What to Submit to IRB

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*Note: Forms are located at IRBnet.org and listed below.

IRB Forms  

IRB logo
Forms Directions
Form 0: IRB Checklist Use this checklist to help guide you in what documents need to be included in your IRB submission.
Form 1: IRB Application
Old versions not accepted after June 1, 2015
Use to apply for initial review and approval of a new human subjects research protocol.
Form 2: Continuing Review/Final Report Form Use to renew your study or to close it.  
Form 3: Protocol Amendment Form Use to modify anything related to your protocol (e.g, procedures, consent, recruitment process, personnel, etc.)
Form 4: Serious Adverse Event/Unanticipated Problem Report Use to report unanticipated problems or adverse events involving risks to subjects or others. (e.g., loss of data, adverse emotional response, physical symptoms, etc.)  Note:  these must be reasonably related to the research interventions and unexpected.
Form 5: Response to IRB Concerns Use to respond to IRB review questions after a Modifications Required letter has been generated through the IRBNET system.
Form 6: Determination of Human Subjects Research Use to help you determine if your study falls under the purview of the FAU IRB.
Form 8: Request for Waiver of Informed Consent Use to help you determine if your study falls under the purview of the FAU IRB. OR Use this form to request that the IRB waive the informed consent requirement altogether.
Form 13: Protocol Deviation Form Use to report deviations from your IRB approved protocol.
Form 14: Translation Affirmation Form Submit this with your IRB application when translating documents into other languages.

HIPAA Forms & Decision Tools  
Visit here for more information on how HIPAA affects your research.

Forms Directions
Assessment Tool 1:  Does HIPAA Apply to My Research? To help you determine if the HIPAA regulations apply to your research
Assessment Tool 2:  Am I Using Protected Health Information To help you determine if you are using Protected Health Information (PHI) and, if so, what approvals to seek.
Assessment Tool 3: What HIPAA Forms Do I Use? To help you determine what forms you need to use to gain IRB approval to use Protected Health Information.
Form 7:  Request for Waiver of HIPAA Authorization Use this form to request a waiver of the federal requirement to obtain a person's Authorization to use their PHI for research. 
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Form 9:  Request to Review PHI Preparatory to Research
Use this form if you need to review PHI (e.g., medical records) to design a research protocol, formulate a hypothesis, or determine if there are patients available to recruit for a study. 
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Form 10:  Request to Use Decedent's PHI for Research
Use this form to review medical records of deceased persons for research purposes.
Form 12:  Data Use Agreement for Limited Data Set Initiate use of this agreement if you are giving a limited dataset (LDS) to an entity for research purposes, AND if you work for one of FAU's covered components. An LDS refers to PHI that only includes 2 categories of direct identifiers (dates and city/state/zip code)

Protocol Templates  

Forms Directions
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Appendix 1a: Basic Protocol Format
 
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Appendix 1b: Chart Review Protocol Format
Use instead of the Basic Protocol Format for researching involving medical record reviews, secondary analysis of existing datasets, etc.
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Appendix 1c: Supplemental Clinical Trials Protocol
Use in addition to the Basic Protocol Format for long-term collection, storage, and analysis of datasets or repositories for internal use or public access.
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Appendix 1d_Registry or Repository Protocol.docx
Use instead of the basic protocol format for long-term collection, storage, and analysis of datasets or repositories for internal use or public access.
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Appendix 1f_Supplemental Personnel Form
The IRB application only has capacity to list 3 co-investigators.  Use this supplemental form to list additional names if needed.  Also, use this form with amendments to add or remove personnel.

Consents & Authorizations   
Choose one or more as applicable.

Forms Directions
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Consent 1: Adult Consent, 2015 Revision
This is the basic consent for research studies involving adults. (requires participant signature)
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Consent 1A: Consent with HIPAA Authorization
This is the basic consent for research studies involving adults, and it also incorporates HIPAA Authorization Language.   Use only as applicable (e.g., study where patients are interviewed AND the researcher obtains information from their medical records)
Consent 2: Verbal Script This is an alternative consent process where consent is administered verbally.  It is best for field research.  Must be accompanied by Form 8 if used.  Participant signature NOT required.
Consent 3: Consent Paragraph or Cover Letter This is an alternative consent process.  Best for low risk, anonymous research such as surveys.  Must be accompanied by Form 8 if used.Participant signature NOT required.
Consent 4: Child Assent Required in verbal or written form for most Children 7-17 unless waived by the IRB. NOTE:  Very important to tailor language to the child's age & reading level.
Consent 5: Parental Consent Required for research involving children 0-17 unless waived by the IRB or otherwise not required by law.  (See Children in Research policy)
Consent 6: Clinical Consent Use this consent format for clinical trials or clinical research studies involving greater than minimal risk procedures.
Consent 7: Internet Consent Use for online data collection (surveys, interviews, etc.)
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Consent 8: Registry Consent
Use for long-term collection, storage, and analysis of datasets or repositories for internal use or public distribution.
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Consent 9: Repository Consent
Use for long-term collection, storage, and analysis of datasets or repositories for internal use or public distribution.
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Consent 10: HIPAA Authorization, Stand Alone
Use for studies in which are seeking permission from participants to obtain or share their protected health information.  This generally applies to the collection of new information versus existing PHI, but there are exceptions.  NOTE:  this is supplemental to the informed consent form!

Miscellaneous Templates   
Use as applicable

Forms Directions
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MISC 1_Recruitment Flyer Template
Use when preparing flyers that will be used in an IRB approved research study.(Format strongly recommended)
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MISC_2_Letter of Cooperation Template
If you answer yes to question 11a on the IRB application, use this template to create a letter of cooperation.  This is typically needed when other entities provide access to participants or data for your study. 
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MISC_3_Medical Clearance for Research Template
Use this for studies involving greater than minimal risk procedures if you do not have the expertise to screen using a health history questionnaire (or if the IRB requires it.)