How can you explain the informed consent process to patients and their families?

2 Provide relevant information

The next step is to provide the patient or the LAR with relevant information about the proposed intervention or research. You should use simple, plain, and culturally appropriate language that matches the patient's literacy level and learning style, while avoiding medical jargon, acronyms, or technical terms that may confuse or intimidate them. Visual aids, such as diagrams, charts, or videos can be used to illustrate the information. This should include the purpose and nature of the intervention or research, its expected benefits and potential risks/harms, available alternatives with their pros and cons, the right to withdraw/decline without penalty/loss of benefits, confidentiality and privacy of patient information/data, and contact details of health care provider/researcher in case of questions/concerns.

3 Check the patient's understanding

After you provide the information, you need to check the patient's understanding and address any questions or concerns they may have. You can use various techniques to check the patient's understanding, such as teach-back, ask-me-3, or open-ended questions. You should also encourage the patient to repeat the information in their own words, clarify any misconceptions, or ask for more details. You should also assess the patient's feelings and emotions about the intervention or research and provide emotional support or reassurance if needed.

4 Obtain the patient's consent

The final step is to obtain the patient's consent. You need to ensure that the patient's consent is voluntary, informed, and documented. You should ask the patient to sign a written consent form that summarizes the information you provided and confirms their agreement to the intervention or research. You should also give the patient a copy of the consent form and keep the original in their medical record. You should also remind the patient that they can change their mind or withdraw their consent at any time.

5 Review and update the consent

The informed consent process is not a one-time event, but an ongoing communication between you and the patient. You need to review and update the consent periodically, especially if there are any changes in the patient's condition, preferences, or circumstances. You also need to monitor the patient's satisfaction and outcomes and provide feedback or follow-up as needed. You should also respect the patient's right to revoke their consent if they choose to do so and document the reasons and consequences of their decision.

6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?