Resources

Policies

IMPORTANT

Mandatory changes must be made to the Informed Consent Form for all new studies approved on or after January 21, 2019! For information on several important changes to the federal regulations governing human research, known as the Common Rule, click here. Among these changes are improvements to the informed consent process, resulting in revisions to the UH Model consent forms.

General Policy Manual

UH Human Research Protection Program General Policy Manual (Revised January 21, 2019)

This manual is updated to reflect the revised Common Rule and applies to new studies approved on/after January 21, 2019 and existing studies transitioned to the revised Common Rule.

Guidance

GUIDE 601 Investigator’s Handbook
GUIDE 602 Review Category Flowchart

IRB Application

GUIDE 603 Guidelines for Developing an IRB Application
GUIDE 604 Guidelines for Developing a Clinical Research Protocol
GUIDE 605 Developing a Social and Behavioral Sciences Research Project Description

Informed Consent

GUIDE 606 Consent Form Guidance
GUIDE 607 Guidelines for Using a Short Form
GUIDE 608 Informed Consent Requirements Checklist
GUIDE 609 Guidance on Disclosing Conflicts of Interest (COI) in Informed Consent Forms
GUIDE 610 ORS – Instructions for Developing a Conflict of Interest Management Plan
GUIDE 612 Guidelines for Designing a Recruitment Flyer for a Research Study
GUIDE 621 Exception from Informed Consent Requirements for Emergency Research (FDA)
GUIDE 622 Informed Consent Process for Non-English Speakers and Persons with Limited Literacy
GUIDE 623 Consent and Assent for Research Involving Children, Mandatory Reporting
GUIDE 625 Findings for Waiver or Alteration of Consent Requirements
GUIDE 626 HIPAA Privacy Rule Authorization Template
GUIDE 627 HIPAA Privacy Rule Checklist
GUIDE 628 Lay Language for Informed Consent and Other Documents for Participant Use

PI Reporting Responsibilities

GUIDE 614 Events and Information that Require Reporting to the IRB
GUIDE 615 UH Engagement Flowchart
GUIDE 617 Federal Funding Agencies – Additional Requirements

Recruitment Material

GUIDE 619 Recruitment Guidelines
GUIDE 620 Advertisements: Appropriate Language for Recruitment Material
GUIDE 630 Research Advertisements that Require vs. Don’t Require IRB Review and Approval

Special Situations

GUIDE 611 Important Regulations that Apply to Research in Public Schools
GUIDE 613 Internet-Based Research Guide
GUIDE 624 Planned Emergency Use Research
GUIDE 629 Research Involving Vulnerable Populations
GUIDE 631 Transnational Research Checklist
GUIDE 633 Protocol Review Guidance for External Sites in Multi-site Research

General

GUIDE 616 Single Patient Use of Investigational Drugs
GUIDE 618 Human Subject Regulations Decision Chart (by OHRP)

Worksheets

Reviewer Worksheets

WKSH 301 Is my Project “Human Subjects Research”?
WKSH 302 Requirements for Exempt Approval
WKSH 303 Non-Exempt Reviewer Checklist
WKSH 304 IRB Reviewer Worksheet – Waiver of Consent
WKSH 305 IRB Reviewer Worksheet – Vulnerable Populations
WKSH 306 IRB Reviewer Worksheet – FDA Regulated Research
WKSH 311 Reviewer Worksheet for Continuing Review, Modification or Study Closure
WKSH 313 Eligibility Criteria for Expedited Review
WKSH 314 Unanticipated Problem/Adverse Event Reviewer Worksheet
WKSH 315 Protocol Violation Reviewer Worksheet

Quality Improvement Worksheets

WKSH 322 Consent Observation Checklist
WKSH 350 Study Documentation Checklist
WKSH 351 Site Visit Questionnaire
WKSH 352 Regulatory Requirement Checklist
WKSH 353 Biomedical Research Monitoring Site Visit Checklist and Report
WKSH 354 Social and Behavioral Sciences Research Monitoring Site Visit Checklist
WKSH 355 IRB Meeting Minutes Quality Assessment
WKSH 357 Quorum and Expertise
WKSH 358 Protocol Assessment – Internal Review Process

