Â鶹´«Ã½Ó³»­

Frequently Asked Questions - Human Subjects (IRB)

The following Frequently Asked Questions (Human Subjects (IRB) FAQs) are provided to address commonly asked questions from researchers about IRB.

Select title below to jump to question, then click the plus (+) symbol to reveal answer.
General Questions
Grant Funds
Consent
CITI Online Training
Special Topics

Do I Need To Submit to the IRB?

The IRB has jurisdiction over research involving human subjects (participants), more information here.
Visit here for assistance in determining whether you need to submit an application to the IRB and if you are doing research involving human subjects.

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

Submissions to the IRB should be through IRB Novelution. Information on how to submit new projects, amendments, continuing reviews, and other IRB materials can be found here.

What are the different categories of IRB review?

The IRB reviews projects based on risk. Per federal regulation, there are three types of IRB review: Exempt (less than minimal risk); Expedited (minimal risk); Full Review (greater than minimal risk). Only the Florida Atlantic IRB designated personnel can make the final determination on research risk can type of review.

It is important to note that exempt does not mean exempt from submission and review. Instead, it means exempt from federal regulations. Florida Atlantic policy requires .

It is important to note that . Instead, it means that one member of the IRB committee will review the submission and that review at a fully convened meeting is not required.

Who should be listed as the Principal Investigator?

The Principal Investigator (PI) must be a full time Florida Atlantic faculty/employee or otherwise eligible. See for more details.

If I am performing a study that may be 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.

What are the deadlines for submitting an IRB application?

Exempt and expedited reviews are conducted on a rolling basis. There is no deadline for submitting these types of projects. Investigators who will conduct studies requiring review at a fully convened meeting should adhere to the submission schedule for these projects. If you are unsure whether your project requires review at a fully convened meeting, please contact the Florida Atlantic IRB for guidance.

Who is supposed to electronically sign my IRB submission?

• For new protocols: the PI, Department Chair, and in some Colleges, the Dean's representative for research, must sign.If PI is also the Department Chair, then his/her Supervising Authority or the Dean's designee must sign off on the application before it is submitted to the IRB.
• For continuing reviews: the PI and Department Chair must sign.
• For responses to the IRB and amendments, only the PI must sign.
• For adverse event and protocol violation reports, the PI and Department Chair must sign.

The assurance section at the bottom of each form tells you which signatures you need before submitting to the IRB. Please obtain ALL electronic signatures before submitting the IRB application.

How long is the review and approval process?

Please allow 4-6 weeks for the IRB to review and approve your application. You cannot start data collection involving human subjects until after the IRB approves your application.

Now that I have submitted my IRB application, can I start my research?

No. You cannot start data collection involving human subjects until AFTER the IRB approves your submission.

Once the IRB has approved my study what should I do?

You will receive a notice of approval to your IRB Novelution registered email. It is important to read that approval letter to understand any requirements or limitations of your approval. Other IRB approved materials such as consents may be accessed through IRB Novelution.

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

Contact information for our office can be found in the staff directory.

I am requesting funding. Do I need to have IRB approval before I submit my proposal?

No. You can submit your proposal to the funding agency and list your IRB approval status as pending. With most federal agencies (NIH, NSF, Dept. of Education) you can submit the approval information "just in time" once you receive a fundable score, or when the agency requests the IRB approval information. However, don't wait too long to submit your IRB application because it can delay the funding agency's decision should you be selected to receive a grant. You should also consult the specific granting agency for its guidelines on the use of human subjects.

I haven't received IRB approval but my grant is ready to be funded, what should I do?

Florida Atlantic and most funding agencies will not release funding until IRB approval has been verified. Contact the Research Integrity office as soon as possible for assistance. We cannot issue an IRB approval immediately, but will work with your granting agency as needed to facilitate the award process.

What is Florida Atlantic's Federal-Wide Assurance (FWA) Number?

Florida Atlantic's FWA # is FWA00000157.

What should I include in my IRB application if the study is funded?

