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:
Some of the items that may be red flags for research with children/students are:
United States Code
Title 20 - EDUCATION
CHAPTER 31 - GENERAL PROVISIONS CONCERNING EDUCATION
SUBCHAPTER III - GENERAL REQUIREMENTS AND CONDITIONS CONCERNING OPERATION AND ADMINISTRATION OF EDUCATION PROGRAMS: GENERAL AUTHORITY OF SECRETARY
Part 4 - Records; Privacy; Limitation on Withholding Federal Funds
Sec. 1232h - Protection of pupil rights Especially (c)(1)(B)
For IRB review of research involving prisoners as subjects, the convened IRB must meet the special composition requirements of 45 CFR §46.304 for all types of review of the protocol, including initial review, continuing review, review of protocol amendments, and review of reports of unanticipated problems involving risks to subjects and other matters requiring full IRB attention. The Kenyon College IRB does not normally include a member qualified to represent prisoners, and must amend the board makeup to comply with the composition requirements, or agree to rely on an IRB that does meet the requirements.