The federal regulations require that IRBs give special consideration to protecting the welfare of particularly vulnerable subjects.

Some groups that may need special protections or considerations are

• Children
• Prisoners
• Pregnant women
• Handicapped persons
• Mentally disabled persons
• Economically or educationally disadvantaged persons. 

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.

For more information see subpart sections B,C,D of HHS Regulations 45 CFR 46 or FDA regulation 21 CFR 56.11(b).