CIP Exam: CIP Exam Study Guide
Minimal Risk
(Ans- 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
(Ans- Respect for persons, beneficence, and justice
IRB
(Ans- 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)
(Ans- The person who signs the OHRP Federalwide Assurance and has
the legal authority to act and speak for the institution, and should be
someone who can ensure that the institution will effectively fulfill its
research oversight function.
OHRP
(Ans- 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
(Ans- 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
(Ans- Proactive, non-punitive, and focused on educating investigators
about their ethical and regulatory responsibilities in the conduct of
research.
IRB Director/Administrator
(Ans- Primary person responsible for managing the IRB office and many of
the administrative aspects of IRB meetings.
IRB Membership
(Ans- 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
(Ans- Refers to the number of voting member positions on the IRB.
Alternate Member
(Ans- When there is more than one member for an IRB roster position.
IRB Subcommittee
(Ans- 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
(Ans- 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
(Ans- A type of review that can be conducted by the Chair, designated IRB
members, or a subcommittee of the IRB.
Research
(Ans- 45 CFR 46.102(d) A systematic investigation including development,
testing, and evaluation, designed to develop or contribute to generalizable
knowledge.
Human Subject
(Ans- 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
(Ans- 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.
Risk
(Ans- Probability and magnitude of the potential harm(s) or discomfort(s)
anticipated by participating in the research.
Privacy
(Ans- 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
(Ans- 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 in ways that are inconsistent with the understanding of the original
disclosure without permission. How information that is obtained from
individuals is protected
Criteria for waiver or alteration of consent
(Ans- 45 CFR 46.116(d) An IRB may approve a waiver or alteration of
consent requirements if:
*the research involves no more than minimal risk;
*the waiver or alteration will not adversely affect the rights and welfare of
the subjects;
*the research could not practicably be carried out without the waiver or
alteration; and
*whenever appropriate, the subjects will be provided with additional
pertinent information after participation.
Informed Consent
(Ans- 45 CFR 46.116(a),(b); 46.117 Process to obtain informed permission
from potential subjects before they participate in research, and an ongoing
opportunity to retain subjects in trials whenever new information is
available. Must be sought under circumstances that minimize the possibility
of coercion or undue influence, and must include the 8 basic information
elements described in the regulations. Information must be presented in a
language understandable to the subject or LAR. The consent process must
be documented with a written form approved by the IRB and signed by the
subject/LAR.
Recruitment
(Ans- The first step in the consent process. How potential subjects are
identified and invited to participate in research.
DSMB
(Ans- A committee that is established specifically to monitor data
throughout the life of a study to determine whether it is appropriate, from
both scientific and ethical standpoints, to continue the study as planned.