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- What is defined as human subject involvement?
- How do I know if I am conducting research?
- Who is my IRB representative?
- One of my students wants to conduct research for their thesis or dissertation under my approved IRB project. What do I need to do?
- If I am performing a study that is exempt, do I have to submit it to the IRB?
- What is the submission date for proposal review?
- Can I receive IRB approval before I complete the Human Subjects Tutorial?
- How long is the process for approval if I submit for Exempt or Expedited review?
- Where can I receive the training for Human Subjects?
- Is Human Subjects Training required for persons not affiliated with FIU who are conducting research with FIU or recruiting from FIU?
- I am requesting funding, do I need to have IRB Approval before I submit my proposal?
- I haven't received approval from the IRB but my grant is ready to be funded, what should I do?
- What are the IRB Registration and Federal Wide Assurance Numbers?
- Are there any requirements of the PI after receiving IRB approval?
- What are the consequences of noncompliance in research involving human subjects?
- Are there University procedures for the reporting injuries (Adverse Events) that occur during an approved research project?
- Who do I contact with general questions in regards to my human subjects proposal submission?
- I received IRB approval but the commencement of my research was delayed, no subjects were recruited and I would like to keep the protocol open. What do I need to do?
- Where do I find the categories for "Type of Review Being Requested"?
- Am I allowed to use
lotteries/raffles/drawings as a form of compensation to the
participants in my research?
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What is defined as human subject involvement? When human beings are asked to participate physically in an activity (i.e. in a survey, answering a questionnaire) or to donate their tissue, organs, fluids and other bodily materials it is considered human subject involvement. Federal Policy (45 CFR 46) and FDA (21 CFR 50)
provide definitions of human subjects. 45 CFR 46: "Human
subject means a living individual about whom an investigator
(whether professional or student) conducting research obtains(1)
data through intervention or interaction with the individual,
or(2) identifiable private information."
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How do I know if I am conducting "research"?
Research means a systematic investigation, including research
development, testing and evaluation, designed to develop or
contribute to generalizable knowledge; when information is sought
from subjects directly (as through interview, examination, or
questionnaire) or indirectly (as through observation), and when
information concerning specific, individually identifiable human
beings is asked for from third parties whether through access to
files, data banks, or other depositories--or through direct
inquiry. Activities which meet this definition constitute
research for purposes of this policy, whether or not they are
conducted or supported under a program which is considered
research for other purposes. For example, some demonstration and
service programs may include research activities.
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- How do I find out who my representative is? The Institutional Review Board (IRB) Representative list as well as in the Human Subjects Manual are located online at the Division of Sponsored Research and Training (DSRT) web page.
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- One of my students wants to conduct research for their thesis or dissertation under my approved IRB project. What do I need to do ? Faculty Supervisors can amend an approved project, using the IRB Form B-1, to add students
as investigators to their existing project. However please
note, that IRB Form B-1 can only be used to add students as additional investigators on the project.
Form B-1 can no longer be used for students that wish to do their
own supplemental projects based off of faculty approved projects.
Supplemental projects must now be submitted as separate projects on
IRB Form A for a standard IRB approval.
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- If I am performing a study that is 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
exempt studies must receive review by an IRB Representative.
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- What is the submission date for proposal review?
Exempt and Expedited review occur on an ongoing basis. Full Board
review occurs once a month on the last Friday of the month (unless
otherwise noted). One (1) copy of your proposal should be submitted
to your College/School Representative by the 15th of the month prior
to the month you would like to receive Full Board review. Your
representative may request revisions prior to providing his/her
signature. You then forward 22 photocopies (plus the original) to the IRB office
located at University Park, MARC 430 . These copies will be disseminated to the Representatives for the upcoming meeting.
The IRB Meeting Schedule is posted for your information.
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- Can I receive IRB approval before I complete the Human Subjects Training? No, a complete application includes the Human Subjects Tutorial Certificate. You will not receive an approval without the submitted training certificate and will not be able to begin your research.
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- How long is the process for approval if I submit for Exempt or Expedited review? The process, under normal circumstances takes about 2 weeks. However, you must take into consideration that your representative may have other proposals that s/he is reviewing at the same time, and the amount of time it takes for the approved proposal to get to the IRB office via campus mail.
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- Where can I receive the training for Human Subjects? FIU is currently using the NIH tutorial to fulfill this educational requirement. Details for educational training and a link to the NIH site can be found at the DSRT Human Subjects Training Module page. The certificate that you receive upon completion needs to accompany the complete application submitted for IRB review.
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- Is Human Subjects Training required for persons not affiliated with FIU who are conducting research with FIU or recruiting from FIU? All Research being conducted at FIU needs to be approved by the IRB. Whether the research is in conjunction with an FIU faculty or you are only recruiting at FIU, the Human Subjects Training is required for all persons participating in research at FIU who will be interacting with the human subjects including those who will be handling the data collected.
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- If I am requesting funding, do I need to have IRB approval before I submit my proposal? In most cases (NIH, NSF, Dept. of Education) you will be submitting the approval information "just in time", when you receive a fundable score, or when the agency requests the IRB approval information. All of these time frames occur prior to the release of the award to the Division of Sponsored Research at FIU. For the most accurate information, the PI should consult the agency for guidelines for the use of human subjects.
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- I haven't received approval from the IRB but my grant is ready to be funded what should I do? FIU and most funding agencies will not release funding for spending until IRB approval has been verified. Contact DSRT and/or the IRB Coordinator for assistance.
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- What are the IRB Registration and Federal Wide Assurance (FWA) Numbers? The IRB Registration number IRB00000905; The FWA number is 00000060
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- Are there any requirements of the PI after receipt of IRB approval? Yes , all proposals approved by Expedited or Full Board Review are required to submit an annual report. In addition, any changes to the Protocol, Methods, and Measures, must receive IRB approval. Consent documents MUST be annually renewed with the filing of the annual report. Proposals that receive Exemption require no additional approval from the IRB as long as the scope of the research remains the same. Any changes to a previously Exempted study requires re-review by the IRB.
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- What are the consequences of noncompliance in research involving human subjects? The IRB reserves the authority to suspend or terminate approval of research. The suspension of an IRB project that is being funded will in turn affect the continued use of funds on the account. Anyone conducting human subjects research without the approval of the IRB may be subject to a finding of research misconduct.
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- Are there University procedures for the reporting injuries ( Adverse Events ) that occur during an approved research project? Yes, there are detailed procedures located at the Adverse Event (AE) Reporting page. This includes definitions of AE's and the appropriate paperwork to be completed by the an Investigator. The Principal Investigator is responsible for knowing reporting procedures, providing written notification to the IRB Office and verifying receipt of notification.
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- Who do I contact with general questions in regards to my human subjects proposal submission? You may contact your college/school representative, the IRB Coordinator, or the IRB Chairperson.
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- I received IRB approval but the commencement of my research was delayed, no subjects were recruited and I would like to keep the protocol open. What do I need to do? If your research was approved through Expedited or Full board Review you are required to complete Form B and submit it to a representative for signature. In addition, you are required to submit a NEW distribution ready consent document for renewal.
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- Where do I find the categories for "Type of Review Being Requested"? The categories are found in the IRB Manual and online under under "Guidelines and Form"
Exempt & Expedited Review Categories
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- Am I allowed to
use lotteries/raffles/drawings as a form of compensation for the
participants in my research? No,
lotteries/raffles/drawings are not permitted for compensation to
participants in research, since the Florida Constitution and
Statutes prohibits it.
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