The federal regulations require that IRBs give special consideration to protecting the welfare of particularly vulnerable subjects, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
Though there are no federal regulations that provide explicit protections for Students and Employees, the involvement of students and employees may present special concerns.
Some groups that may need special protections or considerations are:
- Pregnant women
- Human fetuses
- Individuals with physical disabilities
- Individuals with mental disabilities or cognitive impairments
- Economically disadvantaged
- Socially disadvantaged
- Terminally ill or very sick
- Racial or ethnic minorities
- Institutionalized persons (for example, persons in correctional facilities, nursing homes or mental health facilities)
Individuals in these groups may be considered potentially vulnerable because they may not be able to make informed decisions for themselves, they may be in situations in which they can easily be manipulated, or they may be a convenient and readily available study population.
Four common types of abuses in human research are:
- physical control
- undue influence
A subject or subject group may be considered vulnerable for one or more vulnerable traits that fall into the following types:
- cognitive or communicative