Anyone conducting research that involves data from human participants must submit to the IRB and receive approval before collecting any data. Research is defined by the Code of Federal Regulations (45 CFR 46.102(d)) as: “A systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalizable knowledge."
Frequently Asked Questions
FAQS
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In preparation for your submission please access the IRBGuidance for IRBNet from the main page of this website and register for IRBNet. This is the online submission platform for IRB. Please also complete your Citi ethics trainings and upload the certificates to your IRBNet User Profile.
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Researchers must complete two ethics trainings through the Citi program. Biomedical researchers must complete Biomedical Basic/Refresher and Biomedical Responsible Conduct of Research. Researchers completing social and behavioral research must complete Social and Behavioral Research Basic Refresher and Social and Behavioral Responsible Conduct of Research. Certificates must be uploaded to your user profile on IRBNet and then linked to your project. Please refer to the Information for Researchers section of this webpage, under IRB Required Research Ethics Training
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You will need to submit the IRB protocol form, which can be accessed from the Forms and Templates tab on IRBNet, and all supporting documents related to recruitment and research procedures. This includes recruitment flyers or emails, consent forms or cover letters, and any surveys, interviews, interventions, or other procedures that participants will be exposed to.
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Please refer to the IRB Guidance: Creating an Account and Using IRBNet to learn how to create an account (found on this webpage under Information for Researchers)
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A research project may meet criteria for exempt review and not require review by the full Board. There are 8 categories of research that qualify for an exempt review. The IRB Protocol Form lists the 8 categories. Detailed information about exempt status is available within “The Common Rule” which can be found on IRBNet under “Forms and Templates”
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A research project may meet criteria for expedited review and not require review by the full Board. The IRB Protocol Form lists the requirements for expedition. Detailed information about exempt status is available within “The Common Rule” which can be found on IRBNet under “Forms and Templates”
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The IRB requires that data be kept for a minimum of five years after the completion of the study. The IRB does not require that data be destroyed.
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Attendance at the IRB meeting in which your protocol will be reviewed is not mandatory. However, if questions arise about your protocol, the board may table the discussion and take it up again when you are able to attend.
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Research at Barry University falls under the regulations of the Health Information Portability and Accountability Act (HIPAA). All investigators are required to meet the regulations for privacy as outlined by the HIPAA. If you are collecting individually identifying (personal) information, you are required to follow the HIPAA Guidelines.
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You may begin your study only after you receive the approval letter from the IRB office.
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For studies that are not exempt, and annual report needs to be submitted each year that the study is ongoing. A final report must be submitted upon completion of the study. In addition, a modification/amendment must be submitted if there will be any changes to study procedures and the IRB must be notified immediately of any adverse events. For exempt studies, no reports need to be made to IRB after initial approval unless any study procedures change or there are any adverse events. Forms are available on IRBNet under the Forms and Templates tab for each of these situations.