[Solution]Medical Research and consent

Consent and one special area: research   Required readings for this week are:   Notes for lectures 4 & 5 Textbook, Chapter 6, page 165…

Consent and one special area: research
Required readings for this week are:

Notes for lectures 4 & 5
Textbook, Chapter 6, page 165
Breen, Corner et al, Good Medical Practice: Professionalism, Ethics and Law (2010) Chapter 4, pages 49-57.
National Statement on Ethical Conduct in Human Research (2007)- just scan the contents of this document

These notes are very closely connected to your readings. Give the readings themselves priority and treat these notes as a summary. The lecture for this week will be on the Essendon FC events.
We have looked at excerpts from the Objects section of the CMT&PCA and studied that Act in some detail. The Actaims to support and extend an existing common law right to accept or reject proposed medical treatment. The common law right is expressed in the general principle found in Schloendorff (1914) (Notes and Textbook at 146) and accepted in numerous decided cases. That 96 year-old principleis conventionally used to show that patient self-determination is of primary significance and that consent is a required element in provision of treatment to competent adults.
You may wonder if that legal right expresses an ethical principle as well. It does. The principle is usually calledrespect for autonomy. Precisely what respecting autonomy entails may be debated because we may not immediately agree on what autonomy is:

Is it a psychological feature of people that is being respected (a capacity)? Or is it,


Just a presumption we make about how best to deal with people (they get cranky if their own decision-making capacity is ignored)?


And what is it to respect a principle anyway?


Are we even clear about what it is to respect a person?

