1. Institutional Review of Research Involving Human Participants IRB Presentation
University of Central Florida
Office of Research & Commercialization
or fax
irb.html

2. University of Central Florida Institutional Review Board Overview
Sophia F. Dziegielewski, Ph.D., LCSW
IRB Chair
Michael G. Deichen, MD, MPH
IRB Vice Chair
IRB Office Staff:
Jennifer Neal-Jimenez, MD,MS,MSB,CCRP
IRB Associate Director
Patria Davis, MSP, CIP
Kamille Chaparro,BS
Gillian Morien, BA
Renea Carver, MA

3. INSTITUTIONAL Review Board
The Institutional Review Board consists of a committee established to advocate for the protection of the rights and welfare of human participants involved in research.
Review is required for all research involving human participants conducted by the University of Central Florida (UCF).
Approval must be obtained prior to initiating research.

4. The Role of the IRB Members
IRB Function
The purpose of an IRB is to review research involving human subjects to ensure their rights and welfare are adequately protected.
The Role of the IRB Members
Safeguarding the rights and welfare
Review protocols
Assist and guide researchers

5. Irb Responsibilities
The IRB evaluates proposals for new research and conducts review of on-going research
When reviewing research, the IRB considers:
The process for recruitment
Selection and informed consent of prospective research participants
Assessment of the risks and potential benefits
What additional safeguards are needed if vulnerable populations
Provision for protecting participants’ privacy and maintaining confidentiality.
For on-going research
Evaluate proposed amendments
Requests for research continuation

6. How do I know if a project needs IRB review?
Definition of “research” + Definition of “human subject(s)”
Meets federal definition of “research”-Systematic investigation designed to develop or contribute to generalizable knowledge
Meets definition of “human subject(s)”-The investigator will gather data about living individuals through intervention or interaction OR The investigator will gather data about living individuals that is private AND identifiable.
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information provided for specific purposes and the individual does not expect the information to be made public
-Data from interacting or intervening with subjects (surveys, interviews, focus groups, or
-Identifiable data such as records (school, medical, etc.) or human specimens (blood, tissue, etc)
Identifiable – Names, Social Security Numbers, Addresses, or specific information that could identify a person if the population is small

7. IRB Review of Research
All research projects are categorized into one of three categories for the IRB review process.
Exempt- Explanation of Research
Expedited- Adult Consent or Parent for Child Consent
Full Board Review
*Level of risk is an important factor in study determination
Minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.
At this time, a small percentage of studies go to the full board and those involve either vulnerable populations like children, prisoners OR biomedical studies.

8. Levels of review- Exempt (reviewed by Chair or other IRB member)
Research on commonly accepted educational practices or unidentifiable data Requires Explanation of Research consent
Document review, educational testing, surveys or observation of public behavior
Used cautiously with vulnerable populations (seniors, prisoners, children, pregnant women, fetuses)
“Exempt” does not mean that the study does not need to be reviewed by IRB; it means “exempt” from specific Federal regulations. The researcher cannot determine that a study meets the criteria for “exempt” category; the IRB provides the researcher with an IRB notice of Exempt status for their records. If requested changes would increase risk or include the use of identifiers, a new IRB application may have to be submitted. Consult with the IRB.

9. Levels of review- Expedited (reviewed by Chair or IRB designated member)
Minimal risk and fit into an “Expedited” category
Document review
Surveys or Interviews
Collection of specimens
Routine noninvasive procedures
The vast majority of UCF IRB studies submitted are social/ behavioral/ educational and receive “Expedited” review.

10. Levels of review- Full Board (reviewed by Chair AND IRB members)
Protocols which meet the definition of more than minimal risk
Clinical trials
PI is invited to IRB meeting to clarify concerns
Full Board Review examples here at UCF: The Weight Watchers Study here on UCF campus; psychology studies involving autistic children, alcohol studies involving participants under the age of 21, prisoner research

11. The IRB has the authority to:
Approve
Require modifications
Table
Disapprove
Studies that receive Expedited or Exempt review may not be Disapproved by the IRB reviewer. The reviewer would recommend a second review or full board review.

12. Key Terms
Anonymous – No one, not even the researcher, is aware of who completed the information
Confidentiality- The research knows who completed the information, but no one else will know
Privacy- Refers to a person’s desire to control access of others to themselves. It involves consideration of whether the participants will be comfortable with the Human Research situation

13. Required Training
CITI online human subjects protection training. Study will not be approved until all KSP are trained. Research Personnel must complete either :
Group I. Biomedical Research Investigators and Key Personnel
Group 2. Social Behavioral Research Investigators and Key Personnel (Basic)
See the UCF IRB website for access
Applications may be submitted in iRIS and will be reviewed, but final approval is held until the training requirement has been completed by all key study personnel including faculty advisors, collaborators.

14. QUESTIONS ?