Regulatory Requirements | ICFs

By regulation, the ICF must contain certain basic information and may contain optional elements if the apply. Investigators should check the ICF to make sure that each required element and any applicable optional element has been included. Optional elements are indeed optional. They should only be included when they provided information of value to potential participants.

If the document will combine consent and written authorization, then it must also contain all the required elements of a valid HIPAA Authorization in addition to the requirements for consent.

Basic and Optional Elements of Consent

The Common Rule requirements for the elements of consent are enumerated in 45 CFR 46.116(a) and (b). The FDA's matching regulations can be found in 21 CFR 50.25. All of the basic elements of consent (below) except #6, must be in all consent forms, unless a Waiver of one or more of the elements has been approved by the IRB. When appropriate, one or more of the additional elements of consent shall also be provided to each subject.

45 CFR 46.116 and 21 CFR 50.25

(a) Basic Elements of Consent
Invitation to Participate, Purpose of Research, and Procedures (1) a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
Risks (2) a description of any reasonably foreseeable risks or discomforts to the subject;
Benefits (3) a description of any benefits to the subject or to others which may reasonably be expected from the research;
Alternatives (4) a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
Privacy & Confidentiality (5) a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
Injury Compensation* (6) 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;
Contact Information (7) 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; and
Subject Rights (8) 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.
(b) Additional Elements of Consent
Pregnancy (1) 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;
Discontinuation from Research (2) anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
Costs (3) any additional costs to the subject that may result from participation in the research;
Consequences of Withdrawal (4) the consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
New Findings (5) 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; and
Number of Participants (6) the approximate number of subjects involved in the study.

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