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Acronyms
listed below
ABUSE-LIABLE Pharmacological substances that have the potential for creating
abusive dependency. Abuse-liable substances can include both illicit drugs
(e.g., heroine) and licit drugs (e.g., methamphetamines).
ADJUVANT THERAPY Therapy provided to enhance the effect of an primary therapy;
auxiliary therapy.
ADVERSE EFFECT (AE) An undesirable and unintended, although not necessarily
unexpected, result of therapy or other intervention (e.g., headache following
spinal tap or intestinal bleeding associated with aspirin therapy).
ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION
(ADAMHA) Alcohol, Drug
Abuse, and Mental Health Administration; reorganized in October 1992 as the
Substance Abuse and Mental Health Services Administration (SAMHSA). ADAMHA
included the National Institute of Mental Health (NIMH), the National Institute
on Alcohol Abuse and Alcoholism (NIAAA), the National Institute on Drug Abuse
(NIDA), the Office for Substance Abuse Prevention (OSAP), and the Office
for Treatment Intervention (OTI). NIMH, NIAAA, and NIDA are now part of
the National Institutes of Health (NIH).
ASSENT Agreement by an individual not competent to give legally valid informed
consent (e.g., a child or cognitively impaired person) 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 through
which compliance will be achieved [Federal Policy • ˜ . 1 0 3
] .
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AUTHORIZED INSTITUTIONAL OFFICIAL (AIL) An officer of
an institution with the authority to speak for and legally commit the
institution to adherence to the requirements of the federal regulations
regarding the involvement of human subjects in biomedical and behavioral
research.
AUTONOMY Personal capacity to consider alternatives,
make choices, and act without undue influence or interference of others.
AUTOPSY Examination by dissection of the body of an
individual to determine cause of death and other medically relevant facts.
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. (http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm)
BENEFICENCE An ethical principle discussed in the Belmont Report that entails
an obligation to protect persons from harm. The principle of beneficence can
be expressed in two general rules: (1) do not harm; and (2) protect from harm
by maximizing possible benefits and minimizing possible risks of harm.
BENEFIT A valued or desired outcome; an advantage.
BIOLOGIC Any therapeutic serum, toxin, anti-toxin, or analogous microbial product
applicable to the prevention, treatment, or cure of diseases or injuries.
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BLIND STUDY DESIGNS See: Masked Study Designs; Double-Masked Design; and Single-Masked
Design.
CADAVER The body of a deceased person.
CASE-CONTROL STUDY A study comparing persons with a given condition or disease
(the cases) and persons without the condition or disease (the controls) with
respect to antecedent factors
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) an agency within the Public
Health Service, Department of Health and Human Services.
CHILDREN Persons who have not attained the legal age for consent to treatment
or procedures involved in the research, as determined under the applicable
law of the jurisdiction in which the research will be conducted [45 CFR 46.401(a)J].
CHILDREN'S RISK LEVEL (CRL)
CRL 1 (45 CFR 46.404)—Research not involving greater than minimal risk.
CRL 2 (45 CFR 46.405)—Research involving greater than minimal risk but
of possible direct benefit to the child, in which the risk is at least as favorable
to the subject as that presented by available alternative approaches.
CRL 3 (45 CFR 46.406)—Research involving greater than minimal risk and
no prospect of direct benefit to the individual child, but likely to yield
generalizable knowledge about the disorder or condition, in which the risk
is minor relative to the potential improvement in knowledge to be applied to
general understanding.
CRL 4 (45 CFR 46.407)—Research not meeting the specifications above,
but which presents an opportunity to understand, prevent or alleviate a serious
problem affecting the health and welfare of children
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CLASS I, II, III DEVICES Classification by the Food
and Drug Administration of medical devices according to potential risks
or hazards.
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.
CODE OF FEDERAL REGULATIONS (CFR) "The codification of the general and
permanent rules published in the Federal Register by the executive departments
and agencies of the Federal Government. It is divided into 50 titles that represent
broad areas subject to Federal regulation" (http://www.gpoaccess.gov/cfr/about.html
1).
Regulations related to human research are 45 CFR 46 (Title 45 , Part 46)
and for the FDA only 21 CFR 50 and 56 (Title 21, Parts 50 and 56).
COGNITIVELY IMPAIRED Having either a psychiatric disorder (e.g., psychosis,
neurosis, personality or behavior disorders, or dementia) or a developmental
disorder (e.g., mental retardation) that affects cognitive or emotional functions
to the extent that capacity for judgment and reasoning is significantly diminished.
Others, including persons under the influence of or dependent on drugs or alcohol,
those suffering from degenerative diseases affecting the brain, terminally
ill patients, and persons with severely disabling physical handicaps, may also
be compromised in their ability to make decisions in their best interests.
COHORT A group of subjects initially identified as having one or more characteristics
in common who are followed over time. In social science research, this term
may refer to any group of persons who are born at about the same time and share
common historical or cultural experiences.
