Vicki Hammen, Vice Chair, IRB IRB Brown Bag February 9, 2009

 The Code of Federal Regulations (CFR) addresses the process separately from documentation ◦ 45 CFR and 21 CFR 50.20, 50.23, & covers the process ◦ 45 CFR and 21 CFR deals with documentation

 “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.”

 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)

 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

 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

 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

 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

 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

 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

 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

 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

 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?

 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

 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

 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

 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

 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

 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

 Informed consent is a process in which the outcome is an informed choice regarding the voluntary participation in a research project.

 IRB website  Forms and Checklists