Glossary

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510 (K) Device

A medical device that is considered substantially equivalent to a device that was or is being legally marketed

A

Abdomen, Abdominal
Area around stomach, midsection, belly, stomach area; part of the body cavity holds the stomach, intestines, liver, and other organs

Acute
New, recent, sudden

Adjuvant
Additional treatment; treatment that goes along with main treatment to make it work better

Adverse effect
An undesirable and unintended result of therapy or other intervention

Agitation
Upset

Allergic reaction
An allergy to a medication that can cause swelling, rash, itching or trouble breathing

Ambulate
To walk, be able to walk or have the ability to walk

Ameliorate
Make smaller or less, reduce

Analgesia
Pain relief

Anaphylactic Reaction
A severe and sometimes dangerous allergic reaction which may cause swelling, skin rash, itching, problem breathing and/or lower blood pressure

Anemia
Low red blood cell count that may make a person tire easily and short of breath

Anesthetic (local)
A drug used to decrease pain by numbing an area of the body, without putting you to sleep

Anesthetic (general)
A drug used to decrease or eliminate pain by putting you to sleep

Anonymous
Without identification or without including a name

Anorexia
Without appetite; not feeling hungry

Antibody
Substance produced by your body to protect against infection/disease

Arrhythmia
Abnormal heartbeat

Aspiration
Remove fluid with a tube or needle

Assay
Lab test

Assent
Agreement by an individual not competent to give legally valid informed consent to participate in research

Assurance
A formal written, binding commitment that is submitted to a federal agency in which an institution promises to comply with applicable regulations governing research with human subjects and stipulates the procedures the institution will institute to maintain compliance

Asymptomatic
Without symptoms, having no symptoms

B

Barrier method

A type of birth control such as diaphragm, condom, cervical cap or sponge

Benefit

A valued or desired outcome; an advantage

Benign

Not malignant or threatening, usually without serious consequence

Biologic

Any therapeutic serum, toxin, anti-toxin or analogous microbial product applicable to the prevention, treatment, or cure of diseases or injuries

Bolus

A dose of medicine given at once or over a short period of time

Bone marrow suppression

Decreased growth of blood cells

Bracycardia

Slow heartbeat

C

Capacity (to make decisions)

The ability of an individual to understand the choices presented, to appreciate the implications of choosing one alternative or another, and to make and communicate a decision

Carcinogenic

Capable of causing cancer

Carcinoma

A type of cancer

Cardiac

Heart

Case Controlled Study

A study comparing persons with a given condition or disease (the cases) and persons without the condition or disease

Catheter

A tube placed in the body to remove or introduce fluids into the body; a tube that moves liquids in or out of the blood; a plastic tube placed in a vein or under the skin to withdraw or introduce fluids in the body

Central nervous system

The brain and spinal cord

Central venous catheter

A plastic tube inserted in a vein under the skin of the chest to remove or introduce fluids into the body

Cerebral

The brain, of the brain

Cessation

To stop doing something

CHD

Coronary heart disease, heart disease

Chemotherapy

Drug treatment of a disease, usually cancer

Chronic

Continuing for a long time

Clinical Status

Current state of health

Clinical Trial

A controlled study involving human subjects, designed to determine the safety and effectiveness of a drug, biologic, device or other treatment or behavioral intervention; an experiment with human subjects

Coercive Cognitively Impaired

Having either a psychiatric disorder or a development disorder that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished.

Compensation

Payment or medical care provided to subjects injured in research. (Does not refer to payment for participation in research.)

Competence

Technically, a legal term, used to denote capacity to act on one's own behalf; the ability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice.

Confidential

Information that will not be divulged to others without permission

Congenital

Problem that you are born with

Conjunctivitis

Red, itchy eyes; eye infection

Consent

Approval or acceptance of something done or proposed by another

Consequences

Result or effects

Contraindicated

Should not be used

Control Subjects

Subjects used for comparison who are not given a treatment under study or who do not have a given condition, background or risk factor that is the object of the study

Controlled Study

Research that involves at least two groups: one that receives the intervention being evaluated, and the other that receives either a placebo or another intervention. Sometimes the study also is described as "blind" or "masked"

Conventional Therapy

Standard treatment

Coronary

The blood vessels that are connected to the heart

CT (CAT) Scan

computerized series of x-rays

Culture

Test for infection or organisms that could cause infection; to take a sample of blood, fluid, or tissue to see if bacteria or viruses are found in it

