no subjects have been enrolled and no additional risks have been identified; or (c) where the remaining research activities are limited to data analysis.
9. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
Following review, the expedited reviewer will make one of the following recommendations, and OSP will notify the researchers of the reviewer's decision by email.
APPROVED. IRB approval indicates that the IRB reviewer(s) concluded the research and consent forms meet the federal criteria for approval. An approval determination verifies the IRB agrees with the assessment of the protocol and/or specific findings as described by the researcher in the application. OSP staff process the determination, and the research is provided with an approval letter and, when applicable and practicable, stamped informed consent/assent documents.
REVISIONS and/or ADDITIONAL INFORMATION REQUIRED. The IRB reviewer(s) withhold approval pending submission of revisions and/or additional information. OSP staff return the protocol to the researcher to address concerns and questions provided by the reviewer(s). The researcher responds and re-submits the application to the OSP within 90 days of receiving the requested revisions. OSP staff assign the response to the primary expedited reviewer who made the initial determination for further review and a new determination. Barring extenuating circumstances, if a researcher does not respond to requested revisions in the 90-day time period, the application is withdrawn, and a new protocol submission is required.
FULL REVIEW REQUIRED. The primary expedited reviewer may determine the protocol requires full review by the IRB at a convened meeting.
The primary expedited reviewer may also determine that the project is eligible for exemption or the activities do not fall under the purview of the IRB. If the protocol is determined to be eligible for exemption, the researcher will withdraw their application and submits a new application for determination of exempt status.
OSP staff will include in the approval letter the beginning and end date of approval. The date the primary expedited reviewer approves the study is the date the approval period starts. The approval period will last no more than one year. In some cases, the expedited reviewer may require continuing review of the project more frequently than once per year.