Research Policies and Forms

• 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

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

Children's Forms

Short Consent 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
Sample IRB Authorization Agreement
Individual Investigator Agreement: Application for Individual Investigator to Be Covered by OHSU FWA

Back to IRB

Section 2: The Institutional Review Board

Title	Policy	Procedure	Regulatory Sheet	Supplemental Information	Forms
Functions and Responsibilities
Selection of Institutional Review Board Chairs, Members and Staff
Expectations of IRB Membership
Confidentiality of the Review Process
Research Determinations

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)

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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

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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
Documentation of Informed Consent
Waiver of Documentation of Informed Consent
Waiver of Informed 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

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Section 6: Privacy and Confidentiality

 

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

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Section 7: Reporting Requirements

 

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

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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

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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

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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

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

Title	Policy	Procedure	Regulatory Sheet	Supplemental Information	Forms
Required Training in Human Participants Ethics
Alternative Sources of Information on Human Subjects Ethics
Training for IRB Members & IRB Chairs
Training for ORIO Staff Members

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Section 12: Research Collaborations and Off-Site Research

Title	Policy	Procedure	Regulatory Sheet	Supplemental Information	Forms
Community Partnerships
Multi-Site Studies
Off-Site Activities
Research with the Veterans Administration
Research with Kaiser
International Research
Knowledge of Local Context

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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

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IRB Forms (Human Subjects)

Title	Forms
Proposed Project Questionnaire
Initial Submission Checklist
Lay Language Protocol Summary
Annual Event Summary
Project Revision/Amendment Form (Modification)
Tissue Review Form
Project Termination Form
Protocol Deviation 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