General Institutional Review Board questions
What is the Institutional Review Board (IRB)? An Institutional Review Board (IRB) is a committee designated by an institution to review, approve the initiation of, and conduct periodic review of research involving human participants. The primary purpose of such review is to assure the protection of the rights and welfare of the human participants.
After ethically questionable biomedical studies, such as the Tuskegee study in the 1930s, IRBs have been implemented around the world to prevent unethical treatment of human participants. IRBs are currently regulated by the Food and Drug Administration and the National Institutes of Health's (NIH) Office for Human Research Protections (OHRP).
The purpose of the IRB is to inform and protect human participants used in research. This means that the IRB, during its review of a research project and the informed consent, has the right and responsibility to ensure that the research participant is fully informed of the procedures involved in the study as well as the risks and alternative treatments that are available if participation in the study is refused.
What is the Assurance (FWA) number for the IRB?
Is a Pre-review required?
Yes. All new projects that are requesting Full-Board review must go through the pre-review process before submission will be accepted.
Is the Principal Investigator required to be present at the IRB meeting to present his project?
The principal investigator is required to attend to present his project for the initial review. The PI is not required to attend for amendments, adverse events, continuing reviews or any other submissions unless requested by the IRB.
What is considered "less than minimal risk"?
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. If you have specific questions about classifying less than minimal risk please contact the IRB office at (321) 841-5895.
What is the turn-around-time for an expedited review?
A response to the review is usually sent within 7 working days from the date of a complete submission.
Serious Adverse Events and Protocol Deviation Reporting
I just found that a serious adverse event (SAE) occurred to an enrolled research participant. How soon do I need to report this to the IRB?
All serious (e.g., death, life threatening events needing medical intervention, inpatient hospitalization or prolongation of hospitalization) unexpected adverse events attributed to the research intervention must be reported to the IRB within 5 working days from when you found out.
I just found that a protocol deviation occurred. How do I know if it's a major deviation?
A major protocol deviation is defined as a deviation that:
- affected the safety of the research participants
- violated ethical principles
- affected the integrity of the study data
- affected the scientific design of the study
How soon do I need to report a major protocol deviation to the IRB?
The protocol deviation must be reported to the IRB within 5 working days from when you found out. If this it is a minor deviation, then the deviation is to be reported in the next continuing review for this study.
What are the required training documents for new investigators?
The investigator's most current Curriculum Vitae with the appropriate CITI training (for more information about CITI, click on the link found in the navigation panel on the left) must be required prior to IRB approval of the study the investigator is involved in. NIH Protecting Human Research Participants training (http://phrp.nihtraining.com/users/login.php) will be required for NIH-funded studies.
I did CITI training at another institution. How do I affiliate my training with Orlando Health?
This question is answered on the CITI training page on this website. Click on the link found in the navigation panel on the left.