Research Policy Page

• Oregon Clinical & Translational Research Institute (OCTRI)
• Institutional Review Board (IRB)
• IACUC Policy and Procedure Manual
• IACUC (Animal Subjects) Forms and Appendices
• IBC (Recombinant DNA and Infectious Agents/Toxins) Policies, Forms, and Questionnaires
• Conflict of Interest in Research

Institutional Review Board

The IRB Policies and Forms page has moved!!!  Please update your bookmarks to point to the new location - HERE!

Section 1: OHSU Human Research Protection Program

Section 2: The Institutional Review Board

Section 3: Principal Investigator Responsibilities

Section 4: IRB Review

Section 5: Informed Consent of Research Participants

Section 6: Privacy and Confidentiality

Section 7: Reporting Requirements

Section 8: Procedures for Research with Vulnerable Populations

Section 9: Recruitment and Participant Rights

Section 10: FDA Research Issues - Drugs, Devices & Biologics

Section 11: Education and Training in the Protection of Human Participants

Section 12: Research Collaborations and Off-Site Research

Section 13: Additional Research Issues

Institutional Review Board Forms

Section 1: OHSU Human Research Protection Program

Title	Policy	Procedure	Regulatory Sheet	Supplemental Information	Forms
Purpose and Scope of Policies and Procedures
Federal Wide Assurance (FWA)
Constituting the Institutional Review Board
Roles and Responsibilities
IRB Authorization Agreement - Use this form when OHSU is accepting IRB oversight
IRB Authorization Agreement - Use this form when OHSU is waiving IRB oversight
Individual Investigator Agreement: Application for Individual Investigator to Be Covered by OHSU FWA

Section 2: The Institutional Review Board

Title	Policy	Procedure	Regulatory Sheet	Supplemental Information	Forms
Suspension & Termination Policy
Reporting Policy
Meetings
IRB Minutes
Approval Timeframes - Service Level Understanding

Title	Policy	Procedure	Regulatory Sheet	Supplemental Information	Forms
Protocol Files
Consultants
The Electronic IRB (eIRB
IRB Chair's Advisory Committee (ICAC)

Section 3: Principal Investigator Responsibilities

Title	Policy	Procedure	Regulatory Sheet	Supplemental Information	Forms
PI Eligibility
Research Development
Research Oversight

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Section4: IRB Review

Title	Policy	Procedure	Regulatory Sheet	Supplemental Information	Forms
Requirements for Initial IRB Review
Initial Evaluation of Submitted Projects
Exempt Review
Expedited Review
Full Board Review

Title	Policy	Procedure	Regulatory Sheet	Supplemental Information	Forms
Continuing Review
Modifications
Appeal of Decisions Made by the Institutional Review Board
Non-Compliance with IRB Policies, Procedures, or Decisions
Data and Safety Monitoring
Termination of Study

Section 5: Informed Consent of Research Participants

Title	Policy	Procedure	Regulatory Sheet	Supplemental Information	Forms
Informed Consent
Elements of Informed Consent / Assent Forms
Additional Consent Information for Different Types of Studies
Elements of a Consent

Title	Policy	Procedure	Regulatory Sheet	Supplemental Information	Forms
HIPAA: Waiver of Authorization for the Use and Disclosure of Personal Health Information (PHI)
Obtaining Permission from Legally Authorized Representatives or Family Members
Consent for Special and Vulnerable Populations
Assent
HIV Testing

Section 6: Privacy and Confidentiality

Title	Policy	Procedure	Regulatory Sheet	Supplemental Information	Forms
HIPAA Activities Prep to Research
Certificates of Confidentiality
Research

Section 7: Reporting Requirements

Title	Policy	Procedure	Regulatory Sheet	Supplemental Information	Forms
Protocol Deviations
Unanticipated  Problems
Serious & Continuing Non-compliance
Institutional Reporting Requirements

Section 8: Procedures for Research with Vulnerable Populations

Title	Policy	Procedure	Regulatory Sheet	Supplemental Information	Forms
Inclusion of Pregnant Women, Human Fetuses, and Neonates in Research
Inclusion of Prisoners in Research
Inclusion of Children in Research
Inclusion of Adults who Lack Making Capacity in Research
Inclusion of OHSU Students and Staff in Research
Student Research
Obtaining & Documenting Informed Consent From Subjects with Limited English Proficiency

