IRB Policies and Forms

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Investigator Resources

Requirements for Investigators and tools for submitting to the IRB

Investigator Manual 

Investigator Guidance

HRP-800 – Investigator Obligations

HRP-802 – Informed Consent

HRP-803 – Documentation of Informed Consent

HRP-810 – Additional DoD Obligations

HRP-811 – Additional DoE Obligations

HRP-812 – Additional DoJ Obligations

HRP-813 – Additional ED Obligations

HRP-814 – Additional EPA Obligations

HRP-815 – Additional FDA Obligations

HRP-816 – Additional ICH-GCP Obligations

HRP-820- Students as Research Subjects

Protocol Deviations

Unanticipated Problems and Adverse Events

Consent & HIPAA Forms & Templates

Assent Form-Shriners  

Assent Form-Standard 

Consent- Information Sheet (7.3.2014)

Consent and Authorization Forms - Clinical (8.12.2014)

Consent and Authorization Forms - Knight Cancer Institute (5.3.2013)

Consent and Authorization Forms - Non-Clinical (7.3 2014)

Consent and Authorization Forms - Repository Only (7.3.2014)

Consent and Authorization Forms - Shriners (8.12.2014)

Consent and Authorization Forms Instructions (7.3.2014)

Consent Form - Short - Chinese

Consent Form - Short - English

Consent Form - Short - Farsi

Consent Form - Short - German

Consent Form - Short - Russian

Consent Form - Short - Serbo-Croatian

Consent Form - Short - Spanish

Consent Form - Short - Vietnamese

Consent Form - Treatment Use of Drug or Device (6.28.2012)

Consent Form Language - Gene Transfer Studies (6.28.2012)

Consent Form Language- Costs

Consent Form Language- Liability (7.15.2014)

Consent Form Language- Signature Templates-Children Ages 15-17

HIPAA- Authorization for Obtaining Existing Records Outside of OHSU

HIPAA- Business Associate Agreement

HIPAA- Data Use Agreement

HIPAA- Decedents Representation Form

HIPAA- Prep to Research Form

HIPAA- Waiver or Alteration of HIPAA Authorization

HIV Test Information Sheet

Submission Forms & Resources

Annual Event Summary 

Brief Project Description

Collaborations – Non-OHSU Investigator Example Tracking Sheet

Data and Safety Monitoring Plan

Collaborations- Individual Investigator Agreement (IIA)

Collaborations-IRB Authorization Agreement - (IAA)- OHSU Providing Oversight

Collaborations-IRB Authorization Agreement - (IAA)- OHSU Waiving Oversight

International Supplement 

Local Context Supplement

Proposed Project Questionnaire

Protocol Checklist – Security and Confidentiality

Protocol Template – Minimal Risk Studies

Protocol Template – Minimal Risk Studies – No Instructions

Stem Cell Supplemental Questionnaire

Telephone Script- Recruitment and Screening 

Repository Forms & Templates

Repository Protocol Checklist

Repository Sharing Agreement (De-Identified)

Repository Sharing Agreement (Identifiable)

Repository Submittal Agreement

Repository Tracking Template (EXCEL)

Repository Tracking Template (WORD)

IRB Help Sheets and Quick Guides

Certificates of Confidentiality (Help Sheet)

Clinical Trials – ClinicalTrials.gov Registration Requirements (Help Sheet)

Clinical Trials – Combined Phase Studies (Help Sheet)

Clinical Trials – Phase Descriptions and Regulatory Classifications(Quick Guide)

Collaborations-- Non-OHSU Institutions and Investigators (Help Sheet)

Collaborations – Non-OHSU Researcher Decision Tree (Quick Guide)

Consent – Limited English Proficiency (Quick Guide)

Consent – Re-Consent and Notification (Help Sheet)

Consent- Waiver or Alterations( Help Sheet)

Coordinating Center Activities (Quick Guide)

DSMP and Annual Event Summary Table (Quick Guide)

eIRB – Checking CoIR/RCR Status (Quick Guide)

eIRB – Registration (Quick Guide)

Emergency Research – EFIC Studies (Help Sheet)

Emergency Treatment Use (Quick Guide)

Future Human Subjects and Grants (Quick Guide)

HIPAA - Accounting of Disclosures (Help Sheet)

Humanitarian Use Devices (HUDs) (Help Desk)

Initial Submission Guide (Help Sheet)

International Research (Help Sheet)

Reportable Events (Quick Guide)

Repositories (Help Sheet)

State Laws and Regulations (Help Sheet)

Quality Improvement or Research (Quick Guide)

Vulnerable Populations – Children (Quick Guide) 

Vulnerable Populations- Decisionally Impaired Adults ( Help Sheet)

Vulnerable Populations – Prisoners (Help Sheet)

Human Research Protection Program (HRPP)

Policies and procedures the IRB follows in reviewing your study

The documents found below are for reference only; they are used by the IRB during the review process. You do not need to fill them out or upload them to your studies.

