FDA Requirements for Informed Consent Forms

Obtaining informed consent from participants in a clinical trial study is vital. A key document in the informed consent process is the informed consent form. Food and Drug Administration (“FDA”) regulations establish the minimum requirements for all informed consent forms.

Requirements

Basic Disclosures. Informed consent forms must:

• Notify the participant that the study involves research, explain the purposes of the research and the expected duration of the subject’s participation. 
• Describe the procedures to be followed and identify any procedures that are experimental. 
• Describe the extent, if any, to which confidentiality of records identifying the subject will be maintained and note the possibility that the FDA may inspect the records.
• State that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled and that the subject may discontinue participation at any time without penalty or loss of benefits.

Risks and Benefits. Informed consent forms must contain a description of any:

• Reasonably foreseeable risks or discomforts to the subject; and
• Benefits to the subject or to others which may be reasonably expected from the research.

Studies That Involve Risk. For research involving more than minimal risk, the informed consent should also:

• Explain whether the participant can expect any compensation.
• Describe any medical treatments that are available if the participant is injured, including what the treatments entail and where the participant may obtain further information about them.
• Disclose appropriate alternative procedures or courses of treatment, if any, which might be advantageous to the subject.
• Explain whom to contact for answers to pertinent questions about the participant’s rights and whom to contact in the event of a research-related injury.

Other Disclosures

Depending on the nature of the study, the FDA may require that an informed consent form do some or all of the following:

• Explain that the particular treatment or procedure may involve risks to the participant (embryo or fetus, if the participant is or may become pregnant) that are currently unforeseeable.
• State that significant new findings developed during the course of the research that may relate to the participant’s willingness to continue to participate will be provided to the subject.
• Disclose anticipated circumstances under which the participant’s involvement may be terminated by the investigator without regard to the participant’s consent.
• Identify any additional costs to the participant that may result from involvement in the research.
• Describe the consequences of a participant’s decision to withdraw from the research and the study’s procedures for orderly termination.
• State the approximate number of participants involved in the study.

Conclusion

All informed consent forms should meet the FDA minimum requirements with the expectation that a well drafted informed consent form will exceed those requirements. (See “Drafting Informed Consent Forms” in the Risk Management 101 series.)