CIP Exam Study Guide Complete Latest
2023/2024
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.The Belmont Principles - Correct Answer Respect for persons, beneficence, and justice 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.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.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.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.Research Audit Program - Correct Answer Proactive, non-punitive, and focused on educating investigators about their ethical and regulatory responsibilities in the conduct of research.IRB Director/Administrator - Correct Answer Primary person responsible for managing the IRB office and many of the administrative aspects of IRB meetings.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.IRB Membership Roster - Correct Answer Refers to the number of voting member positions on the IRB.Alternate Member - Correct Answer When there is more than one member for an IRB roster position. 1 / 3
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.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.Expedited Review - Correct Answer A type of review that can be conducted by the Chair, designated IRB members, or a subcommittee of the IRB.Research - Correct Answer 45 CFR 46.102(d) A systematic investigation including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.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.Emergency Use - Correct 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.Risk - Correct Answer Probability and magnitude of the potential harm(s) or discomfort(s) anticipated by participating in the research.Privacy - Correct 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 - Correct Answer 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 - Correct Answer 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. 2 / 3
Informed Consent - Correct Answer 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 - Correct Answer The first step in the consent process. How potential subjects are identified and invited to participate in research.DSMB - Correct Answer 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.Stopping Rules - Correct Answer General term for specific and predetermined parameters that guide the data monitoring process.Exculpatory Language - Correct Answer Language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.Respect for Persons - Correct Answer Principle underlying the doctrine of informed consent. Requires recognition of the individual as an autonomous agent and protection of the individual with diminished autonomy. Requires that researchers carry out the process of informed consent and protect subject privacy.Beneficence - Correct Answer The doing of good, obligates the researcher to secure the individual's well-being by maximizing benefits and minimizing harms to the individual research subject. Requires that the researcher perform a risk/benefit analysis. Requires that competent investigators design ethical research, protect human subjects from risk, and make continuing assessments of the risk/benefit ratio.Factors that may determine when a DSMB is necessary - Correct Answer A large study population, multiple study sites, highly toxic therapies or dangerous procedures, high expected rates of morbidity or mortality in the study population, high chance of early termination.Reasons a DSMB may stop a study - Correct Answer efficacy, futility, or safety Serious or Continuing Non-compliance - Correct Answer A problem that indicates noncompliance that is serious or continuing, OHRP will be notified within 48 hours, regardless of the funding source. If applicable the FDA will be notified.
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