National Statement on Ethical
Conduct in Research Involving Humans
Part 6 - Research Involving Persons Highly Dependent on Medical Care
Emergency care research
Intensive care research
Neonatal intensive care research
Terminal care research
Research involving persons with impaired capacity for
communication
Research involving unconscious persons
Human Research Ethics Committee consideration of research
proposals involving persons highly dependent on medical care
The involvement in research of people who are highly dependent on medical care raises ethical issues that deserve special attention. The gravity of their medical condition may require more invasive measures carrying increased risk. For those carrying out such research, there is a need to acknowledge that the giving of free and informed consent can be compromised by the effect of the medical condition on the person's capacity to form and express an opinion or to communicate. Additionally, there may be a perception of coercion if a person is reluctant to refuse consent in fear that it may compromise his or her medical treatment. Researchers may also need to consider whether an unfair burden of participation [see paragraph 1.5] is being imposed on such groups as are referred to below.
Each type of research raises significant ethical concerns.
6.1 The distinguishing feature of emergency care research is that consent for entry into a project usually has to be obtained rapidly, when the vulnerability of patients and families is likely to be greatest. Moreover, the circumstances surrounding emergency care research are such that it may not always be possible to obtain consent for inclusion from either the patient or next of kin without delaying the initiation of treatment, and so risking a reduction of potential benefits.
6.2 The distinguishing features of intensive care research are the difficulty in communicating with patients receiving ventilatory assistance and the impairment of cognition in heavily sedated individuals.
6.3 Whenever possible, information about and consent to intensive care research should be given to and sought from potential participants before admission to that care.
Neonatal intensive care research
6.4 Research involving infants receiving neonatal intensive care should only be conducted in accordance with the principles in 4. Research Involving Children and Young People. Those principles do not permit research that is contrary to the child's best interests.
6.5 The very small size and vulnerability to harm of some infants is a unique feature of this research which renders all but minimal intrusion likely to be contrary to the child's best interests. The collection of even small blood samples additional to those required for diagnostic purposes or handling of a low birth weight infant to make observations will demand careful scrutiny.
6.6 Research in terminal care is distinguished by the short remaining life expectancy of participants and their potential vulnerability to unrealistic expectations of benefits.
Researchers must take care that the prospect of benefit from research participation is neither exaggerated nor used to justify a higher risk than that involved in the patient's current treatment.
Researchers must respect the needs and wishes of participants to spend time as they choose, particularly with family members.
Research involving persons with impaired capacity for communication
6.7 The distinguishing features of research involving persons with impaired capacity for communication include situations where the impairment is an acute state requiring dependence on medical care as well as non-acute states. In the former, the condition and medical care can mask their degree of cognition and require different means to express known wishes. In the latter, the condition may be such as to prevent the person expressing wishes.
Research involving unconscious persons
6.8 The distinguishing feature of research with unconscious persons is that, due to their incapacity for cognition or communication, it is impossible
for them to be informed about the research or to determine their wishes about it. Consent for participation in research by an unconscious person must be given by others, including relevant statutory authorities, on that person's behalf. Because of their extreme vulnerability such persons should be excluded from all but the most minimally invasive observational research.
Human Research Ethics Committee consideration of research proposals involving persons highly dependent on medical care
6.9 When the nature of the research procedure is such that conformity to the principle of consent [see paragraph 1.7] is not feasible, and neither the individual nor the individual's representative can consider the proposal and give consent in advance, a Human Research Ethics Committee (HREC) may approve a research project without prior consent provided it is satisfied that:
(a) inclusion in the research project is not contrary to the interests of the patient; and
(b) the research is intended to be therapeutic and the research intervention poses no more of a risk than that which is inherent in the patient's condition and alternative methods of treatment; and
(c) the research is based on valid scientific hypotheses which support a reasonable possibility of benefit over standard care; and
(d) as soon as reasonably possible, the patient and/or the patient's relatives or legal representatives will be informed of the patient's inclusion in the research and of the option to withdraw from the research without any reduction in quality of care.
6.10 In the case of research proposals in which it is practicable to approach the patient and/or the patient's relative or legal representative to obtain consent before inclusion in the research, an HREC should also be satisfied that:
(a) adequate provision will be made for informing patients and their relatives about the research to ensure that stress or other emotional factors do not impair their understanding of it; and
(b) the dependency of patients and their relatives on the medical personnel providing treatment does not affect any decision to participate.
[ ^ to top ] [Table of Contents]
[Preamble] [Part 1] [Part 2] [Part 3] [Part 4] [Part 5] [Part 6]
[Part 7] [Part 8] [Part 9] [Part 10] [Part 11] [Part 12] [Part 13]
[Part 14] [Part 15] [Part 16] [Part 17] [Part 18] [Part 19]
[Appendix 1] [Appendix 2] [Appendix 3]