Table 3.

Summary of vulnerabilities and additional protections illustrated in the example studies.

Principle	Wrong	Example	Additional protection
Respect for persons	Inadequate understanding in informed consent	Informed consent is sought from PLWD who lack decision-making capacity	Formal capacity assessments Surrogate consent from substitute decision-makers (e.g., family caregivers or government-affiliated agents) Participant assent
	Inadequate voluntariness in informed consent	PLWD feel as though they must participate in research when approached by LTC staff	Employ researchers with no affiliation to the LTC home to seek informed consent Patient advocates to ensure that prospective research participants understand that participation is voluntary
	Invasion of privacy	Direct observation of PLWD by research personnel during baths	Utilize well-trained LTC home staff as research partners for data collection Stakeholder engagement (e.g., LTC home staff, management, residents, and family caregivers)
Beneficence	Risks of therapeutic procedures are high compared to potential benefits	Physically frail individual in a trial of a group exercise intervention	Additional supervision during exercise sessions
	Risks of non-therapeutic procedures are not minimized consistent with sound scientific design	Distress while filling out questionnaire for data collection	Researcher supervision during data collection Family caregivers or familiar LTC home staff to complete questionnaire by proxy
Justice	Unjust impact on care	Non-participant exposure to research procedures	Gatekeeper permission from LTC home administrators