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Definition of Terms Used in IRB02 Documents
- Names or identifiers are not given to the researcher by the research participant. Data are recorded in such a manner that responses cannot be traced back to the individual participant.
- An affirmative agreement to participate in research by minors or others who cannot provide legal consent. Mere failure to object cannot be construed as assent.
- Persons who have not attained the legal age for consent of treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted. In Florida, minors are people less than age 18.
- Circumstances that may make a potential research participant feel that participation is not fully voluntary or without prejudice.
- When names or other identifiers may be given to the researcher by the research participant and/or data could be traced back to that participant; but, the Principal Investigator has implemented a means of protecting the privacy of that individual.
- The process of informing research participant(s) of the actual purpose of the research, furnishing additional information regarding the research and providing an additional opportunity to withdraw data provided by the participant. Some University departments require debriefing after all research In these cases the IRB02 requires the Principal Investigator to provide a copy of the debriefing procedure with the protocol submission. The IRB02 requires a copy of the debriefing procedure whenever deception is involved.
- Providing the participant with misinformation or withholding explicit information about the research that might influence the participant’s response. The IRB02 requires debriefing whenever deception is involved.
- Expired Protocols
- Approval for a protocol must be renewed by review at least annually. If the IRB has not reapproved a research study by a date one calender year from the first or previous approval, the research will be considered expired. While expired, new subjects accrual must stop. Interventions under the research protocol must be halted unless an over-riding concern for the safety or well-being of the subjects, or other ethical issues, are involved. In such cases, the investigator must contact the IRB immediately.
- Informed consent
- The process of informing potential participants with all the information they might reasonably need to know in order to decide whether to participate in the procedure.
- Minimal risk
- When the risk(s) of harm anticipated in the proposed research is not greater than that ordinarily encountered in daily life or through routine physical or psychological examinations or tests.
- Parental informed consent
- The process of informing potential participant’s parents or guardians of all the information they might reasonably need to know to decide whether to allow the child’s participation in the procedure.
- Principal Investigator
- The person (student, faculty or staff) responsible for the conduct of the research.
- A systematic investigation designed to develop or contribute to generalizable knowledge.
- Research Participant
- A living individual about whom an investigator conducting research obtains data or identifiable private information.
- Terminated Protocols
- A protocol will be terminated at the request of the Principal Investigator or as a result of protocol violation as described elsewhere. When a protocol is terminated, no further subjects may be accrued into the study and all subjects currently enrolled must be notified of the protocol’s termination. Subjects may not be followed for research observation or data collection after such termination.
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