Informed Consent: Good practice solutions to common clinical scenarios
Finding the right balance between theory and everyday practice
Bridging the gap between the quintessential approach to obtaining informed consent to care and the reality of everyday protocols is key to high quality health outcomes. Unsuccessful approval to receiving treatment, failure to advise about risks, alternative options and unsatisfactory outcomes are common sources of litigation risk and professional liability for healthcare practitioners [1].
The legal recommendations are that all ‘material risks must be discussed’, ie, risks that would impact the decision of a reasonable person in the patient’s situation[2]. These two considerations - material risks and a reasonable patient are recurrently precarious, due to their subjective nature and the broad variation amongst practitioners and individuals.
The case studies we discussed highlight the intricacies of obtaining adequate informed consent in common clinical situations. The following is a summary of the key issues that would need to be considered when reviewing the conduct from a legal and regulatory viewpoint.
- Has the hospital and/or EDD P/L and /or Specialist B obtained valid informed consent to Specialist B performing the procedure?
The relevant matters are:
- Would a reasonable person, in the position of the patient, likely attach significance to it (of his limited experience)? (Objective test)
- Was Specialist B aware, or should have reasonably been aware, that this particular patient would likely attach significance to that information? (Subjective test)
If yes to either of the above, then Specialist B has failed to take informed consent.
- Specialist B didn’t re-consent the patient for the surgery instead relying on the consent form witnessed by the initial specialist and which appeared on the patient record. Was Specialist B entitled to rely on the consent form taken and witnessed by the initial specialist?
If the conclusion to Issue 1 above is that Specialist B ought to have informed the patient of his limited experience; then Specialist B is not entitled to rely on the consent taken by Specialist A. What if both the initial specialist O&G (for convenience refer to as Specialist A) and Specialist B were both very experienced?
- The patient gave consent to Specialist A performing the procedure. If Specialist B, or someone on Specialist B’s behalf does not obtain permission from the patient for Specialist B to perform the procedure, Specialist B is not entitled to rely on the consent taken by Specialist A.
- Is it sufficient for Specialist B to ask the patient “do you agree to me performing the procedure instead of Specialist A” and rely on the consent from for the details of the procedure etc. or does Specialist B have to go through the whole process again? The answer is:
- If Specialist A took adequate informed consent, Specialist B would not incur any liability by relying on it*.
*Comment: How could Specialist B possibly know Specialist A took adequate consent? For Specialist B to proceed without personally taking consent from the patient would be foolhardy. Specialist B would be taking on liability for any shortcomings in the conduct of Specialist A
- If Specialist A did not take adequate informed consent and Specialist B relied on it, then Specialist B would be liable, and it is likely that both Specialists A and B would be defendants.
- Was there valid informed consent from the patient in respect of the bilateral salpingo-oophorectomy?
Not unless one of the issues discussed pre-surgery was that a bilateral salpingo-oophorectomy might be necessary. If the patient was not told that a bilateral salpingo-oophorectomy might be necessary but admits, or the court concludes, that had she been told she would have consented to it, Specialist B would still be liable in trespass but not negligence and any damages would be minimal.
- What are the possible repercussions for Specialist B now?Potential outcomes are:
- Civil claim in negligence, failing to obtain informed consent. Query also whether the operation was performed to the standard of “a reasonable O&G”.
- Complaint to AHPRA (Medical Board)
- Complaint to hospital and possible action by hospital which might affect the Specialist’s accreditation at the hospital.
- Has the practitioner discussed the risks material to the circumstances of each of his patients?
A risk is material if:
- A reasonable person in the patient’s position, if warned of the risk, would likely attach significance to it; or
- If the practitioner is or should be reasonable aware that the particular person if warned of the risk would be likely to attach significance to it.
Has this been done in this case? It depends what was in the educational online video and whether the patient watched it, and what discussion was had between the patient and the nurse about risks and what opportunity the patient was given to seek clarification about those risks. If via the video and/or discussion with the nurse the relevant material risks were covered and the nurse was able to answer any queries the patient had this is in the face of it satisfactory. However the exposure of the practitioner lies in the fact that the only time after the discussion with the nurse that the patient had to seek from the practitioner any clarification or ask any questions was at the consultation which took place on the morning of the surgery. This is too late.
- Have the regulatory and legal requirements for an informed consent been met by the practitioner?
No
- What elements relevant to regulatory code and or legal principles around informed consent may have failed in this case?
- The size and location of the breasts was discussed while the patient was under sedation. This is not adequate. The patient can’t be expected to effectively process information whilst under sedation.
- Little if any medical history was taken. This is not satisfactory. The practitioner cannot determine the material risks relevant to any particular case without knowing the patient’s history and condition, eg the risk of intraoperative bleed is different for a haemophiliac.
