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Obtaining informed consent to clinical treatment

Patient-centred care is widely acknowledged as a fundamental dimension of high-quality healthcare. A pivotal aspect of this approach, is the understanding that informed consent to clinical treatment is a two-way dialogue between patients and healthcare professionals about the benefits, risks, costs and alternatives of care, considering the patient’s personal circumstances, priorities and cultural background1.

Informed Consent Checklist

This checklist provides a framework to plan, conduct and review informed consent conversations with your patients2,3. MIPS encourage you to use this tool to guide an open and honest dialogue rather than as a defensive approach to avoid potential clinico legal risk.

Preparation

  • I have reviewed the patient’s medical records including relevant laboratory test, radiological images and other relevant data.
  • I have determined whether the patient needs an interpreter or other form of communication aid.
  • I have determined that the patient has the legal capacity to provide informed consent.

Introduction

  • I have introduced myself and my role in the patient’s care plan including the proposed clinical procedure.
  • I have asked open ended questions to facilitate active patient participation and a two-way dialogue.
  • I have asked the patient to share their values, goals and expectations of the proposed procedure.

Core

  • I have determined the patient has capacity to consent and is not under the effect of drugs, alcohol, anaesthesia, or any other factor that may automatically invalidate their ability to consent.
  • I have discussed with the patient their current health condition and how it relates to the proposed procedure.
  • I have explained the full therapeutic procedure, including:
  • How it will be performed
  • Who will perform it
  • How long it will take
  • I have explained the benefits of the procedure as they relate to the patient’s condition and the risks of not undergoing the procedure.
  • I have explained all the material risks associated with the procedure, including the risk that may not achieve the desired outcome.
  • I have described all the alternatives to the proposed procedure.
  • I have described what to expect after the procedure (length of recovery, limitations on daily activities, any expected pain or discomfort, quality of life).
  • I have explained the fees and costs associated to all procedures involved.
  • I have explained the presence and role of any clinical trainee during the procedure (if applicable)
  • If I need to take photographs, record videos of the procedure, etc., for education and/or training purposes, I have explained this clearly to the patient.
  • I have created opportunities for shared decision making by asking, for example4:
    • “Let’s work together to help you decide whether this procedure is something you want”
    • You and I will work as partners in this conversation. My job is to give you information about the procedure and your job is to ask me questions and to tell me whether you would like to proceed with the procedure”.

Review

  • I have ensured the informed consent was freely given and covers the specific purpose.
  • I have documented the informed consent conversation as accurately as possible in the patient’s medical records.
  • I have documented the patient’s consent to the proposed clinical treatment
  • I have documented the patient’s written consent to photographs, video recording, presence of any clinical trainees during the proposed procedure.
  • I have documented refusal to treatment (if applicable).
  • I have ensured the patient or legal guardian understands the information given to them by:
  • Asking them to teach me back what I’ve said, for example4:
    • Can you tell me in your own words what you have understood from our conversation so I can be sure that I’ve explained it properly?
    • If a family member asked you what we discussed today, what would you tell him or her?
    • In situations where the patient recalls information incorrectly, you may say: “I want to make sure I do a good job of explaining this information, so let’s go over it again in a different way that may be more understandable”
    • In situations where the patient omits an essential piece of information, you may say: “You summarised what we discussed very well. One important thing I did not hear was […]. I just want to make sure you understood that part as well.

Reference

The Royal Australian College of General Practitioners. Information sheet: Informed patient decisions. East Melbourne, Vic: RACGP, 2019.

Khoury BS, Khoury JN. Consent: a practical guide. Australian Dental Journal. 2015 Jun;60(2):138-42.

Firdouse M, Wajchendler A, Koyle M, Fecteau A. Checklist to improve informed consent process in pediatric surgery: a pilot study. Journal of Pediatric Surgery. 2017 May 1;52(5):859-63.

Ripley BA, Tiffany D, Lehmann LS, Silverman SG. Improving the informed consent conversation: a standardized checklist that is patient centered, quality driven, and legally sound. Journal of Vascular and Interventional Radiology. 2015 Nov 1;26(11):1639-46.