Basic Institutional Review Board (IRB) Regulations and Review Process

12 April 2023
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Question 1 A subject in a clinical research trial experiences a serious, unanticipated adverse drug experience. How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence?
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Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB. The most appropriate action for the investigator to take is to report the adverse drug experience in a timely manner using the forms provided by the institution.
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Question 2 How long is an investigator required to keep consent documents, IRB correspondence, and research records?
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For a minimum of three years after completion of the study Research investigators are responsible for retaining signed consent documents, IRB correspondence, and research records for at least three years after completion of the research. Because research records are the property of the institution, local institutional policy or sponsoring agency requirements may dictate these records are kept longer. The sponsor and the IRB office should be contacted to make sure that the minimum of three years meets their requirements.
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Question 3 According to federal regulations, which of the following best describes when expedited review of a new, proposed study may be used by the IRB?
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The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations. Expedited review procedures are appropriate only for protocols that present no greater than "minimal risk" to subjects and involve only procedures included in federally specified categories. Population considerations, such as healthy volunteers, are only relevant insofar as they affect the assessment of risk. The IRB may not conduct an expedited review for the convenience of either the IRB or a student researcher, if the protocol is otherwise not eligible.
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Question 4 Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if:
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The changes must be immediately implemented for the health and well-being of the subject. All amendments involving changes to IRB-approved protocols must be reviewed and approved in advance of implementation, unless changes must be put in place immediately to respond to an unexpected risk or problem arising during the course of a study.
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Question 5 IRB continuing review of a greater than minimal risk approved protocol that is currently enrolling subjects must:
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Occur at least annually. Approved greater than minimal risk protocols must be reviewed at least annually, although IRBs may specify a shorter review period. It is the responsibility of the principal investigator to hold signed consent forms in confidentiality. Copies of these forms are not required by federal regulation to be reviewed by the IRB. Please note, however, that an institution's local policy may require copies of signed consent forms as part of the IRB continuing review process.