I have read aloud and discussed all of these points with the participant and allowed her/him to ask questions. Show
_____________________ ___________ Researcher Date I have had all the points on this form explained to me, and I had the opportunity to ask questions about the true purpose and experimental manipulations that took place in this study. _____________________ ___________ Participant Date Research participant, Now that you have learned the true and full purpose of the current study and know about the actual manipulations that took place as part of this study, will wish to have your data to be included in this research project? The IRB recognizes that the uses of deception or incomplete disclosure in research are valuable research techniques. However, the use of such techniques raises special issues that the IRB will review closely. Deception occurs when participants are deliberately given false information about some aspect of the research. Incomplete disclosure occurs when participants are not given information about the real purpose or the nature of the research. Justifying the Use of Deception in the IRB-1 Protocol ApplicationFederal regulations prohibit the use of deceptive techniques that place participants at greater than minimal risk. An investigator proposing to use deception or incomplete disclosure should justify its use in the IRB-1 protocol application. Address the following when preparing the IRB-1:
Informed Consent Requirements with Use of Deception in ResearchPotential participants should be advised in the consent form that the information they are given is not complete and that they will be debriefed after the research procedures are completed. Address the following when preparing the consent form/information sheet:
Debriefing Requirements for Use of Deception in ResearchThe debriefing is an essential part of the informed consent process and is mandatory when the research study involves use of deception. The debriefing provides participants with a full explanation of the hypothesis being tested, procedures to deceive participants and the reason(s) why it was necessary to deceive them. It should also include other relevant background information pertaining to the study (see below). The Federal Debriefing RequirementWhen required elements of informed consent are waived or altered by the IRB, in accordance with criteria provided in the regulations, participants must be debriefed at the end of the study, when appropriate. When a research study involves use of deception, the IRB must find that:
As indicated above, the debriefing must occur “when appropriate.” It may be inappropriate when: Debriefing regarding the deception may cause more harm than the deception itself. For example, if a student is selected for participation in a study based upon certain physical characteristics (i.e., weight), it might not be appropriate for the debriefing to describe that aspect of the selection process. The timing of the debriefing is also an important consideration. Generally, the IRB expects that participants will be debriefed immediately following their participation in the study. However, it is possible that an immediate debriefing may compromise study results. Participants who have completed the study might tell others about it. If they have been debriefed and have been debriefed may share that information with prospective participants, thus compromising the scientific validity of the study. The IRB recommends the use of the following strategies to handle this situation. If participant names and contact information are collected as part of study procedures, debriefing information can be sent when the study is completed via mail, email or by phone. If participant names and contact information are not collected researchers can:
In most cases, the IRB expects that participants will be given a debriefing statement to take with them after the study is complete and after participants have been given an oral debriefing (script) immediately following completion of the study. Both the debriefing statement and the debriefing script must be reviewed and approved by the IRB. The process to debrief participants must be explained in the IRB-1 protocol. Address the following elements:
At a minimum, the debriefing statement must include the following:
Consider adding the following, additional elements, to the debriefing statement:
In addition to the elements included in the debriefing statement, consider adding the following elements to the oral debriefing that takes place after the participant has completed the study:
Debriefing as an Educational ToolFinally, the IRB suggests that the debriefing also be used as an educational tool, even when the study does not involve use of deception. Participants should be given a simple, clear and informative explanation of the rationale for the design of the study and the methods used. Ask for and answer participant’s questions. Sloan, L and Hull, J. 2006. Deception of Research Subjects 2nd Edition. In E. A Bankert and R. J. Amdur (Eds.), Institutional Review Board Management and Function (210-215). Sudbury, Massachusetts: Jones and Bartlett Publishers. Source material for this policy guidance was provided by the Duke University IRB and the Stanford University Psychology Department. The UConn IRB gratefully acknowledges this support. What is the purpose of debriefing in research?Researchers debrief research participants to help ensure that the participants are fully restored to the condition in which they were prior to their involvement in the study, are informed of details they may not have known prior to participating in the study (e.g., deception that may have been employed and why), and ...
What should be in a debriefing form?The Debriefing Form should include the following:. Study title.. Researcher's name and contact information, if applicable, for follow-up questions.. Thank participants for taking the time to participate in the study.. Explain what was being studied (i.e., purpose, hypothesis, aim). ... . Explain how participants were deceived.. Under what conditions is debriefing necessary?The debriefing is an essential part of the informed consent process and is mandatory when the research study involves use of deception. The debriefing provides participants with a full explanation of the hypothesis being tested, procedures to deceive participants and the reason(s) why it was necessary to deceive them.
What is the purpose of debriefing in research quizlet?Debriefing informs participants about the nature of the research and their role in the study and educates them about the research process.
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