COLLABORATIVE IRB TRAINING INITIATIVE (CITI) An online training program for
researchers and staff, hosted at University of Miami.
Register at http://www.miami.edu/citireg/
After receiving confirmation of registration, login at http://www.courses.miami.edu/bin/common/courses.pl
COMMON RULE Regulations that govern human subjects of research and have been
adopted by seventeen federal agencies, as delineated in Title 45 of the Code
of Federal Regulations Part 46 Subpart A
COMPENSATION Payment or medical care provided to subjects injured in research;
does not refer to payment (remuneration) for participation in research.
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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.
COMPUTERIZED AXIAL TOMOGRAPHY (CAT Scan) An X-ray technique for producing
images of internal bodily structures through the assistance of a computer.
CONFIDENTIALITY Pertains to the treatment of information that an individual
has disclosed in a relationship of trust and with the expectation that it will
not be divulged to others without permission in ways that are inconsistent
with the understanding of the original disclosure.
CONTRACT An agreement; as used here, an agreement that a specific research
activity will be performed at the request, and under the direction, of the
agency providing the funds. Research performed under contract is more closely
controlled by the agency than research performed under a grant.
CONTRAINDICATED Disadvantageous, perhaps dangerous; a treatment that should
not be used in certain individuals or conditions due to risks (e.g., a drug
may be contraindicated for pregnant women and persons with high blood pressure).
CONTROL (SUBJECTS) or CONTROLS Subject(s) 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 study. Control conditions may be concurrent
(occurring more or less simultaneously with the condition under study) or historical
(preceding the condition under study). When the present condition of subjects
is compared with their own condition on a prior regimen or treatment, the study
is considered historically controlled.
CORRELATION COEFFICIENT A statistical index of the degree of relationship between
two variables. Values of correlation coefficients range from -1.00 through
zero to +1.00. A correlation coefficient of 0.00 indicates no relationship
between the variables. Correlations approaching -1.00 or +1.00 indicate strong
relationships between the variables. However, causal inferences about the relationship
between two variables can never be made on the basis of correlation coefficients,
no matter how strong a relationship is indicated.
CROSSOVER DESIGN A type of clinical trial in which each participant experiences,
at different times, both the experimental and control therapy. For example,
half of the participants might be randomly assigned first to the control group
and then to the experimental intervention, while the other half would have
the sequence reversed.
DATA AND SAFETY MONITORING BOARD (DSMB) A committee of scientists, physicians,
statisticians, and others that collects and analyzes data during the course
of a clinical trial to monitor for adverse effects and other trends (such as
an indication that one treatment is significantly better than another, particularly
when one arm of the trial involves a placebo control) that would warrant modification
or termination of the trial or notification of subjects about new information
that might affect their willingness to continue in the trial.
Further
Guidance on a DSMB for Phase I and II Trials,
NIH Announcement, June 5, 2000
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DATA USE AGREEMENTS Data for a Limited Data Set must be
collected according to the terms of “an agreement into which the covered entity enters with
the intended recipient of a limited data set that establishes the ways in which
the information in the limited data set may be used and how it will be protected.” The
data use agreement is the means by which a covered entity obtains satisfactory
assurance that the recipient of the limited data set will use or disclose
the PHI in the data set only for specific purposes.
DEAD FETUS An expelled or delivered fetus that exhibits no heartbeat, spontaneous
respiratory activity, spontaneous movement of voluntary muscles, or pulsation
of the umbilical cord (if still attached) [45 CFR 46.203(f)]. Generally, some
organs, tissues, and cells (referred to collectively as fetal tissue) remain
alive for varying periods of time after the total organism is dead.
DEBRIEFING Giving participants previously undisclosed information about the
research project following completion of their participation in research. (Note
that this usage, which occurs within the behavioral sciences, departs from
standard English, in which debriefing is obtaining rather than imparting information.)
DECLARATION OF HELSINKI A code of ethics for clinical research approved by
the World Medical Association in 1964 and widely adopted by medical associations
in various countries. It was revised in 1975 and 1989.
DEPARTMENT OF HEALTH, EDUCATION AND WELFARE (DHEW) A federal agency, reorganized
in 1980 as the Department of Health and Human Services (DHHS) and the Department
of Education.
DEPARTMENT OF HEALTH AND HUMAN SERVICES (DHHS) A federal agency, formerly the
Department of Health, Education and Welfare (DHEW).
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).
DESCRIPTIVE STUDY Any study that is not truly experimental (e.g., quasi-experimental
studies, correlational studies, record reviews, case histories, and observational
studies).
DIAGNOSTIC (PROCEDURE) Tests used to identify a disorder or disease in a living
person.
DOUBLE-MASKED DESIGN A study design in which neither the investigators nor
the subjects know the treatment group assignments of individual subjects. Sometimes
referred to as "double-blind."
DRUG Any chemical compound that may be used on or administered to humans as
an aid in the diagnosis, treatment, cure, mitigation, or prevention of disease
or other abnormal conditions.