If your protocol is, or will be funded by an outside organization, please note this on the IRB application. You will also need to submit the section of the grant or contract that describes your proposed scope of work with human subjects. Please ensure that the research described in your funding proposal matches the work described in the IRB application, and that the titles match. The IRB must ensure that the research it approves is consistent with what the sponsor is supporting.

When writing the consent form, can I just copy and paste my grant procedures into the consent form?

No. The consent form is meant to inform participants about what is being asked of them in the simplest terms possible. Please do not copy and paste lengthy methodology from a protocol or grant application into the consent form. Ideally, the reading level of a consent form should be at a 6th - 8th grade reading level. Avoid scientific / technical terms and define or spell out all abbreviations and acronyms. Tip: always ask yourself what would you say if you were explaining your research study to a family member.

How can I determine the reading level of my consent form?

In Microsoft Word, there is a tool under Spelling and Grammar that provides a Flesch-Kincaid reading level score. Aim for a score of 8 or less.

Do I always have to obtain a signed consent form for my research study?

No, not all studies required a signed written consent form. Choose the most appropriate consent process for your study. If you think your study does not require a signed consent, you must provide the IRB with a justification as to why this requirement should be waived.

What is a child assent and why is it called assent?

Children cannot legally consent for themselves. Therefore, informing them about the study and asking them to agree to participate is called an assent process. Only parents or guardians can give consent for a child to participate in research, unless the IRB waives this requirement. However, even if a parent consents, if the child refuses to assent, the researcher generally should not enroll the child in his/her study.

Are there any tips for writing child assents?

In general, minors between ages 7 and 17 can give their written assent to participate in research. However, researchers sometimes write an assent document that contains long complex sentences and technical terms. An assent must be tailored to the emotional and educational level of the child. Short, simple sentences and friendly, conversational language is preferred. For very young children a verbal assent script that describes what will be said to the child may be more appropriate. It is also acceptable to not provide assent procedures if the child is extremely young or not capable of understanding (parental consent will still be needed).

I am recruiting subjects who do not speak English. Are there certain consent requirements?

Yes. If you plan to recruit subjects who do not speak English, you need to translate the written consent document to obtain true informed consent. However, since the IRB may request changes, please wait until after the IRB has approved the English version of the consent documents before seeking translation services. If you are using a verbal consent process, you still need to provide a translated version of the script that will be spoken to the participant.

Who needs to take the CITI training?

All members of the research team must have CITI training certificates before a study can be approved. In short, anyone who will be involved in consenting, recruiting, or obtaining data from study participants must complete CITI Human Subjects Research training, unless it is already on file in the IRB office.

How do I register for CITI?

To register for CITI visit www.citiprogram.org. As a new user, you will need to click "Register Here" to register for the training course and select "Â鶹´«Ã½Ó³»­" from the Participating Institutions. Do NOT sign up as an Independent Learner as you will incur a fee and will not be reimbursed. See the for guidance on registering for a new CITI account and adding courses.

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

At Florida Atlantic, CITI IRB training is valid for 3 years. After 3 years, you must complete a refresher course if you are still engaged in human subjects research at Florida Atlantic.

How long does the CITI IRB Training take to complete?

How quickly you complete CITI Training varies, but it will likely take you between 2 to 4 hours to complete all of the training modules. You do not have to complete the IRB training modules all at once. You may re-enter the site as often as necessary and complete the modules at your own pace.

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.

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 Information Privacy and Security (IPS).

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

Yes. Completion of the RCR Training Course from the CITI website does not satisfy the Florida Atlantic IRB Training requirement. All investigators conducting research involving human subjects must complete the CITI Human Subjects Research Course. Courses to choose from include: Biomedical Research Investigators, Social and Behavioral Research Investigators, and Data or Specimens Only Research.

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

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

Is CITI Human Subjects Research Training required for persons not affiliated with Florida Atlantic who are collaborating with Florida Atlantic researchers?

