The Institutional Review Board (IRB) at UCF reviews all human subjects research that is conducted by students and faculty at the university and in the local community. Before a study can be advertised and data collected, the research proposal must be approved by the IRB. Previously, IRB submissions were paper-based. In 2007, the Office of Research and Commercialization adopted an electronic system that permits all IRB submissions to be made online. The new system is called the Integrated Research Information System (iRIS™), and it is completely paperless. All IRB applications and updates will now go through this site.
To submit your research project to UCF’s IRB, go to the iRISTM login page and enter your username and password. Note: If you don’t know your username and password, please visit the iRISTM Log-in Information page. For more information on the new system and its requirements, please visit the Office of Research and Commercialization’s IRB webpage.
In addition, before your study is approved by the IRB, all key study personnel will need to complete a training program on the protection of human research subjects. One training course, offered for free to UCF faculty and students through a university subscription, is provided by the Collaborative IRB Training Initiative (CITI). The CITI course can be accessed online and takes about 4.5 hours to complete (approximately 2 hours for refresher courses). The IRB office has developed instructions and access information to help you begin the CITI training. To access the CITI training course, please visit the CITI Login and Registration page. The IRB will also accept other training courses on the protection of human subjects in lieu of the CITI training. Click here to review alternative training options.
For additional information not presented on the IRB website, please contact:
Barbara Ward, IRB Coordinator (Ph: 407-823-2901)
Joanne Muratori, IRB Coordinator (Ph: 407-882-2276)
OR Janice Turchin, IRB Assistant (Ph: 407-882-2012)
Office of Research & Commercialization
12201 Research Parkway, Suite 501
Orlando, FL 32826-3246
Fax: 407-823-3299
General IRB Email: IRB@mail.ucf.edu
Sample documents to consult as models for successful applications to IRB (Note: These documents were created for the previous IRB application process and may not match questions and fields in the current IRB application): IRB Cell Biology and IRB GTA Class.
Helpful Hints for Fast IRB Approval:
Currently reviews of new protocol submissions are being done on a weekly basis. If the IRB Chairman needs additional information, you will receive an email. Once the Chairman grants final approval, you will be sent an approval letter by either U.S. postal service or campus mail. The expiration date of your minimal risk study will usually be 365 days from the contingent approval date (when the Chairman approved the study based upon certain changes being made). This entire process is taking 2 to 3 weeks at this time. Use the IRB number from your approval letter for recruiting participants using Experimentrak through the Psychology Department. Contact the IRB office when you have completed the study so that it can be terminated.
Approximately 99% of the new submissions and continuing reviews are minimal risk studies and are reviewed by the Chairman, Vice-Chairman or designated reviewer through this expedited review process which means the studies do not have to be presented at a full board IRB meeting for review and approval. The full board meets, when needed, on the fourth Wednesday of the month. If the Chairman determines that the study is greater than minimal risk or there are issues which the full board should discuss, the protocol will be placed on the agenda for the next meeting if the protocol was received at the IRB office by the first working day of the month. Submissions received later than the first working day of the month will be placed on the meeting agenda for the following month.
For on-campus research by UCF professors or students involving:
Students from other universities wanting to use UCF students for research
Permission should be obtained from a UCF professor to conduct the research and the UCF IRB should be notified of the plan prior to starting the research. A copy of the approval letter and submission materials from the other university should be submitted to the UCF IRB as well as any flyers to be used for recruitment on the UCF campus. A UCF IRB formal submission is not required. The UCF IRB will send you a letter saying it acknowledges the other IRB as IRB of Record and that it accepts its approval. It is possible that the UCF IRB will ask for some clarification or changes to the consent form or flyers.
UCF Student Health Services - HIPAA designated component
The Student Health Services is a HIPAA designated component. Studies being done at the Student Health Service must include the use of the UCF HIPAA authorization form for the use and disclosure of protected health information (PHI), and a record of unauthorized disclosures must be kept. UCF approved HIPAA Authorization and Waiver of Authorization forms are on the UCF IRB website.
UCF departments that are not designated components for HIPAA purposes
Some of the departments at UCF that are not designated components include the Communicative Disorders Clinic, the Exercise and Physiology Lab, the Wellness Center, and the Student Counseling Center. These departments maintain medical records and abide by HIPAA protection of private information guidelines, but the use of a HIPAA authorization is not required. If you are in one of these departments and you are receiving PHI from a medical facility (such as the hospital or a doctor’s office), you must make sure your name and UCF department is listed on the HIPAA Authorization that the patient signs at the hospital or doctor’s office as someone they may release protected health information (PHI) to for your use.
UCF online projects
In your IRB submission packet include a hard copy of the consent form which will be displayed online and note that the participant chooses to participate by clicking the agree button. Explain how students will be found and contacted to participate. State on the consent form that by completing the survey, the student confirms that he/she is at least 18 years of age. On the UCFIRB form explain who is creating the website and how it is protected, “https”or other secure design is recommended. Note if Form Manager will be used.
Students doing surveys in the community
Include a statement in the methodology that students will be trained on confidentiality practices, how to approach people and the plan being put in place to protect student surveyors from harm.
For all research:
Experimentrak (Psychology Department) recruiting of participants
Note if Experimentrak in the Psychology Department is to be used for recruiting participants. No promises of a cure or language such as “free treatment” are permissible. Use the 4-digit IRB number from the approval form and letter. Do not start until you receive your approval letter.
Classroom recruitment
Assure the IRB that permission will be obtained from any professor who will present the opportunity to enroll or allow the survey to be conducted in his/her classroom and note which classes will be involved (i.e., introductory Psychology classes).
Students as participants – address age
Include a statement in the methodology that all participants will be at least 18 years of age. In the consent form, include a check off stating “I am at least 18 years of age”. Remember, freshmen are sometimes still age 17. If all students are to be used, a parental consent form and a child assent form must be included as well.