EMANCIPATED MINOR A legal status conferred upon persons who have not yet attained
the age of legal competency as defined by state law (for such purposes as consenting
to medical care), but who are entitled to treatment as if they had by virtue
of assuming adult responsibilities such as being self-supporting and not living
at home, marriage, or procreation.
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EMBRYO Early stages of a developing organism, broadly
used to refer to stages immediately following fertilization of an egg through
implantation and very early pregnancy (i.e., from conception to the eighth
week of pregnancy).
EPIDEMIOLOGY A scientific discipline that studies the factors determining
the causes, frequency, and distribution of diseases in a community or given
population.
EQUITABLE Fair or just; used in the context of selection of subjects to indicate
that the benefits and burdens of research are fairly distributed [Federal Policy • ˜ .
11 1 (a)].
ETHICS ADVISORY BOARD An interdisciplinary group that advises the Secretary,
HHS, on general policy matters and on research proposals (or classes of proposals)
that pose ethical problems.
ETHNOGRAPHIC RESEARCH Ethnography is the study of people and their culture.
Ethnographic research, also called fieldwork, involves observation of and interaction
with the persons or group being studied in the group's own environment, often
for long periods of time.
EXPANDED AVAILABILITY Policy and procedure that permits individuals who have
serious or life-threatening diseases for which there are no alternative therapies
to have access to investigational drugs and devices that may be beneficial
to them. Examples of expanded availability mechanisms include Treatment INDs,
Parallel Track, and open study protocols.
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. Federal
rules permit expedited review for certain kinds of research involving no more
than minimal risk and for minor changes in approved research [Federal Policy §46.110]. Expedited Categories
EXPERIMENTAL Term often used to denote a therapy (drug, device, procedure)
that is unproven or not yet scientifically validated with respect to safety
and efficacy. A procedure may be considered "experimental" without
necessarily being part of a formal study (research) to evaluate its usefulness.
EXPERIMENTAL STUDY A true experimental study is one in which participants are
randomly assigned to groups that experience carefully controlled interventions
manipulated by the experimenter according to a strict logic allowing causal
inference about the effects of the interventions under investigation.
FALSE NEGATIVE When a test wrongly shows an effect or condition to be absent
(e.g., that a woman is not pregnant when, in fact, she is).
FALSE POSITIVE When a test wrongly shows an effect or condition to be present
(e.g. that is woman is pregnant when, in fact, she is not).
FEDERAL POLICY (THE) The federal policy that provides regulations for the
involvement of human subjects in research. The Policy applies to all research
involving human subjects conducted, supported, or otherwise subject to regulation
by any 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. (Also known as the "Common Rule.")
FEDERAL WIDE ASSURANCE (FWA) OF PROTECTIONS FOR HUMAN
SUBJECTS (FWA) is submitted
to OHRP in which an institution promises to comply with applicable regulations
governing research with human subjects and stipulates the procedures through
which compliance will be achieved.
FETAL MATERIAL The placenta, amniotic fluid, fetal membranes, and umbilical
cord.
FETUS The product of conception from the time of implantation until delivery.
If the delivered or expelled fetus is viable, it is designated an infant [45
CFR 46.203(c)]. The term "fetus" generally refers to later phases
of development; the term "embryo" is usually used for earlier phases
of development.
FIELDWORK Behavioral, social, or anthropological research involving the study
of persons or groups in their own environment and without manipulation for
research purposes (distinguished from laboratory or controlled settings).
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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 sponsor planning
to market such a device must submit notification to the FDA 90 days in advance
of placing the device on the market. If the FDA concurs with the sponsor, the
device may then be marketed. 510(k) is the section of the Food, Drug and Cosmetic
Act that describes premarket notification; hence the designation "510(k)
device."
FOOD AND DRUG ADMINISTRATION (FDA) An agency of the federal government, established
by Congress in 1912 and presently part of the Department of Health and Human
Services.
FULL BOARD REVIEW Review of proposed research at a convened
meeting at which a majority of the membership of the IRB are present, including
at least one member whose primary concerns are in nonscientific areas. For
the research to be approved, it must receive the approval of a majority of
those members present at the meeting [Federal Policy • ˜ . 1081.
GENE THERAPY The treatment of genetic disease
accomplished by altering the genetic structure of either somatic (non-reproductive)
or germline (reproductive) cells.
GENOTYPE The genetic constitution of an individual.
GENERAL ASSURANCE Obsolete term, previously used to denote an institutional
assurance covering multiple research projects.
GENERAL CONTROLS Certain FDA statutory provisions designed to control the
safety of marketed drugs and devices. The general controls include provisions
on adulteration, misbranding, banned devices, good manufacturing practices,
notification and record keeping, and other sections of the Medical Device Amendments
to the Food, Drug and Cosmetic Act [21 U.S. Code §360(c) (Food, Drug and
Cosmetic Act §513)].
