Vulnerable Populations and Additional Protections
When research involves participants who may face increased risk, diminished capacity for consent, or other vulnerabilities, authors must take extra care to ensure their protection. This includes, but is not limited to, groups such as:
- children/minors
- individuals with impaired decision-making capacity
- pregnant or postpartum women, and fetuses or neonates
- individuals in institutional settings (e.g., prisoners)
- other groups that may be socially, economically, or otherwise disadvantaged or at risk
Authors must clearly describe in the manuscript whether their study population includes such potentially vulnerable individuals and explain what additional safeguards have been put in place to protect their rights, privacy, and welfare — including, when applicable, consent procedures, data protections, and the appropriateness of the risk–benefit balance.
Where international, national, or institutional regulations apply, authors must ensure that all relevant legal and ethical requirements have been followed. If a study involves vulnerable persons, authors should justify why their inclusion is necessary and demonstrate that protections are adequate and compliant with recognized ethical standards.
This section draws in part on guidance from the U.S. National Institutes of Health (NIH) on the inclusion and protection of vulnerable populations in human subjects’ research. Authors are encouraged to consult the NIH resource for additional detail and examples: https://grants.nih.gov/policy-and-compliance/policy-topics/human-subjects/policies-and-regulations/vulnerable-populations.
