How to Apply for IRB Approval
- How to Apply for Exempt Status
- How to Apply for Approval of Non-Exempt Research (Expedited or Full IRB)
- How to Apply for Approval of Changes to IRB-Approved Research
- Application Forms
- Submission Guidelines
- Submission Deadlines
- Review Timelines
How to Apply for Exempt Status
To apply for exempt status, submit a completed (typed) Application for Exempt Status for Human Subjects Research and append supporting documents listed in Section V of the application form (e.g., informed consent documents, study instruments, etc.). Incomplete applications will be returned to the principal investigator (PI) without review.
There are no submission deadlines for exempt research applications. Email your application to: email@example.com. In the subject line, write, Exempt Application. PDF documents are preferred. The signature of the PI and, if the PI is a student, the signature of the faculty advisor are required. Please scan your signed application to convert it to an efile.
Alternatively, you may mail or hand deliver one copy of the completed and signed application, with supporting documents, to the UH Human Studies Program, UH Manoa, 1960 East-West Road, Biomed B-104, Honolulu, HI 96822. Submissions by fax (808.956.8683) are also accepted.
If there are subsequent modifications in the study design, methods or IRB-approved documents, the Human Studies Program must be contacted, prior to implementing the change. A request for approval of a modification to an exempt study should be submitted by email to firstname.lastname@example.org. Describe the proposed modification and the reason for the change. Please provide the CHS number and attach any revised documents. The Human Studies Program staff will review the proposed modification(s) and communicate its response by email reply.
Sometimes, a modification to an exempt study changes the status of the study to non-exempt. If it does, you will be notified of the need to submit a completed Application for Approval of a New Study Involving Human Subjects for IRB review.
How to Apply for Approval of Non-Exempt Research (Expedited or Full IRB)
Non-exempt research may qualify for review by expedited review. If it does not, it requires review by the full IRB at a convened meeting. The application process for all non-exempt research is the same with one exception: submission deadlines apply to research requiring full IRB review. Applications for review of research that qualifies for expedited review will be accepted at any time. For information on IRB submission deadlines, see the section on application submission deadlines below.
How to Apply for Approval of Changes to IRB-Approved Research
If changes to an IRB-approved study or documents are proposed, it is federal law that these changes have documented IRB approval prior to implementing the change(s). For information on how to apply for approval to modify a research project, see SOPP 103, Submitting Modification Requests to the IRB, and use the Request for IRB Approval of a Study Modification form.
There are several application forms for non-exempt research. Each IRB (Social & Behavioral Sciences, Biomedical, and Cooperative) has unique forms and requirements. All application forms are posted on this website in the Forms and Documents section.
- The UH Cooperative IRB has application forms for initial review and continuing review for use only for research to be reviewed by the Cooperative IRB.
- There is a single Application for Approval of a New Study Involving Human Subjects required to apply for approval by the Social and Behavioral Sciences IRB or the Biomedical IRB.
- The same IRB Continuing Review Application is used for research approved by the Social and Behavioral Sciences IRB and the Biomedical IRB.
- There is single application for Requests for IRB Approval of a Study Modification that is used for all three UH IRBs.
Submit a complete (and signed) initial or continuing review application or a request for approval of a study modification to the Human Studies Program. Make sure that all sections of the application are completed, noting any questions that are not applicable. Incomplete or illegible applications will be returned to the PI without review.
For new study applications, a complete application will include all supplemental documents, including consent forms, assent forms, questionnaires, recruitment materials, and other study documents or tools that will be seen or used by research subjects. New applications for review by the Biomedical IRB require a separate written protocol , following the Guidelines for Developing a Clinical Research Protocol posted on this website
For continuing review or approval of a study modification, append the IRB-approved consent form.
Please submit your application by email (in Word) to email@example.com. In the subject line, write, IRB Application. Since the signature of the PI is required, please scan your signed application to convert it to an efile.
In addition to your electronic submission, please provide the Human Studies Program with 3 paper copies of your complete application. We are located on the UH Manoa Campus at 1960 East-West Road, Biomed B-104, Honolulu, HI 96822.
The Human Studies Program also accepts applications from the neighbor islands by fax (808.956.8683).
- Applications for exempt status and those that qualify for expedited review are accepted at any time. There are no submission deadlines.
- Applications that require full IRB review must be received at the Human Studies Program Office by close of business on the first business day of the month. IRB meetings are held monthly, generally during the 3rd week of the month. Applications received after the submission deadline will be placed on the agenda of the IRB meeting scheduled for the following month (see Calendar).
The process for all levels of review can vary significantly. The turn-around-time may be affected by the complexity of the research and the quality of the IRB application. Applications that are complete and clearly written are likely to be reviewed in a shorter timeframe than applications that are not (see Guidelines for Developing an IRB Application). Following are average review periods:
- Applications for approval as exempt are typically reviewed in two to three weeks.
- Applications for approval under an expedited review procedure are typically reviewed within three to four weeks.
- Applications for approval by the full IRB review are typically reviewed within 1 to 2 months.