Content
Please note:
The Human Research Ethics Handbook – Commentary on the National Statement on Ethical Conduct in Research Involving Humans has been revoked. This information is kept here for archival purposes only. For the current guidelines, Human Research Ethics Committees should refer to the National Statement on Ethical Conduct in Human Research 2007.
Consent
Legal requirements concerning consent
It is a legal requirement that medical procedures must not be undertaken without the consent of those involved, or without other lawful justification, such as an emergency. Under the law of battery, sometimes called trespass, any physical contact with a person, however slight, without his or her consent, or other lawful justification, may give rise to a legal claim for compensation. Each individual who initiates, directs or engages in research that involves touching a person is responsible, under the law of battery, for ascertaining that the person has consented to the procedure.
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Information required for consent to be effective
[NS 1.7]
A person's consent is legally effective if that person is informed in broad terms of the nature of the intended procedure and then gives consent. The procedure is then not a battery even if the person does not fully understand what is involved [Footnote 11] unless there has been misrepresentation or fraud, which may vitiate the consent. Although medical practitioners also have an obligation to provide additional information about a proposed procedure before the participant agrees to it, such as information about potential risks and side effects (see below), failure to provide that information does not make the consent ineffective. [Footnote 12]
One example of a guide to this decision appears in the NHMRC's General Guidelines for Medical Practitioners on Providing Information to Patients [Footnote 13]. This guide was written for clinical and not research contexts.
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Competence to GIVE consent
[NS 1.7]
A person is competent in law if he or she is:
- an adult or a 'mature minor' within the Gillick test (see 'Children' above); and
- able to understand what the procedure involves and to consent to it.
There is little Australian law on the determination of competence. However, some recent English cases and law reform statements give some guidance. In Re C, [Footnote 14] the Court noted three stages in the decision-making process: first, comprehending and retaining treatment information; secondly, believing it; and thirdly, weighing it in the balance to arrive at a choice. The Law Commission of England and Wales proposed a similar approach. [Footnote 15] The Commission suggested that a person lacks capacity, that is, is incompetent, if he or she is:
- unable to understand or retain the information relevant to the decision, including information about the reasonably foreseeable consequences of deciding one way or another or failing to make the decision; or
- unable to make a decision based on that information. [Footnote 16]
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Free and voluntary choice
A free and voluntary choice denotes that there was no coercion or fraud in obtaining consent. The Nuremberg Code [Footnote 17] http://ohsr.od.nih.gov/nuremberg.php3 requires that a research participant be able to exercise 'free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion.' [Footnote 18] And: 'If information is withheld in bad faith, the consent will be vitiated by fraud.' [Footnote 19] Note, however, that in Australian law, consent will be invalidated only where a person is not provided with information about the nature and purposes of what is proposed. [Footnote 20]
Examples of fraud or deceit invalidating consent are rare. Consent will be ineffective where it has been obtained as a result of some actual or threatened physical violence or deliberate and fraudulent withholding of information. [Footnote 21] Where a person initially refused a procedure but later, after being questioned by a physician while affected by pre-operative medication, reluctantly agreed, the consent was held not to have been legally effective. [Footnote 22] Beyond these clear examples, legal principle gives way to ethical conduct. While law may render consent ineffective when it is extracted under pressure or fear, ethical assessment will question the reliability of consent affected by lesser influences.
Some other legal contexts offer possible sources of relevant principle. In contract law, the incompetence of a person to contract will only have consequences where that incompetence is known to the other party to the contract. Law offers a remedy where advantage has knowingly been taken of the less competent party. The remedy is usually release from the contract, but can include compensation for loss that has resulted from performing contractual duties. It is said that developments in contract law in Australia have shown an increasing reliance on principles permitting release from contractual obligations where insistence upon performance by one party would, in the light of their knowledge of all the circumstances, be unconscionable. [Footnote 23]
The essence of these developments lies in the recognition that relief should be available to a person in order to prevent loss from the performance of a contract where that person is, to the knowledge of the other contracting party, in a disadvantageous position, or suffering from a disability of which the other party takes advantage. [Footnote 24] The relationship between researchers and research participants can be likened to one of contract, although the participant's freedom to withdraw would be an unusual term. This relationship often involves very similar imbalances of knowledge and ability to those that have been the basis for release from contractual obligations. A researcher's sensitivity to those imbalances, and to the need to act so that advantage is not taken of those less able, particularly for the purpose of recruitment as research participants, would reflect these emerging legal principles.
