Documentation of Permission by parents or guardians shall be documented in accordance with and to the extent required by 45 CFR 46.117 or 21 CFR 50.27 permission Documentation of When the IRB determines that assent is required, it shall also determine whether and how assent must be documented. assent Wards Children who are wards of the State or any other agency, institution, or Requirements for 46.409, 50.56 entity can be included in research approved under 46.406 or 46. 407 or permission or clinical investigations under 50.53 and 50.54 only if such research or assent if the study clinical investigations are: falls under: related to their status as wards; OR conducted in schools, camps, hospital, institutions, or similar 46.406 & 46.407, or settings in which the majority of children involved as subjects are 50.53 & 50.54 not wards Permission must be If the research or clinical investigation is approved under paragraph (a) obtained from both of this section, the IRB must require appointment of an advocate for child advocate and each child who is a ward. any other individual The advocate will serve in addition to any other individual acting on acting on behalf of behalf of the child as guardian or in loco parentis. the child as guardian One individual may serve as advocate for more than one child. or in loco parentis The advocate shall be an individual who has the background and experience to act in, and agrees to act in, the best interest of the child for the duration of the child’s participation in the research. The advocate must not be associated in any way (except in the role as advocate or member of the IRB) with the research or clinical investigation, the investigator(s), or the guardian organization.
Documentation of permission Permission by parents or guardians shall be documented in accordance with and to the extent required by 45 CFR 46.117 or 21 CFR 50.27 Documentation of assent When the IRB determines that assent is required, it shall also determine whether and how assent must be documented. 46.409, 50.56 Wards Children who are wards of the State or any other agency, institution, or entity can be included in research approved under 46.406 or 46. 407 or clinical investigations under 50.53 and 50.54 only if such research or clinical investigations are: related to their status as wards; OR conducted in schools, camps, hospital, institutions, or similar settings in which the majority of children involved as subjects are not wards If the research or clinical investigation is approved under paragraph (a) of this section, the IRB must require appointment of an advocate for each child who is a ward. The advocate will serve in addition to any other individual acting on behalf of the child as guardian or in loco parentis. One individual may serve as advocate for more than one child. The advocate shall be an individual who has the background and experience to act in, and agrees to act in, the best interest of the child for the duration of the child’s participation in the research. The advocate must not be associated in any way (except in the role as advocate or member of the IRB) with the research or clinical investigation, the investigator(s), or the guardian organization. Requirements for permission or assent if the study falls under: 46.406 & 46.407, or 50.53 & 50.54 Permission must be obtained from both child advocate and any other individual acting on behalf of the child as guardian or in loco parentis
guidance_summary_table_subpart_d.docx