IRB Glossary
A
Administratively Closed
Administrative decision of the IRB based on PI non-responsiveness to IRB requests.
This can occur prior to initial IRB approval or any time following IRB approval.
Adverse Effect
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).
Adverse Event (AE)
Any untoward physical or psychological occurrence in a human subject participating
in research. An AE can be any unfavorable or unintended event including an abnormal
laboratory finding, a symptom or disease associated with the research or the use of
a medical investigational test article. An AE does not necessarily have to have a
causal relationship with the research, or any risk associated with the research or
the research intervention, or the assessment.
Approved
The IRB has reviewed the study and made a determination that the study has met all
requirements. Subjects may be enrolled in the study.
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. Mere failure to
object to the research may not be construed as assent.
Assurance
A written, binding commitment that is submitted to a federal agency in which an entity
promises to comply with applicable regulations governing research with human subjects
and stipulates the procedures through which compliance will be achieved.
Federal-Wide Assurance (FWA)
An agreement between a federally-funded entity and OHRP that stipulates methods by
which the entity will protect research participants (66 Fed Reg 19139, 19141 April
13, 2001).
Multiple Project Assurance (MPA)
An agreement between an entity and OPRR that stipulates the methods by which the entity
will protect the rights and welfare of research participants. Under OHRP, MPAs will
be replaced by FWAs.
Audit
A systematic and independent examination of trial-related activities and documents
to determine whether the evaluated trial-related activities were conducted, and the
data were recorded, analyzed, and accurately reported according to the protocol, sponsor's
standard operating procedures (SOPs), good clinical practice (GCP), and the applicable
regulatory requirement(s).
Authorized Official
An officer of an entity with the authority to speak for and legally commit the entity
to comply with requirements of the federal regulations regarding the involvement of
human subjects in biomedical and behavioral research.
Authorized Representative
A person authorized to make decisions on behalf of another person. In human subjects
research, an individual or judicial or other body may be authorized to consent on
behalf of a prospective subject to the subject's participation in the procedure(s)
involved in the research.
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.
Benefit
A valued or desired outcome; an advantage.
Biologic
Any therapeutic serum, toxin, anti-toxin, or analogous microbial produce applicable
to the prevention, treatment, or cure of diseases or injuries.
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.
C
Case Report Form (CRF)
A printed, optical, or electronic document designed to record all of the protocol-required
information to be reported to the sponsor on each trial subject.
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)].
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.
Closure
See Study Closure.
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.
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. See also Incompetence, Incapacity.
Compliance
Adherence to all the trial-related requirements, good clinical practice (GCP) requirements,
and the applicable regulatory and institutional requirements.
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.
Conflict of Interest Committee
See TTUHSC OP 10.8.
Consent
See Informed Consent.
Continuing Review
Periodic review of a research study by an IRB to evaluate whether risks to participants
are reasonable in relation to potential benefits and to verify that the study continues
to meet regulatory and institutional requirements. Continuing review shall be conducted
at intervals appropriate to the degree of risk but not less than once per year. [45 CFR 46.109(e); 21 CFR 56.109(f)]
Contract
An agreement; as used here, an agreement that a specific research activity will be
performed at the request, and under the direction, of an entity providing funds. Research
performed under the contract is more closely controlled by the entity than research
performed under a grant.
Data and Safety Monitoring Board
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.
Device (medical)
See Medical Device.
DHHS
A federal agency: U.S. Department of Health and Human Services; formerly the Department
of Health, Education and Welfare (DHEW).
Disapproved
The IRB has reviewed the study and determined that it is not approved and may not
receive further review.
Documentation
All records, in any form (including, but not limited to, written, electronic, magnetic,
and optical records; and scans, x-rays, and electrocardiograms) that describe or record
the methods, conduct, and/or results of a trial, the factors affecting a trial, and
the actions taken.
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.
E
Entity
An organization, institution or being that has its own existence for legal or tax
purposes. Legally separate from TTUHSC and possesses OHRP-approved assurances and
IRB agreements with TTUHSC.
Exempt Research
Exempt research is research determined by the IRB to involve human subjects only in
one or more of certain minimal risk categories [38 CFR 16.101(b)].
Equitable
Fair or just; used in the context of selection of subjects to indicate that the benefits
and burdens of research are fairly distributed.
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.
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.
FDA
Food and Drug Administration; an agency of the federal government established by Congress
in 1912 and presently part of the Department of Health and Human Services.
Fetus
The product of conception from implantation until delivery [45 CFR 46.202].
Full Board Review
Review of proposed research at a convened meeting at which a majority of the voting
membership of the IRB is 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 voting members present at the meeting.
Federal-Wide Assurance (FWA)
See Assurance.
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)].
HIPAA
Health Insurance Portability and Accountability Act of 1996.
Human In-vitro Fertilization
Any fertilization involving human sperm and ova that occurs outside the human body.
Human Research Protection Office (HRPO)
Office responsible for the oversight and direction of the human research protection
program at TTUHSC, which includes administrative oversight of the IRB, the TTUHSC
Research Compliance Program and the TTUHSC educational requirements for human research.
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.
I
IDE
See Investigational Device Exemptions.
Incapacity
Refers to a person's mental status and means inability to understand information presented,
to appreciate the consequences of acting (or not acting) on that information, and
to make a choice. Often used as a synonym for incompetence. See also Incompetence.
Incompetence
Technically, a legal term meaning inability to manage one's own affairs. Often used
as a synonym for incapacity. See also Incapacity.
IND
See Investigational New Drug.
