Posted by Al Gordon on January 25, 2000 at 22:45:48:
In Reply to: WHO Xeno Debate posted by Al Gordon on October 08, 1999 at 20:37:29:
WHO EDX January 25, 2000 Volume 6: Number 4
In this posting:
1) E-H. W. Kluge - potential conflict: subject and contacts
In reply to Re-post of Q#6: counseling of potential recipients, it may
be reasonable to suggest that the current guidelines that are in place
in some countries concerning consent to experimentation in general
provide the beginnings of an answer to at least some of the questions
posed.
Specifically, with respect to the question, "How can you counsel
potential candidates and their contacts about risks that are not yet
established? " it would seem reasonable to suggest that the principle of
autonomy provides an answer. That is to say, it is generally accepted
that there are experimental protocols in which the precise level of risk
cannot as yet be quantified, yet the research may go ahead and try to
recruit a subject population because of the potential benefit for
society in general and the experimental subject in particular. Under
those circumstances, the ethically appropriate protocol is to inform the
subject at the very beginning of the recruiting process, prior to
consent being raise in any specific fashion, that there is an as-yet
unquantifiable element of risk involved in the procedure, and then ask
the subject whether, despite this element of uncertainty, he or she
wishes to consider participating.
This approach may be adapted to the present context and formalized into
a dual process where the introductory recruiting and counseling process
itself provides information concerning the nature and level of the
uncertainty that
surrounds the situation, with the requirement that only potential
recipients/significant-others groupings who have reached agreement on
the issue, and have formally indicated this fact, will be included in
the actual consent process. This allows potential subjects to raise the
issue with their significant others (potential contacts) early on in the
process so that any issues that centre lack of adequate information and
in risk to the significant others may be explored prior to engaging the
informed consent process proper. Such a dual process appears justified
by the principle of autonomy - which allows individuals to decide
whether, and under what conditions, they wish to participate in any
procedure - even if that includes conditions of some uncertainty. It
also pays due regard to the fact that recipients are embedded in a
social context that involves potential, as-yet unquantifiable, risk to
third parties.
However, it is at least arguable that the core of the ethical difficulty
does not reside in the element of uncertainty raised by the preceding
tutioristic concern, but in the problematic that obtains if the subject
wishes to participate and her/his significant others (contacts) do not
wish to be exposed to potential risks. Under such circumstances, should
this mean the end of the process - even when the life of the potential
subject of the procedure is at stake?
Eike-Henner W. KLuge
University of Victoria
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