Must investigators obtain IRB approval before involving human subjects in non-exempt research? Yes. Investigators need IRB approval before beginning all human subjects research. Investigators should provide the IRB with sufficient information to allow the IRB to complete a thorough review of the proposal.
Are investigators responsible for obtaining and documenting informed consent? Yes. Investigators are responsible for obtaining and documenting the informed consent of research subjects or their legally authorized representatives, unless the IRB approves a waiver of informed consent or documentation of informed consent.
What should investigators do if they want to revise an IRB approved research study? Should you wish to modify an already approved research study, you should submit a request to the IRB and receive IRB approval before implementing the proposed modification.
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.
What are investigators’ responsibilities once a study is completed? If all research-related activities have been completed, including data analysis and paper writing the investigator is no longer required to obtain continuing review approval for the study. Investigators should request a termination of the study by notifying the IRB of the study’s completion.