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Informed Consent Checklists

45 CFR § 46.116: Basic and Additional Elements

Basic Elements
  A statement that the study involves research
  An explanation of the purposes of the research
  The expected duration of the subject's participation
  A description of the procedures to be followed
  Identification of any procedures which are experimental
  A description of any reasonably foreseeable risks or discomforts to the subject
  A description of any benefits to the subject or to others which may reasonably be expected from the research
  A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
  A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
  For 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 obtained
( ) Research Qs An 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 subject
( ) Right Qs
( ) Injury Qs
  A 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 entitled

Additional elements, as appropriate
  A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant), which are currently unforeseeable
  Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent
  Any additional costs to the subject that may result from participation in the research
  The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject
  A statement that significant new findings developed during the course of the research, which may relate to the subject's willingness to continue participation, will be provided to the subject
  The approximate number of subjects involved in the study

45 CFR § 46.117: Checklist for Documentation of Informed Consent

A. EXCEPT AS PROVIDED IN PARAGRAPH "C" OF THIS SECTION, INFORMED CONSENT SHALL BE DOCUMENTED BY THE USE OF A WRITTEN CONSENT FORM APPROVED BY THE IRB, AND SIGNED BY THE SUBJECT OR THE SUBJECT'S LEGALLY AUTHORIZED REPRESENTATIVE. A COPY SHALL BE GIVEN TO THE PERSON SIGNING THE FORM
WRITTEN The consent form may be either of the following:
  • A written consent document that embodies the elements of informed consent required by §46.116. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator should give either the subject or the representative adequate opportunity to read it before it is signed
DONE ORALLY
  • A short form written consent document, stating that the elements of informed consent required by §46.116 have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form
WAIVER of req't for signed form
  • An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects, if it finds either:
  • That the only record linking the subject and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
  • 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.In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research

 

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