Research Involving Elderly or Terminally Ill Subjects
Elderly & Aged Individuals
It is generally agreed that the elderly are, as a group, heterogenous and not usually in need of special protections, except in two circumstances: cognitive impairment and institutionalization. Under those conditions, the same considerations are applicable as with any other, nonelderly subject in the same circumstances. In the past, persons in nursing homes or other institutions have been selected as subjects because of their easy accessibility. It is now recognized, however, that conditions in institutional settings increase the chances for coercion and undue influence because of the lack of freedom inherent in such situations. Research in these settings should therefore be avoided, unless the involvement of the institutional population is necessary to the conduct of the research.
Points to consider:
- Does the proposed consent process provide mechanisms for determining the adequacy of prospective subjects' comprehension and recall?
- How will subjects' competence to consent be determined?
- Will the research take place in an institutional setting? Has the possibility of coercion and undue influence been sufficiently minimized?
Terminally Ill Individuals
Severe illness often affects a person's competence, and terminally ill patients may be vulnerable to coercion or undue influence because of a real or perceived belief that participation is necessary to receive continuing care from health professionals or because the receipt of any treatment is perceived as preferable to receiving no treatment. Two important reasons for concern regarding research involving terminally ill persons are: (1) they tend to be more vulnerable to coercion or undue influence than healthy adult research subjects; and (2) research involving the terminally ill is likely to present more than minimal risk.
