Who may give permission if the patient lacks the capacity to provide informed consent?
Under the Illinois Health Care Surrogate Act, when a person lacks decision making capacity, permission to participate in clinical research from which the individual patient may derive a benefit may be obtained from a legal guardian or from someone close to the patient, according to a hierarchy of relationship (see Section C.30). In Bureau facilities, before a mentally incompetent person may be enrolled in a study, a physician not associated with the study must attest that the patient is not competent to consent, that any persons with relationships higher in the hierarchy than the person giving permission are not reasonably available to either give or withhold permission, and that the research holds a possibility of benefiting the patient personally. When a patient is not able to give consent because of an emergency medical condition, and the research involves experimental treatment for that condition, under some conditions that patient may be enrolled without any surrogate’s permission
Related Questions
- Do I need Informed Consent from a patient and/or their family, if I am providing off-label use of a medication? If so, what sort of information should be discussed during the informed consent process?
- Can a CA note in the chart that a patient has given informed consent for treatment if the doctor signs the note? Can it be typed as a standard part of a chart and then signed by the doctor?
- Who must sign the informed consent or parental permission document?
