IRB-02: Behavioral/NonMedical Institutional Review Board |
 |
 |
IRB-02:
Behavioral/NonMedical Institutional Review Board
Preparing a Protocol for Review1. Title of Project: The protocol title should relate directly to and briefly describe the research. If funding is being sought for the research and a grant proposal is associated, the title must match verbatim that used in the grant proposal.
2. Principal Investigator: Provide the name(s) of the person(s) conducting the research, degree held (not being sought), title, department, address and phone number where the principal investigator(s) may be contacted (campus address and day-time phone numbers, where applicable). Providing telefax numbers and electronic mail addresses can facilitate our communications.
3. Supervisor: (required for all non-faculty Principal Investigators) Provide the name(s) of faculty supervisor(s), degree held, title, department, campus address and phone number, telefax number and electronic mail address.
4. Dates of Proposed Research: Provide the beginning and ending dates of the proposed research. Where applicable, dates must match grant period. Proposals are not reviewed retroactively and when dates precede submission to the UFIRB, the proposal will be returned to the Principal Investigator without review.
5. Source of Funding for the Protocol: Any and all funding sources (on or off-campus) awarded or being sought must be listed. If funding is not being sought, report "Unfunded" or "None." Do not leave this section blank.
6. Scientific Purpose of the Investigation: Briefly indicate, in non-technical terms, the rationale for conducting this research.
7. Describe the Research Methodology: In non-technical language, describe in detail what will be done with or to the research participant(s). Describe in detail or cite published research instruments to be administered including all surveys, questionnaires, stimulus materials and tools and techniques for collecting other responses. List all phases of the research plan, including pilot testing and follow-up. If semistructured interviews are to be used, indicate the kinds and range of topics to be included.
8. Potential Benefits and Anticipated Risks: List any benefit(s) or risk(s) that may directly affect the participants and steps taken to prevent risks. Note any long-term benefits anticipated as a result of this research.
Risk includes, but is not limited to, physical harm to a participant. Economic, social, and/or psychological harm also must be considered. If the risks of harm to a participant are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations, then state no more than minimal risk. If, however, the protocol involves more than minimal risk, specify procedures for protecting participants.
9. Describe How Participants Will Be Recruited, the Number and Age of Participants, and Proposed Compensation: How many participants are you seeking and from where will you obtain them? If University of Florida students will be recruited from classes, indicate the course number and instructor. In addition, contact the appropriate academic department(s) concerning any specific policies regarding the use of students in their classes. To minimize the perception of coercion, the Board strongly discourages Principal Investigators from recruiting students from their (or their supervisor's) courses to participate in their research.
List the maximum number of participants you anticipate recruiting, and where appropriate, how many might need to be approached to provide that maximum. The amount of risk for a protocol is, of course, dependent in part on the number of participants exposed to that risk. Try to be foresightful in making your estimates, since increases in the maximum approved is considered a revision that must be approved by the IRB before you cna proceed with the larger sample.
If potential participants are younger than age 18, be specific about their age (do not only list grade level). If potential participants are older than 18, you may indicate 18+, unless a specific age category is sought.
Any and all proposed compensation must be listed. Be specific as to type and amount of compensation. If compensation to be awarded is in the form of class or course credit, indicate not only how many points will be awarded for participation, but also how many total points are possible for the course. If there's no compensation, state that explicitly in the consent document. NOTE: Florida state law prohibits lotteries from being conducted by any organization other than the state or specified non-profit entities; so you may not use random drawings for money or prizes as incentives for participation. Compensation can be greater for some participants than others if it is performance-based in some fashion (for example, awarding a special prize or bonus to those scoring the highest on some performance test, or completing an activity the fastest).
10. Describe the Informed Consent Process: Informed consent is the process through which potential research participants are provided all the information reasonably needed for them to decide whether or not to participate. The process additionally provides for obtaining voluntary agreement to participate in the research.
A copy of the informed consent process (whether a written form, cover letter, or script of a verbal process) must be attached to the UFIRB form. (see Appendix for sample consents and checklist)
Waiver of the informed consent process is limited to research involving the collection or study of existing data, publicly available information, and observation of unmanipulated public behavior where data is recorded in such a manner that identifiers cannot be linked to individuals.
11. Signatures: The original signature(s) of the Principal Investigator(s) and faculty supervisor (where applicable) of the research are required at the bottom of the UFIRB protocol. If the protocol is submitted electronically, a paper copy of the protocol bearing these signatures must be received by the office via post or fax.
