Justice

The principle of justice as described in the Belmont Report, requires that the benefits and burdens of research be distributed fairly and that there be fair procedures and outcomes in the selection of research subjects. Essentially, subjects should not be selected to participate in risky research because they are disadvantaged and/or vulnerable, nor should they be left out of a study through which they might derive some benefit.

The Belmont Report has been adopted by the University as the statement of ethical principles guiding research with human subjects. The report highlights the following points:

1. Justice of subject selection relates to subjects as individuals and as members of social, racial, sexual, or ethnic groups.
   
2. Justice involves inclusion in studies with likely benefits.
   
3. Care should be taken not to overburden institutionalized persons who are already burdened by their infirmities and environments.
   
4. Subjects should not be selected because they are available or easy to manipulate.
   
5. Social justice indicates an order of preference in selection of classes of subjects (e.g. adults before children).
   
6. Subjects should not be selected because they are held in disdain (e.g. involving “undesirable persons in risky research).
   

Additional Safeguards for Vulnerable Populations

Federal regulations for the protection of human subjects (45 CFR 46) provide additional protections for the use of pregnant women (Subpart B), prisoners (Subpart C), and children (Subpart D). IRBs must include advocates for these populations and must apply additional review criteria when researchers wish to study these populations.

Points for Investigators to Consider

Number of Subjects

• Is the protocol specific about the number of subjects to be recruited?
• If there are risks to subjects, is the number of participants sufficient to yield meaningful results?

Subject Populations

• Are subjects who would benefit from the study excluded? Can the exclusion be justified? For example, studies involving preschool preparation activities for at-risk students in Durham should probably include Spanish speaking staff so as not to exclude the growing Latino population in the area.
• If the study is funded by NIH, exclusions of women, minorities or children MUST be justified.
• Does the nature of the research require or justify using the proposed subject population? The principle of justice requires that subjects not be selected simply because they are available or easy to manipulate.