EXECUTIVE SUMMARY
Research on critically ill, dying ICU patients is ethically feasible, found a recent study which achieved a 95% consent rate for approached families. Some ethical considerations include the following:
- Patients and family members may lack decision-making capacity due to illness or extreme stress.
- Avoiding research on this patient population means patients and families cannot benefit from attempts to improve care.
- Researchers must consider how to approach patients regaining decisional capacity during the study.
When a group of researchers first proposed to study dying patients during the process of withdrawal of life-sustaining therapies and after death, they met with a fair amount of resistance.
“Initially, there was some hesitation and discomfort from the intensive care research community,” reports Amanda van Beinum, MSc, a researcher at Canada’s Children’s Hospital of Eastern Ontario.
Many experienced researchers thought that the design of the Determination of Death Practices in Intensive Care Units study might not be acceptable to research ethics boards, ICU staff, or families of dying patients.
Regardless, the pilot study went forward, with a requirement that written consent be obtained from families prospectively. It was approved by institutional review boards at all five participating sites, with minimal requested revisions to consent forms.
“That it achieved a 95% consent rate for approached families was, indeed, surprising to many in the critical care research community,” says van Beinum, lead author of a paper about the study’s experiences with consent and feasibility.1
The study demonstrates that prospective, observational research can be ethically conducted even in critically ill, imminently dying populations.
“We can get consent to do research from the families of comatose, dying patients at the end of life,” says van Beinum. “This area of ICU care has been somewhat neglected by researchers due to hesitation to intrude on a sensitive time.”
This information is important when making policy recommendations about quality end-of-life care in ICU and about organ donation practices. Tia Powell, MD, director of the Montefiore Einstein Center for Bioethics in Bronx, NY, says, “It is not only permissible to do research on patients dying in the ICU — it is required if we hope to improve the circumstances of the deaths of these many thousands of patients.”
Judith Gedney Baggs, PhD, RN, Elizabeth N. Gray distinguished professor at Oregon Health & Science University’s School of Nursing in Portland, has studied end-of-life decision-making in multiple ICUs.2 “We, too, found that families were, in general, willing to consent and to participate,” she says. Baggs heard similar concerns from institutional review boards, which underscored the importance of sensitive wording to avoid upsetting family members.
“When I studied end-of-life decision-making, both nursing and medical staff understood the importance of knowledge to be gained,” adds Baggs. Clinicians enthusiastically offered their assistance and support.
Baggs says the ethical implications of studying dying ICU patients are actually similar to any study involving human subjects. There are obligations to not interfere with care, to explain your purpose, and to inform all involved of what the study entails. Researchers need to do these things, says Baggs: “Assure consenters that they can refuse to answer any questions or withdraw from the study, that patient care will not be affected in any event, and that you recognize the difficult situation they are facing.”
The majority of ICU patients are likely too ill to give consent for research. Therefore, Powell would limit research to those who clearly have decision-making capacity, or have a surrogate who can consent on their behalf.
“Patients in the ICU are extremely vulnerable,” adds Powell. “Research should be of minimal to no risk for patients and families, including emotionally.”
It would still be possible to conduct important research, for instance, by interviewing families after the fact about whether the circumstances of the patient’s death were consistent with his or her values. Powell says the following two questions could be looked at prospectively:
- Was pain adequately controlled, from the perspective of both clinicians and family?
- Did the family feel communications with staff were timely, compassionate, and sufficiently informative?
Critically ill patients may lack decision-making capacity regarding participation in research. Family members may be unable to give consent due to extreme distress over a loved one’s critical illness. “It is ethically important that research in this context protect patients and their family members,” says J. Randall Curtis, MD, MPH, director of Cambia Palliative Care Center of Excellence at UW Medicine in Seattle.
Since critically ill patients often lack the capacity to make decisions about participation in research, researchers often turn to surrogate decision-makers. “If patients regain decisional capacity during the study, it is important to consider whether and how researchers will approach patients to confirm their consent to participate in the research,” notes Curtis.
Anna Nolan, MD, MS, assistant professor of medicine and environmental medicine at NYU School of Medicine in New York City, says a central ethical concern with ICU research is that surrogates’ decisions may be based on views that differ from the patient’s. “Surrogates may not know the subject’s values or preferences in the specific situation being studied,” she adds.3
Curtis says similar principles apply to the conduct of ethical research on critically ill patients, as for research on other serious medical illnesses: “We need to understand and incorporate the vulnerabilities of patients and their family members to coercion.” Avoiding such research simply because it’s a stressful time is not the answer, says Curtis. “This is unethical because it means that patients and their families cannot benefit from attempts to improve the provision of critical care.”
REFERENCES
- Van Beinum A, Hornby L, Dhanani, et al. Feasibility of conducting prospective observational research on critically ill, dying patients in the intensive care unit. Journal of Medical Ethics 2017; 43(1) 47-51.
- Wiegand DL, Norton SA, Baggs J. Challenges in conducting end-of-life research in critical care. AACN Advanced Critical Care 2008; 19(2),170-177.
- Burns KE, Zubrinich C, Tan W, et al. Research recruitment practices and critically ill patients. A multicenter, cross-sectional study (the Consent Study). Am J Respir Crit Care Med 2013; 187(11):1212-1218.
SOURCES
- Judith Gedney Baggs, PhD, RN, Elizabeth N. Gray Distinguished Professor, School of Nursing, Oregon Health & Science University, Portland. Phone: (503) 494-1043. E-mail: [email protected].
- J. Randall Curtis, MD, MPH, Director, Cambia Palliative Care Center of Excellence, University of Washington, Seattle. Phone: (206) 744-3356. Fax: (206) 744-8584. Email: [email protected].
- Anna Nolan, MD, MS, Assistant Professor of Medicine and Environmental Medicine, NYU School of Medicine, New York City. Phone: (212) 263-7283. Fax: (212) 263-8442. Email: [email protected].
- • Tia Powell, MD, Director, Montefiore Einstein Center for Bioethics, Bronx, NY. Phone: (718) 920-4630. Fax: (718) 920-4989. Email: [email protected].
- Amanda van Beinum, MSc. Children’s Hospital of Eastern Ontario Research Institute, Ottawa, Canada. Phone: (613) 737-7600 ext.4007 Email: [email protected].
Research on critically ill, dying ICU patients is ethically feasible, found a recent study which achieved a 95% consent rate for approached families.
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