Cutaneous

Relating to the skin

D

DHHS

U.S. Department of Health and Human Services

Data

Factual information (as measurements or statistics) used as a basis for reasoning, discussion, or calculation

Debriefing

Giving subjects previously undisclosed information about the research project following completion of their participation in research

Dehydration

Not enough fluids

Dermatologic

Pertaining to the skin

Diastolic

The lower number in a blood pressure reading

Dilation

Expansion or stretching

Discomfort

Pain, uncomfortable feeling

Disseminated

Widely spread

Distal

Toward the end, away from the center of the body

Distend

Stretch, expand, bloat

Diuretic

Medicine that makes you urinate, sometimes called a "water pill"

Double-blind

Neither the subject nor physician can know what is being given

Drug

Any chemical compound that may be used or administered to humans

Dysfunction

Doesn't work properly

Dysplasia

Abnormal cells

E

Echocardiogram

Sound wave test of the heart

Edema

Increased fluid in the tissues; swelling; puffiness

Efficacy

Effectiveness; how well something works

Electrocardiogram (EKG)

A heart test; a tracing of heartbeat or heart rhythm

Embryo

Early stages of a developing organism (i.e., from conception to the eighth week of pregnancy

Emesis

Vomiting

Endoscopic

Examination of the inside of the body with a lighted tube

Epidural

A type of local anesthesia to decrease or eliminate pain

Eradicate

Get rid of

Erythrocyte

A type of red blood cell

Ethnographic Research

Ethnographic research, also called fieldwork, involves observation of an interaction with the persons or group being studied in the group's own environment, often for long period of time

Expedited Review

Review of proposed research by the IRB chair or a designated voting member or group of voting members rather than by the entire IRB

F

Failed Therapy

Treatment that was not effective for a patient

False Negative

When a test wrongly shows an effect or condition to be absent

False Positive

When a test wrongly shows an effect or condition to be present

FDA

Food and Drug Administration

Fetal Material

The placenta, amniotic fluid, fetal membranes and umbilical cord

Fetus

The product of conception from the time of implantation until delivery (i.e., generally refers to later phases of development)

Fibrillation

Irregular heartbeat

Fibrous

Like scar tissue

Fieldwork

Behavioral, social, or anthropological research involving the study or persons or groups in their own environment and without manipulation for research purposes

G

Gastrointestinal

Stomach and intestines

Gene Therapy

The treatment of genetic disease accomplished by altering the genetic structure of either somatic (non-reproductive) or germ line (reproductive) cells

Genetic Screening

Tests to identify persons who have inherited predisposition to a certain phenotype or who are at risk of producing offspring with inherited diseases or disorders

Granulocyte

A type of white blood cells

Guardian

An individual who is authorized under applicable state or local law to give permission on behalf of a child to general medical care. A guardian may also be appointed by a court to make decisions for an incompetent adult

H

Hematocrit

Number of red blood cells

Hematoma

A bruise; a black and blue mark

Holter monitor

Portable machine for recording heartbeats

Hormonal therapy

Treatment with hormones

Human In Vitro Fertilization

Any fertilization involving human sperm and ova that occurs outside the human body

Human Subject

Individuals who physiologic or behavior characteristics and responses are the object of study in a research project

Hypertension

High blood pressure

Hypotension

Low blood pressure

Hypoxia

Low oxygen level in the blood

I

Immunosuppressive

A drug or therapy that reduces the body's ability to fight infection or helps prevent rejection of a transplanted organ

In Vitro

Literally, "in glass" or "test tube"; used to refer to processes that are carried out outside the living body, usually in the laboratory

In Vivo

Literally, "in the living body"; processes carried out in the living body rather than in a laboratory

Incidence

Number of times something happens

Infarct

Death of tissue due to loss of blood flow

Inflammation

Swelling which is usually painful, red or warm

Informed Consent

A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence

Infusion

Putting a substance into the body, usually into the blood

Institution (1)

Any public or private entity or agency (including federal, state, and local agencies)

Institution (2)

A residential facility that provides food, shelter, and professional services (including treatment, skilled nursing, intermediate or long-term care, and custodial or residential care).

