University of Hawai‘i
Research Compliance

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.

UH Human Research Protection Program General Policy Manual (Revised June 8, 2016)
This manual applies to existing studies approved prior to January 21, 2019 that have not been transitioned to the revised Common Rule.

Guidance

General Guide for Investigators and Key Personnel

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 Consents

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

Recruitement 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 Checklist
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.