfway through the trial so
that each group receives the study product for onehalf
of the trial.
Data and Safety Monitoring Board (DSMB): A group
of people who review data during a clinical trial to
determine whether the risk/benefit ratio remains
acceptable.
Device: A product that is used to prevent, diagnose or
treat disease, but which does not work by a chemical
reaction or metabolism. A device is often an item that
is implanted or applied to the body.
Diagnostic Trial (also screening trial): A clinical trial
that looks for better diagnostic tests for diseases.
Dose: The amount of drug or biologic given at one
time.
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