GENETIC SCREENING Tests to identify persons who have an inherited predisposition
to a certain phenotype or who are at risk of producing offspring with inherited
diseases or disorders.
GRANT Financial support provided for 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.
GUARDIAN An individual who is authorized under applicable state or local law
to give permission on behalf of a child to general medical care [45 CFR 46.402(3)].
HEALTH INSURANCE PORTABILITY & ACCOUNTABILITY ACT (HIPAA) Passed in 1996,
Public Law 104-191 is a federal law that allows a person to keep his/her health
insurance when changing jobs, hence the "portability." It also imposes
new requirements on the disclosure of protected health information (PHI) for
research.
HISTORICAL CONTROLS Control participants (followed at some time in the past
or for whom data are available through records) who are used for comparison
with participants being treated concurrently. The study is considered historically
controlled when the present condition of participants is compared with their
own condition on a prior regimen or treatment.
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HUMAN IN VITRO FERTILIZATION Any fertilization involving human sperm and ova
that occurs outside the human body.
HUMAN SUBJECTS Individuals whose physiologic or behavioral
characteristics and responses are the object of study in a research project.
Under the federal regulations, human subjects are defined as: living individual(s)
about whom an investigator conducting research obtains: (1) data through intervention
or interaction with the individual; or (2) identifiable private information
[Federal Policy • ˜ . I 02(f)].
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 [Federal Policy $1 16; 21 CFR
50.20 and 50.251].
IN VITRO Literally, "in glass"; used to refer to
processes that are carried out outside the living body, usually in the laboratory,
as distinguished from in vivo.
IN VIVO Literally, "in the living body;" processes, such as the
absorption of a drug by the human body, carried out in the living body rather
than in a laboratory (in vitro).
INDEPENDENT VARIABLES The conditions of an experiment that are systematically
manipulated by the investigator.
INSTITUTION (1) Any public or private entity or agency (including federal,
state, and local agencies) [Federal Policy • ˜ . 102(b)].
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). 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 (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 [Federal Policy • ˜ • ˜ .
102(g), - .108, . 1 0 9 ] .
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 [21 CFR 812.201].
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
(e.g., a psychiatric hospital, home, or school for the retarded).
INVESTIGATIONAL DEVICE EXEMPTION (IDE) Exemption from certain regulations
found in the Medical Device Amendments that allow shipment of unapproved devices
for use in clinical investigations [21 CFR 812.20].
INVESTIGATIONAL NEW DRUG OR DEVICE (IND) 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
[21 CFR 312.31]. Any interventions (e.g., drugs) involved in the study are
administered to subjects under the immediate direction of the investigator.
JUSTICE An ethical principle discussed in the Belmont Report requiring fairness
in distribution of burdens and benefits; often expressed in terms of treating
persons of similar circumstances or characteristics similarly.
KEY PERSONNEL All individuals responsible for the design and conduct of the
study. This includes staff who interact with subjects and/or handle identifiable
data.
LACTATION The period of time during which a woman is providing her breast milk
to an infant or child.
LEGALLY AUTHORIZED REPRESENTATIVE (LAR) A person authorized either by statute
or by court appointment to make decisions on behalf of another person. In human
subjects research, 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 [Federal Policy • ˜ .
102(c)].
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LIMITED DATA SETS (LDS) Concerning the type of data collected,
Limited Data Sets contain “PHI that excludes 16 categories of direct identifiers and
may be used or disclosed, for purposes of research, public health, or health
care operations, without obtaining either an individual’s Authorization
or a waiver or an alteration of Authorization for its use and disclosure, with
a data use agreement.” A limited data set may include city; state; ZIP
code; elements of date; and other numbers, characteristics, or codes not listed
as direct identifiers. Direct identifiers listed in the Privacy Rule’s
limited data set provisions apply both to information about the individual
and to information about the individual’s relatives, employers, or
household members.
LOD SCORE An expression of the probability that a gene and a marker are linked.
LONGITUDINAL STUDY A study designed to follow subjects forward through time.
MASKED STUDY DESIGNS Study designs comparing two or more interventions in which
either the investigators, the participants, or some combination thereof do
not know the treatment group assignments of individual participants. Sometimes
called "blind" study designs.
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.
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. Such devices include diagnostic test kits, crutches, electrodes, pacemakers,
arterial grafts, intraocular lenses, and orthopedic pins or other orthopedic
equipment.
MEDICAL DEVICE AMENDMENTS (MDA) Amendments to the Federal Food, Drug and Cosmetic
Act passed in 1976 to regulate the distribution of medical devices and diagnostic
products.
METABOLISM (of a drug) The manner in which a drug is acted upon (taken up,
converted to other substances, and excreted) by various organs of the body.
MINIMAL RISK A risk is 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 [Federal
Policy • ˜ . 1 0 2 ( i ) ] . For example, the risk of drawing a
small amount of blood from a healthy individual for research purposes is no
greater than the risk of doing so as part of routine physical examination.
