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Statement on Palliative Care Research

Approved by the AAHPM Board of Directors on November 4, 2014*

Background

Many palliative care decisions and interventions lack sufficient evidence to either recommend or not recommend. Much remains to be learned that could improve care of these patients, and further research in this field is needed. Debate exists about whether patients with serious illness should be asked to participate in research. Some clinicians, Institutional Review Boards (IRBs), ethics committees, and investigators remain uncertain about the ethical limits of research involving such patients and their families. IRBs have had limited guidance in reviewing palliative care protocols, and often their decisions vary widely. The principles of research ethics applies to all research including palliative care research. The purpose of this document is to offer additional considerations to research on this potentially vulnerable patient population.

Statement

  • Patients who receive palliative care should be considered for participation in clinical studies. Patients regardless of where they are in their disease trajectory (impending death, difficult treatment regimens, complex diagnosis, etc.) should not be excluded from participation in clinical research.
  • Research should be conducted with the informed consent of the patient if possible or surrogate decision maker. The choice to participate should always be voluntary.
  • Uncertainty often exists around a serious or life-threatening illness. Researchers need to be sensitive to the patient situation, and should confer with the clinicians involved in the patient's care. Informed consent in this patient population may be a process rather than a one-time discussion as patient or study circumstances may change during the conduction of the research.
  • Care should be taken to protect all patients and family and especially the emotionally vulnerable from therapeutic  misconception (denial of the possibility of disadvantages of participation in clinical research related to the nature of the research process). Honesty about the benefits and burdens of participation in the study should be conveyed and understood by the patient.
  • Mechanisms should be in place to refer research participants as needed (social services, clergy, bereavement specialists).
  • Ideally a palliative component should be included in clinical trials with patients whose diseases meet criteria for palliative medicine (i.e. stage 4 cancer trials, COPD, ESLD, etc.) with a focus of the research on patient centered outcome measures.
  • If the researcher is the clinician for the patient, non-abandonment should be attached to the protocol. Continuity of care should be provided to these patients should they decide to withdraw from the research investigation.

Bibliography

Appelbaum PS, Lidz CW. Twenty-five Years of Therapeutic Misconception. Hastings Cent Rep 2008; 38:5-6.

Agrawal M, Danis M. End-of-life Care for the Terminally Ill Participants in Clinical Research. J Pall Med 2002; 5: 729-738.

Kleiderman E, Avard D, Black L, Diaz Z, Rousseau C, Knoppers BM. Recruiting Terminally Ill Patients into Non-Therapeutic Oncology Studies: Views of Health Professional. BMC Med Ethics 2012; 13:33.

LeBlanc TW, Wheeler JL, Abernathy AP. Research in End-of-Life Settings: An Ethical Inquiry. J Pain Pall Care Pharmaco 2010; 24: 244-250.

"Ethics in Clinical Research." NIH Clinical Center: Ethics in Clinical Research. Web. Retrieved 30 January 2014. http://clinicalcenter.nih.gov/recruit/ethics.html

Schuklenk U, Lowry C. Terminal Illness and Access to Phase 1 Experimental Agents, Surgeries and Devices: Reviewing the Ethical Arguments. Brit Med Bull 2008; 89:7-22.

Wiegand DL, Norton SA, Baggs JG. Challenges in Conducting End-of-Life Research in Critical Care. AACN 2008; 19:170-177.

World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. JAMA 2013;
310:2191-2194.

http://clinicalcenter.nih.gov/recruit/ethics.html

*Replaces 2007 Palliative Care Research Ethics Joint Position Statement

Read other AAHPM position statements.