A Seventh-day Adventist Organization

Life Cycle: Submit to the IRB

As PI, you are responsible for the submission process to the IRB, whether or not some aspects are delegated to a co-investigator or research coordinator. The following are typical steps in this process.
  1. Assemble IRB Application Packet
  2. Complete departmental review process
  3. Submit IRB Application Packet
  4. Monitor communications from IRB
  5. Track progress of IRB review

1. Assemble the IRB Packet

2. Complete departmental review process

Process the IRB application packet within your department for scientific, budgetary, and administrative review in accord with the policies of that department. Studies should be scientifically reviewed in the school or department to ensure that the scientific question will be answered by the procedures outlined in the protocol. The Department Chair will sign the IRB application as evidence that this review has occurred.

3. Submit the IRB Application Packet

Submit the IRB application packet to the IRB office in accord with applicable review mechanism with regard to deadlines, number of copies.

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4. Monitor communications from IRB

Watch for and note the IRB’s acknowledgement letter that confirms all materials were received, indicates institutional reviews pending, and provides the IRB record number by which the study will be referenced from that point onward. Respond promptly to IRB requests for additional information in order to ensure timely approval of the project. A non-response of 90 days may result in the administrative closure of the study.

5. Track progress of IRB review

Track the progress of the IRB review at My IRB Records. Request login information from the IRB office, if necessary.

You will be notified in writing of the IRB’s decisions, including results of expedited review. This notice includes the approval date, risk classification, and approved project period, and is accompanied by the authorized version of the consent form (indicated by a stamp on behalf of the IRB). A reference number is assigned to each application and provided to the investigator at the time of IRB review. This number must appear on all communications between the investigator and the IRB to assure that all related documents are correctly associated with a given project.

Description of Committee Determinations