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,Question 1
Minimal Risk
Correct Answer
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.
Question 2
The Belmont Principles
Correct Answer
Respect for persons, beneficence, and justice
Question 3
IRB
Correct Answer
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.
Question 4
Institutional Official (IO)
Correct Answer
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.
Question 5
OHRP
Correct Answer
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.
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,Question 6
Minutes
Correct Answer
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.
Question 7
Research Audit Program
Correct Answer
Proactive, non-punitive, and focused on educating investigators about their ethical and
regulatory responsibilities in the conduct of research.
Question 8
IRB Director/Administrator
Correct Answer
Primary person responsible for managing the IRB office and many of the administrative
aspects of IRB meetings.
Question 9
IRB Membership
Correct Answer
Must consist of at least five members and include at least one scientist, one nonscientist and
one person not affiliated with the institution.
Question 10
IRB Membership Roster
Correct Answer
Refers to the number of voting member positions on the IRB.
Question 11
Alternate Member
Correct Answer
When there is more than one member for an IRB roster position.
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, Question 12
IRB Subcommittee
Correct Answer
Committee consisting of one or more experienced reviewers organized for the purpose of
managining a specific task or making a specific type of decision.
Question 13
Social Harm
Correct Answer
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.
Question 14
Expedited Review
Correct Answer
A type of review that can be conducted by the Chair, designated IRB members, or a
subcommittee of the IRB.
Question 15
Research
Correct Answer
45 CFR 46.102(d) A systematic investigation including development, testing, and evaluation,
designed to develop or contribute to generalizable knowledge.
Question 16
Human Subject
Correct Answer
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.
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