The definition of minimal risk for research involving prisoners differs somewhat
from that given for noninstitutionalized adults. [See 45 CFR 46.303(d) and
Guidebook Chapter 6,Section E, "Prisoners. '1
MONITORING The collection and analysis of data as the project progresses to
assure the appropriateness of the research, its design and subject protections.
NIH National Institutes of Health: a federal agency within the Public Health
Service, DHHS, comprising 21 institutes and centers. It is responsible for
carrying out and supporting biomedical and behavioral research.
NATIONAL COMMISSION National Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research. An interdisciplinary advisory body,
established by Congressional legislation in 1974, which was in existence until
1978, and which issued a series of reports and recommendations on ethical issues
in research and medicine, many of which are now embodied in federal regulations.
NATIONAL INSTITUTES OF HEALTH (NIH) National Institutes of Health: a federal
agency within the Public Health Service, DHHS, comprising 27 institutes and
centers. It is responsible for carrying out and supporting biomedical and behavioral
research.(www.nih.gov)
NEW DRUG APPLICATION (NDA) Request for FDA approval to market a new drug.
NONAFFILIATED MEMBER Member of an Institutional Review Board who has no ties
to the parent institution, its staff, or faculty. This individual is usually
from the local community (e.g., minister, business person, attorney, teacher,
homemaker).
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NONSIGNIFICANT RISK DEVICE An investigational medical device
that does not present significant risk to the patient.
NONTHERAPEUTIC RESEARCH Research that has no likelihood or intent of producing
a diagnostic, preventive, or therapeutic benefit to the current participants,
although it may benefit subjects with a similar condition in the future.
NONVIABLE FETUS An expelled or delivered fetus which, although it is living,
cannot possibly survive to the point of sustaining life independently, even
with the support of available medical therapy [45 CFR 46.203 (d) and (e)].
Although it may be presumed that an expelled or delivered fetus is nonviable
at a gestational age less than 20 weeks and weight less than 500 grams [Federal
Register 40 (August 8, 1975): 33552], a specific determination as to viability
must be made by a physician in each instance.
NORMAL VOLUNTEERS Volunteer subjects used to study normal physiology and behavior
or who do not have the condition under study in a particular protocol, used
as comparisons with subjects who do have the condition. "Normal" may
not mean normal in all respects. For example, patients with broken legs (if
not on medication that will affect the results) may serve as normal volunteers
in studies of metabolism, cognitive development, and the like. Similarly, patients
with heart disease but without diabetes may be the "normals" in a
study of diabetes complicated by heart disease.
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 Nazi
war criminals following World War I1 and widely adopted as a standard during
the 1950s and 1960s for protecting human subjects.
OHRP - OFFICE OF HUMAN RESEARCH
PROTECTIONS The office within the National Institutes of Health, an agency
of the Public Health Service, Department of Health and Human Services, responsible
for implementing DHHS regulations (45 CFR Part 46) governing research involving
human subjects.
OFFICE FOR HUMAN RESEARCH PROTECTIONS (OHRP) The office within the National
Institutes of Health, an agency of the Public Health Service, Department of
Health and Human Services, responsible for implementing DHHS regulations (45
CFR Part 46) governing research involving human subjects. Formerly known as
the Office for Human Research Protections (OHRP). (ohrp.osophs.dhhs.gov)
OFFICE FOR PROTECTION FROM RESEARCH RISKS (OPRR)
Former name of the Office for Human Research Protections (OHRP)
OPEN DESIGN An experimental design in which both the investigator(s) and the
participants know the treatment group(s) to which participants are assigned.
PERMISSION The agreement of parent(s) or guardian to the participation of their
child or ward in research [45 CFR 46.402(c)].
PATERNALISM Making decisions for others against or apart from their wishes
with the intent of doing them good.
PERMISSION The agreement of parent(s) or guardian to the participation of
their child or ward in research [45 CFR 46.402(c)].
PHARMACOLOGY The scientific discipline that studies the action of drugs on
living systems (animals or human beings).
PHASE 1, 2, 3,4 DRUG TRIALS Different stages of testing drugs in humans, from
first application in humans (Phase I ) through limited and broad clinical tests
(Phase 3), to post-marketing studies (Phase 4).
PHASE 1 DRUG TRIAL Phase 1 trials include the initial introduction of an investigational
new drug into humans. These studies are typically conducted with healthy volunteers;
sometimes, where the drug is intended for use in patients with a particular
disease, however, such patients may participate as subjects. Phase 1 trials
are designed to determine the metabolic and pharmacological actions of the
drug in humans, the side effects associated with increasing doses (to establish
a safe dose range), and, if possible, to gain early evidence of effectiveness;
they are typically closely monitored. The ultimate goal of Phase 1 trials is
to obtain sufficient information about the drug's pharmacokinetics and pharmacological
effects to permit the design of well-controlled, sufficiently valid Phase 2
studies. Other examples of Phase 1 studies include studies of drug metabolism,
structure-activity relationships, and mechanisms of actions in humans, as well
as studies in which investigational drugs are used as research tools to explore
biological phenomena or disease processes. The total number of subjects involved
in Phase 1 investigations is generally in the range of 20-80.
