exempt from the HHS regulations for the protection of human subjects. This listing refers only to research that is not exempt.)
Collection of data from voice, video, digital, or image recordings made for research purposes.
Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. This listing refers only to research that is not exempt.)
Continuing review of research previously approved by the convened IRB as follows: (a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or (b) where no subjects have been enrolled and no additional risks have been identified; or (c) where the remaining research activities are limited to data analysis.
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