CIP Exam: CIP Exam Study Guide: Updated A+ Solution

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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. [Show More]

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