Institutional Review of Research Involving Human Participants IRB Presentation University of Central Florida Office of Research & Commercialization 407-823-2901 or fax 407-823-3299 www.research.ucf.edu/Compliance/ irb.html

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

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.

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

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

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

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.

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.

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.

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

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.

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

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) https://www.citiprogram.org/ See the UCF IRB website for access http://www.research.ucf.edu/Compliance/irb.html 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.

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