The SRA Symposium - College of Medicine

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Additionally, participants and physician-researchers alike contextualize their relationship in ways
that create complex effects. Studies found that participants held tenaciously to the belief that medical
professionals will always act in the best interest of the participant regardless of the wording of
the informed consent document creating a therapeutic misconception (Kusek, et al., 1996; Schron,
Wassertheil-Smoller, & Pressel, 1997; Joffe, et al., 2001; Miller, 2000) and a failure to understand
the ramifications of randomization in their care (Mills, et al., 2003). Physicians validated these
misconceptions by weaving standard doctor-patient language of individual care and hope with researcher-subject
language of generalized knowledge and unknown outcomes (Sankar, 2004; Miller
and Brody, 2003; Vanderpool and Weiss, 1987).
These contextual difficulties in the interpretation of protocols by participants, critics claim, are reflective
of how ethics deliberations fail to account for social context (Sankar, 2004; Pullman, 2002;
Galarneua, 2002). Such criticism has been debated in the bioethics community in recent years
between those who hold a view that universal principles are at the center of moral life and those
who believe communication is at the center (McCarthy, 2003, p. 65). The former belief is generally
labeled principlism; the latter, has become known as narrative ethics.
The Belmont Report’s “three quintessential requirements for ethical conduct in research” (Penslar,
2002, p. 233) are shaped within a principlist framework, a framework that expresses the general
values underlying rules in the common morality, and then function as guidelines for professional
ethics leaving considerable room for judgment (Beauchamp and Childress, 2001, p. 12). In
fact, The Report was specifically designed as a general framework. It states that the principles are
“stated at a level of generalization that should assist scientists, subjects, reviewers and interested
citizens to understand the ethical issues inherent in research involving human subjects.” It goes on
to say that the objective of such a design is to “provide an analytic framework that will guide the
resolution of ethical problems arising from research involving human subjects” (National Commission,
1979). Feminist theorists counter, however, that a principlist framework, with its topdown,
deductive approach, assumes participants share the same experience creating opportunities
for dominant culture to override an individual’s interpretation and values, and interpret them
in homogenized, usually masculine ways (Donchin, 2001; Potts, et al., 2004) that tend to claim
colonial rights over the body of the individual (Wolf, 1996; Frank, 1995; Sharp, 2000; Fan and Tao,
2004).
A narrative ethics approach holds that every moral situation is unique and unrepeatable, and their
meaning cannot be fully captured by appealing to universal principles. Rather, a narrative ethic
recognizes that experiences are embedded in the total narrative of a person’s life. Choices are not
isolated from all else that happens, but are made part of an ongoing narrative. When we make
choices of value and moral judgment we privilege one narrative over another (Nicholas and Gillett,
1997). Borrowing the analytic tools of literary criticism, narrativists claim that careful listening to
an analysis of the “story,” a thorough understanding of the context in which it is analyzed, and a
reflexive critique of our own interpretations as readers identifies the course of moral action that
should be taken (Nicholas and Gillett, 1997; Chambers, 1999).
In the context of IRB deliberations, the framework chosen to guide protocol review has profound
implications on the review process. The principlist approach is not about the actions of the participant.
It is an ethical action guide for medicine, providing the standards of conduct of medical
professionals – “those values, norms, and rules intrinsic to the actual practice of health care”
(Ten Have, 1994, p. 102). As such, the protocol outlines a story that describes what a researcher
is going to do to a participant. The researcher is active; the participant is passive, the recipient of
the actions of the researcher. The task of the IRB reviewer is to assure that the active character, the
researcher, meets the plotline criteria of respect for persons, beneficence and justice.
2005 Symposium Proceedings Book 29