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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

II.  118 Designation

  • Undefined Research

  • Institutional (Infrastructure) Type or Training Grants

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.

 

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 & Guidance Quicklink 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).

Human Subjects Research Review Category Flowchart

*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 eProtocol Quicklink for more information on how to get started.
    • Application for Exempt Status (Word document; rev. 04/08/15)
  • 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 Approval -- Cooperative IRB (Word document, 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 IRBSocial & Behavioral Sciences IRBCooperative IRB, and Exempt Research

Further guidance on completing application forms can be found HERE

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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.

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Ceding IRB Agreements

IRB Authorization Agreement (IAA) Templates:

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)

Step Four:  Submit all of the above materials via eProtocol and select under the General Checklist section "Request to Rely on Another IRB."

 

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:  Submit all of the above materials via eProtocol and select under the General Checklist section "Request to Have UH IRB be the Relying IRB." 

 

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