Institutional Review Board (IRB)

A specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research

Institutionalized

Confined, either voluntarily or involuntarily (e.g., a hospital, prison, or nursing home)

Institutionalized Cognitively Impaired
Persons who are Confined, either voluntarily or involuntarily, in a facility for the care of the mentally or otherwise disabled

Intravenous

To put something through a vein

Intubate

The placement of a tube into the airway to help a person breathe

Investigational Device Exemptions (IDE)

Exemptions from certain regulations found in the Medical Device Amendments that allow shipment of unapproved devices for use in clinical investigations

Investigational New Drug or Device

A drug or device permitted by FDA to be tested in humans but not yet determined to be safe and effective for a particular use in the general population and not yet licensed for marketing

Investigator

In clinical trials, an individual who actually conducts an investigation

IRB

Institutional Review Board (see above)

Ischemia

Low oxygen in a tissue, usually because of decreased blood flow

L

Lactating

Producing milk

Laparotomy

A procedure where a small cut is made in the stomach area, so a physician can look at the organs

Legally Authorized Representative

A legally authorized representative as an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject?s participation in the procedure(s) involved in the research.

Lethargy

Lack of energy; sluggish

Longitudinal Study

A study designed to follow subjects forward through time

Lumen

Inside a blood vessel

Lymphocyte

A type of white blood cell important for defense against infections

M

Magnetic Resonance Imaging (MRI)

Pictures of the body created using magnetic rather than x-ray pictures

Malaise

Feeling bad; a feeling of bodily discomfort, feeling sick

Malignancy

Cancer which usually spreads and may be fatal if not successfully treated

Masked/Blinded Study Design

Study designs comparing two or more interventions in which either the investigators, the subjects, or some combination thereof do not know the treatment group assignments of individual subjects

Mature Minor

Someone who has not reached adulthood (as defined by state law) but who may be treated as an adult for certain purposes

Medical Device

A diagnostic or therapeutic article that does not achieve any of its principal intended purpose through chemical action within or on the body

Metastasis

Spread of cancer cells from one part of the body to another

Minimal Risk

When the probability and magnitude of harm or discomfort anticipated in the proposed research is not greater (in and of themselves) than those ordinarily encountered in daily life

Monitor

Check on, keep track of, watch carefully

Monoclonal antibody

A type of antibody made outside your body to protect against your particular disease

Morbidity

Sickness/illness; undesired result or complication

Mortality

Death or death rate

Motility

The ability to move

MRI

Magnetic Resonance Imaging (see above)

Murine

Obtained from mice

Myalgia

Muscle aches

Myocardial infarction

Heart attack

N

Nasogastric tube

A tube from the nose to the stomach

Necrosis

Death of tissue

Neonate

A newborn infant, especially one less than four weeks old

Neoplasia

New growth of cells that my be cancerous or non-cancerous

Neural

Brain or nerves

Neutropenia

Decrease in a type of white blood cells

New Drug Application

Request for FDA approval to market a new drug

NIH

National Institutes of Health

Non-invasive

Not breaking, cutting or entering the skin

Non-significant Risk Device

An investigational medical device that does not present significant risk to the patient or research subject, taking into account all of the risks inherent in the study

O

Obviate

To prevent or eliminate

Occlusion

Closing, obstruction, blockage

Occult blood test

Testing a stool sample for small amounts of blood that you canâ??t see

Oncology

The study of tumors or cancer

OPRS

Office for the Protection of Research Subjects

Open Design

An experimental design in which both the investigator(s) and the subjects know the treatment group(s) to which subjects are assigned

Ophthalmic

Pertaining to the eye

Orthopedic

Pertaining to bones

Osteoporosis

Bone disorder resulting in thinning of bones causing them to break easily

Ovaries

Female sex glands that release the egg cells

P

Pancytopenia

Low number of all the blood cells

Paralysis

Permanent or temporary loss of sensation or voluntary motion

Parathesia

Numbness, prickling or tingling feeling

Percutaneous

Through the skin

Perforation

Puncture, tear or hole

Phase 1,2,3,4 Drug Trials

Different stages of testing drugs in humans, from first application in humans (Phase 1) through limited and broad clinical tests (Phase 3), to post-marketing studies (Phase 4)

Phlebitis

Irritation or inflammation of a vein

PHS

Public Health Service

Placebo

A chemically inert/inactive substance like a sugar pill

Platelets

Blood cells that help the blood clot normally

Post

After

Preclinical Investigations

Laboratory and animal studies designed to test the mechanisms, safety, and efficacy of an intervention prior to its application to humans

Pregnancy

The period of time from confirmation of implantation of a fertilized egg within the uterus until the fetus has entirely left the uterus (i.e., has been delivered)

Premarket Approval

Process of scientific and regulatory review by the FDA to ensure the safety and effectiveness of Class III devices

