IRB Glossary of Terms
The below-listed terms are provided as reference and to help inform
the CSUF faculty, staff and students regarding IRB terminology and
the CSUF IRB review process. Many of these terms have been extracted
from the Office for Human Research Protections (OHRP) IRB Guidebook
(Online Version) (2005) and may differ from the interpretation or
meaning as used for the general population. Adaptations to these
terms have been made as they relate to CSUF IRB as well.
ADVERSE EFFECT: An undesirable and unintended, although
not necessarily unexpected, result of therapy or other intervention
(e.g., headache following spinal tap or emotional distress following
an interview about family violence).
ANONYMITY: Collection of data from individuals wherein
no identifiers will be linked to the participant and therefore cannot
in any way be traced to the participant. "Anonymity"
and "confidentiality" do not have the same meaning and
are not interchangeable. Anonymous data collection means
that even the researcher does not know the identity of the subjects.
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.
An assent is typically paired with a parental consent form or permission
from a guardian, and together they comprise the informed consent
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. CSUF’s Assurance No. is FWA 00000135 and
was approved March 12, 2001.
AUTHORIZED INSTITUTIONAL OFFICIAL: 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.
At CSUF, the Authorized Institutional Official is President,
Dr. Milton A. Gordon.
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.
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.
CSUF's IRB application requests information about benefits as they
relate to research participants.
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 46.401(a)].
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 compromised in their ability to make
decisions in their best interests.
COMPENSATION: Payment or medical
care provided to subjects injured in research; does not refer to
payment (remuneration) for participation in research. (For comparison,
see also: Remuneration.)
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,
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. Confidential data collection means that
the researcher knows the identity of the subjects either directly
or through the use of a master list used for coding but will not
release identifying information when sharing the data with others.
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.
CO-PRINCIPAL INVESTIGATOR (CO-PI): The other primary scholar
or researcher involved in conducting the research; if the project
is for a thesis or dissertation, the student is the Co-PI.
DEBRIEFING: Giving subjects 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.
DESCRIPTIVE STUDY: Any study that is not truly experimental
(e.g., quasi-experimental studies, correlational, studies, record
reviews, case histories, and observational studies).
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.
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.
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
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.
Generalizable Knowledge: Information obtained from research
that can be applied outside of the population involved in the research
(i.e.) findings are analyzed and disseminated in a way so that findings
may be presented as new or beneficial to groups outside of the original
GUARDIAN: An individual who is authorized under applicable
state or local law to give permission on behalf of a child to general
HIPAA: the Health Insurance Portability and Accountability
Act of 1996 and the privacy regulations promulgated under the Act.
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.
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.
INCOMPETENCE: A legal term meaning inability to manage
one's own affairs, and often used as a synonym for incapacity.
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.
INSTITUTIONAL REVIEW BOARD (IRB): A specially constituted,
federally mandated review body established or designated by an entity
to protect the welfare of human subjects recruited to participate
in biomedical or behavioral research.
INVESTIGATOR: A researcher conducting the project.
Investigators can be Principal Investigators or Co-Principal Investigators.
Students are always Co-Principal Investigators.
LEGALLY AUTHORIZED REPRESENTATIVE: 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.
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. 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. Note: The
definition of minimal risk for research involving prisoners differs
somewhat from that given for non-institutionalized adults.
NUREMBERG CODE: A code of research ethics developed during
the trials of Nazi war criminals following World War II and widely
adopted as a standard during the 1950s and 1960s for protecting
OFFICE FOR PROTECTION FROM RESEARCH RISKS (OPRR): 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 46 Part 46) governing
research involving human subjects. In 2000 this office was
re-named the Office of Human Research Protection (OHRP).
OFFICE OF HUMAN RESEARCH PROTECTION (OHRP): The new name
of OPRR when it was elevated in 2000 to report to the Secretary
PERMISSION: The agreement of parent(s) or guardian to the
participation of their child or ward in research.
PRINCIPAL INVESTIGATOR (PI): The scientist or scholar with
primary responsibility for the design and conduct of a research
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. Note that this includes adjudicated
PRIVACY: Control over the extent, timing, and circumstances
of sharing oneself (physically, behaviorally, or intellectually)
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.
REMUNERATION: Payment for participation
in research. Remuneration should be appropriate for the amount
of effort involved, and not excessive and thereby coercive.
Remunerations are not considered a benefit.
RESEARCH: A systematic investigation (i.e., the gathering
and analysis of information) designed to develop or contribute to
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.
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." (See also: Minimal Risk.)
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.
SURVEYS: Studies designed to obtain
information from a large number of respondents through written questionnaires,
telephone interviews, door-to-door canvassing, or similar procedures.
VOLUNTARY: Free of coercion, duress,
or undue inducement or influence. Used in the research context to
refer to a subject's decision to participate (or to continue to
participate) in a research activity.