General IRB Process for Investigators
The following is the general process by which an investigator and the IRB interact.
- Investigator determines if IRB approval is necessary by consulting “What Activities Require IRB Review” document.
- If IRB approval is required, investigator completed the “IRB Submission” document.
Note: Only those holding current certification in the use of human participants are eligible for IRB review. Please make sure you have
completed such training and that your certificate is no more than 3 years old. The free training is offered at http://phrp.nihtraining.com/users/login.php
- Investigator submits “IRB Submission” document via email to the IRB’s email address, email@example.com. Documents must be received, in full, by the due date noted on the schedule.
- Within the time frame noted on the schedule, investigator will typically either gain approval or a request for more information.
- IRB approval is typically granted for 1 year of data collection.
- If for some reason there is a modification to the approved protocol, the experimenter submits to the IRB a notice of modification in the form of a memo, following the format for original submissions to the extent needed to reflect the changes.
- When the project is complete, or when the approval period expires, the investigator is asked to submit a Summary Report to the IRB, in the form of a memo.