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PHASE 2 DRUG TRIAL Phase 2 trials include controlled clinical
studies conducted to evaluate the drug's effectiveness for a particular indication
in patients with the disease or condition under study, and to determine the
common short-term side effects and risks associated with the drug. These
studies are typically well-controlled, closely monitored, and conducted with
a relatively small number of patients, usually involving no more than several
hundred subjects.
PHASE 3 DRUG TRIAL Phase 3 trials involve the administration
of a new drug to a larger number of patients in different clinical settings
to determine its safety, efficacy, and appropriate dosage. They are performed
after preliminary evidence of effectiveness has been obtained, and are intended
to gather necessary additional information about effectiveness and safety
for evaluating the overall benefit-risk relationship of the drug, and to
provide and adequate basis for physician labeling. In Phase 3 studies, the
drug is used the way it would be administered when marketed. When these studies
are completed and the sponsor believes that the drug is safe and effective
under specific conditions, the sponsor applies to the FDA for approval to
market the drug. Phase 3 trials usually involve several hundred to several
thousand patient-subjects.
PHASE 4 DRUG TRIAL Concurrent with marketing approval, FDA
may seek agreement from the sponsor to conduct certain postmarketing (Phase
4) studies to delineate additional information about the drug's risks, benefits,
and optimal use. These studies could include, but would not be limited to,
studying different doses or schedules of administration than were used in
Phase 2 studies, use of the drug in other patient populations or other stages
of the disease, or use of the drug over a longer period of time [21 CFR 9312.851].
PHENOTYPE The physical manifestation of a gene function.
PUBLIC HEALTH SERVICE (PHS) Part of the U.S. Department of Health
and Human Services, it includes FDA, NIH, CDC, SAMHSA, and HRSA.
PLACEBO A chemically inert substance given in the guise
of medicine for its psychologically suggestive effect; used in controlled
clinical trials to determine whether improvement and side effects may reflect
imagination or anticipation rather than actual power of a drug.
POSTAMENDMENTS DEVICES Medical devices marketed after enactment
of the 1976 Medical Device Amendments.
PREAMENDMENTS DEVICES Medical devices marketed before enactment of the 1976
Medical Device Amendments.
PRECLINICAL INVESTIGATIONS Laboratory and animal studies designed to test
the mechanisms, safety, and efficacy of an intervention prior to its applications
to humans.
PREDICATE DEVICES Currently legally marketed devices to which new devices
may be found substantially equivalent under the 510(k) process.
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). Implantation is confirmed through a presumptive sign of pregnancy
such as missed menses or a positive pregnancy test [45 CFR 46.203(b)]. This "confirmation" may
be in error, but, for research purposes, investigators would presume that a
living fetus was present until evidence to the contrary was clear. Although
fertilization occurs a week or more before implantation, the current inability
to detect the fertilization event or the presence of a newly fertilized egg
makes a definition of pregnancy based on implantation necessary.
PREMARKET APPROVAL Process of scientific and regulatory review by the FDA
to ensure the safety and effectiveness of Class III devices.
PRESIDENT'S COMMISSION President's Commission for the Study of Ethical Problems
in Medicine and Biomedical and Behavioral Research. An interdisciplinary advisory
group, established by congressional legislation in 1978, which was in existence
until 1983, and which issued reports on ethical problems in health care and
in research involving human subjects.
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 statue; (2) detained pending
arraignment, trial, or sentencing; and (3) detained in other facilities (e.g.,
for drug detoxification or treatment of alcoholism) under statutes or commitment
procedures providing such alternatives to criminal prosecution or incarceration
in a penal institution [45 CFR 46.303(c)].
PRIVACY Control over the extent, timing, and circumstances of sharing oneself
(physically, behaviorally, or intellectually) with others.
PROPHYLACTIC Preventive or protective; a drug, vaccine, regimen, or device
designed to prevent, or provide protection against, a given disease or disorder.
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PROBAND The person whose case serves as the stimulus for the study of other
members of the family to identify the possible genetic factors involved in
a given disease, condition, or characteristic.
PROSPECTIVE STUDIES Studies designed to observe outcomes or events that occur
subsequent to the identification of the group of subjects to be studied. Prospective
studies need not involve manipulation or intervention but may be purely observational
or involve only the collection of data.
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.
PURITY The relative absence of extraneous matter in a drug or vaccine that
may or may not be harmful to the recipient or deleterious to the product.
QUASI-EXPERIMENTAL STUDY A study that is similar to a true experimental study
except that it lacks random assignments of participants to treatment groups.