Section 9: Recruitment and Participant Rights

Title	Policy	Procedure	Regulatory Sheet	Supplemental Information	Forms
Recruitment of Research Participants
Advertising
Web Postings
Enrollment Incentive
Finder's Fees
Costs Associated with Research Participation
Compensation for Research Participation
The Inclusion of Women and Minorities in Research
Billing

Section 10: FDA Research Issues - Drugs, Devices & Biologics

Title	Policy	Procedure	Regulatory Sheet	Supplemental Information	Forms
Investigational Drug Research
Approved and Unapproved Devices in Research
Emergency Single Time Use of a Test Article (Drug, Biologic, Device)
Humanitarian Use Device (HUD)
Off Label Use of Drugs and Devices
Planned Emergency Research
Compassionate and Expanded Use of Drugs and Devices
Research with Biologics
eIRB System: 21 CFR Part 11 Compliance, Approval Signatures, and Approval Stamps

Section 11: Education and Training in the Protection of Human Participants

Section 12: Research Collaborations and Off-Site Research

Section 13: Additional Research Issues

Title	Policy	Procedure	Regulatory Sheet	Supplemental Information	Forms
Genetic Research
Conflict of Interest In Research
Records Retention Requirements
Electronic Signatures
Liability
Coordinating Centers
Repositories and Databases
Stem Cell Research
OHSU Guidance Regarding the International Committee of Medical Journal Editors (ICMJE) Requirement for Clinical Trial Registration

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IRB Forms (Human Subjects)

Title	Forms
Proposed Project Questionnaire
Initial Submission Guide
Lay Language Protocol Summary
Annual Event Summary
Tissue Review Form
Individual Investigator Agreement: Application for Individual Investigator to Be Covered by OHSU FWA
Use of Ionizing Radiation in Human Subjects Research
Clinical Study Billing Schedule
HIPAA Related Forms
eIRB Hard Copy Submission

IRB Sample Forms (Human Subjects)

Title	Forms
Sample Consent Form
Sample Consent Form Barcode
Sample Consent Form for Low Risk Research
Sample Consent and Authorization Form
Sample Consent and Authorization Form Barcode
Sample Knight Cancer Institute Consent Form Barcode
Sample Genetic Consent Form
Sample Genetic Consent Form Barcode
Sample Gene Transfer Consent Form
Sample Humanitarian Use Device Consent Form
Sample Media Consent Form
HIV Information Sheet
Shriners Consent
Shriners Assent

Children's Forms

Title	Forms
Sample Child Assent Form
Children's Oncology Group

Short Consent Forms

Title	Forms
Short Consent Form Instructions
Short Consent Form English
Short Consent Form Spanish
Short Consent Form Russian
Short Consent Form Chinese
Short Consent Form Vietnamese
Short Consent Form Korean
Short Consent Form German
Short Consent Form Serbo-Croatian

IACUC Forms/ Appendices

The IACUC Forms page has moved.  Please update your bookmark to point to the new location.

Title	Forms
Animal Usage and Administrative Review Form
Annual Review USDA Regulated Animals   Annual Self-Certification Non-USDA Regulated Animals
Appendix A
Appendix B
Appendix C
Appendix D
Appendix E
Appendix F
Appendix G
Addendum Form

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IBC (Recombinant DNA/Infectious Agents/Toxins) Policies

  This page has moved.  Please update your booksmark with theNEW LOCATION.

Title	Policy	Supplemental Information	Forms
Recombinant DNA (rDNA) and/or Infectious Agents or Biological Toxins
IBC Review Procedures Flowchart
Financial Conflict of Interest Disclosure for IBC Members
Institutional Biosafety Committee Charter
Annual Review Policy
Protocol Revision Policy
Protocol Deviation Policy
PI Eligibility Policy
Transgenic Animal Research Review Policy

IBC (Recombinant DNA/Infectious Agents/Toxins) Forms

Title	Supplemental Information	Forms
Initial Recombinant DNA Research Classification
Recombinant DNA Research Questionnaire
OHSU Infectious Agent/Toxin Questionnaire
IBC Committee Member Review Form
Investigational Human Gene Transfer Agent Supplemental
Annual Renewal/Modification Form
Protocol Deviation Form
Transgenic Core IBC Approval Form

Conflict of Interest in Research Forms

Title	Policy	Supplemental Information	Forms
Conflict of Interest in Research