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The dilemma
A nurse scientist is designing a randomized trial comparing two sedation strategies in mechanically ventilated adults. Most eligible patients are too sedated or too ill to consent when they are enrolled, and the question the trial asks matters most for exactly these patients. Excluding everyone who can't consent would make the research impossible, but enrolling them raises concerns about respect for people who can't speak for themselves. The study is illustrative.
Ethical frameworks
The Belmont Report. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979) set out three principles for research ethics:
- Respect for persons: treating individuals as autonomous agents, and protecting those with diminished autonomy.
- Beneficence: not harming, and maximizing possible benefits while minimizing possible harms.
- Justice: distributing the burdens and benefits of research fairly.
The dilemma sits mostly between respect for persons and justice. Respect for persons calls for extra protection of patients who can't consent; justice warns against excluding critically ill patients from research that could improve their care.
Emanuel et al.'s (2000) seven requirements. The authors argue that informed consent alone neither makes research ethical nor is always necessary, and propose seven requirements: social or scientific value, scientific validity, fair subject selection, a favorable risk–benefit ratio, independent review, informed consent and respect for enrolled subjects.
Applying the requirements
| Requirement | Application to the sedation trial |
|---|---|
| Value | Sedation practice affects ventilator days, delirium and survival; the question is important |
| Validity | The trial must be adequately powered and well designed, since exposing patients to a poorly designed study can't be justified |
| Fair subject selection | Eligibility based on the scientific question, not on who is easy to recruit; avoiding the exclusion of non-English speakers |
| Favorable risk–benefit ratio | Both strategies are within usual practice, so added risk is limited; monitoring for oversedation and agitation |
| Independent review | Approval by an institutional review board and a data and safety monitoring board |
| Informed consent | Consent from a legally authorized representative, and the patient's own consent as soon as they regain capacity |
| Respect for enrolled subjects | Confidentiality, monitoring of well-being and the right to withdraw at any time, by the patient or the representative |
The regulatory framework
US federal regulations for the protection of human subjects (45 C.F.R. part 46) permit consent to be obtained from a legally authorized representative when a subject cannot consent. Who counts as a legally authorized representative depends on state law, so the protocol must define it for the study's location.
Resolution
Enrolling patients who can't consent is ethically justifiable here if all seven requirements are met. The nurse scientist should:
- Seek consent from a legally authorized representative before enrollment, explaining that the representative's role is to decide as the patient would.
- Reassess each patient's capacity daily and seek their own consent once they are able, respecting a decision to withdraw.
- Ask the institutional review board to review the study's protections for patients who lack capacity.
- Explain the study clearly to bedside nurses, who are often the ones families ask about research.
The role of the clinical nurse
Bedside nurses advocate for patients in research. They can raise concerns if a family seems pressured, if a patient regains capacity and isn't asked, or if a protocol conflicts with the patient's comfort.
References
Emanuel, E. J., Wendler, D., & Grady, C. (2000). What makes clinical research ethical? JAMA, 283(20), 2701–2711. https://doi.org/10.1001/jama.283.20.2701
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. U.S. Department of Health and Human Services. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html
Protection of Human Subjects, 45 C.F.R. pt. 46 (2018). https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46
