Informed consent

DEFINITION: Informed consent is the process whereby a patient decides whether to accept the risks of a major medical procedure, such as a biopsy, surgery, radiation, or chemotherapy, and to undergo that procedure. Its purpose is to protect the rights and welfare of patients. This decision-making process involves receiving comprehensive information about a proposed medical treatment, procedure, surgery, or clinical drug or medical device trial and its possible risks; having all questions satisfactorily answered; and signing a consent form to undergo the proposed course of action or refusing to sign the consent form and thereby refusing to undergo the procedure. By signing this form, patients are providing legal documentation that they have received all necessary information to make an informed decision and are giving permission for a physician to proceed with the proposed course of action. A parent, legal guardian, or court-authorized person may complete the process if the patient is a child or mentally or physically unable to participate in the process.

ALSO KNOWN AS: Written consent

Informing the patient:Patients receive information about the proposed medical course of action. It should be as nontechnical as possible to ensure that it is understandable. Explanations can be in the following forms:

• Verbal, via the physician or other healthcare provider
• Written, via patient information handouts or educational booklets
• Short films on video, DVD, or online
• Computer-provided interactive tutorials

After receiving comprehensive information, patients are to have all their questions answered in language that they are able to understand. Not all treatments or procedures require written consent—for example, blood tests and mammograms; nevertheless, patients and healthcare providers should discuss the purpose of and benefits and risks of the test or treatment. Patients may be given educational materials on such treatments as well.

Nonsurgical treatments: For treatments, the American Cancer Society recommends that patients include questions about the diagnosis that has prompted the procedure, including how serious the condition is; the recommended treatment methods and possible benefits and risks of having, or not having, the treatment, including the effect on normal functions and everyday activities and possible immediate, short-term, and long-term side effects; other treatment options, if available, and their possible benefits and risks; any potential discomforts associated with the treatments and the methods used to prevent or relieve those discomforts; the treatment’s duration; and the treatment’s cost.

Surgical procedures: For surgical procedures, the American College of Surgeons recommends that patients pose questions about the factors that indicate an operation is required; the possible benefits and risks of having, or not having, the operation, including the impact on health or quality of life; the alternatives to the surgery, if available, and their possible benefits and risks; the basic procedures involved in the operation, including expected length of hospitalization, if necessary; expectations during the recovery period, including length of time before resumption of normal activities; and any potential lingering effects from the surgery.

Giving consent: Once patients have had all questions satisfactorily answered, they are asked to decide whether they want to undergo the proposed medical course of action. An affirmative decision is indicated by signing and dating a written informed consent form, signaling voluntary willingness. This form may then be signed by a witness to confirm that the patient has received an accurate explanation of the information contained both in the form and in any other printed or orally delivered material, has understood the information, and has freely given consent.

Clinical trials: For clinical trials, the informed consent process is more detailed than that for a nonexperimental medical course of action. Clinical trials for investigational drugs, medical procedures, or medical devices are to be conducted using Good Clinical Practices (GCPs), as mandated by the Code of Federal Regulations (CFR) of the US Food and Drug Administration (FDA) and by guidelines of the International Conference on Harmonization (ICH). Before screening for possible participation, the potential study subjects must receive information on and have all their questions answered about the investigational drug or medical device being tested and the probability of being assigned to a treatment group or placebo (nonexperimental drug/device) group; the study procedures to be followed (including identification of any that are experimental) and tests to be administered; and the potential risks and benefits involved in study participation.

Patients must also receive information about the expected length of participation, their responsibilities as study subjects, anticipated compensation for participation (if any), the possible circumstances under which participation may be discontinued (despite subjects’ consent), the possible compensation and treatments available should they have a trial-related injury, and the extent to which records that contain information about their identity will be kept confidential.

Once patients have had all questions satisfactorily answered, they are required to sign an informed consent form that has been approved by an institutional review board (IRB) or independent ethics committee (IEC). By providing written informed consent, patients indicate that all their questions have been answered, that their participation in the study is voluntary, and that they understand that they have the right to withdraw this consent to participate at any time during the study.

Clinical researchers must take special measures to include certain patient populations in their trials. For patients who speak or read only a language other than English, materials should be presented in translation. In cases when the patient cannot read or write and gives verbal consent, the informed consent form should be witnessed and signed. Children who can comprehend what is being asked of them must give their assent (defined as "affirmative agreement") in addition to their parents' or guardians' permission. One example of a situation in which children and parents provided informed consent was during trials for administering the COVID-19 vaccination to young adults and children.

During the procedure or clinical trial: Although an informed consent form has been signed to indicate voluntary participation in a clinical trial, the study personnel, including sponsors, investigators, monitors, clinical research assistants, and anyone else involved with clinical trial procedures, are not released from liability for negligence. In addition, patients have the right to have their questions answered throughout the treatment process and to withdraw their consent at any time. In the case of clinical trials, subjects are to be informed if any significant results occur during the study that might affect their willingness to continue to participate in that study. A new informed consent form may be required to document that continued willingness.

Bibliography

Berg, J. W., P. S. Appelbaum, C. W. Lidz, and L. S. Parker. Informed Consent: Legal Theory and Clinical Practice. New York: Oxford University Press, 2001.

Faden, R. R., and T. L. Beauchamp. A History and Theory of Informed Consent. New York: Oxford University Press, 1986.

“Informed Consent. Guidance for IRBs, Clinical Investigators, and Sponsors (August 2023).” FDA, 15 Aug. 2023, www.fda.gov/regulatory-information/search-fda-guidance-documents/informed-consent. Accessed 13 June 2024.

“Informed Consent - StatPearls.” NCBI, 5 June 2023, www.ncbi.nlm.nih.gov/books/NBK430827. Accessed 13 June 2024.

Vorvick, Linda J. "Informed Consent - Adults." Reviewed by David C. Dugdale and Brenda Conaway. MedlinePlus, 13 Oct. 2023, medlineplus.gov/ency/patientinstructions/000445.htm. Accessed 14 Nov. 2024.