Standard Operating Procedures (SOPs)

101 Human Subjects Research Determination
102 Transnational Research
103 When Must a Non-UH Investigator Seek Review by the UH IRB? — The Issue of Engagement
104 Ensure Sound Study Design and Minimize Risk
105 IRB Meeting Preparation and Conduct
106 Avoiding IRB Members’ Conflict of Interest
107 Investigators’ Conflict of Interest
108 Determining and Reporting Non-Compliance and Protocol Violations
109 Suspension or Termination of Research
110 Quality Improvement Activities
111 Exempt Review and Determination
112 Systematic Determination
113 Performing Expedited Review of Research Involving Human Participants
114 IRB Approval of Research with Stipulations
115 Submitting Modification Requests to the IRB
116 Reporting and Reviewing Unanticipated Problems
117 Education of Individuals Responsible for Human Research
118 Addressing Concerns of Research Participants
119 Investigator’s Brochures
120 Collaborative Research
121 Emergency Use of a Test Article
122 Planned Emergency Research
123 Section 118 Designation
124 Research Involving Prisoners

Industry-Sponsored Research

IRB Fee Schedule

Regulatory Documents (Researcher Management Tools)

The forms below are designed to assist researchers and research staff in the conduct and management of clinical research. These documents can be used as guidance for setting up clinical research studies and conducting periodic self-quality assurance reviews.

 

Section 118 Designation

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.  Section 118 Designation Application Form
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.  APP 15 – Annual Report for Institutional Type Grants or Training Grants Form

 

Collaborative Research

For research in which two or more FWA-holding institutions are engaged in a research protocol/proposal, one IRB authority is 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.

Ceding agreement – UH IRB reviewing the research

Step One: Download and complete the IRB Authorization Agreement form

Reviewing IAA Application

Information you will need:
  • 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

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

Step Two: Submit the application

Submit the application to HSP via email or hardcopy. As part of your submission, provide a memorandum addressed to the Human Studies Program Director describing the justification for the reviewing request.

Include a copy of the Local Context Review Form, if any.

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. Include the HSP number  for the project if available.

Ceding agreement – UH is RELYING on another IRB for oversight

Step One: Download and complete the IRB Authorization Agreement form

Ceding (Relying) IAA Application

Information you will need:
  • 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: Submit the application

Submit the application to HSP via email or hardcopy. As part of your submission, provide a memorandum addressed to the Human Studies Program Director describing the justification for ceding authority to another IRB.

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

 

FAQs

Submitting an Application

  1. I developed my own research protocol and it is not funded by an outside party. Do I still need permission from the IRB before I conduct my research?

As required by law, the University of Hawai‘i follow government regulations on the protection of research subjects. These regulations apply to all research performed by UH faculty, staff or students or that meets the requirement for engagement of UH as a research institution. For help in determining whether your research requires IRB approval and oversight, and to determine the level of review, see the Resources page for more information.

  1. Does research conducted by UH students require IRB approval?

By UH policy, masters’ theses and doctoral dissertations that involve human subjects or use private identifiable information about living humans require IRB approval before research activities can be initiated. Graduate students who are unsure whether their project would be deemed human subjects research may inquire with the Human Studies Program Office for guidance. Documentation of approval by an IRB, or the Human Studies Program office is necessary to fulfill the paperwork required by the Office of Graduate Education to register for the thesis or dissertation courses (700 or 800 series) where the student indicates on Form II that Institutional Review Board (RB) approval may be required.

Other graduate-level work and most undergraduate activities performed to meet class requirements typically do not require IRB approval. However, if the research will be published or presented in a public forum, the study will require prior approval. Again, students should contact the Human Studies Program if unsure whether the activities would be considered human subjects research.