In some particular relationships, one party is in such a position to influence the other that the exercise of undue influence is presumed. Therefore, for a contract between such parties to be legally effective, the dominant party must prove that that influence was not exercised. These can be fiduciary relationships, [Footnote 25] such as those between guardian and ward, but can also arise in specific situations of dependence. Although the High Court of Australia has held that the relationship between medical practitioner and patient is not a fiduciary one, [Footnote 26] it was acknowledged that medical practitioners may have certain fiduciary obligations towards their patients, such as a duty not to benefit unfairly from the 'unequal' relationship between them.
Where the relationship between a researcher and participant involves the possibility of such a degree of influence being exercised by the researcher, similar considerations about the exercise of undue influence could lead to doubt as to whether the participant's consent was voluntary. The principles in contract law permit relief from an otherwise binding commitment, thereby protecting the less powerful party from harm resulting from the undue exercise of influence by the other. It is possible that the circumstances of some researcher and participant relationships involve a degree of influence that not only induces participants to enrol in a project, but also to remain when they would otherwise prefer to withdraw from the study. Where continued enjoyment of essential benefits or services is understood by recipients to be dependent on continued participation in a research project, participants may choose not to withdraw even though they find continued involvement is burdensome, stressful or otherwise harmful. In the light of these principles, it could be argued that participation procured as the result of such influence is not voluntary.
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Information
Information about 'risks, inconveniences and discomforts of research'
Although a valid consent can be obtained if a participant understands in broad terms what is proposed in a research procedure, researchers also have a legal duty to take reasonable care in providing other information to participants so they can make an informed choice about whether to take part. This includes information about potential risks and side effects. A person who is not given sufficient information of this type and agrees to a procedure to which he or she would not have agreed if adequately informed, may be able to sue in negligence if he or she suffers injury or loss as a result of the procedure, even if there is no negligence in its actual performance.
The general test for the information that must be given before a procedure is carried out was described by the High Court of Australia in Rogers v. Whitaker. [Footnote 27] The court said that it is part of a medical practitioner's duty of care to inform a patient of a 'material' risk inherent in any proposed treatment. A risk is material if 'in the circumstances of the particular case, a reasonable person in the patient's position, if warned of the risk, 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.' [Footnote 28]
In determining what is a 'material' risk for the purpose of the test in Rogers v Whitaker, a court would almost certainly require a higher standard of disclosure for research than that needed for therapeutic procedures. The reason is that a reasonable person would be more likely to attach significance to risks if the procedure is not being undertaken for that person's own benefit, but, rather, to benefit someone else. This is borne out by the decision of a Canadian provincial court in an action brought by a participant who was injured while taking part in a research project to test a new anaesthetic. Finding for the plaintiff, the court said that the duty to disclose risks was 'at least as great as, if not greater than' the duty where therapy was being considered. The court continued:
There can be no exceptions to the ordinary requirements of disclosure in the case of research as there may well be in ordinary medical practice. The researcher does not have to balance the probable effect of lack of treatment against the risk involved in the treatment itself. The example of risks being properly hidden from a patient when it is important that he (sic) should not worry can have no application in the field of research. The subject of medical experimentation is entitled to a full and frank disclosure of all the facts, probabilities and opinions which a reasonable man (sic) might be expected to consider before giving his (sic) consent. [Footnote 29]
This statement rejects absolutely any reliance in experimental procedures on what the High Court in Rogers v Whitaker [Footnote 30] referred to as 'therapeutic privilege', that is, the medical practitioner's limited discretion to withhold information in the patient's interests.
However, these judicial statements do not provide a simple answer to the practical question: what must be disclosed? Some guidance is given by the NHMRC's General Guidelines for Medical Practitioners on Providing Information to Patients. [Footnote 31]
More specific advice about information disclosure in the research context is given by the United States Federal Regulations made pursuant to the National Research Service Award Act 1974. [Footnote 32] This legislation was intended to apply to all types of research involving humans, whether medical or otherwise. Although not binding in Australian law, it offers a useful guide to information disclosure that would, in all likelihood, fulfil the less specific Australian standards.