Prenatal

Before birth

Principal Investigator

The scientist or scholar with primary responsibility for the design and conduct of a research project

Prisoner

An individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statute; (2) detained pending arraignment, trial or sentencing; and (3) detained in other facilities

Privacy

Control over the extent, timing and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others

Probability

Chance

Proband

Subject in a genetic study

Prognosis

Outlook, probably outcomes

Prophylaxis

A drug given to prevent disease or infection

Prosthesis

Artificial body parts, such as arms, legs, hips

Protocol

The formal design or plan of an experiment or research activity; specifically, the plan submitted to an IRB for review and to an agency for research support. The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data

Proximal

Near; close to the center of the body;

Pruritus

Itching

Psychosis

Serious mental disorder

Pulmonary

Pertaining to the lungs

Q

QID

Four times a day

R

Radiotherapy

Treatment with radiation

Random, Random Assignment, Randomization

Assignment of subjects to different treatments, interventions, or conditions according to chance rather than systematically. Random assignment of subjects to conditions is an essential element of experimental research because it makes more likely the probability that differences observed between subject groups are the result of the experimental intervention.

Recur

Happening again or come back

Refractory

Not responding to treatment

Regimen

Pattern of giving treatment, schedule of when you will get medicine

Relapse

Return or reappearance of a disease

Remission

Disappearance of evidence of cancer or other disease

Remuneration

Payment for participation in research

Renal

Pertaining to the kidney

Research

A systematic investigation designed to develop or contribute to generalizable knowledge

Resect

Remove or cut out surgically

Respiratory failure

Lung failure; stop breathing

Risk

The probability of harm or injury occurring as a result of participation in a research study

S

SAMHSA

Substance Abuse and Mental Health Services Administration; includes the Center for Substance Abuse Prevention, the Center for Substance Abuse Treatment and the Center on Mental Health Services

Significant Risk Device

An investigational medical device that presents a potential for serious risk to the health, safety, or welfare of the subject and are:

  • Intended for use as an implant; or
  • Purported or represented to be of use in supporting or sustaining human life; or
  • Intended for a use that is of substantial important in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health; or
  • A potential source of serious risk to the health, safety, or welfare of human subjects

Single-Masked Design

Typically, a study design in which the investigator, but not the subject, knows the identity of the treatment assignment. Occasionally the subject, but not the investigator, knows the assignment. Sometimes called "single-blind design."

Somnolence

Sleepy

Sponsor (of a Drug Trial)

A person or entity that initiates a clinical investigation of a drug â?? usually the drug manufacturer or research institution that developed the drug. The sponsor does not actually conduct the investigation, but rather distributes the new drug to investigators and physicians for clinical trials.

Sponsor-Investigator

An individual who both initiates and actually conducts, alone or with others, a clinical investigation. Corporations, agencies or other institutions do not qualify as sponsor-investigators.

Staging

Figure out the extent of the disease

Stenosis

Narrowing of a duct, tube, or blood vessel

Stratify

Arrange in groups by age, sex, etc., for analysis

Subcutaneous

Under the skin

Subsequent

Another, next

Supine

Lying on the back

Symptomatic

Having symptoms

Syndrome

A condition with a certain set of symptoms

Systolic

The top number in blood pressure

T

Tachycardia

Fast heart beat

Taper

decrease, reduce

Therapy

Treatment

Thrombosis

A blood clot in a blood vessel

Tinnitus

Ringing in the ears

Titration

Gradual increase or decrease of a drug dose until finding the dose that works best

Topical

Put on the skin, like a cream or lotion

Toxicity

Harm; problem; poisoning; unwanted side effect

Transdermal

Through the skin

Transient

Short-term; brief

Trauma

Injury; wound

Trial

Study

U

Uptake

Taking a substance into the body and the cells

Uremia

Kidney failure

V

Varices

Enlarged veins, usually in the legs or lining of the tube connecting the mouth to the stomach

Vasodilation

Widening of the blood vessels

Vasospasm

Narrowing of the blood vessels due to a spasm of the vessel walls

Vehicle preparation

A cream or liquid used to deliver medicine

Venipuncture

Placing a needle in a vein to take blood

Vertigo

Dizziness; light-headedness

Via

By

Viable Infant

When referring to a delivered or expelled fetus, the term "viable infant" means likely to survive to the point of sustaining life independently, given the benefit of available medical therapy. This judgment is made by a physician.

Voluntary

Free of coercion, duress or undue inducement

W

Waive

Give up; do without