Maybe. CITI Human Subjects Research Training is required for all non-Florida Atlantic researchers who are collaborating with Florida Atlantic researchers in conducting human subjects research, if Florida Atlantic will provide oversight for their role in the study. If the collaborator will be seeking IRB approval from their own institution for their role in the study, then Florida Atlantic has no oversight over the collaborator and they can use the training required by their home institution.

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

To transfer your completed modules from another institution to Florida Atlantic, log on to your previous CITI account and click on the Affiliate with another institution link. Choose Â鶹´«Ã½Ó³»­ 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 Florida Atlantic module and complete any modules Florida Atlantic requires that your former institution did not.

When will I have to take a CITI refresher course?

All CITI course offerings are on a three-year renewal cycle.Ìý This means that a refresher course will be due three years after you first complete a course. CITI will send you emails to remind you when a refresher course is due.Ìý It is important to adjust your email privacy settings so that you can receive these important emails.

When do I need a data use agreement?

A Data Use Agreement (DUA) is a contractual document used for the transfer of nonpublic data that is subject to restrictions on its use. For the guidance on Data Use Agreement please go here.

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

There is a distinction between research conducted by students and classroom research. Student research refers to human subjects research conducted by students in pursuit of an Honor's thesis, Master's thesis, dissertation, DIS, or other similar research. Student research projects should be submitted to the IRB and be actively monitored by the faculty advisor, who serves as Responsible Principal Investigator. Classroom research refers to students' involvement in course activities that are primarily intended to teach them how to conduct human subjects research, rather than contribute to generalizable knowledge. Results of these activities are generally not published or disseminated outside of an instructional setting. In most cases, classroom research does not need to be reviewed by the IRB. If at a later point, you decide to continue a class project as a research project, submit an IRB application for review and approval. More information can be found in the Toolkit for Researchers.

Are there any special issues I should consider with online research projects?

Yes. Please see our guidance on internet research.

With regard to keeping participant's research data safe, I am confused by the terms confidential and anonymous. What is the difference?

Anonymity means that an individual subject cannot be identified. No personal identifiers (e.g., name, signature, SS#, address, etc.) will be collected or associated with the data being used for research. Confidentiality means subjects' identities are known but will be protected to some extent by the investigator. For example: If you audiotape or videotape research subjects, their data is NOT anonymous, but you can take certain measures to ensure the data and recordings are kept confidential.

What information does the IRB need on the recruitment procedures for my study?

In addition to describing your recruitment plan in your protocol, don't forget to attach any advertising materials (flyers, scripts for radio or television ads, e-mail, texts, etc.) that will be used. Also, any incentives (money, extra credit, gift cards, etc.) that will be used to attract and retain participants should be described in your protocol and noted in any consent form(s) or procedures.

May I use a lottery as an incentive to attract participants?

No. Due to Florida law, Florida Atlantic researchers are not able to use lotteries for prizes or cash as incentives for research participants.

The IRB application asks if we are working with cooperating institutions. What does that mean and how does that affect my IRB submission?

If you are collecting data from persons at an institution outside of Florida Atlantic, or an outside institution is helping you with recruitment, you are working with cooperating institutions. The IRB requires a letter of cooperation from an appropriate person at that institution. The letter should be on institution letterhead and signed, however an email is sometimes acceptable if sufficient detail is provided. More information can be found in the Toolkit for Researchers.

I received my IRB approval, so why does another agency also want to review this study?

Some agencies, such as county school districts, the Florida Department of Health, the Florida Department of Corrections, etc. may have their own separate research review processes. Please contact these agencies regarding their specific procedures. These agencies may require an additional review to ensure the study fits within their mission and is conducted according to their logistical or administrative processes. More information can be found in the Toolkit for Researchers.

I am planning to collect data at one of the FAU K-12 schools. Do they have a separate review process?

Yes. More information can be found in the Toolkit for Researchers.

I am working with collaborators at other universities. Does my IRB approval cover my collaborators too?

It depends. If your research involves co-investigators at other sites who are enrolling subjects or collecting data, their institution may require them to undergo separate IRB approval. Please check to see if this is a requirement before submitting your IRB application. More information on collaborative agreements may be found in the Toolkit for Researchers.