The United States Federal Regulations state that information given to a prospective research participant should be in language understandable by the participant. There is an absolute prohibition on 'any exculpatory language through which the subject is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.' [Footnote 33]
The Regulations list the following as those matters to be disclosed to participants:
- a statement that the study involves research, an explanation of the purposes of the research, the expected duration of the participant's involvement, a description of the procedures to be followed and identification of any procedures that are experimental;
- a description of any reasonably foreseeable risks or discomforts to the participant;
- a description of any benefits to the participant, or to others, which may reasonably be expected from the research;
- a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant;
- a statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained;
- for research involving more than minimal risk: an explanation as to whether any compensation and any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
- an explanation of whom to contact for answers to pertinent questions about the research and the research participant's rights, and who to contact in the event of a research related injury to the participant; and
- a statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and that the participant may discontinue involvement at any time without penalty or loss of benefits to which the participant is otherwise entitled.
When it is appropriate, additional matters are to be disclosed. These are:
- a statement that the particular treatment or procedure may involve risks to the participant, or to the embryo or fetus if the participant is or may become pregnant, which are currently unforeseeable;
- anticipated circumstances under which the participant's involvement may be terminated by the researcher without regard to the participant's consent;
- any additional costs to the participant that may result from involvement in the research;
- the consequences of a participant's decision to withdraw from the research and the procedures for orderly termination of involvement by the participant;
- provision of a statement to the participant advising that they will be notified of any significant new findings which develop during the course of the research and which may relate to the participant's willingness to continue their involvement in the project; and
- the approximate number of participants involved in the study.
Insofar as this type of information is legally required to be given, this is on the basis that an ordinary person in the position of a potential participant in a research project would be likely to attach significance to it: the test in Rogers v Whitaker (above).
There are also other matters that HRECs may consider should be included in the information provided to participants in relation to particular research projects. For example:
- the means of protecting confidentiality and intellectual property;
- whether insurance protection will be provided; and
- if there is a possibility of confessions of illegal activity or reportable conduct, whether researchers may be mandated to disclose this to the relevant authorities.
Again, these matters should be discussed if an ordinary person would be likely to attach significance to them.
Comprehension
The Nuremberg Code http://ohsr.od.nih.gov/nuremberg.php3 makes express reference to the need for comprehension of disclosed information. [Footnote 34] Somewhat less specific reference appears in the National Statement, while the United States Federal Regulations require only that the information be disclosed in language 'understandable' to the participant. [Footnote 35] The law is probably similar, requiring that information must be disclosed in an appropriate manner and form, rather than that it must be understood. The High Court of Australia, for example, said in Rogers v. Whitaker that no special medical skill is involved in disclosing information, but: 'Rather, the skill is in communicating the relevant information to the patient in terms which are reasonably adequate for the purpose, having regard to the patient's apprehended capacity to understand that information'. [Footnote 36]
The law's preference for standards that depend on an objective test is understandable. It is much easier to establish whether information was disclosed than whether it was understood. Also, in negligence, the focus is upon the medical practitioner's duty to take care, rather than the patient's level of understanding.
Consent for the collection of information
There are specific legislative provisions that require consent to be obtained before personal information is collected. The Privacy Act 1988 (Cth) [Footnote 37] requires federal agencies collecting personal information about people to obtain consent before the information is collected, stored, used or disclosed. Information Privacy Principles 10 and 11 in the Act deal respectively with use of collected personal information for a purpose other than that for which it was collected and disclosure of such information. In both principles the consent of the person to whom the information relates is sufficient to authorise disclosure, though there are circumstances in which information may be used or disclosed even without consent, for example, to protect third parties.
The Privacy Act does not define the requirements for consent, the standard of information to be provided before consent is sought, or the criteria for determining competence. These are left to the common law.
See also:
' Intellectual or mental impairment, consent and ' in this resource, page L39
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Handbook TOC
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Abbreviations
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Commentary on the National Statement
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A Research Ethics Collection
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A Research Law Collection
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Bibliography
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Appendices
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