Are investigators responsible for obtaining continuing review of research?
Yes. Investigators are responsible for fulfilling requirements associated with continuing review in time for the IRB to carry out review prior to the expiration date of the current IRB approval. Continuing review of research and approval of research studies is required so long as the research study is ongoing, that is, until research-related interactions and interventions with human subjects or the obtaining and analysis of identifiable private information described in the IRB-approved research plan have been completed. Investigators are responsible for submitting sufficient materials and information for the IRB to meet its regulatory obligations, and should follow the institutional policies and procedures for continuing IRB review of research that are required by HHS regulations at 45 CFR 46.103(b)(4) and referenced in the institution’s OHRP-approved Federalwide assurance. OHRP guidance regarding continuing review is available at http://www.hhs.gov/ohrp/humansubjects/guidance/contrev0