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 entity or agents thereof from liability for negligence.
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).
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.
Investigational Product
A device or pharmaceutical form of an active ingredient or placebo being tested or
used as a reference in a clinical trial, including a product with a marketing authorization
when used or assembled (formulated or packaged) in a way different from the approved
form, or when used for an unapproved indication, or when used to gain further information
about an approved use.
Investigator's Brochure
A compilation of the clinical and nonclinical data on the investigational product(s)
which is relevant to the study of the investigational product(s) in human subjects.
In Vitro
Literally, in a glass or test tube; 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).
IRB
See Institutional Review Board.
IRB Records
IRB records include but are not limited to: all minutes of IRB meetings, a copy of
all proposals reviewed including all amendments, investigator brochures, and any supplemental
information including recruitment and informational materials, consent forms, information
submitted for continuing review, all correspondence, and IRB membership with a resume
for each member.
iRIS
Internet Medical Research Information System -- the software through which all IRB
applications, reviews and approvals are submitted and through which information is
communicated between investigators and the IRB.
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.
Legally Authorized Representative
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.
M
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.
Minimal Risk
Minimal risk means that the probability and magnitude of harm or discomfort anticipated
in the research are not greater in and of themselves than those ordinarily encountered
in the participant's daily life or during the performance of routine physical or psychological
examinations or tests [45 CFR 46.102(i); 21 CFR 50.3(k)]. In research involving prisoners, minimal risk is also defined as the probability
and magnitude of physical or psychological harm that is normally encountered in the
daily lives, or in the routine medical, dental, or psychological examination of healthy
persons. [45 CFR 46.303(d)].
Monitoring
The collection and analysis of data as the project progresses to assure the appropriateness
of the research, its design and subject protections.
Multiple Project Assurance (MPA)
See Assurance.
Non-Affiliated Member
Member of an IRB who has no ties to the parent entity, its staff or faculty. This
individual is usually from the local community (e.g., minister, business person, attorney, teacher, homemaker).
Office for Human Research Protections (OHRP)
The office within the U.S. Department of Health and Human Services that's responsible
for implementing DHHS regulations [45 CFR Part 46] governing research involving human
subjects.
Permission
Parent(s) or guardian's written agreement to the participation of their child or ward
in research.
PI
See Principal Investigator.
Pregnancy
The period of time from implantation until delivery. A woman shall be assumed to be
pregnant if she exhibits any of the pertinent presumptive signs of pregnancy, such
as missed menses, until the results of a pregnancy test are negative or until delivery
[45 CFR 46.202].
Principal Investigator
The scientist or scholar with ultimate responsibility for the design and conduct of
a research project.
Prisoner
Any individual involuntarily confined or detained in a penal entity. The term is intended
to encompass individuals sentenced to such an entity under a criminal or civil statute,
individuals detained in other facilities by virtue of statutes or commitment procedures
which provide alternatives to criminal prosecution or incarceration in a penal entity,
and individuals detained pending arraignment, trial, or sentencing.
Privacy Board
IRB or another review body which reviews requests to use or disclose Private Health
Information (PHI) for research purposes without authorization under HIPAA.
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.
Quorum
A quorum is defined as a majority of the voting members appointed to the IRB membership.
In the case of the IRB, a quorum must include at least one member whose primary concerns
are in non-scientific areas. At meetings of the IRB, a quorum must be established
and maintained for the deliberation and vote on all matters requiring a vote.
R
Request for Additional Information
The IRB has reviewed the study and has requested changes or clarifications.
Research
Systematic investigation, including research development, testing, and evaluation,
designed to develop or contribute to generalizable knowledge [45 CFR 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.
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.
Serious Adverse Event (SAE)
A SAE is defined as death; a life threatening experience; hospitalization (for a person
not already hospitalized); prolongation of hospitalization (for a patient already
hospitalized); persistent or significant disability or incapacity; congenital anomaly
and/or birth defects; or an event that jeopardizes the subject and may require medical
or surgical treatment to prevent one of the preceding outcomes.
Sponsor
A person or other entity that initiates a clinical investigation, but that does not
actually conduct the investigation, i.e., the test article is administered or dispensed
to, or used involving, a subject under the immediate direction of another individual.
A person other than an individual (e.g., a corporation or agency) that uses one or
more of its own employees to conduct an investigation that it has initiated is considered
to be a sponsor (not a sponsor-investigator) and the employees are considered to be
investigators.
Study
All components of a research project.
Study Closure
Study approved by the IRB can be closed by the investigator, the sponsor, the IRB,
TTUHSC, or by an affiliated entity. See Administratively Closed.
Study Completed
Study completed as approved by IRB, including data analysis, and finalized.
Suspension/Termination
IRB approval is suspended/terminated and all research activity halted as the result
of unanticipated problems involving risks to subjects or others; serious or continuing
noncompliance with 45 CFR Part 46; or the requirements or determinations of the IRB
(See Sections 5.6, 5.7). Requires prompt reporting to federal regulatory authorities
and TTUHSC pursuant to federal assurance and 45 CFR Part 46.
Survey
Studies designed to obtain information from a large number of respondents through
written questionnaires, telephone interviews, door-to-door canvassing, or similar
procedures.
Tabled
The IRB has reviewed the study and determined that extensive changes are necessary.
The study will be re-reviewed by once changes have been made.
Unexpected Adverse Event
An UAE is any adverse event and/or reaction, the specificity or severity of which
is not consistent with the informed consent, current investigator brochure or product
labeling. Further, it is not consistent with the risk information described in the
general investigational plan or proposal.
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.