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Terms in this set (129)
Minimal Risk The probability of harm or discomfort...not
greater...than those ordinarily encountered in daily
life or during the performance of routine physical
or psychological examinations.
The Belmont Principles Respect for persons, beneficence, and justice
IRB An administrative body composed of scientists and
nonscientists established to protect the rights and
welfare of human research subjects recruited to
participate in research activities conducted under
the auspices of the institution with which it is
affiliated.
Institutional Official (IO) The person who signs the OHRP Federalwide
Assurance and has the legal authority to act and
speak for the institution, and should be somone
who can ensure that the institution will effectively
fulfill its research oversight function.
,OHRP Charged with monitoring and promoting
compliance with DHHS regulations that relate to
the ethical standards of human-subject resarch.
They have the final word on when an institution is
not complying with DHHS regulations and what the
institution must do to correct the problem.
Minutes 45 CFR 46.115 (2) Require sufficiently detailed
documentation to include attendance at the
meeting; actions taken by the IRB; the vote on
these actions, including the number of members
voting for, against, or abstaining; the basis for
requiring changes in or disapproving research; and
a written summary of the discussion of
controverted issues and their resolution.
Research Audit Program Proactive, non-punitive, and focused on educating
investigators about their ethical and regulatory
responsibilities in the conduct of research.
IRB Director/Administrator Primary person responsible for managing the IRB
office and many of the administrative aspects of
IRB meetings.
IRB Membership Must consist of at least five members and include
at least one scientist, one nonscientist and one
person not affiliated with the institution.
IRB Membership Roster Refers to the number of voting member positions
on the IRB.
Alternate Member When there is more than one member for an IRB
roster position.
, IRB Subcommittee Committee consisting of one or more experienced
reviewers organized for the purpose of managining
a specific task or making a specific type of
decision.
Social Harm Decreases in quality of life that result from
information being created or used in a way that is
damaging to the individual in question-- A result of
the creation or transfer of information in a way that
may negatively affect the research subject.
Expedited Review A type of review that can be conducted by the
Chair, designated IRB members, or a subcommittee
of the IRB.
Research 45 CFR 46.102(d) A systematic investigation
including development, testing, and evaluation,
designed to develop or contribute to
generalizable knowledge.
Human Subject 45 CFR 46.102(f)(1), (2) A living individual about
whom an investigator conducting research obtains
(1) data through intervention or interaction with the
individual OR (2) identifiable private information.
Emergency Use A treating physician's request to use an
investigational drug/device in a single patient
during an immediately life-threatening situation in
which no standard acceptable treatment is
available and there is insufficient time to convene a
quorum for full board IRB approval.
Verified | Latest Update 2026
Save
Terms in this set (129)
Minimal Risk The probability of harm or discomfort...not
greater...than those ordinarily encountered in daily
life or during the performance of routine physical
or psychological examinations.
The Belmont Principles Respect for persons, beneficence, and justice
IRB An administrative body composed of scientists and
nonscientists established to protect the rights and
welfare of human research subjects recruited to
participate in research activities conducted under
the auspices of the institution with which it is
affiliated.
Institutional Official (IO) The person who signs the OHRP Federalwide
Assurance and has the legal authority to act and
speak for the institution, and should be somone
who can ensure that the institution will effectively
fulfill its research oversight function.
,OHRP Charged with monitoring and promoting
compliance with DHHS regulations that relate to
the ethical standards of human-subject resarch.
They have the final word on when an institution is
not complying with DHHS regulations and what the
institution must do to correct the problem.
Minutes 45 CFR 46.115 (2) Require sufficiently detailed
documentation to include attendance at the
meeting; actions taken by the IRB; the vote on
these actions, including the number of members
voting for, against, or abstaining; the basis for
requiring changes in or disapproving research; and
a written summary of the discussion of
controverted issues and their resolution.
Research Audit Program Proactive, non-punitive, and focused on educating
investigators about their ethical and regulatory
responsibilities in the conduct of research.
IRB Director/Administrator Primary person responsible for managing the IRB
office and many of the administrative aspects of
IRB meetings.
IRB Membership Must consist of at least five members and include
at least one scientist, one nonscientist and one
person not affiliated with the institution.
IRB Membership Roster Refers to the number of voting member positions
on the IRB.
Alternate Member When there is more than one member for an IRB
roster position.
, IRB Subcommittee Committee consisting of one or more experienced
reviewers organized for the purpose of managining
a specific task or making a specific type of
decision.
Social Harm Decreases in quality of life that result from
information being created or used in a way that is
damaging to the individual in question-- A result of
the creation or transfer of information in a way that
may negatively affect the research subject.
Expedited Review A type of review that can be conducted by the
Chair, designated IRB members, or a subcommittee
of the IRB.
Research 45 CFR 46.102(d) A systematic investigation
including development, testing, and evaluation,
designed to develop or contribute to
generalizable knowledge.
Human Subject 45 CFR 46.102(f)(1), (2) A living individual about
whom an investigator conducting research obtains
(1) data through intervention or interaction with the
individual OR (2) identifiable private information.
Emergency Use A treating physician's request to use an
investigational drug/device in a single patient
during an immediately life-threatening situation in
which no standard acceptable treatment is
available and there is insufficient time to convene a
quorum for full board IRB approval.
