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Table of Contents

I. General Policy Manual

II. Standard Operating Procedures

III. Guidance Documents

IV. Worksheets

 

General Policy Manual

201-217 UH Human Research Protection Program General Policy Manual (Revised June 8, 2016)
201 The Human Research Protection Program
  • Entities Covered Under the UH HRPP
  • Organizational Components of the UH HRPP
  • Delegation of Responsibility for Implementing HRPP
  • Laws and Ethics Governing Human Participant Research
  • Research Covered by HRPP
  • Scientific and Scholarly Review
  • HRPP Resources
  • Investigator Resources to Ensure Care and Safety of Participants in Human Research
  • Communication Between HRPP Components
202 Structure and Composition of the Institutional Review Board
  • Scope of UH IRB Authority
  • Composition and Membership
  • IRB Member Scientific and Schoalrly Expertise
  • Members' Conflicts of Interest
  • Training of IRB Chairs and Members
  • IRB Roster and Quorum Requirements
  • IRB Meeting Schedule and Materials
203 Monitoring and Maintaining Compliance
  • Assurance of Compliance
  • Access to Policies, Procedures, and Other Resources
  • Independence of the UH IRBs
  • Regulatory Defition of "Human Subject Research"
  • Conflicts of Interest
  • Non-Compliance
  • Unanticipated Problems and Other Reportable Information
  • HRPP Quality Improvement
204 Systematic Review
  • Protocol Review
  • IRB PRotocol Applications (eProtocol)
  • Assignments of Protocols or Proposals for Review
  • Protocol/ Proposal Review
  • Full-Board Review
  • Expedited Review
  • IRB Decisions
  • Approval Date and Determination of Expiration Date
205 Documentation of IRB Activities
  • IRB Records
  • IRB Research Files
  • Minutes of IRB Meetings
  • Other Documentation
  • Record Retention
206 Risks to Research Participants
  • What is "Risk"?
  • Minimizing Risk in Human Participant Research
  • Data and Safety Monitoring
  • Risks to Vulnerable Populations
  • Suspension and Termination of IRB Approval
207 Participant Recruitment and Selection
  • Equitable Selection
  • Review of Recruitment Plan, Advertisements and Compensation
208 Privacy and Confidentiality
  • Protecting Participants' Privacy
  • Protecting the Confidentiality of Participant Information
  • Confidentiality Breach -- Unauthorized Research of Information
209 Informed Consent and Assent
  • Requirement for Informed Consent
  • Elements of Informed Consent
  • Additional Consent Requirement
  • Documentation of Informed Consent - Signature Requirements
  • Types of Informed Consent Process and Documentation
  • Consenting Vulnerable and Other Special Populations
  • Consent Templates and Guidance
  • IRB Review of the Consent Process and Documentation
  • Observation of the Consent Process
210 Knowledge of Human Research Protection
  • Education and Training of Individuals Responsible for Human Research
  • Required Training in Human Research Protections
211 Education and Outreach
  • Online Resources and Educational Materials
  • Participant Research Inquiries
  • Outreach
  • Evaluation
212 Addressing Research Participants' Concerns
  • Written Materials
  • Responding to Participant Concerns
  • Website Information for Participants
213 Investigational or Unlicensed Test Articles -- Research with Drugs, Devices or Biologics
  • Research with Test Articles
  • Research involving Drugs
  • Research with Devices
  • Research with Biologics
  • Handling of Test Articles
  • Emergency Use of a Test Article
  • Planned Emergency Research
214 Communication among IRBs in Multi-Site and Collaborative Research
  • Communication among IRBs in Multi-Site and Collaborative Research
  • Managing Information in Multi-Site Research
215 Human Participant Protection in Sponsored Research
  • Protection of Human Participants Agreement
  • Provision Addressing Medical Care for Participants
216 Communication from Sponsors Affecting IRB Oversight
  • General
  • Data and Safety Monitoring (DSM) in Sponsor Agreements
217 Dissemination and Communication of Research Findings
  • Publication of Research Results
  • Communicating Research Results to Participants
  Definitions

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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
106.3  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
113.2 Performing Expedited Review of Research Involving Human Participants
114.2 IRB Approval of Research with Stipulations
115.3 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
120.2 Collaborative Research
121 Emergency Use of a Test Article
122 Planned Emergency Research
123 Section 118 Designation
124 Research Involving Prisoners

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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 (rev. 5-15-12)
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 628 Lay Language for Informed Consent and Other Documents for Participant Use
GUIDE 626 HIPAA Privacy Rule Authorization Template
GUIDE 627 HIPAA Privacy Rule Checklist

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 Materials

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

General

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

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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 Assesment - Internal Review Process

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