Extra credit for participation
Include a statement in the methodology and in the consent form explaining how much extra credit will be given for completing the study and what is required to earn it as well as how much will be given for partial completion. If extra credit for participation is offered, an alternative activity requiring equal time and effort must also be offered for those in the class who choose not to participate in the research project.
Payment for participation
Usually $5 to $15 is appropriate for completing a study that will take the participant up to one hour (a per hour rate may also be used). The consent form and methodology should give details explaining how much will be paid for partial fulfillment and what is required, as well as how much will be paid for complete fulfillment and the details of what that encompasses.
Flyers or advertising for recruitment
Include a copy of the flyer or advertisement to be used and in the recruitment section of the UCFIRB form explain how this will be done. Particularly in a medically-related study, no promise of a cure or “free” treatment may be included. Flyers should include: 1) Name and address of the investigator and/or research facility/institution; 2) Condition under study and/or purpose of the research; 3) Inclusion/exclusion criteria in summary form; 4) A brief list of procedures involved; 5) Time or other commitment required (number of visits, total duration including follow-up visits, etc.); 6) Compensation/reimbursement; and 7) Location of research and contact person for further information.
Deception
Deception of participants is sometimes used in studies that evaluate fundamental aspects of human behavior. The rationale for deception is that it is not possible to obtain accurate information about how people behave when they know that they are being observed or evaluated. If deception is a part of the research study, include a debriefing form which will be given to participants at the completion of their involvement clarifying what the real purpose of the research was and how participants were deceived.
Sensitive issues which might cause upset to participants
In the methodology section as well as the consent form explain what counseling is available and how students can make arrangements for such counseling. Explain any other process to calm a disturbed participant.
Student researchers
List the supervisor as the Principal Investigator and list students as Co/Sub Investigators and include supervisor’s signature on the UCF IRB Protocol Submission Form. Include the supervisor’s name and contact information in the consent form. Include current address where approval letter should be mailed.
Children as the participants
Enclose a parental consent form and a child assent form if the children will be between the ages of 7 and 17 (this can be a verbal script to the classroom without a child’s signature if the risk is minimal). If children do not have the mental capacity to assent, the parental consent form will be sufficient, but this must be stated in the methodology. Investigators may not collect surveys from all participants regardless of age then sort out those from participants who are less than 18 years of age. The information should not be gathered at all without parental permission.
Audio or video taping
Include in the methodology section of the UCFIRB form a description of how those not giving permission will be seated in another area or given some other means of not participating. Include a statement in the parental consent form with a “yes” or “no” check-off for permission or refusal for their child to be audio or video taped. Include this information in an adult consent form as well if participants are adults. Explain when audio or video tapes will be destroyed or erased (after transcription, at the end of analysis, etc.) and explain who will have access to the tapes, where they will be stored, and how identities will be protected.
Lotteries and prizes
Avoid the use of drawings for prizes where only one or two participants can win. The least coercive inducement is something given to every participant. Some examples of allowable incentives are a candy bar, a scratch-off Florida lottery ticket, or a one-dollar bill. In general, due to Florida’s strict state laws regarding lotteries and the appearance of coercion in research studies, the IRB does not allow lotteries unless the study is investigating the lottery process or psychological effects of lotteries as the purpose of the study.
Use of public information
State in the methodology section if data is de-identified public information that will be received, who or where it is coming from, and that permission has been obtained from the supplier of the data. If the data is pre-existing data that comes to the PI already de-identified, there is a chance that the study may be exempt, but the UCF IRB Protocol Submission Form must still be submitted so that the Chairman can determine that exempt status.
Pre- and post-tests, surveys
Include a copy of pre- and post-tests, surveys, and questionnaires. If a treatment is being pre- and post-evaluated, the investigator must explicitly state what that treatment is that will be evaluated.
Interviews
The subject matter to be discussed or, preferably, actual interview questions should be included in the IRB submission. Interviews require the signature on the consent form. If these will be done in a work place, permission is needed from the employer. If the questions involve opinions about the participants’ employer or work environment which may cause backlash from the employer, this risk should be stated in the consent form and an explanation should be provided as to how the investigator will protect information and minimize this risk.
Waiver of documentation of consent
Federal regulations allow a consent information sheet to be given to participants with all the information normally included in a consent form if the study is minimal risk and no identities will be known. A “Dear Student” (Educator, Teacher, Principal, etc.) consent letter may still be used, but the lines for signatures should be removed as well as all reference to signing. The inclusion of contact information for the investigator, his/her supervisor and the IRB is mandatory. This is called a waiver of documentation of consent because the participant has been given all the information and protections that a consent form includes, but he/she does not sign the document. Most survey research can be done this way, and it is easier and cheaper than sending the participants a separate mailing envelope for the surveys and a separate mailing envelope for the consent forms in order to maintain anonymity. This waiver is not possible if the investigator needs to maintain an identifier in order to give extra credit to those students who have completed the study or if the researcher needs to know who did what survey.
Difference between anonymous and confidential research
If the investigator is receiving data that has already been de-identified or if the investigator uses the waiver of documentation of consent and no signatures are obtained, that is anonymous. The investigator cannot link the person’s answers to his name. If the investigator receives the names of participants or has a “key” so that he/she can link a number with a name, the investigator can only guarantee confidentiality. An investigator may not receive the information with names, then remove the identifiers and call the research anonymous. To be anonymous he/she must receive the information without names.
Make everything match
If the protocol, UCF IRB Protocol Submission Form, methodology , flyers and consent form do not all match on how things will be done, how much time will be required, what the payment will be, etc., the IRB Chairman will not approve the study with-out changes being made. It is faster to make everything match the first time.