VCOM Institutional Policy and Procedure Manual
Assent is a child’s affirmative agreement to participate in research. Failure to object should not, in the absence of affirmative agreement, be construed as assent. Permission is defined as the written agreement of the parent(s) or guardian to the participation of their child or ward in research or clinical investigation. Legally Authorized Representative is one who has the authority to make research participation decisions on behalf of another. PROCEDURE 1. The current IRB approved, most recent version of the Informed Consent Form (ICF) is used for obtaining written informed consent. 2. All aspects of the study including procedures, benefits, risks, alternatives to study participation, voluntary nature of participation, confidentiality issues, and ability to withdraw from study participation must be explained to the study subject or legal representative by the investigator/subinvestigator. 3. The subject, or person providing consent, must be given adequate time to read the ICF, or have it read to them, and must have all their questions answered. 4. If additional information is requested by the subject, or their legal representative, this must be provided by the investigator/subinvestigator prior to implementation of the study. 5. The investigators and sub-investigators, as listed on the FDA 1572 or protocol as applicable, will obtain informed consent from the potential study subject or their legally acceptable representative. 6. The subject, or legal representative, must initial each page of the ICF, and then sign and date the last page of the ICF. 7. The investigator and/or subinvestigator and one witness must sign and date the last page of the ICF. The witness may not be staff involved in the conduct of the study. 8. Telephone or verbal consents are not acceptable. 9. Two copies of the ICF must be made: the original document is filed with study documents; one copy is included in the source documentation; and one copy is given to the patient or legal representative. 10. A detailed note must be written and entered into the source document describing the consent process. 11. Informed Consent must be obtained prior to the initiation of any protocol- required screening, procedure, test, or treatment that is not considered part of routine clinical care. 12. Children of age to understand the Informed Consent language, generally > age seven, must assent to study participation in conjunction with the consent and written permission of the parent or legal guardian. The enrollment and assent of children must be IRB approved. 13. Study procedures may begin at this point. 14. Throughout the course and conduct of the study, if the ICF is revised, subjects actively enrolled must be re-consented at the next available opportunity, for example the next clinic visit. The investigator must provide explanation to subjects for any new information in regard to risks or benefits that may influence the subject’s decision to continue or withdraw participation in the study. 15. Any deviations to the Informed Consent regulations must be reported to the IRB immediately in writing. 16. Emergency enrollment of a patient without informed consent is not permitted. 6.
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