eProtocol is a web-based program that enables principal investigators, staff, and IRB members to prepare, submit, review, and communicate the status of protocols.
- eProtocol runs on any major Web browser.
- Disable your browser pop-up blocker or allow pop-ups for the URL: https://uhmanoa.keyusa.net.
- How to: Chrome • Firefox • Edge • Safari
- After closing the browser and starting it again, you should be able to connect to eProtocol.
- If you still are not able to connect to eProtocol, let us know the details via email at firstname.lastname@example.org.
Who is able to access eProtocol?
All UH-affiliates (faculty, students, staff, etc.) can access eProtocol using their UH username. Non-UH affiliates will need to obtain a UH username and password to access the system.
Submitting a New Protocol
Effective July 1, 2016, all new research protocol applications (excludes Cooperative studies) must be submitted through the eProtocol system.
Determine Whether or Not Your Project is Human Subjects Research
To help you determine whether your project is considered human subjects research, download Worksheet 301- Is My Project “Human Subjects Research?”.
Choose your Application Form
To help you determine whether your research qualifies for EXEMPT, EXPEDITED, or FULL-BOARD review, use the Review Category Flowchart.
Below are links to the various application forms you will need:
- For exempt, non-exempt, expedited, and full-board research, use the eProtocol system to submit your application: Access the eProtocol system
- For Cooperative IRB, use the UH Cooperative IRB New Research Project Application Note: This form is for applications to the Cooperative IRB only.
The Cooperative IRB reviews federally funded research involving UH and one or more participating hospital/institutions (Queens Medical Centers, Hawaiʻi Pacific Health facilities, Castle Medical Center). If your research does not involve those institutions (or is not federally funded), do not use this form. To confirm that your research qualifies for the Cooperative IRB, contact the Human Studies Program.
Complete the application form according to the instructions provided within the form
- Include all applicable study documents (i.e., consent form documentation, recruitment material, surveys and instruments, etc.)
- Make sure to complete your required Human Subjects Research Training.
Submit completed application to the Human Studies Program
Exempt and expedited applications are reviewed in the order that they are received. See the Full-board submission deadlines.
Modifying a Protocol
Circumstances for submitting modification request include:
- Change in research site
- Change in PI
- Change to the approved protocol
- Revisions to study documents (i.e. Informed consent, recruiting flyers, survey instruments, etc).
- Adding research materials
Guidance on completing the Modification Form can be found in SOP 115.3.
Modification Application Forms
- To modify an applications submitted and approved via eProtocol, use the eProtocol Modification form: Access the eProtocol system
- Modify an approved protocols predating eProtocol (originally approved prior to June 2016): Request for IRB Approval of a Study Modification form
- Modify a protocols approved by the Cooperative IRB: Request for IRB Approval of a Study Modification form
Exempt research predating eProtocol
For research approved as exempt and predating eProtocol, no modification form is needed. Submit your request of changes via email to email@example.com, referencing your CHS number in the subject line.
If you are unsure of what form to use, contact the Human Studies Program Office.
Renewing a Protocol
For active protocols submitted and approved via eProtocol, use the eProtocol Continuing Review form found in eProtocol: Access the eProtocol system
For active protocols that were not submitted and approved via eProtocol refer to the following forms:
- Annual review of Cooperative IRB studies: Continuing Review Application Form
- Annual review, including studies reviewed by Biomedical OR Social & Behavioral Sciences: Continuing Review Application Form
- Active research requiring more than one continuous review per year as dictated by the UH IRB: Status Report Form
- Annual report for Institutional/Training Grants: 118 Designation Annual Report
For non-eProtocol applications, please submit via email a signed copy of the completed continuing review application to firstname.lastname@example.org, and send two (2) hard copies to:
UH Human Studies Program
2425 Campus Road, Sinclair 10
Honolulu, HI 96822
Further guidance on completing continuing review forms can be found on the Policies page.
Closing a Protocol
Circumstances for submitting a closure request include:
- All study participant enrollment and interactions have been completed
- Any study data still being analyzed, or stored, is de-identified. That is, there is no linkage directly or via code to an individual, or identifiable information
- Use the eProtocol Study Closure Form