- Patients consulted with the practitioner for the first time on the day of surgery. This is not good enough. There was limited opportunity for a patient to seek clarification or ask about material risks and even if they did there was insufficient time to process the new information and make an informed choice. Most patients by then feel “locked in” to the process then in train and feel that proceeding is inevitable.
- The relationship between XYZ Financial Services and the practitioner was not disclosed. There was a considerable possibility that the patient might have inferred by the fact that XYZ referred her to the practitioner that this was an independent endorsement of the practitioner.
- What are the likely repercussions for the practitioner in this case?
Potential repercussions are:
- Civil claim in negligence for failing to obtain informed consent and query also whether the operation was performed to the standard of “a reasonable cosmetic surgeon”
- Complaint to AHPRA (Medical Board)
- Reputational damage
- What were the material risks involved in this case?
The patient’s severe autism and history of acute stress sensitive seizures and bruxism were relevant to advising the patient about the best treatment for her and the way to deliver that treatment.
- What do you think Dr J could have done differently to avoid criticism and allegations of sub optimal care including inadequate consent?
Dr J should have clarified with the GP the patient’s medical history and taken this into account when considering the options for treatment. Following that Dr J should have discussed the treatment options and the risks and benefits of each with the patient’s mother who was the patient’s legal guardian.
- What are the implications of Jasmine’s parents’ marital status and legal standing regarding this case?
The patient was 12 years old and unable to provide consent. The grandmother was not capable of providing consent because that right fell to the patient’s mother who was the court appointed legal guardian.
Note: In general, separated parents have the same rights as non-separated parents. Only the consent of one of those parents is needed unless the practitioner is aware or should reasonably be aware that the other parent objects or is likely to object, or if there is a specific court order in place requiring consent of both parents.
- What are the possible repercussions for Dr J?
- Civil claim for failing to obtain consent (actionable per se) and possibly for negligent treatment.
- Complaint to AHPRA
- Reputational damage personally and to the practice
- What were the materials risks involved in this case?
Staining is a material risk in this case because:
- A reasonable stage performer if told of the risk of staining would likely attach significance to it;
- The GP was aware that the patient was a stage performer and she had mentioned that she was concerned about her appearance. As such the GP was or should have reasonably been aware that the patient would likely attach significance to the risk of staining.
- Was the informed consent conversation appropriate?
It seems to have been, although the facts provided are limited. The facts record that the patient was informed of the risk of staining although query whether she was told it would be permanent. Secondly, the GP recommended IM injection because it is said to be more effective than tablets. The facts don’t record why the GP recommended IM injection over IV infusion. If the reason was not explained to the patient it would expose the GP for not having obtained informed consent. The patient should be informed of the risks and benefits of both and why the GP recommends IM over IV.
- Should it (the informed consent discussion) have included the nurse who performed the injection?
This is not necessary.
- Would it have made any difference to the ‘informed consent’ conversation if the patient had not been a stage performer?
As a generalisation, stage performers are likely to be somewhat more concerned about cosmetic risks than many members of the public, However there wouldn’t be many patients not concerned at all about cosmetic risks so it is likely in most cases there will be a discussion about cosmetic risk. The level of detail necessary to provide will vary from patient to patient. The law states that a GP in respect of any patient is obliged to inform that patient of those risks that:
- a reasonable person, in the position of the patient, would likely attach significance.
And those risks that
- the GP is aware, or should reasonably be aware, that the patient they are treating would likely attach significance to that risk.
- What is the nurse’s liability here?
If the nurse administered the injection negligently the patient would have a meritorious claim in negligence against the nurse and if the nurse was employed by the GP, against the GP also under the law of vicarious liability. Registered nurses are required to have their own indemnity as AHPRA registered health professionals.
- What are the likely repercussions for the practitioner in this case?
Potential repercussions are:
- Civil claim in negligence for:
- failing to obtain informed consent, and
- perhaps also for insufficient direction to the nurse on how best to administer the injection to minimise the risk of staining; and
- Negligent administration of the injection by the nurse
- Complaint to AHPRA (Medical Board)
Useful resources
RACGP Informed Patient Decisions
Australian Commission on Safety and Quality in Health Care – Informed Consent
RACGP Informed Consent Information Sheet
RACS Position Paper Informed Consent
MIPS related resources
Webinars
Practice notes
[1] Li Ching Ng, A., McRobb, L. S., White, S. J., Cartmill, J. A., Cyna, A. M., & Seex, K. (2020). Consent for spine surgery: an observational study. ANZ Journal of Surgery.
[2] Carver, T., & Smith, M. K. (2018). Informed consent and professional liability for causation of harm post Montgomery.