The SRA Symposium - College of Medicine

Papers
The narrative approach, on the other hand, “seeks to contextualize and particularize the conflicts”
and “seeks to recognize the narrative coherence, however obscured, of the patient’s life” (Charon,
1994, p. 261). In this approach, the IRB member faces narrative tasks in identifying the multiple
tellers of the story – the sponsor, the protocol writers, the researchers, the administrative and legal
editors, and the multiple readers – the IRB, the potential participant, and the public. Additionally,
in that vein, they must address the contradictions among the story’s multiple plotlines, conflicts
among tellers and listeners, and the ambiguities of the projected events. All characters in the story
are now active, producing a different rendering of respect for persons, beneficence and justice.
The standard language contained in the informed consent document assures the participant
that withdrawal from a study is possible at any time without consequences. Within a principlist
framework, such language adequately meets the criteria of autonomy. The active character offers
the passive character an opportunity to act, a choice to withdraw. Within a narrativist framework,
contextualizing the interaction and rendering all characters active, the participant’s world beyond
the protocol is recognized. Once the experimental agent is injected or consumed, the categories
of the participant’s body dysfunction and disintegration defined, the inflections and gestures of
prognosis insinuated, the effects are irretrievable. They are now a permanent part of the lived experience
of the participant, complete with its unknown consequences and complications, positive
and negative, to the personal identity and body of the participant. Within a principlist framework,
which is decontextualized, recognizing only the actions of the researcher in an atemporal setting,
autonomy is real and satisfied using the standard language of withdrawal. Within a narrativist
framework, which is contextual, recognizing the actions of the researcher and the participant and
temporally situated, autonomy is an illusion and unsatisfied. It becomes clear that the participant
has enrolled in the Hotel California clinical trial. She can check out from the clinical trial anytime
she likes, but she can never leave.
Participants, plotted as the passive characters, may not choose what study drugs they want to
experiment with or when. They may not choose what diagnostics should be used on their bodies.
They may not choose when they meet with the study physician or learn the progress, or lack
thereof, of the study drugs. Participants may not choose which “adverse events” are adverse, the
meaning of symptoms, remission or cure. They are discouraged from discussing their experience
with other participants in the same trial. Because of the rules of study disclosure, they may never
know whether their participation in the study was meaningful or contributed to the greater good
of society. If there is no opportunity for choice - the expression of value and preference, no opportunity
for communication – the negotiation or clarification of needs, desires and motivations,
on what information does beneficence, “in the best interest of the participant,” by the researcher or
IRB reviewer rest?
In the absence of contextual information, whose values do IRB members use to evaluate the
ethical principles? Do IRB members share uniform definitions of autonomy, physical or mental
integrity, and respect for privacy, risk, benefit or what it means to be adequately informed with
the participants they are entrusted to protect? Do IRB members conceptualize participants as
homogenous or diverse in their interests and motivations? Are the principles uniformly applied
by all IRB members to all participants regardless of trial or disease process and more importantly,
should they be? How might consideration of their own contextual assumptions safeguard respect
for persons, beneficence, and justice?
30 2005 Symposium Proceedings Book