Informed Consent

Informed Consent Form

In the United States, the informed consent forms used in epidemiologic research include, at a minimum, the following eight elements:

• 1.
  information about the purpose of the research and the study procedures (highlighting any components that are experimental),
• 2.
  potential risks of the research for participants,
• 3.
  potential benefits of the research for participants and for others,
• 4.
  information about alternative treatment available (if it exists),
• 5.
  information about the level of confidentiality that will or will not occur,
• 6.
  information about compensation for injury if more than minimal risk exists,
• 7.
  information about who to contact to learn more about the research or to contact if a participant thinks his or her rights have been violated or he or she has been harmed, and
• 8.
  a clear statement that participation in the research is voluntary, that the choice of participation will not affect care otherwise provided at the study site, and that the participant can quit at any time.

For studies that involve special circumstances, such as criteria that must be met for continued participation, additional information in the consent process is required.

The language level and format must optimize readability and understanding for potential study participants. Typical recommended reading levels range from fifth grade to eighth grade, depending on the educational level of the population. Innovative formats, such as question and answer, are currently in favor because they enhance reader comprehension.

In addition to providing detailed information, researchers must ensure that the potential participants understand the study procedures. This is particularly true for studies involving risk to the participants. Simply signing the form is not sufficient for meeting this [Page 537]standard. True consent is only granted by individuals who have autonomy in their decision.

In most research, individuals must sign the informed consent form to participate in the study. The purpose of the signed informed consent form is to ensure that participants have seen it, read it, and understood the content. However, it is important that the researchers assess understanding. A signed informed consent form is not sufficient for meeting the standard. For individuals to provide consent, they must be informed and have autonomy in their decision. Depending on the risks involved in the research, different levels of assessing understanding of procedures and rights are used. In high-risk studies, often multiple methods are used to provide information to participants, including video information about the study, conversation with research assistants well trained in the informed consent process, and written materials. For research involving significant risk, such as randomized trials of experimental medications, the standard for understanding is such that potential participants are quizzed and only after passing a test on the information contained in the informed consent may the individual choose to participate and sign the form.

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