University of Hawai‘i
Research Compliance

UH eProtocol

Welcome to UH IRB eProtocol
Go to ePROTOCOL

Getting Started
Learn more about how the system works.

Accessing the eProtocol Website

  • Please use one of the following supported browsers for accessing eProtocol: FireFox, Safari, Internet Explorer.
  • Before entering the eProtocol site, please disable your browser’s pop-up blocker or allow for exceptions for https://uhmanoa.keyusa.net.

Frequently Asked Questions (FAQs) Regarding eProtocol

Submit a New Protocol

I. New Research Protocol or Proposal

Effective July 1, 2016, all new research protocol applications (excludes Cooperative studies) must be submitted through the eProtocol system

To Submit a New Research Protocol or Proposal:

Step One: Determine Whether or Not Your Project is “Not Human Subjects Research.”
To help you determine whether your project is considered “human subjects research,” you may use the guidance here. You can also find this guidance under the Policies page under the subheading Reviewer Worksheets.

Step Two: Choose your Application Form:
To help you determine whether your research qualifies for EXEMPT, EXPEDITED, or FULL-BOARD review, use the Review Category Flowchart* (also located under Policies & Guidance).

*Note: Exception on children in normal curriculum/ class settings. In such cases, these types of research may qualify for EXEMPT review. 

Below are links to the various application forms you will need:

  • For exempt research, please use eProtocol to submit your application (effective date 04/15/16); see above for more information on how to get started.
  • Effective May 15, 2016, use eProtocol to submit your non-exempt biomedical or social/ behavioral sciences research protocol
    • Application for New Approval (Word document; rev. 06/30/15) – this form should be used for research that may qualify for either EXPEDITED or FULL-BOARD
  • Application for New ApprovalCooperative IRB (rev. 10/29/14)
    • 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, Hawaii Pacific Health facilities, Castle Medical Center). If your research does not involve those institutions (or is not federally funded), do not use this form.

Step Three: Complete the Application Form according to the instructions provided within the form.

  • Make sure to complete your required Human Subjects Research Training
  • Include all applicable study documents (i.e., consent form documentation, recruitment material, surveys and instruments, etc.)

Step Four: Submit completed application to the Human Studies Program according to the instructions shown below:
Table: Quick reference on form and deadline per review category

Review Category Which Application to Use Deadline How to Submit
Exempt eProtocol First-come first-serve Electronic via eProtocol
Expedited eProtocol
or
Application for New Approval (Cooperative IRB)
First-come first-serve Electronic via eProtocol
or
Email and 2 hard copies for Cooperative IRB applications ONLY
Full-Board eProtocol
or
Application for New Approval (Cooperative IRB)
Check IRB calendar Electronic via eProtocol
or
Email and 2 hard copies for Cooperative IRB applications ONLY

Information on Biomedical IRB, Social & Behavioral Sciences IRB, Cooperative IRB, and Exempt Research

Further guidance on completing application forms can be found here.

II. 118 Designation

  • Undefined Research
  • Institutional (Infrastructure) Type or Training Grants

To Request Approval for 118 Designation (aka Institutional/ Training Grants or Undefined Research):

§46.118 Applications and proposals lacking definite plans for involvement of human subjects.

Certain types of applications for grants, cooperative agreements, or contracts are submitted to departments or agencies with the knowledge that subjects may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal. These include activities such as institutional type grants when selection of specific projects is the institution’s responsibility; research training grants in which the activities involving subjects remain to be selected; and projects in which human subjects’ involvement will depend upon completion of instruments, prior animal studies, or purification of compounds. These applications need not be reviewed by an IRB before an award may be made. However, except for research exempted or waived under §46.101(b) or (i), no human subjects may be involved in any project supported by these awards until the project has been reviewed and approved by the IRB, as provided in this policy, and certification submitted, by the institution, to the department or agency.

Step One: Apply for 118 Designation

  • If your project meets the description stated above, complete the “Section 118 Designation” Application according to the instructions provided within the form, and submit it with any supporting documents to the Human Studies Program.
    • The “Section 118 Designation” Application Form can be found here.

Step Two: Keep Track

  • Once you receive an approval letter for 118 Designation of your project from the Human Studies Program, make sure to keep track:
    • For Undefined Research – once the project is ready to involve human participants, you MUST submit a separate application for initial approval (see steps for new protocol or proposal above). You must not start involving human participants in your project until you receive an initial approval for your human subjects research project.
    • For Training / Institutional Type Grants – keep track of all human subjects research sub-studies during its review period (time frame between approval date and expiration date). You will need to provide an annual report of all sub-studies funded by your grant during the review period to Human Studies Program prior to the expiration date in order to renew your 118 Designation.
      • The “Annual Report for Institutional Type Grants or Training Grants” Form can be found here.

III. Collaborative Research – Ceding Agreements

  • For research in which two or more FWA-holding institutions are engaged in a research protocol/ proposal, investigators may request to have UH IRB be the relying IRB or cede IRB authority to another IRB. For more information, see SOP 120: Collaborative Research.

