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Adverse Effect: An undesirable and unintended, although not
necessarily unexpected, result of therapy or other intervention.
Autonomy: Personal capacity to consider alternatives, make
choices, and act without undue influence or interference of others.
Belmont Report: A statement of basic ethical principles governing
research involving human subjects issued by the National Commission for the Protection
of Human Subjects in 1978.
Clinical Research Associate (CRA): An individual who represents
the sponsor and who is responsible for the accuracy and management of data and
overall supervision of day-to-day activities of the study. Also called
a monitor.
Clinical Trial: A controlled study involving human subjects,
designed to evaluate prospectively the safety and effectiveness of new drugs
or devices or of behavioral interventions.
Cohort: A group of subjects initially identified as having
one or more characteristics in common who are followed over time.
Contraindicated: Pertains to the use of a treatment that should
not be used in certain individuals or conditions due to risks that are disadvantageous,
or, perhaps, dangerous results.
Control: Subjects who are not given a treatment under study
or do not have a given disorder, background or risk that is the object of study,
and who are comparable to subjects in the study.
Data Points: Any text or numbers generated during a study.
Data and Safety Monitoring Board (DSMB): A committee of scientists,
physicians, statisticians and others that collect and analyze data during the
course of a clinical trial to monitor for adverse effects and other trends that
would warrant modification or termination of the trial or notification of the
subjects about new information that might affect their willingness to continue
in the trial.
Declaration of Helsinki: A code of ethics for clinical research
approved by the World Medical Association in 1964 and widely adopted by medical
associates in various countries. It has been revised several times, most
recently in 2000.
Dependent Variables: The outcomes that are measured in an experiment. Dependent
variables are expected to change as a result of an experimental manipulation
of the independent variable(s).
Double-blind Design: A study comparing two or more treatments
in which neither the investigators nor the subjects know to which treatment group
individual subjects have been assigned.
Emancipated Minor: A legal status conferred upon persons who
have not yet attained the age of legal competency as defined by state law, but
who are entitled to treatment as if they had by virtue of assuming adult responsibilities
such as self-support, marriage or procreation.
Epidemiology: A scientific discipline that studies the factors
determining the causes, frequency, and distribution of diseases in a community
or given population.
Exclusion Criteria: A list of specific conditions which make
an individual ineligible to enroll in a research study.
Exculpatory: Pertaining to that which relieves of a responsibility,
obligation or hardship; clearing from accusation or blame.
Experimental: A term often used to denote a therapy (drug,
device or procedure) that is unproven or scientifically unvalidated with respect
to safety and efficacy. A procedure may be considered “experimental” without
necessarily being part of a formal study to evaluate its usefulness.
Federal Policy: Federal regulations governing the involvement
of human subjects in research. The Policy applies to all research involving
human subjects conducted, supported, or otherwise subject to regulation by and
federal department or agency that takes appropriate administrative action to
make the Policy applicable to such research. Currently, sixteen federal
agencies have adopted the Federal Policy. For this reason, it is also known
as the Common Rule.
Geneotype: The genetic constitution of an individual.
Grant: Financial support provided for a research study designed
and proposed by the principal investigator(s). The granting agency exercises
no direct control over the conduct of approved research supported by a grant.
Hypothesis: The proposition, to be tested statistically, about
the expected outcome of the study.
Human Subject: Under DHHS regulations human subjects
are living individuals about whom an investigator conducting research obtains
1) data through intervention or interaction with the individual or 2) identifiable
private information. Intervention includes both the physical procedures by which
data are gathered (e.g., venipuncture) and manipulations of the subject or the
subject’s environment that are performed for research purposes. Interaction
includes communication or interpersonal contact (e.g., questionnaires, interviews)
between the investigator and the subject (45 CFR 46.102). Private information
includes information about behavior that occurs in a context in which an individual
can reasonably expect that no observation or recording is taking place, and information
which has been provided for specific purposes by an individual and which the
individual can reasonably expect will not be made public (for example, a medical
record). Private information must be individually identifiable (i.e., the identity
of the subject is or may readily be ascertained by the investigator or associated
with the information) in order for obtaining the information to constitute research
involving human subjects. Under FDA regulations a human subject is defined
as “an individual who is or becomes a participant in research, either as
a recipient of a test article or as a control (21 CFR 50.03, 21 CFR §56.103(e),
21 CFR §312.3(b)). A subject may be either a healthy individual or a patient.” If
the research involves a medical device, human subjects are individuals when they
participate in an investigation, either as an individual on whom or on whose
specimen an investigational device is used or as a control (21 CFR §812.3(p)).
Inclusion Criteria: A list of specific conditions that an individual
must meet to enroll in a research study.
Informed Consent: Informed consent means “knowing consent,” the
exercise of a free power of choice without undue inducement, force, fraud, deceit,
duress or other form of constraint or coercion. If the subjects are minors
or are not capable of giving consent, parental, guardian or other legal representative
consent is required. Use of a written consent form that includes all of
the basic elements of informed consent must be documented by a signature of the
subject or legally authorized representative.
Institution: A residential facility that provides food, shelter
and professional services (including treatment, skilled nursing, intermediate
or long-term care and custodial or residential care). Examples include
general, mental or chronic disease hospitals, inpatient community mental health
centers, halfway houses and nursing homes, alcohol and drug addiction treatment
centers, homes for the aged or dependent, residential schools for the mentally
or physically handicapped, and homes for dependent and neglected children.
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 research.
Intervention: Intervention includes both physical procedures
by which data are gathered (e.g., venipuncture) and manipulation of the subject
or the subject’s environment that are performed for research purposes.
Investigator: Clinician responsible for conducting the study.
Longitudinal Study: A study designed to follow subjects forward
through time.
