Women's Health Action Submission on the current revised draft statement on informed consent

Submission on the current revised draft statement on informed consent
19 June 2001

lntroduction

Women's Health Action has a particular interest in the rights of consumers who use health services. We have had ongoing input into Medical Council documents relating to rights and professional accountability so are pleased to be able to now comment on the proposed revision to the statement on informed consent.

We would like to commend the Medical Council for the efforts to keep pace with informed consent issues, and in particular to include the particular requirements for consent to screening. This provides an important message to doctors that we are very pleased to see.

We have some suggestions of changes that we consider will further enhance the drait. These are listed in order of where they arise in the draft.

Specific Comments on the draft

Page 1

Introductory statement:

Paragraph 1:

Rather than endorsing the Code of Rights, which is a statutory obligation, we would like to suggest a change to the wording to read

‘The Medical Council of New Zealand's statement on informed consent is based on the Code of Health and Disability Services Consumers' Rights …'

Paragraph 2:

The Code of Rights is the position although there are varying interpretations and

perspectives on how to apply the Code in practice. We therefore suggest the following change to the first sentence in this paragraph to say:

This statement is an attempt to synthesis the different perspectives on informed consent currently…

Background

The following changes are suggested with the first paragraph in the section on

background.

1. The Council affirms that trust is a vital element.
It is our view that a successful doctor-patient relationship relies on a number of factors of which trust certainly has a key role. However, there are other elements that also need to be present. These include listening skills, sincere interest in the patient's wellbeing, as well as honesty and confidence in the doctor's practice and level of competency

We also suggest the following change to the last sentence of this paragraph so the focus is on the recommended/required actions ofthe doctor, rather than the patient.

'The doctor needs to provide the patient with information about the potential risks and benefits of all proposed treatments.'

Page 2 Informed consent

Number 6

We suggest inserting the word ongoing before opportunities so that there is a clear expectation that this matter will be revisited on an ongoing basis over time.

Number 7

In order to be consistent with the Code of Rights there also needs to be a reference to the need for written consent where the treatment or procedure poses a significant risk of adverse effects to the consumer.

When a patient is not competent to give informed consent

It would be helpful if this section also includes a statement on emergency situations. Our suggestion is as follows:

In emergencies the person is often not able to give consent and there may be no time to contact the next-of-kin or other designated person able to act on their behalf. In situations like this, the primary need is to treat the person. Where the ability to consent is absent or impaired, the treatment provided should be no more than that needed to treat the immediate emergency. Once the emergency is over, the person must be given information about the treatment they received and provided with the opportunity to consent to any further treatment that is recommended.

Consent of Minors (pg 2-3)

We would like to see an additional comment added to this section on children.

Children's wishes about treatment options and recommended procedures should be sought and taken into account. The older the child the more involved they should be in the consent process.

Page 3 Informed consent in relation to education and research

We would like to see the word training included alongside references to teaching as some doctors make a distinction between teaching undergraduates and ongoing training of a postgraduate nature.

Number 12

We would like to see the following sentence added to the start of number 12. -

All research must be approved by an accredited ethics committee before patients are invited to participate and consent to their involvement in any innovative treatments or research activities.

Number 14

We suggest adding to the end of this sentence '…of the information available in line with ethics committee requirements.'

Screening for potential disease

Number 15

We would like to see an additional piece added in after the first sentence:
Doctors have a special duty of care when inviting apparently healthy asymptomatic people to participate in an intervention that has not been initiated by the patient for the purposes of treatment or relief of symptoms.

We would also like to recommend a change to the second sentence as follows:

It is generally accepted that no screening test is 100% accurate. This means screening involves uncertainties, in particular, the risk of false positive and false negative results.

After the second dot point it would be helpful to add in a new dot point:

The significance of a positive result

For the purposes of clarity we recommend adding to the next dot point after the word predisposition: (eg. insurance policies)

Standards expected of doctors

Number 16

At the end of the third line we suggest adding in the word informed before decisions.

Number 17

In line 2 we suggest changing the word endeavour to take steps as this sounds more

proactive than endeavour.