IRB Authorization Agreement (IAA) Templates:

  1. UH IRB is the Relying IRB
  2. UH IRB is Ceding Authority to Another IRB

To establish a ceding agreement in which UH IRB cedes authority to another IRB:

Step One: Select the above IAA #2 template and provide the following information in the IAA: 

  • Name of the Other Institution
  • The other institution’s IRB Registration Number (if relying on the another IRB) or FWA # (if using UH IRB as the relying IRB)
  • Project Name
  • Principal Investigator(s) of all Institutions listed in the IAA, with their respective institution’s name in brackets next to the name
  • Funding Source and Award Number, if applicable
  • Name of the Other Institution’s Institutional Official (IO)
  • Title of the Other Institution’s IO

Step Two: Provide a memorandum addressed to the Human Studies Program Director for the justification of ceding authority to another IRB

Step Three: For requesting to cede to the other institution’s IRB, provide HSP with a copy of the other institution’s IRB application and approval letter (if received)

  • Include a copy of the protocol, and informed consent, especially as relating to local participation

To establish a ceding agreement in which UH IRB is the relying IRB:

Step One: Select the above IAA #1 template and provide the following information in the IAA:

  • Name of the Other Institution
  • The other institution’s IRB Registration Number (if relying on the another IRB) or FWA # (if using UH IRB as the relying IRB)
  • Project Name
  • Principal Investigator(s) of all Institutions listed in the IAA, with their respective institution’s name in brackets next to the name
  • Funding Source and Award Number, if applicable
  • Name of the Other Institution’s Institutional Official (IO)
  • Title of the Other Institution’s IO

Step Two: Provide the Local Context Review Form to the relying institutions to complete, if they wish to input any local context consideration, administrative review.

Step Three: Provide a memorandum addressed to the Human Studies Program Director for having UH IRB be the relying IRB

Step Four: The UH IRB will need to review and approve the project.
 If you have not already obtained UH IRB approval, submit an IRB application for review. If you have an approval, and are adding a new collaborator or new site, you may need to submit a modification application to your project. Be sure to submit all of the above materials with your application, and indicate you are: “Requesting to Have UH IRB be the Relying IRB.”

Modify a Protocol

Modification Application Form

If you are unsure of what form to use, contact the Human Studies Program Office at (808)956-5007 or email uhirb@hawaii.edu

Circumstances for submitting modification request

  • 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 under SOP 115.3.

To close a study, please use our Study Closure Form, which may be downloaded here.

For pre-eProtocol research approved as exempt, no modification form is needed. Submit your request of changes to uhirb@hawaii.edu, referencing your CHS# on the subject line.

Renew a Protocol

Continuing Review Application Form

For active protocols previously submitted and approved via eProtocol, use the eProtocol Continuing Review form.
You may access by logging into eProtocol, and clicking on the protocol link for your project under “Approved Protocols”.

For active protocols that were not submitted and approved via eProtocol (originally approved prior to June 2016):

For non-eProtocol applications, please submit a signed electronic (scanned) copy of the completed continuing review application to uhirb@hawaii.edu AND two (2) hard copies to: UH Human Studies Program, UH Mānoa, 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

Study Closure Form

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

Non-eProtocol Study Closure Form may be downloaded here (Use this form if your protocol predates eProtocol).

eProtocol Study Closure Form may be accessed using eProtocol. Activate the menu by selecting an already approved eProtocol application on your Investigator dashboard. (Use this if you submitted your application using eProtocol)

Report a Protocol Violation or Unanticipated Problem

Unanticipated Problem and Protocol Violation Report Forms

An UNANTICIPATED PROBLEM is any unfavorable incident, experience, or outcome that is unexpected, related or possibly related, and suggests that the research places participants or others at greater risk of harm than expected for this research.

A PROTOCOL VIOLATION is any deviation or departure from the IRB-approved protocol that does not have prior approval by the IRB.

  1. For protocols previously submitted and approved via eProtocol, use the eProtocol Protocol Violation form.
  2. For protocols that were not submitted and approved via eProtocol (originally approved prior to June 2016):
    • Reporting Form for Unanticipated Problems
      • An Unanticipated Problem Report may be submitted to the Human Studies Program by email at uhirb@hawaii.edu OR by hard-copy delivery to Human Studies Program, University of Hawai‘i at Mānoa, 2425 Campus Road, Sinclair 10, Honolulu, HI 96822
    • Reporting Form for Protocol Violations (rev. 12-28-2014)
      • Submit the Protocol Violation Report to the Human Studies Program via email at uhirb@hawaii.edu AND delivery of a hard-copy with original signature to Human Studies Program, University of Hawai‘i at Mānoa, 2425 Campus Road, Sinclair 10, Honolulu, HI 96822 

Further guidance on completing these forms can be found under SOPs 101 and 104 here.