ࡱ> UfTc  bjbj 4V^\^\ `` W  $O22222R>'0<0"5QW2222`> : Eastern Illinois University Institutional Review Board for Review of Research Involving Human Subjects Informed Consent Form Checklist Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a subject in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension. Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the subjects understanding of the reasons why one might or might not want to participate. Informed consent/assent forms should be written in second person (e.g., You are being asked to participate). Basic elements to include: A statement that the study involves researchAn explanation of the purposes of the researchThe expected duration of the subjects participationA description of the procedures to be followedIdentification of any procedures which are experimentalA description of any reasonably foreseeable risks or discomforts to the subject, an estimate of their likelihood, and a description of what steps will be taken to prevent or minimize themA description of any benefits to the subject or to others which may reasonably be expected from the research. Monetary compensation is not a benefit. If compensation is to be provided to research subjects or healthy volunteers, the amount should be stated in the consent documentA disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subjectA statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. Include a description of whom may have access to research recordsFor research involving more than minimal risk, an explanation as to whether any compensation, and an explanation as to whether any medical treatments are available, if injury occurs and, if so, what they consist of, or where further information may be obtainedAn explanation of whom to contact for answers to pertinent questions about the research and research subjects rights, and whom to contact in the event of a research-related injury to the subjectA statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits, to which the subject is otherwise entitledOne of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens: a) That identifiers might be removed from the identifiable private information or biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another PI for future research studies without additional informed consent from the subject, IF this might be a possibility, or b) The subjects information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research.  Continued Additional elements, as appropriate: A statement that the particular treatment or procedure may involve risks to the subject which are currently unforeseeable (or to the embryo or fetus if the subjects is or my become pregnant)Anticipated circumstances under which the subjects participation may be terminated by the investigator without regard to the subjects consentAny additional costs to the subject that may result from participation in the researchThe consequences of a subjects decision to withdraw from the research and procedures for orderly termination of participation by the subjectA statement that significant new findings developed during the course of the research, which may relate to the subjects willingness to continue participation, will be provided to the subjectThe approximate number of subjects involved in the studyA statement that the subjects biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profitA statement regarding whether clinically relevant research results, including individual research results, will be disclosed to the subjects, and if so, under what conditionsFor research involving biospecimens, whether the research will (if known) or might include genome sequencingAn explanation as to why subject is eligible to participateA statement that the collection of data will be audiotaped or videotapedPayment for participationgive amount and if/how it will be prorated if subject does not complete studyWhen appropriate, a statement concerning an investigators potential financial or other conflict of interest in the conduct of the study fgh  $%BCPstuv7t} ¼¼¶¼¼° hLCJ hQ!CJ hV)CJ hh64CJ hm9{CJhEhECJ hECJhohm9{CJhohm9{5OJQJ\ hoh vnB`2ǃ,!"E3p#9GQd; H xuv 0F[,F᚜K sO'3w #vfSVbsؠyX p5veuw 1z@ l,i!b I jZ2|9L$Z15xl.(zm${d:\@'23œln$^-@^i?D&|#td!6lġB"&63yy@t!HjpU*yeXry3~{s:FXI O5Y[Y!}S˪.7bd|n]671. tn/w/+[t6}PsںsL. 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