  1. Can researchers who have no formal affiliation with UH submit applications to a UH IRB?

In general, researchers who have no formal affiliation with UH cannot submit applications to the Human Studies Program or a UH IRB. If a UH-affiliated researcher is included on the study as a co-investigator, the Human Studies Program is likely to agree to review the research project. In this case, the UH-affiliated investigator (administrative Principal Investigator) will be the contact person with the UH IRB.

UH has formal agreements in place with a few unaffiliated institutions, under which research that does not involve UH can be reviewed by a UH IRB. See the Institutional Review Board page for more information.

  1. I am affiliated with UH, but my research project requires approval by another institution’s IRB. Do I also need approval by the UH IRB?

For most research, yes, UH affiliated researchers need IRB approval from UH, as well as any other involved institutions. In limited circumstances, UH will accept human subjects approval and oversight by a non-UH IRB. For example, UH has an agreement with The Queen’s Medical Center IRB intended to eliminate duplicate IRB review of must-research projects. See the Institutional Review Board page for more information about our existing agreements. Contact the Human Studies Program Director for more details.

  1. Aren’t some research “exempt” from IRB approval?

Yes, there are two types of human subjects research: Exempt and Non-Exempt. These categories are defined by federal regulations. Both exempt and non-exempt research must be reviewed by the UH Human Studies Program. Exempt research is considered to be low risk and is subject to fewer requirements. There is an application for approval of exempt research on this website. Completing this application will help you determine whether your research qualifies as exempt.

  1. How do I apply for approval of my research project?

Application forms and guidance provide include step-by-step instructions to help UH researchers apply for IRB approval. The HSP Investigator’s Handbook provides additional details on how to apply for approval of research involving human participants.

  1. My research involves no risk to human participants. Why does IRB approval need to be renewed every year?

All human subjects research potentially involves some risk to study participants. Even low risk studies involving innocuous surveys, for example, present a time burden to participants. Research involving record review presents the potential for loss of privacy. If your research qualifies as exempt, it does not require continuing review on a regular basis. However, if your research is non-exempt, requiring expedited or full IRB review, federal regulations require continuing review and re-approval at least annually at a schedule to be determined by the IRB. You must apply for continuing review, using the appropriate application form.

If your IRB approval expires, you must stop all study activities until you have received written documentation from the Human Studies Program that your project has been reapproved.

  1. How long will it take for the IRB to approve my study?

This depends on a number of factors, most importantly, the quality of the application and its attachments (e.g., consent forms, questionnaires, etc.).

In general, the turnaround time from start of review to decision is as follows:

Exempt (2-3 weeks)
Expedited (3-4 weeks)
Full-Board (4-8 weeks)

Take note, that turnaround time may be longer during busy months (October-November, March-April) when the Human Studies Program receives higher volume of applications.

  1. Is there a calendar listing IRB meetings?

 The IRB meeting calendar provides the deadline dates for submitting applications for full-board review.

  1. What if I want to change my study after the IRB has approved it?

Changes to IRB-approved research must have prior written approval by the IRB before implementation. This is federal law. For information on how to apply for approval to modify a research project, see the Investigator’s Handbook. In addition, see  Human Studies Program SOP 115: Submitting Modification Requests to the IRB.

  1. What are the training requirements for conducting human subjects research at UH?

See the Human Studies Program training requirements for investigators and IRB members.

  1. Are approvals needed by departments other than the Human Studies Program?

This will depend on a number of factors. Here are a few examples:

    • Research to be performed in a Hawai‘i Department of Education (HIDOE) school or office requires prior approval by the State Superintendent. Check the HIDOE website for more information, application, and instructions.
    • Research involving University of Hawai‘i institutional data requires review by the UH Data Governance Program. For more information, see http://www.hawaii.edu/uhdatagov/.
    • If your research will be performed, in whole or in part, by a non-UH institution (e.g., a local hospital or other facility), you may need to apply for IRB approval by UH and at the other institution.

Other Resources

UH:
Non-UH:

External Website Resources to Regulations, Guidance, and Ethical Codes Related to the Human Research Protection

U.S. Regulations:
Guidance:
Ethics:
Important Organizations:
Other Pertinent Links: