IRB Frequently Asked Questions

The following FAQs are provided to address commonly answered questions from researchers.

General Issues

1. What is defined as human subject involvement?

When human beings are asked to participate physically in an activity (i.e. in a survey, answering a questionnaire) or to donate their tissue, organs, fluids and other bodily materials it is considered human subject involvement. Federal Policy (45 CFR 46) and FDA (21 CFR 50) provide definitions of human subjects.

2. How do I know if I am conducting research?

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge; when information is sought from subjects directly (as through interview, examination, or questionnaire) or indirectly (as through observation), and when information concerning specific, individually identifiable human beings is asked for from third parties whether through access to files, data banks, other depositories, or through direct inquiry. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

3. Does a pilot, feasibility, mock, or dry-run study require IRB review and approval?

A pilot study is usually a preliminary investigation of the feasibility of a larger study, usually done on a small scale and is exploratory in nature. It is designed to help the investigator refine data collection procedures and instruments or prepare a better, more precise research design. Sometimes pilot studies are conducted to collect initial data in support of or preparation for a grant submission. Pilot studies, sometimes called feasibility studies, mock studies, or dry-run studies, involving human subjects (no matter how small the sample size is) require the same scrutiny as full-scale research projects and therefore, must be submitted for IRB review and approval. This requirement applies regardless of whether pilot data will be used for publication purposes or not. It is recommended to explicitly identify in an IRB submission when a study is intended as a pilot study.

4. Does a self-experimentation study require IRB review and approval?

Federal regulations do not distinguish between self-experimentation and research on subjects recruited for a specific project. Faculty, staff, and students who wish to act as participants in their own research are considered human subjects. All self-experimentation human research activities require IRB review and approval prior to commencing the study.

5. Where can I learn more about the requirements for conducting research with human subjects?

Please view our Obtaining IRB Approval web page for a basic snapshot of the IRB approval process. In addition, our Policies and Procedures web page provides information on a number of IRB specific areas (Informed Consent, Review Criteria, Data Security, etc.).

6. How do I submit an application to the IRB for review and approval?

IRB protocols need to be submitted through the online TOPAZ Electronic Protocol Application System. Please access the Quick Reference Guide for a high level overview of the TOPAZ system and the Full User Guide for a more detailed explanation with step-by-step screenshots of the submission process.

7. If I am performing a study that is exempt, do I have to submit it to the IRB?

Yes, the PI does not have the authority to deem his/her proposal as exempt even if it meets all the criteria. All official approvals come from the IRB office.

8. What are the deadlines for submitting an IRB application?

Exempt and Expedited review occur on an ongoing basis. Full Board review occurs once a month during the last week of the month (unless otherwise noted). The IRB Meeting Schedule is posted for your information.

9. How long is the review and approval process?

Exempt and Expedited submissions normally take approximately 2-3 weeks. This time frame will vary depending on a number of circumstances. The complexity of the protocol, the completeness of the submission, and the current workload will all impact the time frame.

Full Board submissions normally take 1-2 months. This time frame will vary depending on a number of circumstances. The complexity of the protocol, the completeness of the submission, and the current workload will all impact the time frame.

10. I am requesting funding, do I need to have IRB Approval before I submit my proposal?

In most cases (NIH, NSF, Dept. of Education) you will be submitting the approval information “just in time”, when you receive a fundable score, or when the agency requests the IRB approval information. All of these time frames occur prior to the release of the award to the Office of Research and Economic Development at FIU. For the most accurate information, the PI should consult the agency for guidelines for the use of human subjects.

11. I haven’t received approval from the IRB but my grant is ready to be funded, what should I do?

FIU and most funding agencies will not release funding for spending until IRB approval has been verified. Contact the Office of Research and Economic Development and/or the IRB Coordinator for assistance.

12. What are FIU’s Federal-Wide Assurance (FWA) and IRB registration Numbers?

Federal-Wide Assurance (FWA): FWA00000060 (Expires: 02/11/2019)
Health Sciences IRB Registration Number: IRB00008168
Social and Behavioral IRB Registration Number: IRB00008169

13. Are there any requirements of the PI after receiving IRB approval?

Yes, all proposals approved by Expedited or Full Board Review are required to submit an annual report. In addition, any changes to the protocol, methods, measures, etc. must receive IRB approval. Consent documents MUST be annually renewed. Proposals that receive Exemption require no additional approval from the IRB as long as the scope of the research remains the same.

14. What are the consequences of noncompliance in research involving human subjects?

What are the consequences of noncompliance in research involving human subjects? The IRB reserves the authority to suspend or terminate approval of research. The suspension of an IRB project that is being funded will in turn affect the continued use of funds on the account. Anyone conducting human subjects research without the approval of the IRB may be subject to a finding of research misconduct.

15. Are there University procedures for the reporting injuries (Adverse Events) that occur during an approved research project?

Yes, there are detailed procedures located at the Adverse Event (AE) Reporting. This includes definitions of AE’s and the appropriate paperwork to be completed by the Investigator. The Principal Investigator is responsible for knowing reporting procedures, providing written notification to the IRB Office and verifying receipt of notification.

16. Who do I contact with general questions in regards to my human subjects proposal submission?

You may contact the IRB Coordinator or an IRB Member.

17. Where do I find the categories for "Type of Review Being Requested"?

The categories are found in the Policies and Procedures page under the “Review Criteria” section.

18. Am I allowed to use lotteries/raffles/drawings as a form of compensation to the participants in my research?

No, lotteries/raffles/drawings are not permitted for compensation to participants in research, since the Florida Constitution and Statutes prohibits it.

19. How long do I need to keep the signed consent forms that I have collected as part of my research study?

Investigators are required by HHS regulations to keep signed consent forms for at least three years after the completion of the study.

TOPAZ Online Protocols

1. How can learn more about submitting a protocol through the online TOPAZ Electronic Protocol Submission System?

Investigators should first review the “Obtaining Approval” page for an overview of the approval process. Investigators should then proceed to review the “TOPAZ information” page, which includes information on training sessions, user guides, and other helpful information on accessing the TOPAZ system.

2. What are some of the primary differences between the old paper-based IRB process and the new TOPAZ system IRB process?

Investigators no longer need to submit their application directly to an IRB member. The IRB Office will distribute protocols to IRB members.

Investigators no longer need to complete an IRB Proposal document. All of the content from the IRB Proposal is now integrated into the Form.

There are now two different initial forms that can be used for applying for approval. The “IRB Exemption Form” is used for obtaining an Exempt Review. The “IRB Approval Form” is used for obtaining an Expedited or Full Board Review. Investigators should only complete one of these forms (not both). Access the Types of IRB Review web page for more information on the review types.

3. How do I do an Amendment or a Renewal to an existing paper-based IRB approved protocol in the new TOPAZ system?

Investigators are required to submit their existing project through the TOPAZ system as a new original protocol submission when the time comes for the investigator to do his/her first amendment or renewal of the paper-based protocol (this is a one-time requirement). Learn more on the Online TOPAZ System web page.

4. Who should I contact if I have a technical question about using the TOPAZ system?

Investigators should send an email to topaz-help@fiu.edu. A response will normally be provided within 24 hours during the normal business hours of 9 AM – 5 PM, Monday-Friday. In rare cases, the response time might be 24-48 if there are a large number of inquiries.

5. What should I do if I am unable to log into the TOPAZ system?

Please ensure that you are using your Panther ID as your username. The system will only accept your numerical Panther ID (it will not accept an alias login name). All investigators with active IRB paper-based protocols should be able to login to the TOPAZ system. If you are unable to access the system, then you will need to follow the “System Access Request” instructions below, so we can create a TOPAZ account for you.

  • TOPAZ System Access Request for FIU Personnel:
    If you are FIU Personnel (i.e., individuals with existing Panther IDs) and unable to login, please fill out and submit the following form to have a TOPAZ account created: Personnel Access Request Form. You should expect to receive an email confirming that your account has been created within 1-2 business days of submitting the request.
  • TOPAZ System Access Request for Non FIU Personnel:
    If you are Non FIU Personnel (i.e., individuals without existing Panther IDs) and are unable to login to Topaz, please have the Principal Investigator fill out the Person of Interest form referenced on the Division of Human Resources website here.
    Per the HR website: “A POI form can be completed either by the Manager or the Person of Interest. The POI form can be found under the Recruitment forms in the Manager Self Service or Employee Self Service within PantherSoft Human Resources. Once completed, print form and both the supervisor and the person of interest must sign.
    If you have any questions regarding this form, please contact HR directly at: (305) 348-2181.
    After you have submitted this form and received a Panther ID, please proceed to filling out the Personnel Access Request Form to have a TOPAZ account created. You should expect to receive an email confirming that your account has been created within 1-2 business days of submitting the request.

6. What is the difference between a "Co-Investigator" role and a "Key Associate" role?

Individuals that are designated in the application as Co-Investigators will have the ability to “view and edit” this application.

Individuals that are designated in the application as Key Associates will only receive TOPAZ system email notices.

7. What type of naming convention should I use when attaching files to my electronic application submission in TOPAZ?

Make the file name sufficiently descriptive and clear. Avoid using certain special characters in a file name (& * ? < # : ) as they may cause problems and you most likely won't be able to save the document. A dash (-) or underscore (_) may be used. File names should use consistent date formatting. For example, a file modified on March 24, 2011 should include 24MAR2011 in the file name. Use version numbers to manage the revisions of attachments (e.g., V1, V2, V3) Consider including the document file name and version in small font in the footer of the document. If you do this, remember to update the footer each time the document is revised.

8. What should I do if the email address associated with my TOPAZ is no longer used and needs to be updated?

Please send an email address to topaz-help@fiu.edu along with your full name, your panther ID, your old email address, and your new email address. It is strongly advised to keep your email address in the TOPAZ system up to date to ensure you are receiving all applicable email notices from the TOPAZ system.

CITI Online Training

1. I have already completed the NIH PHRP IRB Training. Do I still need to complete the CITI IRB Training?

Completion of the NIH PHRP IRB Training Course no longer satisfies the FIU IRB Training requirement. The new CITI IRB Training requirement applies to all new IRB submissions received on or after January 2, 2013. It also applies when adding new personnel onto an active IRB-approved study. Investigators with active IRB protocols will need to ensure that all project personnel have satisfied this new IRB training requirement when submitting for their next IRB continuing review.

2. I have already completed the CITI IRB Training Course. How long is my IRB Training valid for?

All key personnel are required to complete a CITI IRB Training Refresher Course every 3 years. The CITI system will send you a courtesy reminder notice via email in advance of your training’s expiration date.

3. How long does the CITI IRB Training take to complete?

It will likely take you between 2-4 hours to complete the training modules.

4. Do I need to complete the CITI IRB Training in one sitting or can I start and stop at my own convenience?

You do not need to complete the training in one sitting. You can start and stop at your own convenience.

5. What is the minimum grade that is required for passing the CITI IRB Training?

You will need to score at least an 80% in order to pass the training course.

6. I will be doing research with medical records. Are there any additional training requirements for me to take?

Yes, researchers accessing protected health information (PHI) will also be required to complete the CITI Health Information Privacy and Security (HIPS) Training.

7. I have already completed the CITI Responsible Conduct of Research (RCR) Training. Do I still need to complete the CITI IRB Training?

Completion of the RCR Training Course from the CITI website does not satisfy the FIU IRB Training requirement. All investigators conducting research involving human subjects must complete the CITI IRB Training.

8. Can I receive IRB approval before I complete the Online CITI IRB Training Course?

No, you will not receive IRB approval unless you have already completed the required IRB training.

9. Where can I receive the training for Human Subjects?

Details for IRB educational training and instructions for accessing the CITI IRB Training are available from the IRB Training page.

10. Is Human Subjects Training required for persons not affiliated with FIU who are conducting research with FIU or recruiting from FIU?

Human Subjects Training is required for all persons participating in research at FIU who will be interacting with the human subjects including those who will be handling the data collected. Human Subjects Training is also required for all non-FIU researchers that are collaborating with FIU researchers in conducting research with human subjects.

11. How do I transfer my CITI completion records from another institution?

To transfer your completed modules from another institution to FIU, log on to your previous CITI account and click on the “Affiliate with another institution” link. Choose “Florida International University” from the drop-down menu. When prompted, choose the Basic Human Research Course, either Biomedical Research or Social and Behavioral Research to match the coursework that you completed previously. Review the FIU module and complete any modules FIU requires that your former institution did not. To view your course completion history, click on “Modules Completed.”

12. Do non-FIU researchers need to take the CITI IRB Training if they have already completed a comparable course as required by their own institution’s IRB?

The FIU IRB can accept a comparable IRB training certificate from a non-FIU researcher if he/she has already obtained the required IRB training from his/her external institution (e.g., NIH, CITI, etc.). However, if the external IRB training does not appear to be adequate, then the non-FIU researcher will be asked to complete the CITI IRB training.

Student Research

1. Do I need IRB approval for doing a classroom research project?

All classroom activities that involve “research” with “human subjects” require IRB approval. However, classroom activities that only involve “research training” are not subject to IRB approval because such studies are conducted specifically for educational purposes only (without publication or presentation of the data). It is always best to obtain IRB approval in advance if you think your project will produce data that you may one day wish to use for research purposes (e.g., you collect the data for educational purposes, but later wish to publish the information). Please note, the IRB is unable to provide retroactive approval, so it is always best to check with the IRB Coordinator if you are uncertain about the applicability of IRB review.