Does IRB review of a quality improvement project that is also non-exempt human subjects research always need to be carried out at a convened IRB meeting?
No. If the human subjects research activity involves no more than minimal risk and fits one or more of the categories of research eligible for expedited review, the IRB chair or another member designated by the IRB chair may conduct the review. The categories of research eligible for expedited review are available at http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm.
Related Questions
- If a quality improvement project involves non-exempt research with human subjects, do I always need to obtain informed consent from all subjects (patients and/or providers) involved in the research?
- If a quality improvement project is human subjects research requiring IRB review, do I need to obtain separate IRB approval from every institution engaged in the project?
- Does IRB review of a quality improvement project that is also non-exempt human subjects research always need to be carried out at a convened IRB meeting?
