ࡱ> fhe%` M%bjbj 0D̟̟jddddHHH8<<qNt04X">#$3#MMMMMMM$OhMRN$!"$$Nddo+N"'"'"'$dM"'$M"'"'\J8TM IH%xK"MAN0qNKR%RDMRM<G#0w#""'##G#G#G#NN&^G#G#G#qN$$$$Dddddddd Investigator Checklist for Research Involving Children PROTOCOL TITLE: INVESTIGATOR: This checklist is designed to assist the IRB in determining if your research fulfills all the requirements of the federal regulations as outlined in 45 CFR 46 Subpart D and/or 21 CFR Parts 50 and 56 for inclusion of children as research subjects. Special risk/benefit determinations must be discussed and documented by the IRB. Provided below are categories of research that are permissible in children if the listed requirements are met. Adequate provisions are required for soliciting permission from parents or guardian, and soliciting the assent of each child when the IRB deems the children are capable of assent.  1. Rationale for Inclusion of Minors: provide rationale/justification for including minors as subjects in the IRB protocol application: Summary of Activities (Non-biomedical application) or Study Design (Biomedical Research application) 2. Age Range: Specify the eligible age range for minors in this study: 3. Informed Consent (Permission from Parent(s)/Guardian(s) and Assent from Minors Indicate the consent/permission and assent that will be used for this study:  FORMCHECKBOX  Informed consent addressed to parent(s) and minor  FORMCHECKBOX  Simplified assent form addressed to the subject, 7-12 years old (parents get separate form)  FORMCHECKBOX  Assent form addressed to the subject, 13 years and older (for subjects and parents)  FORMCHECKBOX  Request waiver of consent and/or assent: Complete question #4 4. Waiver of Permission/Assent (45 CFR 46.408) Under certain circumstances, the federal regulations allow for waiver of parental permission or childs assent. If you wish to request either type of consent waiver, then check the appropriate box and provide justification in the relevant section.  FORMCHECKBOX  Waiver of parental/guardian permission (45 CFR 46.408(c)) Permission is not a reasonable requirement to protect the subjects (e.g., neglected/abused children) An appropriate mechanism for protecting children in research is substituted; and The waiver is not inconsistent with Federal, State or local law. OR The waiver meets the provisions set forth in 45 CFR 46.116 Subpart A (IRB must find that (1) research involves no > than minimal risk, (2) waiver will not adversely affects rights/welfare of subjects, (3) research could not practicably be carried out without waiver, and (4) subjects will be given additional information after participation Justification for waiver of parental permission:  FORMCHECKBOX  Waiver of minors assent (45 CFR 46.408(a)) The capability of some or all of the children is so limited that they cannot be reasonably consulted, OR The research holds out a prospect of direct benefit that is important to the health or well-being of the children and is availabe only in the context of the research, OR The waiver meets the provisions set forth in 45 CFR 46.116 Subpart A (The IRB must find that: (IRB must find that (1) research involves no > than minimal risk, (2) waiver will not adversely affects rights/welfare of subjects, (3) research could not practicably be carried out without waiver, and (4) subjects will be given additional information after participation Justification for waiver of assent: 5. Select the appropriate classification of the proposed research.   FORMCHECKBOX  Research not involving greater than minimal risk to children   FORMCHECKBOX  Greater than minimal risk but presenting the prospect of direct benefit to the individual subject. 1) Are the risk justified by the anticipated benefits?  FORMCHECKBOX  YES: Describe:  FORMCHECKBOX  NO 2) Is the relationship of the anticipated benefit at least as favorable as alternative procedures?  FORMCHECKBOX  YES  FORMCHECKBOX  NO   FORMCHECKBOX  Greater than minimal risk and no reasonable prospect of direct benefit to the individual subject, but likely to yield generalizable knowledge about the subjects disorder or condition. 1) Does the risk represent a minor increase over minimal risk?  FORMCHECKBOX  YES: Describe:  FORMCHECKBOX  NO Does the intervention or procedure present experiences commensurate with those inherent in the subjects actual or expected medical, dental, psychological, social or educational needs?  FORMCHECKBOX  YES  FORMCHECKBOX  NO Is the intervention or procedure likely to yield generalizable knowledge about the subjects disorder or condition that is vital to understanding or ameliorating the subjects disorder or condition?  FORMCHECKBOX  YES  FORMCHECKBOX  NO (Note: Both parents or legally appointed guardian must give consent unless one parent or guardian is deceased, incompetent or not reasonably available).   FORMCHECKBOX  Research not otherwise approvable which presents the opportunity to understand, prevent or alleviate a serious problem affecting the health or welfare of children. If the IRB finds that the research presents a reasonable opportunity to further the understanding, prevention or alleviation of a serious problem affecting the health or welfare of children, the research must be considered by the Secretary of DHHS and/or FDA in consultation with a panel of experts and the opportunity for public comment.   FORMCHECKBOX  Children who are wards. For research involving no direct benefit or otherwise not approvable, children who are wards of the State or institution may be included only if: 1) Is the research related to their status as wards?  FORMCHECKBOX  YES  FORMCHECKBOX  NO -- OR - - Is the research conducted in settings in which the majority of the children are not wards?  FORMCHECKBOX  YES  FORMCHECKBOX  NO The IRB shall require appointment of an advocate for the child participants. The advocate must be independent of the research Signature of Principal Investigator Date      PAGE  PAGE 1  FILENAME \p J:\Sandy & Cynthia & Cece\IRB Apps\Research Forms\IRB-Children Investigator Checklist.doc Page  PAGE 1 of  NUMPAGES 3 Definition of minimal risk: The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. EXAMPLES of minimal risk procedures per FDA guidance include: clean-catch urinalysis, administering electroencephalograms, minimal changes in diet or daily routine, tests of devices involving temperature readings orally or in ear, use of standard psychological tests, there may also be some circumstances under which products with established safety profile in adults may present no more than minimal risk in children. 45 CFR 46.404; FDA 50.51 45 CFR 46.405; FDA 50.52 45 CFR 46.406; FDA 50.53 45 CFR 46.407; FDA 50.54 45 CFR 46.409; FDA 50.55 IRB Use Only: (IRB Reviewer to Complete) I Agree with the Principal Investigators Assessment. I Do Not Agree with the Principal Investigators Assessment. 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