Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB: Is limited to review of unanticipated problems. Is not required unless additional risks have been identified. Must occur within 12 months of the approval date. Must be conducted by a convened IRB.
Question
Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB: Is limited to review of unanticipated problems. Is not required unless additional risks have been identified. Must occur within 12 months of the approval date. Must be conducted by a convened IRB.
Solution
The continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB must occur within 12 months of the approval date. This review is not limited to just unanticipated problems, and it is required even if no additional risks have been identified. The review must be conducted by a convened IRB to ensure the study continues to meet the requirements for approval.
Similar Questions
According to federal regulations, the expedited review process may be used when the study procedures pose: Any level of risk, but all the subjects are adults. More than minimal risk, but the study replicates previously approved research. No more than minimal risk and the research activities fall within regulatory categories identified as eligible. A minor increase over minimal risk and the sponsor needs approval before the next IRB meeting.
What information should be provided to an IRB for review at the initiation of a study?
Study participant recruitment cannot begin until the IRB has approved the:A. Informed Consent form.B. Protocol.C. Advertisements.D. All of the above.
The risks of the research process should only be discussed after the study has been made.Select one:TrueFalse
When is it necessary to obtain IRB approval for a user study?Group of answer choiceswhen conducting online or mail studieswhen using data from a publicly available source like a newspaper or magazinewhen the results are used only in a class but won't be publishedwhen the data obtained is about individuals who are not livingall of these require IRB approval
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