In conclusion we would appreciate being kept informed of any further drafts and included in any further consultation on informed consent and ant other matters relating to the rights of patients/consumers.

	home		Women's Health Action Trust Patients' rights and ethics Submission on the current revised draft statement on informed consent
	Site search engine
	related Patients' rights & ethics links:[ethics committees] [patients' rights general][health records][Health Commissioner][Cartwright] [Cartwright followup][Direct-to-consumer advertising]
	Submission on the current revised draft statement on informed consent 19 June 2001 lntroduction Women's Health Action has a particular interest in the rights of consumers who use health services. We have had ongoing input into Medical Council documents relating to rights and professional accountability so are pleased to be able to now comment on the proposed revision to the statement on informed consent. We would like to commend the Medical Council for the efforts to keep pace with informed consent issues, and in particular to include the particular requirements for consent to screening. This provides an important message to doctors that we are very pleased to see. We have some suggestions of changes that we consider will further enhance the drait. These are listed in order of where they arise in the draft. Specific Comments on the draft Page 1 Introductory statement: Paragraph 1: Rather than endorsing the Code of Rights, which is a statutory obligation, we would like to suggest a change to the wording to read ‘The Medical Council of New Zealand's statement on informed consent is based on the Code of Health and Disability Services Consumers' Rights …' Paragraph 2: The Code of Rights is the position although there are varying interpretations and perspectives on how to apply the Code in practice. We therefore suggest the following change to the first sentence in this paragraph to say: This statement is an attempt to synthesis the different perspectives on informed consent currently… Background The following changes are suggested with the first paragraph in the section on background. 1. The Council affirms that trust is a vital element. It is our view that a successful doctor-patient relationship relies on a number of factors of which trust certainly has a key role. However, there are other elements that also need to be present. These include listening skills, sincere interest in the patient's wellbeing, as well as honesty and confidence in the doctor's practice and level of competency We also suggest the following change to the last sentence of this paragraph so the focus is on the recommended/required actions ofthe doctor, rather than the patient. *'The doctor needs to provide the patient with information about the potential risks and benefits of all proposed treatments.'* Page 2 Informed consent Number 6 We suggest inserting the word ongoing before opportunities so that there is a clear expectation that this matter will be revisited on an ongoing basis over time. Number 7 In order to be consistent with the Code of Rights there also needs to be a reference to the need for written consent where the treatment or procedure poses a significant risk of adverse effects to the consumer. When a patient is not competent to give informed consent It would be helpful if this section also includes a statement on emergency situations. Our suggestion is as follows: In emergencies the person is often not able to give consent and there may be no time to contact the next-of-kin or other designated person able to act on their behalf. In situations like this, the primary need is to treat the person. Where the ability to consent is absent or impaired, the treatment provided should be no more than that needed to treat the immediate emergency. Once the emergency is over, the person must be given information about the treatment they received and provided with the opportunity to consent to any further treatment that is recommended. Consent of Minors (pg 2-3) We would like to see an additional comment added to this section on children. Children's wishes about treatment options and recommended procedures should be sought and taken into account. The older the child the more involved they should be in the consent process. Page 3 Informed consent in relation to education and research We would like to see the word training included alongside references to teaching as some doctors make a distinction between teaching undergraduates and ongoing training of a postgraduate nature. Number 12 We would like to see the following sentence added to the start of number 12. - All research must be approved by an accredited ethics committee before patients are invited to participate and consent to their involvement in any innovative treatments or research activities. Number 14 We suggest adding to the end of this sentence '…of the information available in line with ethics committee requirements.' Screening for potential disease Number 15 We would like to see an additional piece added in after the first sentence: Doctors have a special duty of care when inviting apparently healthy asymptomatic people to participate in an intervention that has not been initiated by the patient for the purposes of treatment or relief of symptoms. We would also like to recommend a change to the second sentence as follows: It is generally accepted that no screening test is 100% accurate. This means screening involves uncertainties, in particular, the risk of false positive and false negative results. After the second dot point it would be helpful to add in a new dot point: The significance of a positive result For the purposes of clarity we recommend adding to the next dot point after the word predisposition: (eg. insurance policies) Standards expected of doctors Number 16 At the end of the third line we suggest adding in the word informed before decisions. Number 17 In line 2 we suggest changing the word endeavour to take steps as this sounds more proactive than endeavour. In conclusion we would appreciate being kept informed of any further drafts and included in any further consultation on informed consent and ant other matters relating to the rights of patients/consumers.