Table 2 Vulnerabilities and corresponding additional ethical protections
Ethical principle | Vulnerability | Additional ethical protection |
|---|---|---|
Autonomy | Inadequate understanding in informed consent | Records of clinical decision-making capacity consulted in lieu of formal research capacity assessments Surrogate consent obtained from SDMs for residents lacking decision-making capacity |
Inadequate voluntariness in informed consent | Informed consent obtained by researchers with LTC facility administrators present, to make clear that participation is voluntary | |
Invasion of privacy | Exposure to the intervention only in common areas Data collection procedures in residents’ bedrooms performed by LTC facility staff, as part of routine care Stakeholder engagement with pre-trial interviews and ongoing newsletters and surveys | |
Welfare | None—the study intervention and data collection procedures pose no more than minimal risk to participants | Not applicable |
Justice | Unjust impact on care of nonparticipants | Gatekeeper permission obtained from LTC facility administrators Stakeholder engagement with pre-trial interviews and ongoing newsletters and surveys |