Elements of Informed Consent

If you are planning to use human subjects in your research, obtaining informed consent is an important step of the research process.  An informed consent must be written by the investigator, approved by the Institutional Review Board (IRB), or Ethics Committee, signed by the subject (patient or volunteer) or authorized representative, and witnessed.

The points below should be included in all informed consents:

  • A statement that the study involves research, an explanation of the purpose of the research and the expected duration, a description of the procedures, and identification of any procedures that are experimental.
  • A description of any reasonably foreseeable risks or discomforts to the patient.
  • A description of the benefits to the patient or to others that may be expected from the research.
  • A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the patient.
  • A statement describing the extent, if any, to which confidentiality of the records identifying the patient will be maintained and that FDA may inspect the records.
  • For research involving more than minimal risk, an explanation as to whether any compensation will be paid, whether any medical treatments are available if injury occurs, and what those treatments are; information should also be provided on how further information about this study may be obtained.
  • An explanation of whom to contact for answers to questions and whom to contact in the event of a research-related injury.
  • A statement that participation is voluntary, that refusal to participate will not result in penalty or loss of benefits to which the patient is otherwise entitled, and that the patient may discontinue participation at any time without penalty.

Additional elements of informed consent that should be present when appropriate:

  • A statement that the particular treatment or procedure may involve risks to the patient or to the fetus (if the patient is pregnant) that are currently unforeseeable.
  • Anticipated circumstances under which the patient’s participation may be terminated by the investigator.
  • Any additional costs to the patient resulting from participation in the research.
  • The consequences and procedures for withdrawing from the research.
  • A statement that significant new findings (such as new hazards) developed during the research will be provided to the patient.
  • The approximate number of patients who will be enrolled in the clinical trial.

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