Special/Vulnerable Subjects

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:

• Pregnant women
• Human fetuses
• Neonates
• Prisoners
• Children
• 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,
• coercion,
• undue influence, and
• manipulation

A subject or subject group may be considered vulnerable for one or more vulnerable traits that fall into the following types:

• cognitive or communicative,
• institutional,
• deferential,
• medical,
• economic, and
• social

Children/Students as Subjects

Some of the items that may be red flags for research with children/students are:

• Political affiliations or beliefs of the student or the student’s parent.
• Mental or psychological problems of the student or the student’s family.
• Sex behavior or attitudes.
• Illegal, anti-social, self-incriminating, or demeaning behavior.
• Critical appraisals of other individuals with whom respondents have close family relationships.
• Legally recognized privileged or analogous relationships, such as those of lawyers, physicians, and ministers.
• Religious practices, affiliations, or beliefs of the student or the student’s parent.
• Income (other than that required by law to determine eligibility for participation in a program or for receiving financial assistance under such program).

see:
20 U.S.C.
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)

20 USC Title 20 - Education

OHRP Research Involving Children Frequently Asked Questions

FAQs for OHRP research involving children

Research with Prisoners

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. 

Ohio Prisoner Research  

State by State Prison Access Policies from the Society of Professional Journalists