Question

According to federal regulations, the expedited review process may be used when the study procedures pose: a minor increase over minimal risk and the sponsor needs approval before the next irb meeting. more than minimal risk, but the study replicates previously approved research. any level of risk, but all the subjects are adults. no more than minimal risk and the research activities fall within regulatory categories identified as eligible

Answer 1

The answer is no more than minimal risk and the research activities fall within regulatory categories identified as eligible. In addition, an expedited review procedure contains a review of research connecting human subjects by the Institutional Review Board chairperson or by one or more experienced reviewers chosen by the chairperson from between members of the Institutional Review Board in agreement with the requirements set onwards in 45 CFR 46.110. The expedited review process is conducted at an Institutional Review Board expedited review session. The submission goes through by staff in discussion with the Chair as needed, to govern if an expedited review process may be directed. If the procedure encounters the regulatory standards for an expedited review, it will be sent to the expedited review conference.

Answer 2

According to federal regulation, the expedite review process may be used when the study procedure poses NO MORE THAN MINIMAL RISK AND THE RESEARCH ACTIVITY FALL WITHIN REGULATORY CATEGORIES IDENTIFIED AS ELIGIBLE.
Review research projects are categorized into three different classes, which are: exempt, expedite and full board review. A review research is qualified to be an expedite review if it is considered to include only minimal risk, deprived of intentional deception, does not make use of sensitive population sample and it incorporate necessary informed consents. For instance, a project that involve the gathering of  physical data by mean of non invasive method is qualified to be considered as an expedite project.