RADIOACTIVE DRUG Any substance defined as
a drug in §201(b)(1) of the
Federal Food, Drug and Cosmetic Act that exhibits spontaneous disintegration
of unstable nuclei with the emission of nuclear particles or photons [21 CFR
310.3(n)]. Included are any nonradioactive reagent kit or nuclide generator
that is intended to be used in the preparation of a radioactive drug and "radioactive
biological products," as defined in 21 CFR 600.3(ee). Drugs such as carbon-containing
compounds or potassium-containing salts containing trace quantities of naturally
occurring radionuclides are not considered radioactive drugs.
RADIOACTIVE DRUG RESEARCH COMMITTEE (RDRC) An institutional committee responsible
for the use of radioactive drugs in human participants for research purposes.
Research involving human participants that proposes to use radioactive drugs
must meet various FDA requirements, including limitations on the pharmacological
dose and the radiation dose. Furthermore, the exposure to radiation must be
justified by the quality of the study and the importance of the information
it seeks to obtain. The committee is also responsible for continuing review
of the drug use to ensure that the research continues to comply with FDA requirements,
including reporting obligations. The committee must include experts in nuclear
medicine and the use of radioactive drugs, as well as other medical and scientific
members [21 CFR 36.1].
RADIOPAQUE CONTRAST AGENTS Materials that stop or attenuate radiation that
is passed through the body, creating an outline on film of the organ(s) being
examined. Contrast agents, sometimes called "dyes," do not contain
radioisotopes. When such agents are used, exposure to radiation results only
from the X-ray equipment used in the examination. The chemical structure of
radiopaque contrast agents can produce a variety of adverse reactions, some
of which may be severe — and possibly life-threatening — in certain
individuals.
RADIOPHARMACEUTICALS Drugs (compounds or materials) that may be labeled or
tagged with a radioisotope. These materials are largely physiological or subpharmacological
in action, and, in many cases, function much like materials found in the body.
The principal risk associated with these materials is the consequent radiation
exposure to the body or to specific organ systems when they are injected into
the body.
RANDOM (also Random Assignment, Randomization, Randomized) Assignment of participants
to different treatments, interventions, or conditions according to chance rather
than systematically (e.g., as dictated by the standard or usual response to
their condition, history, or prognosis, or according to demographic characteristics).
Random assignment of participants 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.
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RECOMBINANT DNA TECHNOLOGY "The ability to chop up DNA, the stuff of which
genes are made, and move the pieces, [which] permits the direct examination
of the human genome," and the identification of the genetic components
of a wide variety of disorders [Holtzman (1989), p. I]. Recombinant DNA technology
is also used to develop diagnostic screens and tests, as well as drugs and
biologics for treating diseases with genetic components. See Guidebook Chapter
5, Section H, "Human Genetic Research."
REMISSION A period in which the signs and symptoms of
a disease are diminished or in abeyance. The term "remission" is
used when one cannot say with confidence that the disease has been cured.
REMUNERATION Payment for participation in research. (NOTE: It is wise to confine
use of the term "compensation" to payment or provision of care for
research-related injuries.)
RESEARCH A systematic investigation (ie., the gathering and analysis of information)
designed to develop or contribute to generalizable knowledge [Federal Policy •˜-.
102(d)].
RESPECT FOR PERSONS An ethical principle discussed in the Belmont Report requiring
that individual autonomy be respected and that persons with diminished autonomy
be protected.
RETROSPECTIVE STUDIES Research conducted by reviewing records from the past
(e.g., birth and death certificates, medical records, school records, or employment
records) or by obtaining information about past events elicited through interviews
or surveys. Case control studies are an example of this type of research.
REVIEW (OF RESEARCH) The concurrent oversight of research on a periodic basis
by an IRB. In addition to the at least annual reviews mandated by the federal
regulations, reviews may, if deemed appropriate, also be conducted on a continuous
or periodic basis [Federal Policy $ . 108(e)].
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."
ROENTGEN EQUIVALENT IN MAN (REM) The unit of measurement for a dose of an ionizing
radiation that produces the same biological effect as a unit of absorbed does
(1 rad) of ordinary X-rays. One millirem is equal to 1/1000 of a rem.
SCIENTIFIC REVIEW GROUP A group of highly regarded experts in a given field,
convened by NIH to advise NIH on the scientific merit of applications for research
grants and contracts. Scientific review groups are also required to review
the ethical aspects of proposed involvement of human participants. Various
kinds of scientific review groups exist, and are known by different names in
different institutes of the NIH (e.g., Study Sections, Initial Review Groups,
Contract Review Committees, or Technical Evaluation Committees).
SECRETARY A U.S. Cabinet Officer. In the context of DHHS-conducted or -supported
research, usually refers to the Secretary of Health and Human Services.
SIGNIFICANT RISK DEVICE An investigational medical device that presents a
potential for serious risk to the health, safety, or welfare of the subject.
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."
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SITE VISIT A visit by agency officials, representatives,
or consultants to the location of a research activity to assess the adequacy
of IRB protection of human subjects or the capability of personnel to conduct
the research.
SOCIAL EXPERIMENTATION Systematic manipulation of, or experimentation in,
social or economic systems; used in planning public policy.
