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Other aspects of consent

End of life decisions

When patients are seriously ill and lack the capacity to make medical decisions on their own behalf, clinicians are obliged to make treatment decisions in the patient’s best interests. This might include choosing not to intervene if a treatment or procedure would be burdensome and of little benefit to the patient.

The Medical Council advises: “There is no obligation on you to start or continue a treatment, or artificial nutrition and hydration, that is futile or disproportionately burdensome, even if such treatment may prolong life. You should carefully consider when to start and when to stop attempts to prolong life, while ensuring that patients receive appropriate pain management and relief from distress.”11 and “You must not participate in the deliberate killing of a patient by active means.”12
There is no obligation on you to start or continue a treatment, or artificial nutrition and hydration, that is futile or disproportionately burdensome, even if such treatment may prolong life

Perhaps the most vexed question is that of “do not resuscitate” (DNR) orders. The decision not to intervene in the event of a patient suffering a heart attack should not be taken lightly, or in isolation. Ideally, such decisions should be made in consultation with the healthcare team, the patient (if possible or advisable) and with the patient’s relatives and carers. The decision, and the reasons for it, should be clearly documented in the patient’s records.

There is currently no specific guidance on DNRs available in Ireland. Clinicians might also find the joint statement published by the British Medical Association, the Resuscitation Council (UK) and the Royal College of Nursing a useful resource in this regard (see the "Further Reading" section).

An advance treatment plan has the same ethical status as a decision by a patient at the actual time of an illness

Advance directives

An advance directive is a statement made by a competent adult in anticipation of a time in the future when he or she may lack the capacity to make healthcare decisions. Such statements usually take the form of advance refusal of specified treatments, but may also contain information about the patient’s values and beliefs.

At present there is no legislation covering advance directives in Ireland and there is very little relevant Irish case law to clarify their legal status, but a discussion document published by the Medical Council states, in its 2009 Professional Conduct and Ethics Guide, “An advance treatment plan has the same ethical status as a decision by a patient at the actual time of an illness and should be respected on condition that:

  1. the decision was an informed choice, according to the principles of informed consent in paragraph 33
  2. the decision covers the situation that has arisen, and
  3. the patient has not changed their mind.”13

A case heard in the Supreme Court in 199614 has some relevance here. Though it did not feature an advance directive, the justices set out the ethical, constitutional and legal considerations regarding end of life decisions, and their deliberations indicate that the courts would give considerable weight to advance directives that met the above criteria. (See Appendix 1 for a summary of the case.)

If there is any doubt about the validity or applicability of an advance decision, the patient should be provided with care to secure his/her best interests while the issue is resolved, if necessary by reference to the courts.

Clinical trials and research

The Control of Clinical Trials Act 1987 makes it an offence to include a person in a clinical trial without his or her valid consent, given voluntarily in light of the information set out in Box 8. The consent must be in writing and signed by the participant.

Where alleviating a patient’s illness is an objective of the trial, and the patient has the capacity to consent but is unable to sign, the consent must be obtained by the doctor who is treating his or her condition in the presence of two witnesses, who must then sign a written expression of the patient’s consent.15

If a patient is not capable of giving consent, written consent must be obtained from “a person or persons, independent of the person who applied to undertake or is conducting the trial, who in the opinion of the ethics committee is or are competent to give a decision on such a participation”.16

Participants’ written consent must also be obtained before including them in other forms of research, and the same requirements regarding informed consent apply. If a potential research participant lacks the capacity to consent, “Parental or guardian’s consent must be sought, but such consent can only be accepted where the research in question is clearly in the best interests of the subject concerned, or where the research concerned carries minimal risk or impact on the subject concerned”.17

Participants in clinical trials and other research should be told that they have the right to withdraw from the research at any time without penalty. A patient’s care should not be compromised in any way by his or her refusal to participate in research.

The consent should also be sought in a context where it can be freely given without any sense on the patient’s part that refusal would carry a penalty, whether real or implied, in relation to treatment

Box 8: What patients should know before agreeing to participate in clinical trials

a. the objectives of the trial
b. the manner in which the substance or preparation is to be administered
c. the risks and any discomfort involved in, and the possible side effects of, the trial
d. whether or not a pharmacologically inactive substance or preparation is to be administered to some persons in respect of each of whom a consent has been given to being a participant in the trial.

Control of Clinical Trials Act (1987), section 9(3)

Regarding consent to the collection, use and storage of personal information, the Data Protection Commissioner has issued the following guidance: “The key issue is respect for the patient’s reasonable expectation that their health information will be kept confidential and not used or disclosed without their consent other than to those directly involved in patient care and directly related activity.

“In the absence of a specific legal basis to underpin the processing of personal health data for research or clinical audit purposes, consent needs to be part of the process in order to meet the legal obligations as set out in the Data Protection Acts.

"Capturing an explicit and informed patient consent for further processing of a person’s data for research purposes at the first opportune point a person presents to the health services and thereafter as necessary, is advocated as the optimal way forward both from a data protection and efficiency perspective. Such an approach should be systematically built into health facility procedures so that the patient fully understands what further use is planned for their personal information and the safeguards that will be put in place.

"The patient should be given an opportunity to explicitly grant or deny consent for such use. The consent should also be sought in a context where it can be freely given without any sense on the patient’s part that refusal would carry a penalty, whether real or implied, in relation to treatment.”

Data Protection Commissioner, Data Protection Guidelines on Research in the Health Sector, section 4.