HRPP Policies

HRP-001 - Definitions

HRP-002 - Abbreviations

HRP-003 - Designations

HRP-010 - Human Research Protection Program

HRP- 020- IRB Member Review Expectations

HRP-021-Legally Authorized Representatives Children and Guardians

HRP-022 - End Approval Dates

HRP-023 - IRB Records

HRP-024 - IRB Roster

HRP-040 - Principal Investigator Eligibility

HRP-080 – IRB Member Review Expectations HUD

HRP Compliance Statement-eIRB Approval Signatures and Stamps 

HRP Position Statement- Subject Injuries and Liability Language



HRP-101 – Regulatory Review

HRP-102 – Designated Reviewers

HRP-103 – Non-Committee Review Preparation

HRP-104 – Non-Committee Review Conduct

HRP-105 – Committee Review Preparation

HRP-106 – Committee Review Conduct

HRP-107 – Committee Review Monitoring

HRP-108 – Minutes

HRP-109 – Not Otherwise Approvable Research

HRP-110 – Consultation

HRP-111 – Post Review

HRP-112 – New Information

HRP-113 – Unexpected Incarceration

HRP-114 – Suspension and Termination by the Organization

HRP-120 – Management of Financial Interests

HRP-122 – Undue Influence of the HRPP

HRP-130 – IRB Formation

HRP-131 – IRB Deactivation

HRP-132 – IRB Member Appointment

HRP-133 – IRB Member Removal

HRP-141 – Annual Tasks

HRP-142 – Monthly Expedited Review Reports

HRP-143 – Expiration of IRB Approval

HRP-144 – Meeting Scheduling

HRP-180 – Emergency and Compassionate Uses

HRPP Forms

HRP-210-Regulatory Review

HRPP Checklists

 HRP-300 – Waiver of Consent HHS

 HRP-301 – Waiver of Consent Emergency Research

 HRP-302 – Waiver of Consent Leftover Specimens

 HRP-303 – Waiver of Documentation of Consent

 HRP-305 – Pregnant Women

 HRP-306 – Neonates of Uncertain Viability

 HRP-307 – Nonviable Neonates

 HRP-308 – Prisoners

 HRP-309 – Unexpected Incarceration

 HRP-310 – Children

 HRP-311 – Wards

 HRP-313 – Non-Significant Risk Device

 HRP-320 – VA Criteria for Approval

HRPP Worksheets

 HRP-400 – Criteria for Approval

 HRP-401 – Scientific and Scholarly Review

 HRP-402 – Advertisements

 HRP-403 – Payments

 HRP-404 – Short Form

 HRP-405 – Additional Criteria DOD

 HRP-406 – Additional Criteria DOJ

 HRP-407 - Additional Criteria ED

 HRP-408 - Additional Criteria EPA

 HRP-409 - Additional Criteria DOE

 HRP-410 - Additional Criteria International

 HRP-411 - New Information

 HRP-413 - Termination Request Criteria

 HRP-414 - Adults Lacking Capacity

 HRP-420 - Regulatory Review

 HRP-421 - Human Research

 HRP-422 - Engagement

 HRP-423 - Exemptions

 HRP-424 - Expedited Review

 HRP-425 - Drugs

 HRP-426 - Devices

 HRP-427 - HIPAA Authorization

 HRP-428 - HIPAA Waiver of Authorization

 HRP-430 - IRB Composition

 HRP-431 - Quorum

 HRP-450 - Criteria for Approval HUD

 HRP-451 - Emergency Use Drugs and Biologics

 HRP-452 - Emergency Use Devices

 HRP-453 - Compassionate Use Devices

 HRP-461 - Oregon Genetic Research Anon-Coded

 HRP-470 - External IRB Screening

 HRP-480 - FERPA

 HRP-481 - PPRA

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