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.
The drug is administered to subjects under the immediate direction of an investigator
who is not also a sponsor. A clinical investigator may, however, serve as a
sponsor-investigator. The sponsor assumes responsibility for investigating
the new drug, .including responsibility for compliance with applicable laws
and regulations. The sponsor, for example, is responsible for obtaining FDA
approval to conduct a trial and for reporting the results of the trial to the
FDA.
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.
STATISTICAL SIGNIFICANCE A determination of the probability of obtaining the
particular distribution of the data on the assumption that the null hypothesis
is true. Or, more simply put, the probability of coming to a false positive
conclusion. [See McLarty (1987), p. 2.1 If the probability is less than or
equal to a predetermined value (e.g., 0.05 or 0.01), then the null hypothesis
is rejected at that significance level (0.05 or 0.01).
STERILITY (1) The absence of viable contaminating microorganisms; aseptic state.
STERILITY (2) The inability to procreate; the inability to conceive or induce
conception.
SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION
(SAMSHA) Includes
the Center for Substance Abuse Prevention, the Center for Substance Abuse Treatment
and the Center on Mental Health Services. Formerly the Alcohol, Drug Abuse,
and Mental Health Administration (ADAMHA). (www.samhsa.gov/)
SURVEYS Studies designed to obtain information from a large number of respondents
through written questionnaires, telephone interviews, door-to-door canvassing,
or similar procedures.
THERAPEUTIC INTENT The research physician's intent to provide some benefit
to improving a subject's condition (e.g., prolongation of life, shrinkage of
tumor, or improved quality of life, even though cure or dramatic improvement
cannot necessarily be effected.) This term is sometimes associated with Phase
1 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.
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THERAPY Treatment intended and expected to alleviate a disease or disorder.
UNIFORM ANATOMICAL GIFT ACT Legislation adopted by all 50 States and the District
of Columbia that indicates procedures for donation of all or part of a decedent's
body for such activities as medical education, scientific research, and organ
transplantation.
VACCINE A biologic product generally made from an infectious agent or its components
- a virus, bacterium, or other microorganism -that is killed (inactive) or
live-attenuated (active, although weakened). Vaccines may also be biochemically
synthesized or made through recombinant DNA techniques.
VOLUNTARY Free of coercion, duress, or undue inducement. Used in the research
context to refer to a subject's decision to participate (or to continue to
participate) in a research activity.
Acronyms
A | B | C | D | E | F | G | H | I |
J | K | L | M | N |
O | P | Q | R | S | T |
U | V | W | X | Y | Z
ADAMHA
Alcohol, Drug Abuse, and Mental Health Administration
Reorganized in October 1992 as the Substance Abuse and Mental Health Services
Administration (SAMHSA).
AE
Adverse Effect or Adverse Event
AIL
Authorized Institutional Official
CAT Scan
Computerized Axial Tomography
CDC
Centers for Disease Control and Prevention
CFR
Code of Federal Regulations
CHMC
Children’s Hospital and Medical Center
CITI
Collaborative IRB Training Initiative
CRF
Case Report Form
CRL
Children’s Risk Level
CRC/GCRC
Clinical Research Center/General Clinical Research Center
CRO
Contract Research Organization or Clinical Research Organization
DSMB
Data and Safety Monitoring Board
DHEW
U.S. Department of Health, Education and Welfare
Reorganized in 1980 as the Department of Health and Human Services (DHHS) and
the Department of Education.
DHHS
U.S. Department of Health and Human Services
FDA
U.S. Food and Drug Administration
FHCRC
Fred Hutchinson Cancer Research Center
FWA
Federalwide Assurance (USDHHS)
GCS
Grants & Contract Services (Renamed OSP, Office of Sponsored Programs.)
HIPAA
Health Insurance Portability and Accountability Act of 1996
HMC
Harborview Medical Center
HRSA
Health Resources and Services Administration (www.hrsa.gov)
IBC
Institutional Biosafety Committees
ICF or CF
Informed Consent Form or Consent Form
IDE
Investigational Device Exemption
IND
Investigational New Drug or Device (FDA)
IRB
Institutional Review Board
LAR
Legally Authorized Representative
LDS
Limited Data Sets
MDA (s)
Medical Device Amendments
MPA
Multiple Project Assurance
MTA
Materials Transfer Agreement
NIH
National Institutes of Health
NDA
New Drug Application
NSF
National Science Foundation
OHRP
Office for Human Research Protection
OPRR
Office for Protection from Research Risks (Renamed OHRP.)
OSP
Office of Sponsored Programs (formerly GCS, Grants and Contract Services.)
PHS
U.S. Public Health Service
RDRC
Radioactive Drug Research Committee
REM
Roentgen Equivalent in Man
RSC
Radiation Safety Committee
SAE
Serious Adverse Event
SPA
Single Project Assurance
VA
Veterans Affairs
VAPSHCS
Veterans Affairs Puget Sound Health Care System
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