What to Submit to IRB

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

Be certain to always use the most recent versions of IRB forms. It is not advised to save forms to your desktop or other places. Always access versions from IRBNet.

IRB Forms

Forms	Directions
Form 1: IRB Application Old versions not accepted after Oct. 1, 2022	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 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 and 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.
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.
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 two categories of direct identifiers (dates and city/state/zip code)

Protocol Templates

Document	Directions
New! Greater than Minimal Risk Protocol	Use for the following projects: Research involving drugs and medical devices that may require FDA review and/or have not undergone FDA review Research collecting data involving invasive procedures such as surgical procedures Research wherein the probability and magnitude of harm or discomfort anticipated in the research would be greater than what a participant may encounter during routing daily life or during the performance of routine physical or psychological examinations or tests.

Consents & Authorizations
Choose one or more as applicable.

Document	Directions
New! Assent Ages 7-12	Use when conducting research with minor ages 7-12
New! Assent Ages 13-17 or Persons with Diminished Decisions Making Capacity	Use when conducting research with minors ages 13-17 or with a population that may require a guardian signature
New! Exempt and Minimal Risk Research or Waiver of Documentation Consent	Use when conducting research that may be exempt; research that is minimal risk, and/or when a study meets the requirements for waiver of documentation of consent if any of the following conditions apply: (i) That the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. (ii) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or (iii) If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.
New! Non-Biomedical Research Consent	Use when conducting research that includes range of methodologies and tackles questions that seek to improve our understanding of human behavior, attitudes, beliefs and interactions as well as social and economic systems, organizations, and institutions.
New! Biomedical Research Consent	Use when conducting research that involves drugs, devices, or biospecimen collection.
New! HIPAA Authorization	This information is contained the Biomedical Research Consent. If a study is not biomedical research focused but HIPAA does apply, investigators should copy/paste the HIPAA section of the Biomedical Research Consent into the appropriate consent document. Be advised, waiver of documentation of consent is not permitted for HIPAA applicable projects.

Miscellaneous Templates
Use as applicable

Forms	Directions
MISC 1_Recruitment Flyer Template	Use when preparing flyers that will be used in an IRB approved research study.(Format strongly recommended)
MISC_2_Letter of Cooperation Template	This is typically needed when other entities provide access to participants or data for your study.

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