IRB Forms

• Application Forms
• Continuing Review (CRR) and Modification Forms
• Supplements and Other Forms
• Noncompliance and Unanticipated Problem Reporting Forms
• Model Consent and HIPAA Authorization Templates
• Multi-Center Related Documents and Template Authorization Agreements
• Translated Short Form Consents and Related Forms
• Funding Related Forms
• Other Documents 

Application for Review - Interventional Research  - New
Version date 11-01-12  - 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  - New
Version date 11-01-12  - 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  - New
Version date 11-01-12  - 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  - New
Version date 09-14-12  - Use for application for research projects where FHCRC IRB is not the IRB of record.  (This form replaces the Cooperative Review and IRB Authorization Agreement options from the old Protocol Disposition Form).

Continuing Review Report (CRR) and Research Modification Form:   

Research Modification Form - New
Version date 11-01-12 - Use for any change to your research.

Continuation Review Report - New
Version date 11-01-12 - 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  - New
Version date 1-31-12 - 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 - Updated
Version date 11-01-12  

Multi-Center Supplement -  New (replaces old Coordinating Center Supplement)
Version date 11-01-12     

Waiver of Consent Supplement - Updated
Version date 1-31-12 

HIPAA Supplement - Updated
Version date 1-31-12       

Expedited Review Checklist for Minimal Risk Activities - Reformatted
Version date 1-31-12 

Exempt Checklist - Updated
Version date 1-31-12 

Human Subjects Research Determination - Updated
Version date 9-1-12 

Less Commonly Used Supplements:

Children Supplement - New
Version date 1-31-12  

Department of Defense (DoD) Supplement - Reformatted
Version date 1-31-12 

Device Supplement - New
 Version date 1-31-12    

GWAS Submission Supplement - Reformatted
Version date 1-31-12    

International Research Performance Site Assessment Supplement - Reformatted
Version date 1-31-12  

Prisoner Certification Checklist for Investigator - Reformatted
Version date 1-31-12    

Repository, Registry or Databank Supplement - New
Version date 7-20-12   

Statistical Center Supplement - Reformatted
Version date 1-31-12      

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Noncompliance and Unanticipated Problem Reporting Forms:   

Expedited Reporting Form for Unanticipated Problems or Noncompliance - Reformatted
Version date 11-01-12       

Adverse Event Reporting Form - Reformatted
Version date 11-01-12 - This form is used in conjunction with the Expedited Reporting Form for Unanticipated Problems or Noncompliance. 

3rd Party Safety Reporting Form - Reformatted
Version date 11-01-12 

Allegation of Human Subjects Noncompliance Reporting Form
Version date 02-09-11     

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Model Consent and HIPAA Authorization Templates:     

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

Model Consent for Minimal/Low Risk Studies
Version date 07-20-12  [info]

Model Consent for Research
Version date 10-11-12  [info]

Model Consent R
Version date 07-20-12  [info]

PHS Model Consent Form
Version date 10-11-12 

PHS Model Consent Form for Minimal Risk Studies
Version date 10-15-11 

HIPAA Authorization to Use, Create and Share Health Information for Research
Version date 12-07-09

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Multi-Center Related Agreements and Template Authorization Agreements:     

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

Individual Investigator Agreement
Version date 03-20-13   [instructions]

IRB Authorization Agreement (when FHCRC is the IRB of record)
Version date 03-20-13 

IRB Authorization Agreement (when FHCRC is relying on an offsite institution for IRB review)
Version date 03-20-13  

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

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Translated Short Form Consents and Related Forms:     

Interpretation Certification Form
Version date 04-07-12   [instructions]

Sample Short Form (English)
Version date 08-01-07    [instructions]

Short Forms (other languages) (web page)

Translation Certification Form
Version date 08-01-07    [instructions]

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Funding Related Forms:     

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

Funding Verification and Activation Form
Version date 06-22-12    [instructions]

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Other Documents:    

Emergency Treatment Acknowledgement Report
Version date 03-20-13   [instructions]

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

IRB Investigator Guidelines (web page)
Version date 07-15-10

Lay Terms for Adverse Events

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