Informed Consent in Palliative Care Clinical Trials: Challenging but Possible

Abstract

Obtaining informed consent is a key protection that should be afforded universally to people using health services and the basis around which any participation in clinical trials is built. Randomized controlled effectiveness studies are necessary to answer key questions in hospice and palliative care, in order to help systematically improve the quality of care. In order to be properly generalizable, such trials need to have broad inclusion criteria to reflect the population most likely to be affected by the condition. The inclusion of patients who are seriously ill, and therefore potentially vulnerable, requires careful exploration of ethical and legal principles that underpin informed consent. Specific challenges in obtaining informed consent for randomised clinical trials (RCTs) in clinically unstable populations such as hospice and palliative care include higher rates of people with impaired cognitive capacity as well as interventional studies in clinical situations which may present as a sudden change in condition. None of these challenges is unique to hospice and palliative care research, but the combination and frequency with which they are encountered require systematic and considered solutions. This article outlines five different ethically valid consent approaches and discusses their applicability to hospice and palliative care research trials. These include: consent by the patient (at the time of enrolment, in advance of the study, or delayed until after the study has commenced); a proxy (or legally authorised representative); or a consent waiver. Increased use of the less traditional modes of informed consent may lead to greater participation rates in hospice and palliative care trials, thereby improving the evidence base more rapidly in part by better reflecting the population served and hence improving generalizability.

Ethical difficulties in the innovative surgical treatment of patients with recurrent glioblastoma multiforme

“…Autonomy is the ethical and philosophical justification for both shared decision making and informed consent, and permits patients to have significant control over their treatment course. 1,55 Autonomy extends even to extreme cases. Ethicists have repeatedly reaffirmed the right of a patient to refuse treatment, even in cases when it will certainly cause her or his harm or death.…”

“…Informed consent is a fundamental principle of ethical clinical research that depends significantly on acknowledging the right of a patient to autonomy. 1,3,[5][6][7]9,30,34 When a patient undergoes an innovative surgical procedure, informed consent requires a higher standard than in the course of normal clinical care, due to the lower quality of evidence in favor of the intervention and the unique nature of experimentation in the surgical patient. 9 First, surgeons performing the innovative procedure must disclose to the patient the exact nature of the innovation, specifically stating that the strategy being used is not part of the standard treatment for the patient's disease.…”

“…Outcomes for patients with recurrent GBM remain poor, and many patients opt for palliative care over aggressive intervention at the time of recurrence. 1,26,45 Innovative treatment for GBM is desperately needed, and dozens of clinical trials around the world are investigating new treatment options for this disease. 21,22,27,29 Even with the most aggressive treatment possible in a patient diagnosed early with GBM, which includes some combination of neurosurgery, radiotherapy, and systemic chemotherapy, mean survival time is short and tumor recurrence almost always occurs.…”

Using social media in supportive and palliative care research: Table 1

“…Difficulties relating to supportive and palliative care research are well documented 1 2. The topic under investigation, namely the process of dying, is often considered to be the main challenge.…”

“…However, these strategies may be too time-consuming for healthcare professionals to adopt in the demanding day-to-day clinical practice. Agar et al 2 recently provided an overview of mechanisms to ensure that ethical principles are met when obtaining informed consent in palliative care research. Giving potential participants the choice to opt out rather than opt into the study, for both patients and healthcare professionals, has been used with success 7.…”