SUBMITTING TO THE IRB

All IRB applications/submissions are reviewed initially by the IRB administrative staff. For all submissions, IRB staff will review the submission for completeness and notify the research team if any changes are required. The HRPP/IRB Coordinator may issue exempt determinations.

Expedited studies must be reviewed by both an IRB Coordinator and by one or two members of the IRB committee. The minority of IRB submissions are reviewed by the "Full Board" at a committee meeting.

What to Submit to IRB

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

IRB Application Checklist

IRB Forms

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.

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.

WHEN TO SUBMIT TO IRB?

The following is for review of new projects.

Exempt research is reviewed on a rolling basis. Projects meeting this definition are reviewed by IRB staff and a determination of exemption is issued. Average time from submission to letter issuance is approximately 3 weeks.
Expedited research is reviewed on a rolling basis. Projects meeting this definition are initially reviewed by an IRB staff member before being assigned to one or more IRB committee members for review and approval. Average time from submission to approval letter issuance is approximately 4-6 weeks.
Greater than minimal risk projects require review by a fully convened committee. Projects meeting this definition are initially reviewed by one or more IRB staff members prior to assignment to an IRB meeting. Investigators are advised to submit their projects by the designated committee deadline. Average time from submission to approval letter issuance is 6-8 weeks. Investigators must plan accordingly.

For projects seeking research funding, investigators are strongly encouraged to contact the IRB and/or begin their IRB submission as soon as they receive notice of favorable review from the funding source. Delays in IRB submission may delay funding acceptance. The Office of Sponsored Programs requires verification of IRB review prior to releasing any research funding in support of research involving human subjects.

*Note: Researchers often interpret the word exempt to mean there is no IRB review needed. At FAU, a study must be reviewed by an IRB in order to be designated as exempt from further review.

HOW TO SUBMIT VIA IRBNET

The new regulations impact studies approved on or after the proposed implementation date of January 21, 2019. For new studies, expect to see updated forms and templates adopting the revised changes. Further OHRP guidance documents to follow as it becomes available.

All studies being submitted to the IRB must be submitted electronically through IRBNet. All forms and templates are located in the IRBNet system. IRBNet is one of the industry's leading Institutional Review Board (human subjects research) software programs, and provides electronic protocol management, on-line submissions and many other important features to the FAU research community. In addition to being an intuitive system, IRBNets secure web-based solution is accessible anytime, anywhere.

How to REGISTER as a new user.
How to SUBMIT a new IRB application via IRBNet (visual tutorial).
STEPS TO SUBMIT a new application via IRBNet (written instructions).
How to SIGN IRBNet submissions for Deans, Department Chairs and other Signatory Officials.
How to submit AMENDMENTS, CONTINUING REVIEWS or any additional information to my IRB.
How to submit CITI TRAINING CERTIFICATES in IRBNet.

Video Tutorials

To view video tutorials, go to: irbnetresources.org. Then, using the log-in information below, log into the FAU resources page:

Username: fauresearch
Password: boca1t
Go to:

If you have any questions on how to use IRBNet, please contact any of the Research Integrity IRB coordinators.