Current regulations do not include eery group that we might classify as vulnerable. For example, they do not include provisions for approaching the very elderly who may have conditions that would limit their ability to understand the requisite information for giving truly informed consent or that would limit their ability to consent.  Institutionalization of these individuals in nursing and on-age homes may increase the vulnerability of potential subjects. Recent research efforts by the National Institutes of Health with the elderly have produced new mechanisms for securing the consent of subjects. 

Many Different types of subject situations create vulnerabilities. Employment, age, mental capacity, and physical capacity may limit the freedom of choice of potential subjects. So too may association with certain groups, such as the armed forces, municipal law enforcement and fire fighting agencies, the national guard, or the student body or class of an educational institution. In these kinds of cases, the subject’s situation ay contain inherent elements of coercion for which research procedures must compensate in order to protect subject rights.

Many groups of individuals engage in behaviors or activities that make the vulnerable tin respect to research, in some cases because of the illegality of such activities, in other cases because of general social disapproval or debate over the propriety of the behavior. For example, society debates the acceptability of some sexual behaviors (e.g., homosexuality), while others are illegal in most states (e.g., prostitution). In either case, subjects of research into such behaviors or activities are automatically vulnerable. Drug, alcohol, and child abuse may place some subject groups in automatic jeopardy upon inclusion in research.  Research designs must carefully protect the privacy of such subjects. In some cases, there may be requirements to report certain observed illegal behaviors, whether the focus of research or incidental to it.  Researchers must take this fact into account in constructing their protocols and must make potential subjects aware of this fact when inviting their participation in the project. 

Vital research into certain conditions or diseases, such as AIDS, may require the involvement of subjects engaged in behaviors whose expropriate is under social debate. If the research requires by its very nature self-revelation of those behaviors, potential social injury ma follow.  since such research imposes upon individuals, despite its importance, the investigator must carefully design both the study and the approach to subjects to minimize social discomfort to the subject and social injury thereafter. The American Psychological Association has produced an important study, Ethical Issues in Psychological research on AIDS, which provides and exemplary model for dealing not only with the populations concerned with this disease, but as well with other vulnerable subjects. 

No set of rules can cover every research encounter with vulnerable populations. In fact, the vulnerability of populations may shift with social conditions and social values. Consequently, we cannot expect DHHS to enlarge greatly the regulations that set forth procedures for securing consent form and working with vulnerable subject. Perhaps we have models enough to alert us to those areas in which we need to develop sensitivity in designing research. In the final analysis, our commitment to the ethical principles of the Belmont Report, to the provisions of the code of professional ethics governing our research discipline, and to the health and well-being of the potential subjects of our research remain the best guides to working with vulnerable subjects. 




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