OHSU

Research Policies and Forms


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)


FWA



FWA for Non-OHSU Partners



Constituting the Institutional Review Board






Roles and Responsibilities

Folder





Sample IRB Authorization Agreement




Sample Authorization Agreement

Individual Investigator Agreement: Application for Individual Investigator to Be Covered by OHSU FWA





Individual Investigator Agreement


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



Service Level Understanding



Title Policy Procedure Regulatory Sheet Supplemental Information Forms

Protocol Files






Consultants






The Electronic IRB (eIRB
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




PI Eligibility Requirements


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

Exempt Review Policy



Exempt Review Regulatory Sheet

45cfr46.101



Expedited Review

Expedited Review Policy


Expedited Review Regulatory Sheet


HHS Expedited Info



Full Board Review







Title Policy Procedure Regulatory Sheet Supplemental Information Forms

Continuing Review

Continuing Review Policy


Continuing Review Regulatory Sheet

HHS Continuing Review Info.


Modifications

Modifcation Policy





Appeal of Decisions Made by the Institutional Review Board






Non-Compliance with IRB Policies, Procedures, or Decisions
Non-Compliance Policy

Non-Compliance Regulatory Sheet



Data and Safety Monitoring

DSMP

DSM Procedures

Data and Safety Monitoring Regulatory Sheet

Data and Safety Monitoring Plan Guide

Data and Safety Monitoring Templates

Termination of Study
 
Termination of Study Policy
       


Back to IRB

 

 


Section 5: Informed Consent of Research Participants

 

Title Policy Procedure Regulatory Sheet Supplemental Information Forms

Informed Consent

Folder


HHS Informed Consent Info

Forms


Elements of Informed Consent / Assent Forms
Elements of Consent

Elements of Consent Regulatory Sheet
Informed Consent FAQs


Additional Consent Information for Different Types of Studies






Elements of a Consent
Elements of a Consent

Regulatory Sheet
Informed Consent Checklist


Documentation of Informed Consent





 
Waiver of Documentation of Informed Consent
       
 

Waiver of Informed Consent
     
 Tips for Modifying the Consent Process
 
Title Policy Procedure Regulatory Sheet Supplemental Information Forms

HIPAA: Waiver of Authorization for the Use and Disclosure of Personal Health Information (PHI)



HIPAA & Research


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   

HIPAA Activiites Prep to Research Policy



HIPAA Activities Prep to Research Regulatory Sheet


HIPAA Research Guidelines


Certificate Prep to Research


Certificates of Confidentiality

Certificates of Confidentiality Policy


Certificates of Confidentiality Regulatory Sheet

HHS Certificate of Confidentiality



Research











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Section 7: Reporting Requirements

 

Title Policy Procedure Regulatory Sheet Supplemental Information Forms

Protocol Deviations

Folder


Regulatory Sheet



Unanticipated  Problems

Folder

Procedures

Regulatory Sheet

UP Information & Guidance

Forms

Serious & Continuing Non-compliance
Folder

Regulatory Sheet



Institutional Reporting Requirements
Folder





Back to IRB
 

 

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
Folder

Regulatory Sheet



Inclusion of Children in Research






Inclusion of Adults who Lack Making Capacity in Research

Procedures




Inclusion of OHSU Students and Staff in Research





 
Student Research
         

Back to IRB

 

 

Section 9: Recruitment and Participant Rights


Title Policy Procedure Regulatory Sheet Supplemental Information Forms

Recruitment of Research Participants






Advertising

Folder





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
         

Back to IRB
 

 

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
Folder

Regulatory Sheet



Emergency Single Time Use of a Test Article (Drug, Biologic, Device)
Folder

Regulatory Sheet



Humanitarian Use Device (HUD)
Folder

Regulatory Sheet



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
       21 CFR 11  

Back to IRB
 

 

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   






Back to IRB
 


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

Folder


Regulatory Sheet

Genetice Output Flowcharts


Conflict of Interest In Research

Intranet Only




CoI Homepage


Forms


Records Retention Requirements






Electronic Signatures






Liability





Liability Language Document


Coordinating Centers
       
 
Repositories and Databases
         
 
Stem Cell Research
       

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IRB Forms (Human Subjects)

Title Forms

Proposed Project Questionnaire

Forms

Initial Submission Checklist

Forms


Lay Language Protocol Summary


Forms


Annual Event Summary

Forms

Project Revision/Amendment Form (Modification)

Forms

Tissue Review Form

Forms

Project Termination Form

Forms

Protocol Deviation Form

Forms

Individual Investigator Agreement: Application for Individual Investigator to Be Covered by OHSU FWA

Forms

Use of Ionizing Radiation in Human Subjects Research

Forms

Clinical Study Billing Schedule

FormsOZONE Internal

HIPAA Related Forms

Forms

eIRB Hard Copy Submission

Forms
 

IRB Sample Forms (Human Subjects)

Title Forms

Sample Consent Form

Forms

Sample Consent Form Barcode

Forms

Sample Consent Form for Low Risk Research
Forms