Chapter 6 - Special Classes of Subjects -OHRP Guide Book
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:
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:
A subject or subject group may be considered vulnerable for one or more vulnerable traits that fall into the following types: