UNF: IRB Frequently Asked Questions

How do I know if I need IRB approval for my research?

Please see the Does My Project Need IRB Review webpage.

IRB approval is required BEFORE starting any data collection. This is very important. If you begin your research and start collecting data without prior IRB approval, there is a risk you may not be able to use that data. In addition, the IRB cannot approve a project retroactively.

How do I know if I know if my project is Exempt, Expedited, or Full Board review?

Please see Preparing an IRB Submission webpage as a guide as to the level of review needed for your research. Although only IRB members or designees can make the final determination about the review type for a project, PIs must anticipate the review category so that they can complete the correct documents. If you have questions, it is best to reach out to Research Integrity staff before beginning your submission.

What is the difference between submitting a new Project and submitting a new Package in IRBNet?

When you have a new research project to submit for review, log into IRBNet and left click “Create New Project” on the left-hand side the screen. If you are asked to make revisions to this project after submission and IRB review, you will create a new package. In IRBNet, left click on “My Projects” and choose the project to which you must make revisions. Once you have opened the project, left click on “Create a New Package” under Project Administration on the left-hand side of the screen. You will submit your revisions in the new package. Please note that on certain occasions when documents are missing from your original project submission, Research Integrity staff may unlock your original project to allow for the upload of required documents without you having to create a new package. You also create a new package when you submit an Amendment Request or complete a Continuing Review. Please note: Always be sure to both Submit and Sign your package, two options under Project Administration.

Is there any guidance about how to craft an Informed Consent form?

Yes! For help putting together your Informed Consent form and including all required elements, please see Guidelines for Creating an Informed Consent document and Informed Consent Checklist document. Please note there are some circumstances where a PI may request a waiver of written Informed Consent, depending on the nature of the research.

When should a modification (Amendment) to an approved research study be submitted?

Any changes to a project that has received approval from the IRB must be reviewed and approved before the changes are implemented. To amend a protocol that was approved under expedited or full board review, submit an Amendment Request in IRBNet. This requires the creation of a new package in a project. After logging into IRBNet, go to “My Projects.” Click on the title of the project that you would like to amend/modify. Click on the “Create New Package” button. The Amendment Request will be submitted here as a new file. All other documents must also be updated to be consistent with the Amendment. For example, new personnel deleted/added must be adjusted in the NF-IRB Protocol form.

For exempt studies, only substantive changes must be submitted to the IRB for prospective review. In some circumstances, changes to the protocol may disqualify the project from exempt status. If investigators are unsure of whether a revision needs to be submitted, contact the Research Integrity staff for clarification.

What is Continuing Review?

Research projects that were approved by expedited or full board review are re-evaluated on a regularly scheduled interval as required by the federal government. Unless otherwise specified, the approval period for research is one year from the date of the approval letter sent by the IRB. Email reminder(s) are sent to the researcher prior to the project expiration. To complete your continuing review, fill out and submit the Status Request document in IRBNet as a new package.

If continuing review is not completed before the expiration date of previous approval, the project will expire and all research activities, including participant recruitment, experimental manipulation/treatment, data collection and data analysis of identifiable private information must cease.

How do I securely store and protect my data?

If data will be recorded in a manner that will allow participant identities to be tied to participant responses by the investigator or others (this includes both audio and video recordings), you are collecting identifiable information. When researchers collect data that could be identifiable, there are minimal data security standards to which all researchers must comply. Data can be stored on UNF secure servers, in a locked location in a locked office, or other specialized secure servers (inquire with a Research Integrity administrator for more information – link to contact info). When data are sensitive, additional security controls such as encryption may be required.

Identifiers (including signed informed consent documents), data, and master lists (i.e., documents connecting pseudonyms/codes with identifiers) should be stored in separate and secure locations from each other. By storing this information separately, the risk of a breach of confidentiality is lessened.

Anonymous data can be stored anywhere that is convenient for the researcher. Please note that data are not anonymous if a code exists that will allow the data to be re-identified or if the information could be used alone or in combination with other information to identify the individual who is the subject of the information.

Do I need to submit my project to the IRB if I use data originally collected for a non-research activity?

Maybe, depending on if identifiable, private information was originally collected. The results of a non-research activity could be used to develop or contribute to generalizable knowledge after the initial project is complete. If the initial purpose or a project is not to develop or contribute to generalizable knowledge, the project is not classified as research at the outset. However, if later someone decides to use identifiable private information from that project with the aim of developing or contributing to generalizable knowledge, that analysis may need IRB review.

Can I compensate my research participants?

Payment or non-monetary reward can be given to subjects as remuneration for time and inconvenience of participation, as well as an incentive to participate. Compensation can include remuneration that is monetary (cash, gift cards) and/or nonmonetary (extra credit). Federal regulations provide no clear guidance on the level of compensation that may be offered to research subjects. The regulations do require that researchers seek consent only under circumstances that minimize the possibility of coercion or undue influence (45 CFR 46.116). Coercion can potentially be created in certain situations, such as when a third party is paid for a subject’s participation. Undue influence refers to an offer of excessive or inappropriate reward. To avoid an appearance of coercion or undue influence, PIs must ensure that subject compensation is equitable, and the confidentiality of information related to payments should be protected. For example, PIs are often advised to pro-rate compensation for subjects who do not fully complete their participation. Please note that compensation is not considered a “benefit” of the study for the participants.

Raffles for Random Incentives in Research

Random incentitives for recruiting participants are not allowed. It's not just UNF; it's a state law. Random incentives are like a lottery game or game of chance that the State of Florida does not allow. See, <Lotteries and “Random Awards” as Incentives for Research Participation » Institutional Review Board » University of Florida (ufl.edu)> and <Lotteries, Raffles, or Drawings for Participants - Research (fiu.edu)>

UNF PIs make the determination whether they want to revise their protocol (strongly recommended) and/or how to proceed based on the law and UNF's guidance. PI's should stay mindful that the Controller's office can deny raffle/random drawing payments.

I want to conduct a study that involves the use of deception. Is this allowed?

The use of deception in research is not prohibited by the federal regulations, but must be considered carefully. As deception in research may violate the trust that participants put in a researcher, it may only occur in research when withholding information about the study is the only way to achieve valid results, and never to get participants something that they would not do otherwise. Researchers must describe the justification for the deception in their IRB application, and how they will inform participants the full purpose of the research as soon as feasible. This may occur through a debriefing process that discloses the purpose of the research, why deception was necessary, and allows participants to withdraw their data if they choose.