Chapter 4.4: People highly dependent on medical care who may be unable to give consent. National Statement on Ethical Conduct in Human Research (2007) - Updated 2018

Introduction – Chapter 4.4

Medical care increasingly offers interventions or treatment for people at times of serious risk to their life or wellbeing. These risks may be temporary or permanent. People can become highly dependent on those interventions and treatments and may be incapable of comprehending their situation or of communicating about it. At the same time, research on those interventions and treatments is necessary to assess and improve their efficacy.

This chapter describes conditions under which research involving people highly dependent on medical care might proceed although their capacity to give consent is limited or non-existent.

In every instance, relevant jurisdictional laws will need to be taken into account.

Significant ethical issues are raised by research conducted in the following settings:

  • neonatal intensive care
  • terminal care
  • emergency care
  • intensive care
  • the care of unconscious people.

Research to which this chapter applies must be reviewed and approved by a Human Research Ethics Committee (HREC) rather than by one of the other processes of ethical review described in paragraphs 5.1.7 and 5.1.8, except where that research uses collections of non-identifiable data and involves negligible risk, and may therefore be exempted from ethical review.

Values, principles and themes that must inform the design, ethical review and conduct of all human research are set out in Sections 1 and 2 of this National Statement. The guidelines and headings below show how those values, principles and themes apply specifically in research that is the subject of this chapter.

Guidelines – Chapter 4.4

Research merit and integrity

4.4.1 Research involving people who are highly dependent on medical care may be approved where:

  1. (a) it is likely that the research will lead to increased understanding about, or improvements in, the care of this population
  2. (b) the requirements of relevant jurisdictional laws are taken into account
  3. (c) either
    1. (i) any risk or burden of the proposed research to this particular participant is justified by the potential benefits to him or her, or
    2. (ii) where participants have capacity to consent, any risk or burden is acceptable to them and justified by the potential benefits of the research.


4.4.2 People highly dependent on medical care may be exposed to severe threats to their lives, so that recruiting them into research might seem unfair. However, those people are entitled to participate in research and, when the conditions of paragraph 4.4.1 are met, their involvement is not unfair.


4.4.3 The distinguishing features of neonatal intensive care research are the small size and unique developmental vulnerability of the participants and the potential for very long-range impact on their growth, development and health. In this research, risks and potential benefits should be assessed with particular care by individuals or groups with relevant expertise.

4.4.4 The distinguishing features of terminal care research are the short remaining life expectancy of participants and their vulnerability to unrealistic expectations of benefits. Terminal care research should be designed so that:

  1. (a) the benefits of research to individual participants or groups of participants, or to others in the same circumstances, justify any burden, discomfort or inconvenience to the participants
  2. (b) the prospect of benefit from research participation is not exaggerated
  3. (c) the needs and wishes of participants to spend time as they choose, particularly with family members, are respected
  4. (d) the entitlement of those receiving palliative care to participate is recognised.


4.4.5 People involved in research to which this chapter applies may have impaired capacity for verbal or written communication. Provision should be made for them to receive information, and to express their wishes, in other ways.

4.4.6 In emergency care research, recruitment into a research project often has to be achieved rapidly. Where the research involves emergency treatment and meets the requirements of 4.4.1, consent for the research may be waived provided the conditions of paragraph 2.3.10 are satisfied.

4.4.7 In intensive care research, heavy sedation may impair participants' cognition, and communication is difficult with people receiving ventilatory assistance. Whenever possible, consent to intensive care research, based on adequate information, should be sought from or on behalf of potential participants before admission to that level of treatment. When prior consent to research is not possible, the process described in paragraphs 4.4.9 to 4.4.14 should be followed.

4.4.8 In research with unconscious people, the participants cannot be informed about the research and their wishes cannot be determined. Those who are unconscious should be included only in minimally invasive research, or in research designed both to be therapeutic for them and to improve treatment for the condition from which they suffer.

Process to be followed

4.4.9 Consent should be sought from people highly dependent on medical care wherever they are capable of giving consent and it is practicable to approach them.

4.4.10 Where it is not practicable to approach a person highly dependent on medical care, or the person is not capable of making such a decision, consent should be sought from the participant's guardian, or person or organisation authorised by law, except under the circumstances described in paragraph 4.4.13.

4.4.11 When consent is to be sought, either from the potential participant or another on his or her behalf, steps should be taken to minimise the risk that:

  1. (a) stress or emotional factors may impair the person's understanding of the research or the decision to participate
  2. (b) the dependency of potential participants and their relatives on the medical personnel providing treatment may compromise the freedom of a decision to participate.

4.4.12 Where the researcher is also the treating health professional, it should be considered whether an independent person should make the initial approach and/or seek consent from potential participants or from others on their behalf.

4.4.13 When neither the potential participant nor another on his or her behalf can consider the proposal and give consent, an HREC may, having taken account of relevant jurisdictional laws, approve a research project without prior consent if:

  1. (a) there is no reason to believe that, were the participant or the participant's representative to be informed of the proposal, he or she would be unwilling to consent
  2. (b) the risks of harm to individuals, families or groups linked to the participant, or to their financial or social interests, are minimised
  3. (c) the project is not controversial and does not involve significant moral or cultural sensitivities in the community
  4. and, where the research is interventional, only if in addition:
  5. (d) the research supports a reasonable possibility of benefit over standard care
  6. (e) any risk or burden of the intervention to the participant is justified by its potential benefits to him or her
  7. (f) inclusion in the research project is not contrary to the interests of the participant.

4.4.14 As soon as reasonably possible, the participant and/or the participant's relatives and authorised representative should be informed of the participant's inclusion in the research and of the option to withdraw from it without any reduction in quality of care.

Authors of this National Statement

This National Statement has been jointly developed by the National Health and Medical Research Council (NHMRC), the Australian Research Council (ARC) and Universities Australia (UA). This joint undertaking reflects a widely shared conviction that there is a need for ethical guidelines that are genuinely applicable to all human research and it gives expression to the shared responsibility for ethically good research described above.

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