Philosophical questions to one side, the primacy of the legalprinciple in discussions of consent is now a settled convention, so we can simply acknowledge it here.
Apart from anethical principle working to provide a reason to respect personal choices in health care there is a purely legal side (read: a purely self-interested or prudential reason) for compliance with the principle:
The purely legal reason for a doctor to obtain a patient’s consent to a medical procedure is to provide a defence to a criminal charge of assault and battery or to a civil claim for damages (from Re W (a Minor) (consent to medical treatment) [1992] 4 All ER 627, Lord Donaldson)).
In Australian law battery is unlawful touching or physical interference with another person (trespass to the person is an older expression for the same thing), and no hostile intent on the part of the person ‘touching’ is required to prove it. The crucial element is that no consent to physical contact was given by the recipient.
You will have noted that both the CMT&PCA (SA)and our common law source (Rogers v Whitaker (1992)) put great weight on obtaining valid consent where significant medical procedures are being contemplated. The creation of documentary evidence of the consent procedure is paramount.  It is also of importance where people consent to participation in clinical trials and social research studies (this distinction is explained later in these notes).
But what about situations were the treatment is not so significant or is seemingly trivial and routine?
Your text makes it clear that implied consent is often accepted as valid consent and there are clear examples given. However, caution is necessary here, as the case of Hart v Herron (1984) Aust Torts Reports 80-201 makes clear:
a man voluntarily admits himself to a psychiatric hospital. He then receives treatments that he was not aware of; these render him unconscious/incompetent and were not remotely what he had in mind when he did give explicit consent tobe treated
That case is notorious because the facts involved took place at the Chelmsford Private Hospital in NSW, a psychiatric facility where the so-called ‘deep-sleep therapy’ was used on patients. Hart’s case was one of the precipitators of a NSW Royal Commission (1990) into the treatment regimes at the Chelmsford Private Hospital.
See: http://chelmsfordhospital.blogspot.com.au/p/intro.html
You should also note that verbal dissent (the flip-side of consent) to certain elements of care canbe expressed by a patient prior to some medical procedures (remember that the CMT&PCA (SA) says, s 13(1)(c) the patient (if of or over 16 years of age) has not, to the best of the medical practitioner’s knowledge, refused to consent to the treatment.
But mere verbal refusal, in a situation where documentary forms of refusal are available, can be ineffective:
This matter was examined in a recent Victorian case,Qumsieh v Guardianship and Administration Board [1998] 146, where a blood transfusion was rejected in advance on religious grounds by a 20 year old woman, but nonetheless a state appointed guardian – her husband – approved its use when she was unconscious). (See text, 159 and 173)
The Victorian Court did not support the prior verbal expression of refusal by the woman. [Full details are in the textbook at 159]. For interest you should look at the textbook’s report on page 158 of a Canadian case, Malette v Shulman  (1990) 2 med LR 162, resting on slightly different facts and having a different outcome. (See text, 158, 171 and 173)
How informed must informed consent be? Both your textbook and the main case, Rogers v Whitaker (1992), make reference to the doctor or health professional’s duty to provide information about the possible risks of any proposed procedure. The High Court’s clarification here is in terms of the concept of material risk. That concept is explained in your text at page 139 via a citation from the case:
A risk is material if, in the circumstances of the particular case, a reasonable person if warned of the risks would be likely to attach significance to it or if the medical practitioner is or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it. (Rogers v Whittaker (1992) 175 CLR 479, 490)
There is a duty on health professionals to inform when the issue of material risk arises. As I mentioned in lectures 4&5, that was not always so and the standard in Rogers(1992) displaces a much older standard, the Bolam principle, that is explained as follows:
A doctor is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art…[it is not an objection if] there is a body of opinion that would take a contrary view.
Bolam v Friern Hospital Management Committee [1957] 1 WLR 582, 586 (McNairn J))
The Bolam principle was endorsed in a later case, Sidaway v Bethlehem Royal Hospital and Maudsley Board [1985] AC 871 where a patient was rendered paraplegic after undergoing a neurosurgical procedure to relieve chronic arm pain. He was not advised that this catastrophic outcome was a risk even though he did have a preoperative discussion with the surgeon.
Historically there was always broad scope given to what is called ‘therapeutic privilege’ (what we have discussed as discretion). The decision in Rogers (1992) has significantly reduced that scope to virtually nil if the issue is information to be conveyed to patients prior to elective procedures.
The new legal approach following from Rogers (1992) is also reflected in our civil liability legislation, Civil Liability Act 1936 (SA); note especially the relationship between the bolded parts:
41—Standard of care for professionals
(1)    A person who provides a professional service incurs no liability in negligence arising from the service if it is established that the provider acted in a manner that (at the time the service was provided) was widely accepted in Australia by members of the same profession as competent professional practice.
(2)    However, professional opinion cannot be relied on for the purposes of this section if the court considers that the opinion is irrational.
(3)    The fact that there are differing professional opinions widely accepted in Australia by members of the same profession does not prevent any one or more (or all) of those opinions being relied on for the purposes of this section.
(4)    Professional opinion does not have to be universally accepted to be considered widely accepted.
(5)    This section does not apply to liability arising in connection with the giving of (or the failure to give) a warning, advice or other information in respect of a risk of death of or injury associated with the provision of a health care service.
[Section 5 clearly implies that a case revolving around treatment procedures or surgical error would allow section 41(1)-(4) to come into play.]
For a considerable stretch of the 20th century two things were clear: first, that competent adult patients who faced a choice about treatment were free to accept or reject what was proposed; and second, the scope of medical professional discretion was very wide. For most of that century the discretion of medical professionals covered both what they thought people should know and what procedures should be chosen for use in treatments.
You can see that the question of what people should be told has been taken out of the domain of discretion but use of procedures is still a matter of standards evaluated by the profession.
Medical Research and consent
In the notes on the CMT&PCA (SA) I put a question to you about how the consent covered in that Act related to the consent that is usually very formally obtained from people who are approached to act as participants (‘subjects’ or ‘volunteers’ in some places) in medical research.
Most cases of medical procedures conducted for the purposes of research are the administration of experimental therapeutic drugs to populations of patients who are suffering from known illnesses thatthe experimental drugs have being designed to treat. Less commonly, but very significantly these days, the research trial involves drugs that have never before been tested in humans. These are Phase 1 first-in-human studies. The volunteers or participants need to be in very good health (commonly called ‘healthy volunteers’). Some research trials investigate medical devices and surgical procedures. And a lot of research is social and does not involve any clinical interventions at all.
Given the public importance of these research programs, and also the compelling financial reasons that bring pharmaceutical companies into the field, you may wonder why our state consent legislation is silent on this crucial matter.
Part of the reason is that the federal government takes the overall responsibility in this area. Its area of control extends to the protection of both human and non-human animals that are made subject toexperimentation. The Commonwealth agency charged with this responsibility is the Australian Health Ethics Committee (AHEC), a peak committee within the National Health and Medical Research Council. That latter body is created under the National Health and Medical Research Council Act 1992 (Cth).
From time to time AHEC publishes a set of guidelines covering human research: National Statement on Ethical Conduct in Human Research (2007 and updated in 2010).
Section 2 of the Statementrelates to consent for participation. The guidelines in the Statement are administered around the country by hundreds of Human Research Ethics Committees (HREC) many of which are found within hospital and university systems. The membership of these committees is governed by section 5.
Since medical research is conducted across the human lifespan -for the full range of medical conditions -from neonates to the elderly and the terminally ill, you will appreciate that the ethical evaluation of the consent procedures (both by individuals consenting for themselves and for consent via representatives like parents or guardians) is very complex. Hence the social task that is borne by these committees is quite onerous.
Because the governance of health related research on humans is federal (conducted under national guidelines that the Commonwealth promulgates) the state Act does not need to operate in this area. In particular you should notice that the stated age for consent to medical procedures in SA is 16, whereas for research the age is18 (that being the age of majority in all Australian jurisdictions; for example:
Age of Majority (Reduction) Act 1971 (SA): An Act to reduce the age of majority; to confer upon persons who have attained the age of eighteen years the juristic competence and capacity of full age and to confer and impose the attendant rights, privileges, responsibilities and obligations; and for other purposes
and following the definition of a child as under 18 in the Family Law Act 1975 (Cth):
Each parent has parental responsibility (subject to court orders)
(1) Each of the parents of a child who is not 18 has parental responsibility for the child.
Significantly, research is not an area where cases have been brought before courts for legal adjudication. This is quite surprising given the vast number of participants across the nation and the gravity of some of the procedures/drugs that are trialed.
In part the absence of cases might be explained by the fact that one avenue for compensation – for trial related injuries – is handled through Medicines Australia, the pharmaceutical industry peak body.
Social science researchthat is not based on drugs or surgical interventions is also under the umbrella of these HRECs. However, because the research methodologies used in social science research are variable and do not follow the principles of clinical controlled trials, the expertise you find in the committees that provide ethical review has a strong representation of social scientists. Here atUniversity the review of social science protocols is handled by the Social and Behavioural Research Ethics Committee).

Words or phrases that name important concepts
Respect for persons (a contested notion)
Oral consent
Implied consent
Written consent
Consent procedures for medical treatment
Consent procedures for research
The National Statement on Ethical Conduct in Human Research
A material risk
A widely accepted practice (clinical)
Advice or information in respect of a risk of death of or injury associated with the provision of a health care service.

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