Quiz Results - Basic Institutional Review Board (Irb) Regulations and Review Process

658 Words Jul 9th, 2014 3 Pages
Quiz Results - Basic Institutional Review Board (IRB) Regulations and Review Process
You correctly answered 3 of 5 and received 3 of 5 possible points.
Scroll down to review the quiz questions and the explanation of the answers.
Question 1
Question : | 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? |
Your answer : | 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. |
Correct Answer : | Report the adverse drug experience in a timely manner, in keeping with
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Your answer : | The study does not require informed consent or survey instruments. |
Correct Answer : | The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified in federal regulations |
Comment : | 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. |
Points Earned : | 0 |
Question 4
Question : | Amendments involving changes to IRB approved protocols do NOT need prior IRB approval if: |
Your answer : | The changes must be immediately implemented for the health and well being of the subject. |
Correct Answer : | The changes must be immediately implemented for the health and well being of the subject. |
Comment : | 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