Position Statements

Statement on Palliative Care Research Ethics

Approved by the Board of Directors
February 14, 2007
(replaces 2002 Statement on the Ethics of Palliative Care Research)

Since adequate evidence does not exist for many palliative care decisions and interventions, and much remains to be learned that could improve care, further research in this field is needed. However, debate exists about whether patients near the end of life should ever be asked to participate in research. Consequently, some clinicians, Institutional Review Boards (IRBs), ethics committees, and investigators remain uncertain about the ethical limits of research involving dying patients and their families. In addition, because IRBs have limited guidance in reviewing palliative care protocols, and because their members may have had little experience with this population, their review decisions vary widely.

AAHPM believes there is an urgent need for further palliative care research that will a) increase overall knowledge in the field; b) provide evidence to define the standard of care and c) increase access to high quality care. The ethical mandate to protect vulnerable patients must be addressed by attention to 8 elements of the design and conduct of palliative care research. These elements are not unique to palliative care research, but they deserve emphasis because of the unique vulnerability of this patient population.

1. Study design: Study questions must be important and well-defined. Studies must be methodologically sound and properly designed to answer the question(s) posed.


2. Use of placebos: All subjects in a clinical trial should have access to the best available standard of care. A placebo alone should never be used in comparison to a treatment with known efficacy. A placebo control arm may be ethically acceptable if either: 1) subjects receive a placebo in addition to the standard of care; or, 2) the symptom under study has no effective treatment. Negative research endpoints (e.g. failure of a treatment arm whether placebo or not) should be clearly defined and adhered to.


3. Minimization of incremental risks: Investigators should always attempt to minimize a study's incremental risks. Incremental risk is the amount of additional risk due to study participation above and beyond the known risks of standard treatment.


4. Minimization of burdens: Due to the frequency of malaise, energy limitations, and potentially limited life span, investigators should justify the importance of each survey, interview, and/or study visit. Investigators should also minimize the burdens that a study creates for caregiving friends and family members as well as patients.


5. Minimization of distress: The risks of causing distress, especially in interview studies, are very small, and may be balanced by the benefits that subjects receive (e.g. from the opportunity to talk about difficult issues). Limited research indicates that the risk of self-reported distress from participation in palliative care research is usually small, though there is wide variation among studies, primarily related to subject characteristics. Survey questions ought to be worded sensitively to further minimize any risk of causing distress.


6. Decision-making capacity: Patients who consent to participate in research should have adequate decision-making capacity. This includes subjects' ability to understand relevant information, appreciate the significance of that information, and reason through to a conclusion that makes sense for them. Strategies to evaluate decision-making capacity should account for the prevalence of cognitive impairment in the study population and balance risks and benefits a study offers.


7. Surrogate consent: If a patient is a child or lacks the capacity to give consent, a legally authorized representative may give consent for research. Federal guidelines governing research involving children suggest that surrogate decision makers should be allowed to consent to research just as they are allowed to consent to medical therapy. If a patient is able to participate in decisions but does not have adequate decisional capacity to independently consent to research, investigators should obtain assent from the patient and informed consent from the patient's surrogate. This "dual consent" ensures that patients are as involved in the decision as possible, yet provides the additional protection of a surrogate's consent. Investigators should be aware of state laws which may restrict surrogate consent for research in certain circumstances.


8. Voluntary Consent: A choice is voluntary if it is made without significant controlling influences. Assurance of voluntariness can be strengthened by recruiting subjects from an environment with excellent standards of palliative care and by paying careful attention to the consent process.

The field of palliative care depends upon rigorous research to guide clinical care. Subjects can be protected and research can proceed by ensuring optimal study design, by minimizing risks, burdens, and distress of these vulnerable patients and their families, by ensuring a careful informed consent process, and by recruiting subjects from an environment with excellent standards of palliative care.

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