About This Series
Publication Date: January 2010
minus iconWho Approves Affected Activities?
minus iconForms and Written Statements
minus iconAppendixes
Text Size:   A  |  A |  A |  A
Questions?  Contact OVC TTAC
About This GuideResources

Why Protect Human Subjects?

Why do human subjects need to be protected, and
what federal regulations are in place to protect them?

In social science research, a human subject is a person from whom or about whom you collect information during your assessment or evaluation. For example, a human subject could be a person who fills out a questionnaire or survey, participates in a focus group, or whom you interview. These persons could be service providers, clients, community members, or government representatives.

Research activities involving human subjects raise ethical concerns that should be carefully considered. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research addresses these concerns in the Belmont Report, published in 1979. This report lays out the basic ethical principles of research activities involving human subjects:

  • Respect for persons. Individuals should be treated as autonomous agents, and persons with diminished autonomy are entitled to protection.
  • Beneficence. Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm but also by making efforts to secure their well-being to maximize possible benefits and minimize possible harms that may occur.
  • Justice. The selection of research subjects needs to be scrutinized to determine whether some classes are being systematically selected simply because of their easy availability, their compromised position, or their manipulability rather than for reasons directly related to the problem being studied.

Federal regulations regarding the protection of human subjects in research activities are based on these guiding principles. For the U.S. Department of Justice, these regulations can be found in Title 28 of the Code of Federal Regulations (CFR) in Part 46, “Protection of Human Subjects.” The Office of Justice Programs also has regulations related to privacy and confidentiality of private information, which can be found in Title 28 of the CFR in Part 22, “Protection of Confidentiality of Identifiable Research.” Copies of these regulations are included in appendix A (PDF 92.1 KB). In brief—

  • Part 46, “Protection of Human Subjects,” states in part that human subjects of federally supported research and statistical activities must be protected against undue and unnecessary risks. These regulations, among other things, govern the establishment and operation of Institutional Review Boards (IRBs) to review research designs that involve human subjects. In general, federal funds cannot be used for research involving human subjects unless the research team first seeks IRB approval. However, the regulations include some categories of research that are exempt from this requirement.
  • Part 22, “Protection of Confidentiality of Identifiable Research,” states in part that, if research activities involve the collection, analysis, or use of information identifiable to a private person, these research activities must maintain the confidentiality of this information. Identifiable information can only be used, disclosed, or revealed as authorized.

    Identifiable information is information that is labeled by either a name or other personal identifiers or that can be reasonably interpreted, by virtue of sample size or other factors, as referring to a particular person. This could include Social Security numbers and the names of service providers and clients.