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.
- Assemble IRB Application Packet
- Complete departmental review process
- Submit IRB Application Packet
- Monitor communications from IRB
- Track progress of IRB review
- Assemble the IRB application packet as follows:
- IRB Application Checklist
- For clinical studies: CTC Feasibility Checklist
- For investigational devices: LLU Device Study Worksheet
- IRB Application Form
- Abstract (see Abstract Template)
- Informed Consent Document(s)/Assent Forms (see Checklist for Informed Consent)
- If applicable, California Experimental Subject's Bill of Rights
- If applicable, (HIPAA) Authorization for the Use of Protected Health Information (to determine if a Waiver of HIPAA Authorization is required, see LLU's Privacy in Research pages
- Protocol (see Protocol Outline) (download)
- Recruitment materials, as appropriate
- Letter/s of support from other departments whose resources are being used on the project (see below)
- For clinical studies: CTC Billing Grid (download)
- If relevant, other subject-related study material if not referenced in published literature (i.e., surveys, data collection forms, questionnaires, scripts, etc.)
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.
- Standard Applicant Checklist (New! Replaces separate checklists for Full Board and Administrative reviews)
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.
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