IRB Forms

Use these forms for submissions to the FHCRC IRB (or Cancer Consortium IRB). The forms are Word documents for download unless otherwise noted. Instructions (where applicable) are web pages for reading onscreen or printing.
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Forms are updated regularly. To make sure you are filling out the current version of a form, visit this page first. [ctrl-d to bookmark]

Note to users: Updates to instructions are in progress and will roll out gradually. If you have questions or suggestions for improving the instructions, feel free to contact the IRO department.   

All application forms, display the icon to indicate additional documentation is required to be attached.

All applications/submissions must meet minimum accepted standards or they will be returned by the Institutional Review Office.  Minimum accepted standards can be found here - IRB Applications/Submissions - Minimum Accepted Standards.

All forms are designed for Microsoft Word version 2003 and higher.  All forms are protected to prevent accidental editing of questions.  If you need to unlock the form for special editing, notes, or to add additional grids, the forms can be unprotected with no password.


New Application Forms - Use the application which describes your new research project:           

Application for Review - Interventional Research  
Current Version date 08-01-16                                                                                           Use for research involving a research intervention with the intent to change the participant. Research involving a clinical intervention, behavioral interventions, dietary interventions, or any other interaction with a living participant with the intent to change their biomedical condition or behavior should use this form. 

Application for Review - Observational Research  
Current Version date 08-18-16 
Use for research involving interactions with a living participant for the purpose of collecting data or specimens from the participant with no intent to change them. Biospecimen collection, survey research, long term follow-up, observational research, and other data/specimen gathering involving an interaction with a living participant should use this form. Note, if the collection of data or specimens also involves an intervention, use the Interventional Research version of the IRB application.

Application for Review - Specimen and Data (No Participant Contact) Research  
Current Version date 08-01-16
Use for research projects involving human specimens or data where the scope of the research project does not involve interacting with a living participant. Ancillary studies involving specimens or data collected under another research protocol, repositories and coordinating centers with no participant interactions, research involving non-commercially available de-identified specimens/data/cell lines derived from a human, and any other activity involving human specimens or data where there is no interaction with the human.  Note, if the collection of data or specimens also involves interaction with a human, use the Observation or Interventional version of the IRB application.

Application for Review - Cooperative Review or IRB Authorization Agreement  
Current Version date 08-01-14 
Use for application for research projects where FHCRC IRB is not the IRB of record. 

Continuing Review Report (CRR) and Research Modification Form:   

Research Modification Form 
Current Version date 08-01-16
Use for any change to your research.

Continuation Review Report
Current Version date 08-01-14 
Use for all Continuing Review Reports for all types of research.  Depending on the status of your research the form asks more or less questions.  Start at the top and work your way through. 

Cooperative or IRB Authorization Agreement - CRR Cover Sheet 
Current Version date 08-01-14 
Use for reporting continuing review for Coopertive Review and IRB Authorization Agreements IRB files where FHCRC is relying on another institution for IRB review. 

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Supplements and Other Forms used with New Applications, CRRs, and Modifications:   

Funding Source Supplement 
Current Version date 08-01-16  

Multi-Center Supplement 
Current Version date 01-01-17     

Waiver of Consent Supplement
Current Version date 12-06-16 

HIPAA Supplement 
Current Version date 01-01-14       

Expedited Review Checklist for Minimal Risk Activities 
Current Version date 08-01-16 

Exempt Checklist
Current Version date 08-01-16 

Human Subjects Research Determination 
Current Version date 01-01-14 

Less Commonly Used Supplements:

Children Supplement
Current Version date 08-01-16  

Department of Defense (DoD) Supplement 
Current Version date 08-01-16 

Device Supplement 
Current Version date 08-01-16    

Genomic Data Sharing Supplement 
Current Version date 08-01-16    

International Research Performance Site Assessment Supplement 
Current Version date 08-01-16  

Prisoner Certification Checklist for Investigator 
Current Version date 08-01-16    

Repository, Registry or Databank Supplement 
Current Version date 08-01-16   

Statistical Center Supplement 
Current Version date 08-01-16   

Transfer of IRB Oversight Supplement                                                                     Current Version date 08-18-16

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Noncompliance and Unanticipated Problem Reporting Forms:   

Expedited Reporting Form for Unanticipated Problems or Noncompliance 
Current Version date 08-01-16       

Adverse Event Reporting Form 
Current Version date 08-01-16                                                                                        
This form is used in conjunction with the Expedited Reporting Form for Unanticipated Problems or Noncompliance. 

3rd Party Safety Reporting Form 
Current Version date 08-01-16 

Allegation of Human Subjects Noncompliance Reporting Form  
Current Version date 08-01-16

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Model Consent and HIPAA Authorization Templates:     

Model Consent for Clinical Research
Current Version date 03-27-15  [info]

Model Consent for Minimal/Low Risk Studies
Current Version date 09-01-14  [info]

Model Consent R
Current Version date 09-01-14  [info]

PHS Model Consent for Research
Current Version date 09-01-14 

PHS Model Consent for Minimal Risk Studies
Current Version date 09-01-14 

Model Assent
Current Version date 04-07-12  [info]

HIPAA Authorization to Use, Create and Share Health Information for Research
Current Version date 06-07-15

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Multi-Center Related Agreements and Template Authorization Agreements:     

Assurance Identification/IRB Certification/Declaration of Exemption (rtf)
Current Version date 01-31-12    [instructions]

Individual Investigator Agreement
Current Version date 01-01-17   [instructions]

IRB Authorization Agreement (when FHCRC is the IRB of record)
Current Version date 08-01-14 

IRB Authorization Agreement (when FHCRC is relying on an offsite institution for IRB review)
Current Version date 03-07-14  

Sample Letter of Support from the Collaborating Investigator's Institution
Current Version date 08-01-07

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Translated Short Form Consents and Related Forms:     

Interpretation Certification Form 
Current Version date 08-01-16   [instructions]

Sample Short Form (English) 
Current Version date 07-01-13    [instructions]

Short Forms (other languages) (web page)

Translation Certification Form
Current Version date 08-01-16    [instructions]

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Funding Related Forms:     

IRO Confirmation of Limited Activity Form
Current Version date 03-20-13 

Funding Verification and Activation Form
Current Version date 05-15-14    [instructions]

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Other Documents:    

Emergency Treatment Acknowledgement Report 
Current Version date 08-01-14 [instructions]

Glossary of Terms and Acronyms
Current Version date 07-15-10

IRB Investigator Guidelines (web page)
Version date 08-01-14

Transfer Agreement                                                                                                   Version date 06-26-15   

Guidance for IRB Forms                                                                                                 Version date 06-26-15 

Institutional Approval Email Template Example for IRB Applications                             Version date 08-01-16 

Lay Terms for Adverse Events

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