Informed Consent

Informed consent is a voluntary agreement to participate in research. It is a process that includes an informed consent document that must be signed prior to participation in the research. The goal of the informed consent process is to provide sufficient information so that a participant can make an informed decision about whether or not to enroll in a study or to continue participation. The informed consent document must be written in language easily understood by the participant, it must minimize the possibility of coercion or undue influence, and the subject must be given sufficient time to consider participation.

The informed consent process must:

  • Be presented in language easily understood by the subject,
  • Minimize the possibility of coercion or undue influence,
  • Allow subject sufficient time to consider participation,
  • Allow subject to refuse or discontinue participation at any time,
  • Distinguish between research and standard medical care,
  • Not include exculpatory language,
  • Be appropriately presented for the subject’s physical, emotional and psychological capacity, and vulnerable status, and
  • Assure that subject understands what participation entails.

These are required elements of informed consent:

  • Purpose and procedures involved in the research,
  • Alternatives to participation,
  • Explanation that participation is voluntary,
  • Explanation as to whether any compensation or medical treatments are available if injury occurs,
  • Extent to which confidentiality of records will be maintained,
  • All foreseeable risks and discomforts to the subject (e.g. physical injury, psychological, social, or economic damage),
  • Benefits of the research to society and the individual subject, and
  • Person to contact for answers to questions or in the event of a research-related injury or emergency.

The IRB may allow the method of consent to vary depending on the level of risk and the nature of the research. In addition to the consent process described above, the process may be modified to allow:

  • verbal consent;
  • the use of a short form or an information/fact sheet;
  • assent of a minor with the consent of the parent(s);
  • waiver of documentation of informed consent; and
  • waiver of elements of informed consent.

The HHS Secretary's Advisory Committee for Human Research Protections (SACHRP) provides specific guidance on what should be included in research consent forms, on waiving consent and on minimal risk research. View this guidance »