Validation & Documentation of Patient's Understanding for Informed Consent

Do you need to obtain informed consent from a patient (or proxy) prior to a procedure or treatment?

Have you started the process early so that there is sufficient time for all of the issues involved?

Has a time and place been selected that is appropriate for a confidential discussion?

Have you identified one or more family members or other decision makers for inclusion in the process?

Are all of the necessary legal documents in order?

Have you arranged for all necessary tests, including a competency determination if indicated?

Have you gauged the person's capacity to understand the key concepts?

Have you proceeded slowly, based on feedback from the patient?

Have you described things in simple words rather than medical terms?

Have you used visual aids and handouts that the patient can understand?

Have you limited the information given at each session?

Have you encouraged the patient to ask questions?

Have you frequently asked the patient to tell you what you just told them in their own words?

Have you asked the patient at subsequent meetings to restate key elements from past discussions?

Has each visit and discussion been documented in the medical record?

On completion of the process has the consent been signed by the patient (or proxy), the primary care provider, and a suitable witness?