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Published byEvan Franklin Modified over 9 years ago
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Vicki Hammen, Vice Chair, IRB IRB Brown Bag February 9, 2009
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The Code of Federal Regulations (CFR) addresses the process separately from documentation ◦ 45 CFR 46.116 and 21 CFR 50.20, 50.23, 50.24 & 50.25 covers the process ◦ 45 CFR 46.117 and 21 CFR 50.27 deals with documentation
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“Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative.”
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According to the Belmont Report, informed consent falls under the principle of ‘Respect for Persons’ ◦ “…requires that individuals, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them.” It has been stated that a signed document without an effective informed consent process is not worth the paper it is written on (Cohen, J., personal communication, 2008)
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The three important elements that must be address in the informed consent process are: ◦ Information about the research study Full disclosure of the nature of the research and the subject’s participation ◦ Comprehension Does the potential participant fully understand the information presented to him/her? ◦ Voluntariness Process must be free from any form of coercion or undue influence
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Tampa Tribune article, March 2000 ◦ A lawsuit accusing USF doctors of experimenting on pregnant women without their consent is settled for 3.8 million dollars The experiment was not considered risky and no adverse events were recorded ◦ The failure of the physicians to obtain informed consent from the pregnant women cost their hospital
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Women were given a 3 page, densely written document to read Document was given while women were in active labor None of the women thought they were participating in a research study There were no benefits to participation for the mothers or their babies A law firm specializing in clinical research problems filed suit on behalf of the unwitting participants
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Information about the Research Project ◦ Purpose: Why are you conducting this research? ◦ Duration: How long will you need the subject? ◦ Experimental: If the procedure is experimental are there any other approved methods of choice? Usually only necessary in biomedical or pharmaceutical clinical studies
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Information, con’t ◦ Procedures: Method to convey the information may vary depending on the type of research, the complexity, and prospective participant Must be thorough but avoid MEGO (My Eyes Glaze Over) Sometimes too much information is worse than too little Consider using pictures, demonstrations, or videos
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Risks ◦ Are there any risks to participating? What are the reasonably foreseeable risks—not all possible How likely are the risks? Benefits ◦ Do not feel that you have to provide substantial benefits for the subjects ◦ Payment for participation is not a benefit
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Alternatives to participating ◦ Typically included in biomedical studies Confidentiality ◦ Very rare to be able to guarantee complete confidentiality, even with anonymous Internet surveys ◦ Address how you will protect the confidentiality of the subject’s data during the project, if they wish to withdraw, and following
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Compensation for Injury ◦ Not typically required, only for studies with greater than minimal risk ◦ May need to address how any reactions will be handled Contact information ◦ Who to contact with addition questions or concerns
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Right to refuse or withdraw ◦ Need to explain what will happen to the individual if they decide to withdraw participation during the experimental session or afterwards ◦ Will there be any consequences?
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Informed consent is not valid unless the prospective subject understands the information that has been presented It is the investigator’s responsibility to insure comprehension Simply stating that the subject is to ask questions if they do not understand is not sufficient
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Most subjects will not ask questions so as not to appear unintelligent or that they were not listening The researcher needs to insure the potential subject has the answers to who, what when, where, and how as they pertain to the research study
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Informed Consent Evaluation Feedback Tool ◦ A list of 10 questions posed to the subject ◦ Provides information about subject’s level of understanding ◦ Subject is given the questions to review at the start of the informed consent interview ◦ Question address: Purpose, benefits, risks, other options, costs, alternatives, withdrawal, voluntariness, record review, questions for the researcher
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The provision of consent must be free from any form of coercion or undue influence ◦ Particular concern when seeking students as research participants A faculty member cannot recruit subjects from students in their classes or advisees ◦ Implied authority Individual obtaining consent in a medical setting wearing a lab coat
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Only legally competent adults can give consent ◦ Minors can give assent, not consent ◦ Incompetent adults cannot give consent, but their legally authorized representative can Must be sensitive to more subtle forms of coercion ◦ Social pressure Especially from vulnerable populations: children, prisoners ◦ Request from authority figures ◦ Undue incentives for participation
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The subject gives their ‘knowledable agreement’ to participate Must have sufficient capacity to understand what is happening and feels free to express his/her wishes ◦ Children above age 7 must provide assent ◦ Can be a very simplified description If they object this can veto parental or guardian consent
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Informed consent is a process in which the outcome is an informed choice regarding the voluntary participation in a research project.
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IRB website Forms and Checklists
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