Clearly, scientific investigation has extended and enhanced the quality of life and increased our understanding of ourselves, our relationships with others, and the natural world. It is one of the foundations of our society's material, intellectual, and social progress. For many citizens, scientific discoveries have alleviated the suffering caused by disease or disability. Nonetheless, the prospect of gaining such valuable scientific knowledge need not and should not be pursued at the expense of human rights or human dignity.
National Bioethics Advisory Commission, 2001
Human Subjects Protection
Research involving vulnerable persons, such as persons who are unable to provide informed consent or who may be socially marginalized, are of special concern. Ethical principles and federal as well as state laws compel investigators and research institutions to provide these persons with additional protection when they are involved as subjects in research.
Decisionally impaired persons
Persons who may be unable to make decisions about taking part as human subjects in research represent a vulnerable population group in terms of research, based primarily upon the fact that their informed consent is inherently dubious or impossible. In some research contexts consent of these subjects may be waived or obtained from surrogates ("legally authorized representatives"), but the appropriateness or effectiveness of surrgate consent for research is the subject of much debate. Learn more about surrogate consent and decisional impairment in research here . . .
Socially marginalized populations
We have conducted prior NIH-funded studies to better understand the nature of prisoners’ vulnerabilities as subjects, and to train investigators to address and minimize related risks. Based upon these projects, we developed a special reference guide for clinical investigators. To find out more or to access these resources, visit our Prisoners as Human Subjects resource page.
NEW! from the National Academies & Institute of Medicine