WITH CORRECT ANSWERS GRADED A+
• Minimal Risk.
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.
• The Belmont Principles.
Answer: Respect for persons, beneficence, and justice
• IRB.
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.
• Institutional Official (IO).
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.
• OHRP.
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.
• Minutes.
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.
• USATCES has submitted your ESSP for final approval. Who did they
submit to?.
Answer: DDESB
• What is the minimum distance permitted between an A&E location and the
installation headquarters building?.
Answer: Inhabited Building Distance (IBD)
• What is the minimum distance permitted between a PES and an interstate
highway?.
Answer: Public Traffic Route Distance (PTRD)
• What is the minimum distance permitted between any two operating
buildings and sites within an operating line?.
Answer: Intraline Distance (ILD)
• What is the minimum distance permitted between an earth-covered
magazine and a nearby above-ground magazine?.
Answer: Intermagazine Distance (IMD)
• What do you call the collection of documents that identifies the relationship
between a PES and any facilities or personnel who may be exposed to the
PES?.
Answer: ESSP
• Your installation is putting a new roof on an existing PES facility. Do you
need to complete an ESSP?.
Answer: No, this type of change does not require one
• Your installation is changing the NEW of an existing facility and will be
storing a hazard division not previously approved in it. Do you need to
complete an ESSP?.
Answer: Yes, and it must be approved by the DDESB
• Research Audit Program.
Answer: Proactive, non-punitive, and focused on educating investigators
, about their ethical and regulatory responsibilities in the conduct of research.
• Which of the following is a phase of the ESSP process?.
Answer: Development and Evaluation
• IRB Director/Administrator.
Answer: Primary person responsible for managing the IRB office and many
of the administrative aspects of IRB meetings.
• IRB Membership.
Answer: 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.
Answer: Refers to the number of voting member positions on the IRB.
• Alternate Member.
Answer: When there is more than one member for an IRB roster position.
• IRB Subcommittee.
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.
• Social Harm.
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.
• Expedited Review.
Answer: A type of review that can be conducted by the Chair, designated
IRB members, or a subcommittee of the IRB.
• How many ESSP categories are there?.
Answer: Five
• how must the ESSP package be submitted?.
Answer: Electronically
, • Research.
Answer: 45 CFR 46.102(d) A systematic investigation including
development, testing, and evaluation, designed to develop or contribute to
generalizable knowledge.
• Human Subject.
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.
• Emergency Use.
Answer: 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.
• Which three items are in the Maps and Drawings section of an ESSP
package?.
Answer: Facilities maps Installation maps Site maps
• Which three items are included in the Evaluations section of an ESSP
package?.
Answer: Electrical installation Lightning protection information Glass
hazard risk assessment
• Risk.
Answer: Probability and magnitude of the potential harm(s) or discomfort(s)
anticipated by participating in the research.
• Privacy.
Answer: Can be defined in terms of having control over the extent, timing,
and circumstances of sharing one's self (physically, behaviorally, or
intellectually) with others. Individuals' right to have control over access to
themselves and their information.
• Confidentiality.