What do I need to know about informed consent?

What is informed consent?

Informed consent is a process by which a subject voluntarily confirms his or her willingness to participate in a research project, after having been informed of all aspects of the research that are relevant to the subject’s decision to participate.

Documentation of informed consent

Informed consent should be documented by a written form that is signed by the subject or the subject’s legally authorized representative. The researcher should keep the signed consent forms for at least three years after the research has ended.

The consent form may be either of the following:

  • A written consent document that embodies the elements of informed consent. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator should give either the subject or the representative adequate opportunity to read it before it is signed.
  • A short form written consent document, stating that the required elements of informed consent have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation.  Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form.

See Informed Consent Template
 

Basic principles of informed consent

Unless a waiver is granted, the researcher must obtain the informed consent of each subject to participate in the research. If the subject is deemed lacking decisional capacity to consent, it must be obtained from the subject's legally authorized representative such as a parent, guardian, or conservator.

The researcher should seek such consent only under circumstances that give the prospective subject or the representative sufficient opportunity to consider the matter carefully and that minimize the possibility of coercion or undue influence.

The information that is given should be in a language and in words understandable to the subject or the representative. It should be a full, clear, but succinct explanation, without jargon or technical terms, calculated to inform a person with a 7th grade reading level.

No informed consent may include any language, whether oral or written, through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, including release of the researcher, the sponsor, the University, or its agents from liability for negligence.

Research Involving Minors

When research involves minor children, special rules apply. The researcher should obtain the assent of the children insofar as they are capable of providing it, taking into account their age, maturity, ability to read, and psychological state. If the children are old enough to read and write, they should be invited to sign an assent form (which can either be its own document or be included on their parents' consent form). Except in unusual cases, the researcher should also obtain the informed consent of each child's parents or guardians. If only one parent is reasonably available or has legal responsibility for the care of the child, that parent's consent is sufficient. For more information, see Child or Adolescent Assent to Participate in Research or contact the UCSC IRB.