A

Abdomen, Abdominal
Area around stomach, midsection, belly, stomach area

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

Ambulate
walk, able 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, no name asked/given

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

Archived
On the shelf prior to submitting an application to the HSPC

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

Benefit
A valued or desired outcome; an advantage

Benign
Not cancer, harmless

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

Benign
Not malignant or threatening, usually without serious consequence

Bolus
An amount given all at once

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 for withdrawing or introducing fluids

Cerebral
The brain, of the brain

Cessation
Stopping

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

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

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

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

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, puffiness

Efficacy
Effectiveness

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

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

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

FDA
Food and Drug Administration

Failed Therapy
Subjects do not "fail therapies" but therapies fail to help subjects

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

510 (K) Device
A medical device that is considered substantially equivalent to a device that was or is being legally marketed

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 Vetro 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; helps prevent rejection of a transplanted organ;

Incidence
Number of times it happens

Infarct
Death of tissue due to loss of blood flow

Inflammation
Swelling which is usually painful, red and 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).

IRB
Institutional Review Board – 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

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

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

Intravenous
Putting in the vein

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

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

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

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 can’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

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
Closer 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

Remission
Disappearance of evidence of cancer or other disease

Remuneration
Payment for participation in research

Renal
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 – 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
Place a needle in a vein to take blood

Vertigo
Dizziness; lightheadedness

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