Mature Minor: Someone who has not reached adulthood (as defined
by state law) but who may be treated as an adult for certain purposes (e.g.,
consenting to medical care). Note that a mature minor is not necessarily
an emancipated minor.
Minimal Risk: Risk in minimal where the probability and magnitude
of harm or discomfort anticipated in the proposed research are not greater, in
and of themselves than those ordinarily encountered in daily life or during the
performance of routine physical or psychological examinations or tests.
Monitor: Designated individual selected by a sponsor or contract
research organization to oversee the progress of a clinical investigation.
Null Hypothesis: The proposition, to be tested statistically,
that the experimental intervention has no effect, meaning that the treatment
and control groups will not differ as a result of the intervention. Investigators
usually hope that the data will demonstrate some effect from the intervention,
thereby allowing the investigator to reject the null hypothesis.
Nuremberg Code: A code of research ethics developed during
the trials of the Nazi war criminals following World War II and widely adopted
as a standard during the 1950s and 1960s for protecting human subjects.
Open Design: An experimental design in which both the investigator(s)
and the subjects know the treatment group to which subjects are assigned.
Pharmacokinetic: Related to the absorption, distribution, metabolism
and elimination of drugs by the body.
Pharmacology: The scientific discipline that studies the action
of drugs on living systems (animals or humans).
Phase I (Clinical) Trial: The first
stage in testing an unapproved (by the FDA) drug in man. The drug is administered
to a small number of normal subjects to generate preliminary information on its
safe dosage, toxicity, tolerance, absorption and metabolism. However, in some
instances, if the drug is intended to treat a specific disease, it may be appropriate
to test the drug in patients with that disease.
Phase II (Clinical) Trial: The second
stage in testing a new drug in man generally carried out on patients with the
disease or condition of interest to obtain information on the treatment efficacy
and to supplement information on safety obtained from Phase I trial.
Phase III (Clinical) Trial: The third
and usually final stage in testing a drug in man. The study is designed to include
a control treatment and random allocation to treatment on a large subject population
in different clinical settings. The drug is used as would be when marketed and
the study is primarily concerned with assessments of dosage effects and efficacy
and safety. Once this phase is completed, the drug manufacturers may request
permission to market the drug by submission of a New Drug Application to the
FDA.
Phase IV (Clinical) Trial: Generally
carried out after FDA approval and licensure of the drug for that indication.
The study is a randomized controlled trial designed to evaluate the long-term
safety and efficacy of a drug for the given information.
Placebo: An inactive or inert substance, identical in appearance
to the active form of the drug. It is administered to patients to determine
whether effects observed during clinical trials are actually caused by the study
drug or by the psychophysiological (psychosomatic) effects of the treatment.
Principal Investigator: The scientist of scholar with primary
responsibility for the design and conduct of a research project.
Private Information: Private
information includes information about behavior that occurs in a context in which
an individual can reasonably expect that no observation or recording is taking
place, and information which has been provided for specific purposes by an individual
and which the individual can reasonably expect will not be made public (e.g.,
a medical record). Private information must be individually identifiable (i.e.,
the identity of the subject is or may readily be ascertained by the investigator
or associated with the information) in order for obtaining the information to
constitute research involving human subjects.
Protocol: A protocol is the
researcher's plan of a scientific experiment or treatment. A protocol includes
a description of the research design or methodology to be employed, the eligibility
requirements for prospective subjects and controls, the treatment regime(s) and
the proposed methods of data analysis.
Quality Assurance: A
system of activities whose purpose is to provide assurance that the overall control
of quality is being done effectively.
Quasi-experimental: A study
that is similar to a true experimental study except that it lacks random assignments
of subjects to treatment groups.
Randomization or Randomized Clinical Trials: Assignment
of subjects to different treatments, interventions or conditions according to
chance rather than with reference to some aspect of their condition, history
or prognosis.
Risk: The probability of harm
or injury (physical, psychological, social or economic) occurring as a result
of participation in a research study. Both the probability and magnitude of possible
harm may vary from minimal to significant. Federal regulations define only "minimal
risk."
Single-blind Design: Typically,
a study designed in which the investigator, but not the subject, knows the treatment
assignment. Occasionally the subject, rather than the investigator, knows the
assignment.
Site Visit: A visit by agency
officials, representatives or consultants to the location of a research activity
to assess an investigation or the adequacy of IRB protection of human subjects.
Source Documents: The original
recording of data about a research participant. Examples of sources documents
are:
history and physical report; laboratory results; diagnostic test results; physician
progress notes; nurses notes; etc.
Sponsor (of a drug trial): The
developer of a new drug who distributes it to investigators and physicians for
clinical trials, and who is responsible for securing FDA clearance for trials
and form reporting the results of those trials to the FDA. A sponsor may be either
a private pharmaceutical manufacturer, a research institute, a clinical investigator
or a federal agency.
Sponsor: The company/person
who initiates the study.
Test Article: Any drug (including
a biological product for human use), medical device for human use, or any other
article subject to regulation under the Food, Drug, and Cosmetic Act of 1938
or under sections 351 and 354-360F of the Public Health Service Act.
Therapeutic Intent: The research
physician's intent to provide some benefit to improving a subject's condition
(e.g., prolongation of life, shrinking of tumor, or improved quality of life,
even though cure or dramatic improvement cannot necessarily be effected). This
term is sometimes associated with Phase I drug studies in which potentially toxic
drugs are given to an individual with the hope of inducing some improvement in
the patient's condition, as well as assessing the safety and pharmacology of
a drug.
Therapeutic Research: Research
involving an intervention that has the likelihood of providing a therapeutic,
diagnostic or preventive benefit to the subjects.
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