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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.

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.

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 ÀÏ°ÄÃÅ×ÊÁÏ 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.

Random incentitives for recruiting participants are not allowed. It's not just ÀÏ°ÄÃÅ×ÊÁÏ; 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, <> and <>

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