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Human Subjects

The opportunity to conduct research using human subjects is a professional privilege. With that privilege comes responsibilities. The most basic of these responsibilities is to recognize that research has the potential to harm its subjects, directly or indirectly, and to strive to minimize that potential. Harm may be social, psychological, financial, or physical. In addition to the research subject, individuals discussed in a study, investigators, society, and institutions sponsoring research may be subject to harm. Research can never be free from risk, but, as professionals, investigators and other key personnel on a study must be aware of risks and work to minimize them.

During the 20th century, national and international researchers undertook a number of studies with human subjects that appalled their peers, and society more broadly. In response to these projects and the controversy they generated, governments have established ethical standards for the involvement of humans as subjects in research. In the United States, the federal government has established an extensive process to ensure ethical treatment of human subjects.
Projects that led to the reassessment of the involvement of human subjects in research and increased regulation include:

  • Medical research supported by Nazi Germany
  • The U.S. Public Health Service study of untreated syphilis
  • Stanley Milgram's psychological studies of obedience to authority

What Rules Apply?

Ethical Principles

The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, published in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, provides the philosophical underpinnings for current federal laws that govern research involving human subjects. The commission set out three basic principles:

  • Respect for persons
  • Beneficence
  • Justice

he principle of respect for persons simultaneously requires that researchers treat most people as autonomous and protect people with reduced autonomy. Treating someone as autonomous means recognizing that the person can and should freely make decisions and that researchers must respect these decisions. The concept implies that investigators must provide information to potential subjects of research so that they can truly make free decisions about participation. In practice, this principle leads researchers to focus on obtaining informed consent from research participants.

The concept of beneficence holds that researchers should maximize the benefits of research and minimize any potential harm. Beneficence requires that researchers seek a balance between benefit and harm and between individuals and society.

The principle of justice holds that the risks of participating in research and the beneficial results of research should be distributed fairly across both the groups to which research subjects belong and the larger society.

Federal Regulations

The current U.S. federal policy on protecting human subjects in research comes from the Department of Health and Human Services (DHHS) and is codified as title 45, part 46 of the Code of Federal Regulations (45 CFR 46). This policy, also know as the Common Rule, defines human subject research and provides detailed requirements for the protection of human research participants for federally funded institutions. It establishes:

  • A definition of human subjects
  • A definition of research
  • Agreements between research institutions and the federal government to uphold the Common Rule
  • Peer bodies to review and approve research involving people (Institutional Review Boards or IRBs)
  • Procedures for submitting research for review and approval
  • Information that must be disclosed to potential participants in order to obtain informed consent
  • Additional protections for special populations including children, persons with disabilities, prisoners and other institutionalized individuals, fetuses, pregnant women, and individuals who are likely to be vulnerable to coercion or undue influence, including University students or employees

The federal Health Insurance Portability and Accountability Act (HIPAA) has provisions to protect the privacy of medical records, and HIPAA can apply to human subjects research. For information on HIPAA, see the University of Maryland College Park HIPAA website.

University Policies

If you engage in human subjects research at the University of Maryland College Park, you will be required to complete on-line human subjects training and the research must be conducted according to an IRB approved human subjects protocol.

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