of Ethics Online Collection: None
Resolustion on Biomedical Experimentation in the Institutional Setting: Suggestion for Protection of "Captive" Populations
In recent years increased attention has been given to the
rights of subjects in biomedical experimentation Missing
from these discussions. however, has
been a response to the special problems of research conducted upon institutionalized
or other "captive" populations.
The perception of convicts those in mental hospitals, institutionalized juvenile
delinquents, and other captive populations has in the past lead to the exploitation
of these populations for research purposes. There has been relatively little
concern about the impact of research upon the health status, psychological
or physiological, of the subjects.
Further, little attention has been given to the issue of
subtle coercion of captive populations for research. Voluntary
participation in research takes
on a new meaning in the grim and austere surroundings of institutional life.
The bleak surroundings may lead persons to volunteer for medical experimentation
simply to break the monotony, or to enjoy the advantage, of the more tastefully
decorated physical environment of the medical ward, or the superior food served
there. A subtle coercion may also operate in terms of the perception by the
subjects of "pleasing the keepers. " In the mental hospital, questions
arise as to the nature of informed consent when those involved as subjects
may not have the necessary understanding of the proposed research to truly
give their informed consent.
Because of the unavoidability of exploitation of captive subjects biomedical
experimentation must be severely limited and, where conducted, the review process
for such experimentation must include a closer attention to the requirements
set forth by the Department of Health, Education. and Welfare, and its Food
and Drug Administration. This includes a monitoring of ongoing research for
altered research plans, or other changed circumstances, in addition to the
review of research protocols. Such monitoring of ongoing research would help
to avoid a repetition of experiences of the Tuskegee Study, where penicillin
was withheld from the subjects long after it became the accepted cure for syphilis
.
APHA urges DHEW to review its policies and to adopt the principles enunciated
below.
1. Biomedical research will be conducted upon members of a live population
only if the research design is such that a captive population will be made
by the Committee on Human Subjects Research of the proposed institution, and
not by the investigator.
2. Committees on Human Subject Research in institutional settings will follow
the most current guidelines by the Food and Drug Administration and or the
Department of Health, Education, and, Welfare relating to this question. and
will be composed, in addition to the membership of representatives of the proproposed
subject population, and non-institutionally affiliated professionals selected
by the subjects and other appropriate citizens from the community at large.
3. The question of informed consent should be followed to the letter and will
be strengthened by including the principles listed below:
A. Prospective participants should be informed or the sources of funding of
the experiment and of the purposes to which the results of the experimentation
will be put (to the extent these are known at the time).
B. Participants should be informed of the existence of the Committee on Human
Subjects Research and invited to communicate with if regarding any concerns
arising out of their involvement in the experiment.
C. Participants should be informed concerning changed circumstances, including
heretofore unknown side effects or cures for their particular ailments.
