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8 Basic Elements in an ICF The following eight basic elements of informed consent are required to be provided in the course of the consent process. Consent Requirements ? In addition to the 8 required elements, one or more of the following elements are to be provided to the subject when appropriate to the study : ? Procedures- in lay terms! Suggestions for Improvement ICF Version Control Tips ? Use of expired forms or unapproved forms ? Use of wrong form (child signing parental permission form or subject signing the wrong version) Check the Validation Box on the last page of the consent form BEFORE you consent the subject (for paper forms).
Suggestions for Improvement Failure to Obtain Consent ? Failure to obtain written informed consent (forgot to have subjects sign a consent form) or failure to have HIPAA RAF signed ? Missing consent documents ? No documentation that consent process took place & no signed consent document on file Consent should be the VERY FIRST research activity (even if subjects had a form previously mailed to them) and the VERY LAST thing you do before subject leaves Switch to a compound form (or staple it to the consent). The investigator must ensure that these elements and any others required by the IRB are presented in such a manner as to facilitate the prospective participant’s ability to understand involvement in the research study.


Tell which are experimental ? Research not medical treatment & purpose of the research ? Possibility of unforeseeable risks ? The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject.
Discuss New ICF Versions at regular staff meetings to inform all personnel of changes and to ensure all staff will use the correct version. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.
Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or ? (2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative.


No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.
Maintain the original in the regulatory binder for the study records but any copies of expired or outdated documents should be destroyed, and electronic copies should be moved to archive folder on computer.



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