The selection of subjects must be fair. Social justice requires that distinction be drawn between classes of subjects that ought, and ought not, to participate in any particular kind of research, based on the ability of members of that class to bear burdens and on the appropriateness of placing further burdens on already burdened persons. One special instance of injustice results from the involvement of vulnerable subjects. Certain groups, such as racial minorities, the economically disadvantaged, the very sick, and the institutionalized may continually be sought as research subjects, owing to their ready availability in settings where research is conducted. Given their dependent status and their frequently compromised capacity for free consent, they should be protected against the danger of being involved in research solely for administrative convenience, or because they are easy to manipulate as a result of their illness or socioeconomic condition.
Consent is required.
See page 20 for more details. It is permissible for an investigator to perform a chart or record review to obtain names and other identifying information for recruiting purposes. When a patient enters the teaching institutions for care, the standard release form states that records may be used for research purposes. Recruitment should be in a sensitive manner and the source of the information should be identified. For most studies, it is appropriate to include the primary physician or caretaker in the communication link with the patient.